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A Study of the Efficacy and Safety of Albiglutide in Subjects With Type 2 Diabetes With Renal Impairment.

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
albiglutide
sitagliptin
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring sitagliptin, albiglutide, renal impairment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Renally impaired with a historical diagnosis of type 2 diabetes mellitus and is experiencing inadequate glycemic control on their current regime of diet and exercise or their antidiabetic therapy of metformin, TZD, SU, or any combination of these oral antidiabetic medications
  • BMI >/=20 kg/m2 and </=45 kg/m2
  • Fasting C-peptide >/=0.8 ng/mL (>/=0.26 nmol/L)
  • HbA1c between 7.0% and 10.0%, inclusive.

Exclusion Criteria:

  • History of cancer
  • History of treated diabetic gastroparesis
  • Current biliary disease or history of pancreatitis
  • History of significant gastrointestinal surgery
  • Recent clinically significant cardiovascular and/or cerebrovascular disease
  • History of human immunodeficiency virus infection
  • Abnormal liver function or acute symptomatic infection with hepatitis B or hepatitis C
  • Female subject is pregnant (confirmed by laboratory testing), lactating, or <6 weeks postpartum
  • Known allergy to any GLP 1 analogue, sitagliptin, other study medications' excipients, excipients of albiglutide, or Baker's yeast
  • Receipt of any investigational drug or sitagliptin within the 30 days or 5 half lives, whichever is longer, before Screening or a history of receipt of an investigational antidiabetic drug within the 3 months before randomization or receipt of albiglutide in previous studies

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

albiglutide

sitagliptin

Arm Description

albiglutide weekly subcutaneous injection + sitagliptin matching placebo

albiglutide matching placebo + sitagliptin

Outcomes

Primary Outcome Measures

Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26
HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline in HbA1c was calculated as the value at Week 26 minus the value at Baseline. The analysis was performed using an Analysis of Covariance (ANCOVA) model with treatment group, region, history of prior myocardial infarction (yes versus no), and age category (<65 years versus >=65 years) as factors and Baseline HbA1c as a continuous covariate. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.

Secondary Outcome Measures

Mean Change From Baseline in HbA1c at Weeks 4, 8, 12, 16, and 20: LOCF
HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline in HbA1c was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. Participants were analyzed in a particular treatment week if they had received at least one dose in that treatment week.
Mean Change From Baseline in HbA1c at Weeks 4, 8, 12, 16, 20, 26, 36, 48, and Week 52: Observed Cases
HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline in HbA1c was calculated as the post-Baseline value minus the Baseline value. The Observed Cases (OC) method (no imputation of missing data) was used. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. Participants were analyzed in a particular treatment week if they had received at least one dose in that treatment week.
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26
The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is define as the last non-missing value before the start of treatment. Change from Baseline in FBG was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. Participants were analyzed in a particular treatment week if they had received at least one dose in that treatment week. Based on ANCOVA: Change = treatment + Baseline FPG + renal impairment + prior myocardial infarction history + age category + region.
Mean Change From Baseline in FPG at Weeks 4, 8, 12, 16, 20, and 26: LOCF
The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline in FBG was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. Participants were analyzed in a particular treatment week if they had received at least one dose in that treatment week.
Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 1, 2, 3, 4, 8, 12, 16, 20, 26, 36, 48, and Week 52: OC
The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is defined as the last non-missing value prior to treatment. Change from Baseline in FBG was calculated as the post-Baseline value minus the Baseline value. The OC method (no imputation of missing data) was used. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. Participants were analyzed in a particular treatment week if they had received at least one dose in that treatment week.
Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5% and <7.0% at Week 26: LOCF
The number of participants who acheieved the HbA1c treatment goal (i.e., the number of participants who achieved HbA1c <7% and <6.5% at Week 26) was assessed. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.
Number of Participants Who Achieved a Clinically Meaningful Improvement in the HbA1c Response Level of >=1.0%, >=1.5%, and >=2.0% at Week 26: LOCF
The number of participants who a clinically meaningful improvement from Baseline in the HbA1c response level of >=1.0%, >=1.5%, and >=2.0% at Week 26 were assessed. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.
Number of Participants Who Achieved a Clinically Meaningful HbA1c Response Level of <6.5% and <7.0% at Week 52: OC
The number of participants who acheieved the HbA1c treatment goal (i.e., number of participants who achieved HbA1c <7% and <6.5% at Week 26) was assessed. The OC method (no imputation of missing data) was used. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.
Number of Participants Who Achieved a Clinically Meaningful Improvement in the HbA1c Response Level of >=1.0%, >=1.5%, and >=2.0% at Week 52: OC
The number of participants who a clinically meaningful improvement from Baseline in the HbA1c response level of >=1.0%, >=1.5%, and >=2.0% at Week 52 assessed. The OC method (no imputation of missing data) was used. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.
Number of Participants With the Indicated Time to Hyperglycemic Rescue Through Week 52
Hyperglycemic rescue was defined as meeting one of the following criteria, confirmed by a second sample drawn within 7 days and analyzed by the central laboratory: for the Week 2 to Week 4 visit, a single FPG value >=280 milligrams per deciliter (mg/dL); for the >Week 4 and <Week 12 visits, a single FPG value >=250 mg/dL and previous titration for >=4 weeks; for the >=Week 12 and <Week 26 visits, HbA1c >=8.5% and a <=0.5% reduction from Baseline and previous titration for >=4 weeks; for the >=Week 26 and <Week 48 visits, HbA1c >=8.5% and previous titration for >=4 weeks; for the >=Week 48 and <Week 52 visits, HbA1c >=8.0% and previous titration for >=4 weeks. Time to hyperglycemia rescue is the time between the date of first dose and the date of hyperglycemia rescue plus 1 day, or the time between the date of first dose and the date of last visit during active treatment period plus 1 day for participants not requiring rescue.
Time to Hyperglycemic Rescue Through Week 52
Hyperglycemic rescue was defined as meeting one of the following criteria, confirmed by a second sample drawn within 7 days and analyzed by the central laboratory: for the Week 2 to Week 4 visit, a single FPG value >=280 milligrams per deciliter (mg/dL); for the >Week 4 and <Week 12 visits, a single FPG value >=250 mg/dL and previous titration for >=4 weeks; for the >=Week 12 and <Week 26 visits, HbA1c >=8.5% and a <=0.5% reduction from Baseline and previous titration for >=4 weeks; for the >=Week 26 and <Week 48 visits, HbA1c >=8.5% and previous titration for >=4 weeks; for the >=Week 48 and <Week 52 visits, HbA1c >=8.0% and previous titration for >=4 weeks. Time to hyperglycemia rescue is the time between the date of first dose and the date of hyperglycemia rescue plus 1 day, or the time between the date of first dose and the date of last visit during active treatment period plus 1 day for participants not requiring rescue. This time is divided by 7 to express the result in weeks.
Change From Baseline in Body Weight at Week 26: LOCF
Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The Baseline weight value is defined as the last non-missing value prior to treatment. This analysis used the LOCF method for missing post-Baseline weight values. Weight values obtained after hyperglycemia rescue werre treated as missing and were replaced with pre-rescue values. Based on ANCOVA: Change = treatment + Baseline weight + renal impairment + prior myocardial infarction history + age category + region.
Change From Baseline in Body Weight Through Week 26: LOCF
Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The Baseline weight value is defined as the last non-missing value prior to treatment. This analysis used the LOCF method for missing post-Baseline weight values. Weight values obtained after hyperglycemia rescue werre treated as missing and were replaced with pre-rescue values.
Change From Baseline in Body Weight Through Week 52: OC
Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The Baseline weight value is defined as the last non-missing value prior to treatment. This analysis used observed weight values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.
Plasma Concentrations (Conc.) of Albiglutide at Week 8 and Week 16
Sparse population pharmacokinetic (PK) data were collected for population PK and PK/pharmacodynamic (PD) analyses. Participants (par.) who received albiglutide were initiated on a 30 mg weekly dosing regimen. Beginning at Week 4, uptitration of albiglutide was allowed based on glycemic parameters. As such, albiglutide plasma conc. achieved at each sampling time represent a mixed population of par. who received either 30 mg or 50 mg weekly for various durations. The PK and PK/PD of albiglutide were characterized using a population modeling approach. Mean albiglutide plasma conc. observed at Weeks 8 and 16 are presented. Par. came to the clinic at Weeks 8 and 16 without taking albiglutide/matching placebo. The pre-dose PK sample was taken immediately prior to dosing. The Week 8 post-dose sample was taken between Weeks 8 and 10, >=2 days after a dose of medication. The Week 16 post-dose PK sample was taken any time between Weeks 16 and 20, >=2 days after the previous dose of albiglutide.

Full Information

First Posted
April 1, 2010
Last Updated
January 16, 2017
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT01098539
Brief Title
A Study of the Efficacy and Safety of Albiglutide in Subjects With Type 2 Diabetes With Renal Impairment.
Official Title
A Randomized, Double-Blind, Active-Controlled, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of Albiglutide as Compared With Sitagliptin in Subjects With Type 2 Diabetes Mellitus With Renal Impairment
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This randomized, double-blind, active-controlled study evaluates the efficacy and safety of a weekly dose of albiglutide as compared with sitagliptin. Subjects who are renally impaired with a historical diagnosis of type 2 diabetes mellitus and whose glycemia is inadequately controlled on their current regimen of diet and exercise or their antidiabetic therapy of metformin, thiazolidinedione, sulfonylurea, or any combination of these oral antidiabetic medications will be recruited into the study.
Detailed Description
This randomized, double-blind, active-controlled, 2 parallel-group, multicenter study evaluates the efficacy and safety of a weekly subcutaneously injected dose of albiglutide as compared with sitagliptin. Subjects who are renally impaired with a historical diagnosis of type 2 diabetes mellitus and whose glycemia is inadequately controlled on their current regimen of diet and exercise or their antidiabetic therapy of metformin, thiazolidinedione, sulfonylurea, or any combination of these oral antidiabetic medications will be recruited into the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
sitagliptin, albiglutide, renal impairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
507 (Actual)

8. Arms, Groups, and Interventions

Arm Title
albiglutide
Arm Type
Active Comparator
Arm Description
albiglutide weekly subcutaneous injection + sitagliptin matching placebo
Arm Title
sitagliptin
Arm Type
Active Comparator
Arm Description
albiglutide matching placebo + sitagliptin
Intervention Type
Biological
Intervention Name(s)
albiglutide
Intervention Description
albiglutide weekly subcutaneous injection + sitagliptin matching placebo
Intervention Type
Drug
Intervention Name(s)
sitagliptin
Intervention Description
albiglutide matching placebo + sitagliptin (25mg, 50mg or 100mg depending on level of renal impairment)
Primary Outcome Measure Information:
Title
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26
Description
HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline in HbA1c was calculated as the value at Week 26 minus the value at Baseline. The analysis was performed using an Analysis of Covariance (ANCOVA) model with treatment group, region, history of prior myocardial infarction (yes versus no), and age category (<65 years versus >=65 years) as factors and Baseline HbA1c as a continuous covariate. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.
Time Frame
Baseline; Week 26
Secondary Outcome Measure Information:
Title
Mean Change From Baseline in HbA1c at Weeks 4, 8, 12, 16, and 20: LOCF
Description
HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline in HbA1c was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. Participants were analyzed in a particular treatment week if they had received at least one dose in that treatment week.
Time Frame
Baseline; Weeks 4, 8, 12, 16, and 20
Title
Mean Change From Baseline in HbA1c at Weeks 4, 8, 12, 16, 20, 26, 36, 48, and Week 52: Observed Cases
Description
HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline in HbA1c was calculated as the post-Baseline value minus the Baseline value. The Observed Cases (OC) method (no imputation of missing data) was used. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. Participants were analyzed in a particular treatment week if they had received at least one dose in that treatment week.
Time Frame
Baseline; Weeks 4, 8, 12, 16, 20, 26, 36, 48, and 52
Title
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26
Description
The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is define as the last non-missing value before the start of treatment. Change from Baseline in FBG was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. Participants were analyzed in a particular treatment week if they had received at least one dose in that treatment week. Based on ANCOVA: Change = treatment + Baseline FPG + renal impairment + prior myocardial infarction history + age category + region.
Time Frame
Baseline; Week 26
Title
Mean Change From Baseline in FPG at Weeks 4, 8, 12, 16, 20, and 26: LOCF
Description
The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline in FBG was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. Participants were analyzed in a particular treatment week if they had received at least one dose in that treatment week.
Time Frame
Baseline; Weeks 4, 8, 12, 16, 20, and 26
Title
Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 1, 2, 3, 4, 8, 12, 16, 20, 26, 36, 48, and Week 52: OC
Description
The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is defined as the last non-missing value prior to treatment. Change from Baseline in FBG was calculated as the post-Baseline value minus the Baseline value. The OC method (no imputation of missing data) was used. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. Participants were analyzed in a particular treatment week if they had received at least one dose in that treatment week.
Time Frame
Baseline; Weeks 1, 2, 3, 4, 8, 12, 16, 20, 26, 36, 48, Week 52
Title
Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5% and <7.0% at Week 26: LOCF
Description
The number of participants who acheieved the HbA1c treatment goal (i.e., the number of participants who achieved HbA1c <7% and <6.5% at Week 26) was assessed. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.
Time Frame
Week 26
Title
Number of Participants Who Achieved a Clinically Meaningful Improvement in the HbA1c Response Level of >=1.0%, >=1.5%, and >=2.0% at Week 26: LOCF
Description
The number of participants who a clinically meaningful improvement from Baseline in the HbA1c response level of >=1.0%, >=1.5%, and >=2.0% at Week 26 were assessed. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.
Time Frame
Week 26
Title
Number of Participants Who Achieved a Clinically Meaningful HbA1c Response Level of <6.5% and <7.0% at Week 52: OC
Description
The number of participants who acheieved the HbA1c treatment goal (i.e., number of participants who achieved HbA1c <7% and <6.5% at Week 26) was assessed. The OC method (no imputation of missing data) was used. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.
Time Frame
Week 52
Title
Number of Participants Who Achieved a Clinically Meaningful Improvement in the HbA1c Response Level of >=1.0%, >=1.5%, and >=2.0% at Week 52: OC
Description
The number of participants who a clinically meaningful improvement from Baseline in the HbA1c response level of >=1.0%, >=1.5%, and >=2.0% at Week 52 assessed. The OC method (no imputation of missing data) was used. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.
Time Frame
Week 52
Title
Number of Participants With the Indicated Time to Hyperglycemic Rescue Through Week 52
Description
Hyperglycemic rescue was defined as meeting one of the following criteria, confirmed by a second sample drawn within 7 days and analyzed by the central laboratory: for the Week 2 to Week 4 visit, a single FPG value >=280 milligrams per deciliter (mg/dL); for the >Week 4 and <Week 12 visits, a single FPG value >=250 mg/dL and previous titration for >=4 weeks; for the >=Week 12 and <Week 26 visits, HbA1c >=8.5% and a <=0.5% reduction from Baseline and previous titration for >=4 weeks; for the >=Week 26 and <Week 48 visits, HbA1c >=8.5% and previous titration for >=4 weeks; for the >=Week 48 and <Week 52 visits, HbA1c >=8.0% and previous titration for >=4 weeks. Time to hyperglycemia rescue is the time between the date of first dose and the date of hyperglycemia rescue plus 1 day, or the time between the date of first dose and the date of last visit during active treatment period plus 1 day for participants not requiring rescue.
Time Frame
Week 2 to Week 52
Title
Time to Hyperglycemic Rescue Through Week 52
Description
Hyperglycemic rescue was defined as meeting one of the following criteria, confirmed by a second sample drawn within 7 days and analyzed by the central laboratory: for the Week 2 to Week 4 visit, a single FPG value >=280 milligrams per deciliter (mg/dL); for the >Week 4 and <Week 12 visits, a single FPG value >=250 mg/dL and previous titration for >=4 weeks; for the >=Week 12 and <Week 26 visits, HbA1c >=8.5% and a <=0.5% reduction from Baseline and previous titration for >=4 weeks; for the >=Week 26 and <Week 48 visits, HbA1c >=8.5% and previous titration for >=4 weeks; for the >=Week 48 and <Week 52 visits, HbA1c >=8.0% and previous titration for >=4 weeks. Time to hyperglycemia rescue is the time between the date of first dose and the date of hyperglycemia rescue plus 1 day, or the time between the date of first dose and the date of last visit during active treatment period plus 1 day for participants not requiring rescue. This time is divided by 7 to express the result in weeks.
Time Frame
Week 2 to Week 52
Title
Change From Baseline in Body Weight at Week 26: LOCF
Description
Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The Baseline weight value is defined as the last non-missing value prior to treatment. This analysis used the LOCF method for missing post-Baseline weight values. Weight values obtained after hyperglycemia rescue werre treated as missing and were replaced with pre-rescue values. Based on ANCOVA: Change = treatment + Baseline weight + renal impairment + prior myocardial infarction history + age category + region.
Time Frame
Baseline; Week 26
Title
Change From Baseline in Body Weight Through Week 26: LOCF
Description
Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The Baseline weight value is defined as the last non-missing value prior to treatment. This analysis used the LOCF method for missing post-Baseline weight values. Weight values obtained after hyperglycemia rescue werre treated as missing and were replaced with pre-rescue values.
Time Frame
Baseline; Week 1, Week 2 , Week 3, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 26
Title
Change From Baseline in Body Weight Through Week 52: OC
Description
Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The Baseline weight value is defined as the last non-missing value prior to treatment. This analysis used observed weight values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.
Time Frame
Baseline; Week 1, Week 2 , Week 3, Week 4, Week 8, Week 12, Week 16, Week 20, Week 26, Week 36, Week 48, and Week 52
Title
Plasma Concentrations (Conc.) of Albiglutide at Week 8 and Week 16
Description
Sparse population pharmacokinetic (PK) data were collected for population PK and PK/pharmacodynamic (PD) analyses. Participants (par.) who received albiglutide were initiated on a 30 mg weekly dosing regimen. Beginning at Week 4, uptitration of albiglutide was allowed based on glycemic parameters. As such, albiglutide plasma conc. achieved at each sampling time represent a mixed population of par. who received either 30 mg or 50 mg weekly for various durations. The PK and PK/PD of albiglutide were characterized using a population modeling approach. Mean albiglutide plasma conc. observed at Weeks 8 and 16 are presented. Par. came to the clinic at Weeks 8 and 16 without taking albiglutide/matching placebo. The pre-dose PK sample was taken immediately prior to dosing. The Week 8 post-dose sample was taken between Weeks 8 and 10, >=2 days after a dose of medication. The Week 16 post-dose PK sample was taken any time between Weeks 16 and 20, >=2 days after the previous dose of albiglutide.
Time Frame
Week 8 Pre-dose (immediately prior to dose), Week 8 Post-dose (at least 2 days after a dose of medication), Week 16 Pre-dose (immediately prior to dose), and Week 16 Post-dose (at least 2 days after previous dose of albiglutide)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Renally impaired with a historical diagnosis of type 2 diabetes mellitus and is experiencing inadequate glycemic control on their current regime of diet and exercise or their antidiabetic therapy of metformin, TZD, SU, or any combination of these oral antidiabetic medications BMI >/=20 kg/m2 and </=45 kg/m2 Fasting C-peptide >/=0.8 ng/mL (>/=0.26 nmol/L) HbA1c between 7.0% and 10.0%, inclusive. Exclusion Criteria: History of cancer History of treated diabetic gastroparesis Current biliary disease or history of pancreatitis History of significant gastrointestinal surgery Recent clinically significant cardiovascular and/or cerebrovascular disease History of human immunodeficiency virus infection Abnormal liver function or acute symptomatic infection with hepatitis B or hepatitis C Female subject is pregnant (confirmed by laboratory testing), lactating, or <6 weeks postpartum Known allergy to any GLP 1 analogue, sitagliptin, other study medications' excipients, excipients of albiglutide, or Baker's yeast Receipt of any investigational drug or sitagliptin within the 30 days or 5 half lives, whichever is longer, before Screening or a history of receipt of an investigational antidiabetic drug within the 3 months before randomization or receipt of albiglutide in previous studies
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
GSK Investigational Site
City
Gulf Shores
State/Province
Alabama
ZIP/Postal Code
36542
Country
United States
Facility Name
GSK Investigational Site
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
GSK Investigational Site
City
Toney
State/Province
Alabama
ZIP/Postal Code
35773
Country
United States
Facility Name
GSK Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85028
Country
United States
Facility Name
GSK Investigational Site
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
GSK Investigational Site
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92648
Country
United States
Facility Name
GSK Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Facility Name
GSK Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90022
Country
United States
Facility Name
GSK Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Facility Name
GSK Investigational Site
City
Los Gatos
State/Province
California
ZIP/Postal Code
95032
Country
United States
Facility Name
GSK Investigational Site
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
GSK Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
GSK Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
Facility Name
GSK Investigational Site
City
San Dimas
State/Province
California
ZIP/Postal Code
91773
Country
United States
Facility Name
GSK Investigational Site
City
Tarzana
State/Province
California
ZIP/Postal Code
91356
Country
United States
Facility Name
GSK Investigational Site
City
West Hills
State/Province
California
ZIP/Postal Code
91307
Country
United States
Facility Name
GSK Investigational Site
City
Whittier
State/Province
California
ZIP/Postal Code
90602
Country
United States
Facility Name
GSK Investigational Site
City
Whittier
State/Province
California
ZIP/Postal Code
90603
Country
United States
Facility Name
GSK Investigational Site
City
Doral
State/Province
Florida
ZIP/Postal Code
33172
Country
United States
Facility Name
GSK Investigational Site
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
GSK Investigational Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32205
Country
United States
Facility Name
GSK Investigational Site
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33141
Country
United States
Facility Name
GSK Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
GSK Investigational Site
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34653
Country
United States
Facility Name
GSK Investigational Site
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33028
Country
United States
Facility Name
GSK Investigational Site
City
Plantation
State/Province
Florida
ZIP/Postal Code
33322
Country
United States
Facility Name
GSK Investigational Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
GSK Investigational Site
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
GSK Investigational Site
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32792
Country
United States
Facility Name
GSK Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30312
Country
United States
Facility Name
GSK Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
GSK Investigational Site
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
Facility Name
GSK Investigational Site
City
Blue Ridge
State/Province
Georgia
ZIP/Postal Code
30513
Country
United States
Facility Name
GSK Investigational Site
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30032
Country
United States
Facility Name
GSK Investigational Site
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
GSK Investigational Site
City
Stone Mountain
State/Province
Georgia
ZIP/Postal Code
30088
Country
United States
Facility Name
GSK Investigational Site
City
Valparaiso
State/Province
Indiana
ZIP/Postal Code
46383
Country
United States
Facility Name
GSK Investigational Site
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Facility Name
GSK Investigational Site
City
Mission
State/Province
Kansas
ZIP/Postal Code
66202
Country
United States
Facility Name
GSK Investigational Site
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40504
Country
United States
Facility Name
GSK Investigational Site
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42003
Country
United States
Facility Name
GSK Investigational Site
City
Alexandria
State/Province
Louisiana
ZIP/Postal Code
71301
Country
United States
Facility Name
GSK Investigational Site
City
Bangor
State/Province
Maine
ZIP/Postal Code
04401
Country
United States
Facility Name
GSK Investigational Site
City
Hyattsville
State/Province
Maryland
ZIP/Postal Code
20782
Country
United States
Facility Name
GSK Investigational Site
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01107
Country
United States
Facility Name
GSK Investigational Site
City
Dearborn
State/Province
Michigan
ZIP/Postal Code
48124
Country
United States
Facility Name
GSK Investigational Site
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48235
Country
United States
Facility Name
GSK Investigational Site
City
Flint
State/Province
Michigan
ZIP/Postal Code
48504
Country
United States
Facility Name
GSK Investigational Site
City
St Clair Shores
State/Province
Michigan
ZIP/Postal Code
48081
Country
United States
Facility Name
GSK Investigational Site
City
Taylor
State/Province
Michigan
ZIP/Postal Code
48180
Country
United States
Facility Name
GSK Investigational Site
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
GSK Investigational Site
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64128
Country
United States
Facility Name
GSK Investigational Site
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
GSK Investigational Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
GSK Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
GSK Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89103
Country
United States
Facility Name
GSK Investigational Site
City
North Massapequa
State/Province
New York
ZIP/Postal Code
11758
Country
United States
Facility Name
GSK Investigational Site
City
Staten Island
State/Province
New York
ZIP/Postal Code
10301
Country
United States
Facility Name
GSK Investigational Site
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
GSK Investigational Site
City
Hurst
State/Province
North Carolina
ZIP/Postal Code
76054
Country
United States
Facility Name
GSK Investigational Site
City
Shelby
State/Province
North Carolina
ZIP/Postal Code
28150
Country
United States
Facility Name
GSK Investigational Site
City
Tabor City
State/Province
North Carolina
ZIP/Postal Code
28463
Country
United States
Facility Name
GSK Investigational Site
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
GSK Investigational Site
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
GSK Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
GSK Investigational Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
GSK Investigational Site
City
Gallipolis
State/Province
Ohio
ZIP/Postal Code
45631
Country
United States
Facility Name
GSK Investigational Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
GSK Investigational Site
City
Medford
State/Province
Oregon
ZIP/Postal Code
97501
Country
United States
Facility Name
GSK Investigational Site
City
Altoona
State/Province
Pennsylvania
ZIP/Postal Code
16602
Country
United States
Facility Name
GSK Investigational Site
City
Downington
State/Province
Pennsylvania
ZIP/Postal Code
19335
Country
United States
Facility Name
GSK Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19146
Country
United States
Facility Name
GSK Investigational Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29412
Country
United States
Facility Name
GSK Investigational Site
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29204
Country
United States
Facility Name
GSK Investigational Site
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
GSK Investigational Site
City
North Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29582
Country
United States
Facility Name
GSK Investigational Site
City
Taylors
State/Province
South Carolina
ZIP/Postal Code
29687
Country
United States
Facility Name
GSK Investigational Site
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
Facility Name
GSK Investigational Site
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37067
Country
United States
Facility Name
GSK Investigational Site
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37923
Country
United States
Facility Name
GSK Investigational Site
City
Tullahoma
State/Province
Tennessee
ZIP/Postal Code
37398
Country
United States
Facility Name
GSK Investigational Site
City
Arlington
State/Province
Texas
ZIP/Postal Code
76011
Country
United States
Facility Name
GSK Investigational Site
City
Arlington
State/Province
Texas
ZIP/Postal Code
76014
Country
United States
Facility Name
GSK Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78751
Country
United States
Facility Name
GSK Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78758
Country
United States
Facility Name
GSK Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75224
Country
United States
Facility Name
GSK Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
GSK Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75251
Country
United States
Facility Name
GSK Investigational Site
City
Deer Park
State/Province
Texas
ZIP/Postal Code
77536
Country
United States
Facility Name
GSK Investigational Site
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
GSK Investigational Site
City
Grapevine
State/Province
Texas
ZIP/Postal Code
76051
Country
United States
Facility Name
GSK Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77027
Country
United States
Facility Name
GSK Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
GSK Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77036
Country
United States
Facility Name
GSK Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77070
Country
United States
Facility Name
GSK Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
GSK Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77081
Country
United States
Facility Name
GSK Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77088
Country
United States
Facility Name
GSK Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77099
Country
United States
Facility Name
GSK Investigational Site
City
Humble
State/Province
Texas
ZIP/Postal Code
77338
Country
United States
Facility Name
GSK Investigational Site
City
Hurst
State/Province
Texas
ZIP/Postal Code
76054
Country
United States
Facility Name
GSK Investigational Site
City
Irving
State/Province
Texas
ZIP/Postal Code
75039
Country
United States
Facility Name
GSK Investigational Site
City
Midland
State/Province
Texas
ZIP/Postal Code
79707
Country
United States
Facility Name
GSK Investigational Site
City
North Richland Hills
State/Province
Texas
ZIP/Postal Code
76180
Country
United States
Facility Name
GSK Investigational Site
City
Pearland
State/Province
Texas
ZIP/Postal Code
77584
Country
United States
Facility Name
GSK Investigational Site
City
Plano
State/Province
Texas
ZIP/Postal Code
75075
Country
United States
Facility Name
GSK Investigational Site
City
Richardson
State/Province
Texas
ZIP/Postal Code
75080
Country
United States
Facility Name
GSK Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
GSK Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78217
Country
United States
Facility Name
GSK Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Facility Name
GSK Investigational Site
City
Schertz
State/Province
Texas
ZIP/Postal Code
78154
Country
United States
Facility Name
GSK Investigational Site
City
Sugarland
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Facility Name
GSK Investigational Site
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
Country
United States
Facility Name
GSK Investigational Site
City
Bountiful
State/Province
Utah
ZIP/Postal Code
84010
Country
United States
Facility Name
GSK Investigational Site
City
South Burlington
State/Province
Vermont
ZIP/Postal Code
05403
Country
United States
Facility Name
GSK Investigational Site
City
Burke
State/Province
Virginia
ZIP/Postal Code
22015
Country
United States
Facility Name
GSK Investigational Site
City
Manassas
State/Province
Virginia
ZIP/Postal Code
20110
Country
United States
Facility Name
GSK Investigational Site
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23510
Country
United States
Facility Name
GSK Investigational Site
City
Salem
State/Province
Virginia
ZIP/Postal Code
24153
Country
United States
Facility Name
GSK Investigational Site
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
GSK Investigational Site
City
Garran
State/Province
Australian Capital Territory
ZIP/Postal Code
2606
Country
Australia
Facility Name
GSK Investigational Site
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
GSK Investigational Site
City
Auchenflower
State/Province
Queensland
ZIP/Postal Code
4066
Country
Australia
Facility Name
GSK Investigational Site
City
Caboolture
State/Province
Queensland
ZIP/Postal Code
4510
Country
Australia
Facility Name
GSK Investigational Site
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
GSK Investigational Site
City
Kippa Ring
State/Province
Queensland
ZIP/Postal Code
4021
Country
Australia
Facility Name
GSK Investigational Site
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
GSK Investigational Site
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
GSK Investigational Site
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3081
Country
Australia
Facility Name
GSK Investigational Site
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3135
Country
Australia
Facility Name
GSK Investigational Site
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
GSK Investigational Site
City
Fremantle
State/Province
Western Australia
ZIP/Postal Code
6160
Country
Australia
Facility Name
GSK Investigational Site
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90035-170
Country
Brazil
Facility Name
GSK Investigational Site
City
Brasília
ZIP/Postal Code
71625-009
Country
Brazil
Facility Name
GSK Investigational Site
City
Mogi das Cruzes
ZIP/Postal Code
08780 - 090
Country
Brazil
Facility Name
GSK Investigational Site
City
São Paulo
ZIP/Postal Code
05302-001
Country
Brazil
Facility Name
GSK Investigational Site
City
Barrangquilla
Country
Colombia
Facility Name
GSK Investigational Site
City
Bogota
ZIP/Postal Code
110221
Country
Colombia
Facility Name
GSK Investigational Site
City
Floridablanca-Santander
Country
Colombia
Facility Name
GSK Investigational Site
City
Bad Nauheim
State/Province
Hessen
ZIP/Postal Code
61231
Country
Germany
Facility Name
GSK Investigational Site
City
Bad Lauterberg
State/Province
Niedersachsen
ZIP/Postal Code
37431
Country
Germany
Facility Name
GSK Investigational Site
City
Mainz
State/Province
Rheinland-Pfalz
ZIP/Postal Code
55116
Country
Germany
Facility Name
GSK Investigational Site
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01307
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
10115
Country
Germany
Facility Name
GSK Investigational Site
City
Ahmedabad
ZIP/Postal Code
380015
Country
India
Facility Name
GSK Investigational Site
City
Bangalore
ZIP/Postal Code
560 010
Country
India
Facility Name
GSK Investigational Site
City
Bangalore
ZIP/Postal Code
560 054
Country
India
Facility Name
GSK Investigational Site
City
Bangalore
ZIP/Postal Code
560043
Country
India
Facility Name
GSK Investigational Site
City
Bangalore
ZIP/Postal Code
560052
Country
India
Facility Name
GSK Investigational Site
City
Bangalore
ZIP/Postal Code
560078
Country
India
Facility Name
GSK Investigational Site
City
Belgaum,
ZIP/Postal Code
590010
Country
India
Facility Name
GSK Investigational Site
City
Belgaum
ZIP/Postal Code
590001
Country
India
Facility Name
GSK Investigational Site
City
Chennai
ZIP/Postal Code
600013
Country
India
Facility Name
GSK Investigational Site
City
Lucknow
ZIP/Postal Code
226005
Country
India
Facility Name
GSK Investigational Site
City
Manipal
ZIP/Postal Code
576104
Country
India
Facility Name
GSK Investigational Site
City
Mumbai
ZIP/Postal Code
400 008
Country
India
Facility Name
GSK Investigational Site
City
Nasik
ZIP/Postal Code
422013
Country
India
Facility Name
GSK Investigational Site
City
Ashkelon
ZIP/Postal Code
78278
Country
Israel
Facility Name
GSK Investigational Site
City
Beer-Sheva
ZIP/Postal Code
84101
Country
Israel
Facility Name
GSK Investigational Site
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
GSK Investigational Site
City
Haifa
ZIP/Postal Code
35251
Country
Israel
Facility Name
GSK Investigational Site
City
Holon
ZIP/Postal Code
58100
Country
Israel
Facility Name
GSK Investigational Site
City
Kfar Saba
ZIP/Postal Code
44281
Country
Israel
Facility Name
GSK Investigational Site
City
Safed
ZIP/Postal Code
13110
Country
Israel
Facility Name
GSK Investigational Site
City
Seongnam-si
ZIP/Postal Code
463712
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
135-720
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
136-705
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
139-872
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Suwon, Kyonggi-do
ZIP/Postal Code
443-721
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Callao
State/Province
Lima
ZIP/Postal Code
Callao 2
Country
Peru
Facility Name
GSK Investigational Site
City
Arequipa
ZIP/Postal Code
54
Country
Peru
Facility Name
GSK Investigational Site
City
Ica
ZIP/Postal Code
11
Country
Peru
Facility Name
GSK Investigational Site
City
Lima
ZIP/Postal Code
01
Country
Peru
Facility Name
GSK Investigational Site
City
Lima
ZIP/Postal Code
17
Country
Peru
Facility Name
GSK Investigational Site
City
Lima
ZIP/Postal Code
Lima 1
Country
Peru
Facility Name
GSK Investigational Site
City
Piura
Country
Peru
Facility Name
GSK Investigational Site
City
Trujillo
Country
Peru
Facility Name
GSK Investigational Site
City
Cebu City
ZIP/Postal Code
6000
Country
Philippines
Facility Name
GSK Investigational Site
City
Iloilo City
ZIP/Postal Code
5000
Country
Philippines
Facility Name
GSK Investigational Site
City
Makati City
ZIP/Postal Code
1218
Country
Philippines
Facility Name
GSK Investigational Site
City
Pasay
ZIP/Postal Code
1300
Country
Philippines
Facility Name
GSK Investigational Site
City
Tagbilaran City
ZIP/Postal Code
6300
Country
Philippines
Facility Name
GSK Investigational Site
City
Nizhniy Novgorod
ZIP/Postal Code
603126
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Saratov
ZIP/Postal Code
410030
Country
Russian Federation
Facility Name
GSK Investigational Site
City
St'Petersburg
ZIP/Postal Code
194156
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Yaroslavl
ZIP/Postal Code
150062
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Port Elizabeth
State/Province
Eastern Cape
ZIP/Postal Code
6014
Country
South Africa
Facility Name
GSK Investigational Site
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2013
Country
South Africa
Facility Name
GSK Investigational Site
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2193
Country
South Africa
Facility Name
GSK Investigational Site
City
Lenasia
State/Province
Gauteng
ZIP/Postal Code
1827
Country
South Africa
Facility Name
GSK Investigational Site
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0084
Country
South Africa
Facility Name
GSK Investigational Site
City
Durban
State/Province
KwaZulu- Natal
ZIP/Postal Code
4092
Country
South Africa
Facility Name
GSK Investigational Site
City
Phoenix
State/Province
KwaZulu- Natal
ZIP/Postal Code
4068
Country
South Africa
Facility Name
GSK Investigational Site
City
Houghton
ZIP/Postal Code
2198
Country
South Africa
Facility Name
GSK Investigational Site
City
Pretoria
ZIP/Postal Code
0002
Country
South Africa
Facility Name
GSK Investigational Site
City
Somerset West
ZIP/Postal Code
07129
Country
South Africa
Facility Name
GSK Investigational Site
City
Tygerberg
ZIP/Postal Code
7505
Country
South Africa
Facility Name
GSK Investigational Site
City
Alicante
ZIP/Postal Code
03114
Country
Spain
Facility Name
GSK Investigational Site
City
La Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
GSK Investigational Site
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
GSK Investigational Site
City
Palma de Mallorca
ZIP/Postal Code
07014
Country
Spain
Facility Name
GSK Investigational Site
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
GSK Investigational Site
City
Sevilla
ZIP/Postal Code
41003
Country
Spain
Facility Name
GSK Investigational Site
City
Torrevieja (Alicante)
ZIP/Postal Code
03186
Country
Spain
Facility Name
GSK Investigational Site
City
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan
Facility Name
GSK Investigational Site
City
Taichung
ZIP/Postal Code
404
Country
Taiwan
Facility Name
GSK Investigational Site
City
Tainan
ZIP/Postal Code
71044
Country
Taiwan
Facility Name
GSK Investigational Site
City
Coventry
State/Province
West Midlands
ZIP/Postal Code
CV2 2DX
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Birmingham
ZIP/Postal Code
B9 5SS
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Hertfordshire
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Hull
ZIP/Postal Code
HU3 2RW
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Liverpool
ZIP/Postal Code
L9 7AL
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Livingston
ZIP/Postal Code
EH54 6PP
Country
United Kingdom
Facility Name
GSK Investigational Site
City
London
ZIP/Postal Code
SE1 9NH
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Plymouth
ZIP/Postal Code
PL6 8BX
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Swansea
ZIP/Postal Code
SA6 6NL
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Citations:
PubMed Identifier
25387217
Citation
Young MA, Wald JA, Matthews JE, Scott R, Hodge RJ, Zhi H, Reinhardt RR. Clinical pharmacology of albiglutide, a GLP-1 receptor agonist. Postgrad Med. 2014 Nov;126(7):84-97. doi: 10.3810/pgm.2014.11.2836.
Results Reference
derived
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
114130
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
114130
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
114130
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Annotated Case Report Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
114130
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
114130
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
114130
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
114130
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

A Study of the Efficacy and Safety of Albiglutide in Subjects With Type 2 Diabetes With Renal Impairment.

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