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Dose Ranging Study of Albiglutide in Japanese Subjects

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
albiglutide
placebo
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 dose-ranging, pharmacokinetics, GSK716155, Japan, albiglutide

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subject with a historical diagnosis of type 2 diabetes mellitus who is currently treated with diet and exercise only or one OAD
  • BMI ≥18 kg/m2 and <35 kg/m2 at Screening
  • HbA1c between 7.0% and 10.0%, inclusive
  • Fasting C-peptide ≥0.8 ng/mL (≥0.26 nmol/L)
  • Female subjects of childbearing potential must be practicing adequate contraception .
  • Able and willing to monitor his/her own blood glucose concentrations with a home glucose monitor.
  • Able and willing to provide written informed consent

Exclusion Criteria:

  • Diagnosis of type 1 diabetes mellitus
  • Uncorrected thyroid dysfunction
  • Previous use of insulin within one month prior to screening, or more than seven total days of insulin treatment within three months prior to screening

  • Clinically significantly cardiovascular and/or cerebrovascular disease including, but not limited to the following:

    • Previous history of stroke or transient ischemic attack
    • Active, unstable coronary heart disease within the past six months before Screening
    • Documented myocardial infarction within one year before Screening
    • Any cardiac surgery including percutaneous transluminal coronary angioplasty, coronary stent placement, or coronary artery bypass graft surgery within one year before Screening
    • Unstable angina
    • Clinically significant arrhythmia or valvular heart disease
    • Current heart failure NYHA class II to IV
    • Resting systolic pressure >160 mm Hg or diastolic pressure >95 mm Hg at Screening
    • ECG criteria at Screening
  • Heart rate: <40 and >110 bpm
  • PR interval: <120 and > 210 msec
  • QRS interval: <70 and >120 msec
  • QTc interval (Bazett): >450 msec or >480 msec with bundle branch block
  • Fasting triglyceride level >400 mg/dL at Screening
  • AST or ALT >2xULN, ALP and bilirubin >1.5xULN (except known Gilbert's syndrome and a fractionated bilirubin that shows conjugated bilirubin <35% of total bilirubin)
  • If female, is currently lactating, within 6 weeks post-partum, pregnant, or actively trying to become pregnant

  • Has significant renal disease as manifested by one or more of the following:

    • Creatinine clearance at screening <60 mL/min (calculated by Cockcroft-Gault formula) at Screening
    • Known loss of a kidney either by surgical ablation, injury or disease level
  • A hemoglobinopathy that may affect determination of HbA1c level
  • History of treated diabetic gastroparesis
  • History of significant gastrointestinal surgery, including gastric bypass and banding, or surgeries thought to significantly affect upper gastrointestinal function
  • Current ongoing symptomatic biliary disease or history of acute/chronic pancreatitis.
  • Lipase and amylase at Screening > ULN
  • Severe diabetic neuropathy, preproliferative retinopathy or proliferative retinopathy, history of ketoacidosis or hyperosmolar coma
  • History of cancer, other than squamous cell or basal cell carcinoma of the skin, that has not been in full remission for at least 3 years before Screening. (A history of treated cervical intraepithelial neoplasia I or cervical intraepithelial neoplasia II is allowed)
  • Acute or chronic history of liver disease, positive hepatitis B surface antigen (HBsAg) or positive hepatitis C testing at Screening
  • Current and history of alcohol or substance abuse
  • Clinically significant anaemia or any other abnormal haematological profile that is considered by the investigator to be clinically significant
  • Prior use of a GLP-1 analog
  • Known allergy to any formulation excipients, or Baker's yeast, or history of drug, or other allergy which, in the opinion of the responsible study physician, contradicts participation
  • History of or family history of medullary carcinoma of the thyroid.
  • History of or family history of multiple endocrine neoplasia type 2
  • Receipt of any investigational drug within the 12 weeks before Screening

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

albiglutide 15mg weekly

albiglutide 30mg weekly

albiglutide 30mg every other week

placebo

Arm Description

once weekly subcutaneous injection of albiglutide 15mg

once weekly subcutaneous injection of albiglutide 30mg

subcutaneous injection of 30mg albiglutide every other week

once weekly subcutaneous injection of placebo to match albiglutide

Outcomes

Primary Outcome Measures

Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 16
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 was calculated as the value at Week 16 minus the value at Baseline. Based on Analysis of Covariance (ANCOVA): Change = treatment + Baseline HbA1c + prior therapy. 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

Change From Baseline in HbA1c at Weeks 4, 8, 12, and 16
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 was calculated as the value at Week 16 minus the value at Baseline. 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.
Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 4, 8, 12, and 16
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. The LOCF method was used to impute missing post-Baseline FPG values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Change From Baseline in Body Weight at Week 4, 8, 12, and 16
The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The LOCF method was used to impute missing post-Baseline weight values.
Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5% and <7% at Weeks 4, 8, 12, and 16
The number of participants who achieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5% and <7%) were assessed.
Mean Clearance of Albiglutide
Clearance is defined as the volume of plasma cleared of albiglutide per unit time. Samples were collected prior to the administration of study medication on dosing days (Weeks 0, 1, 4, 5, 8, 12, and 13) and on the day of the clinic visit at Weeks 16, 20, and 24. At Weeks 0, 1, 4, 8, and 12, pharmacokinetic (PK) samples were collected immediately prior to dosing if a dose was scheduled for that week. At Weeks 16, 20, and 24, PK samples were collected at any time during the visit. The Week 5 post-dose PK sampling was performed any time between Weeks 4 and 6, within 2 to 5 days after administration of a dose; Week 13 post-dose PK sampling was performed any time between Weeks 12 and 14, within 2 to 5 days after administration of a dose of study medication. Modeled population PK data are presented; data were analyzed using a non-linear mixed effect modeling approach. A one-compartment PK model with first-order absorption and elimination processes was selected to describe GSK716155 PK.
Mean Volume of Distribution of Albiglutide
Volume of distribution is defined as the apparent volume in which albiglutide is distributed. Samples were collected prior to the administration of study medication on dosing days (Weeks 0, 1, 4, 5, 8, 12, and 13) and on the day of the clinic visit at Weeks 16, 20, and 24. At Weeks 0, 1, 4, 8, and 12, PK samples were collected immediately prior to dosing if a dose was scheduled for that week. At Weeks 16, 20, and 24, PK samples were collected at any time during the visit. The Week 5 post-dose PK sampling was performed any time between Weeks 4 and 6, within 2 to 5 days after administration of a dose; Week 13 post-dose PK sampling was performed any time between Weeks 12 and 14, within 2 to 5 days after administration of a dose of study medication. Modeled population PK data are presented; data were analyzed using a non-linear mixed effect modeling approach. A one-compartment PK model with first-order absorption and elimination processes was selected to describe GSK716155 PK.
Mean Absorption Rate of Albiglutide
Absorption rate is defined as the rate at which albiglutide enters the blood circulation. Samples were collected prior to the administration of study medication on dosing days (Weeks 0, 1, 4, 5, 8, 12, and 13) and on the day of the clinic visit at Weeks 16, 20, and 24. At Weeks 0, 1, 4, 8, and 12, PK samples were collected immediately prior to dosing if a dose was scheduled for that week. At Weeks 16, 20, and 24, PK samples were collected at any time during the visit. The Week 5 post-dose PK sampling was performed any time between Weeks 4 and 6, within 2 to 5 days after administration of a dose; Week 13 post-dose PK sampling was performed any time between Weeks 12 and 14, within 2 to 5 days after administration of a dose of study medication. Modeled population PK data are presented; data were analyzed using a non-linear mixed effect modeling approach. A one-compartment PK model with first-order absorption and elimination processes was selected to describe GSK716155 PK.
Mean Half-maximal Effective Concentration (EC50) of Albiglutide for HbA1c and FPG
EC50 is defined as the concentration of albiglutide that give a half-maximal HbA1c and FPG response. Samples were collected prior to the administration of study medication on dosing days (Weeks 0, 1, 4, 5, 8, 12, and 13) and on the day of the clinic visit at Weeks 16, 20, and 24. At Weeks 0, 1, 4, 8, and 12, PK samples were collected immediately prior to dosing if a dose was scheduled for that week. At Weeks 16, 20, and 24, PK samples were collected at any time during the visit. The Week 5 post-dose PK sampling was performed any time between Weeks 4 and 6, within 2 to 5 days after administration of a dose; Week 13 post-dose PK sampling was performed any time between Weeks 12 and 14, within 2 to 5 days after administration of a dose of study medication. EC50 estimates used PK data as well as HbA1c and FPG efficacy data. EC50 was estimated from an inhibitory Emax (maximal possible effect of albiglutide) model.

Full Information

First Posted
February 12, 2010
Last Updated
November 29, 2016
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT01098461
Brief Title
Dose Ranging Study of Albiglutide in Japanese Subjects
Official Title
A Dose Finding Study of GSK716155 Versus Placebo in the Treatment of Type 2 Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (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 is a randomized, double-blind, placebo-controlled, multicenter, 4-parallel-group, dose ranging study evaluating the dose response, efficacy and safety of subcutaneously injected GSK716155 (albiglutide) in Japanese subjects with type 2 diabetes mellitus.
Detailed Description
This is a Phase IIb, randomized, double-blind, placebo-controlled, multicenter, 4-parallel-group, dose ranging, superiority study evaluating the dose response, efficacy and safety of weekly and every other week subcutaneously injected GSK716155 (albiglutide) in subjects with type 2 diabetes mellitus.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
dose-ranging, pharmacokinetics, GSK716155, Japan, albiglutide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
215 (Actual)

8. Arms, Groups, and Interventions

Arm Title
albiglutide 15mg weekly
Arm Type
Active Comparator
Arm Description
once weekly subcutaneous injection of albiglutide 15mg
Arm Title
albiglutide 30mg weekly
Arm Type
Active Comparator
Arm Description
once weekly subcutaneous injection of albiglutide 30mg
Arm Title
albiglutide 30mg every other week
Arm Type
Active Comparator
Arm Description
subcutaneous injection of 30mg albiglutide every other week
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
once weekly subcutaneous injection of placebo to match albiglutide
Intervention Type
Biological
Intervention Name(s)
albiglutide
Other Intervention Name(s)
placebo, albiglutide 30mg weekly, albiglutide 15mg weekly, albiglutide 30mg every other week
Intervention Description
subcutaneous injection of albiglutide
Intervention Type
Biological
Intervention Name(s)
placebo
Intervention Description
subcutaneous injection of placebo to match albiglutide
Primary Outcome Measure Information:
Title
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 16
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 was calculated as the value at Week 16 minus the value at Baseline. Based on Analysis of Covariance (ANCOVA): Change = treatment + Baseline HbA1c + prior therapy. 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 and Week 16
Secondary Outcome Measure Information:
Title
Change From Baseline in HbA1c at Weeks 4, 8, 12, and 16
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 was calculated as the value at Week 16 minus the value at Baseline. 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 4, Week 8, Week 12, and Week 16
Title
Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 4, 8, 12, and 16
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. The LOCF method was used to impute missing post-Baseline FPG values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time Frame
Baseline; Week 4, Week 8, Week 12, and Week 16
Title
Change From Baseline in Body Weight at Week 4, 8, 12, and 16
Description
The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The LOCF method was used to impute missing post-Baseline weight values.
Time Frame
Baseline; Week 4, Week 8, Week 12, and Week 16
Title
Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5% and <7% at Weeks 4, 8, 12, and 16
Description
The number of participants who achieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5% and <7%) were assessed.
Time Frame
Week 4, Week 8, Week 12, and Week 16
Title
Mean Clearance of Albiglutide
Description
Clearance is defined as the volume of plasma cleared of albiglutide per unit time. Samples were collected prior to the administration of study medication on dosing days (Weeks 0, 1, 4, 5, 8, 12, and 13) and on the day of the clinic visit at Weeks 16, 20, and 24. At Weeks 0, 1, 4, 8, and 12, pharmacokinetic (PK) samples were collected immediately prior to dosing if a dose was scheduled for that week. At Weeks 16, 20, and 24, PK samples were collected at any time during the visit. The Week 5 post-dose PK sampling was performed any time between Weeks 4 and 6, within 2 to 5 days after administration of a dose; Week 13 post-dose PK sampling was performed any time between Weeks 12 and 14, within 2 to 5 days after administration of a dose of study medication. Modeled population PK data are presented; data were analyzed using a non-linear mixed effect modeling approach. A one-compartment PK model with first-order absorption and elimination processes was selected to describe GSK716155 PK.
Time Frame
Weeks 0, 1, 4, 5, 8, 12, 13, 16, 20, and 24
Title
Mean Volume of Distribution of Albiglutide
Description
Volume of distribution is defined as the apparent volume in which albiglutide is distributed. Samples were collected prior to the administration of study medication on dosing days (Weeks 0, 1, 4, 5, 8, 12, and 13) and on the day of the clinic visit at Weeks 16, 20, and 24. At Weeks 0, 1, 4, 8, and 12, PK samples were collected immediately prior to dosing if a dose was scheduled for that week. At Weeks 16, 20, and 24, PK samples were collected at any time during the visit. The Week 5 post-dose PK sampling was performed any time between Weeks 4 and 6, within 2 to 5 days after administration of a dose; Week 13 post-dose PK sampling was performed any time between Weeks 12 and 14, within 2 to 5 days after administration of a dose of study medication. Modeled population PK data are presented; data were analyzed using a non-linear mixed effect modeling approach. A one-compartment PK model with first-order absorption and elimination processes was selected to describe GSK716155 PK.
Time Frame
Weeks 0, 1, 4, 5, 8, 12, 13, 16, 20, and 24
Title
Mean Absorption Rate of Albiglutide
Description
Absorption rate is defined as the rate at which albiglutide enters the blood circulation. Samples were collected prior to the administration of study medication on dosing days (Weeks 0, 1, 4, 5, 8, 12, and 13) and on the day of the clinic visit at Weeks 16, 20, and 24. At Weeks 0, 1, 4, 8, and 12, PK samples were collected immediately prior to dosing if a dose was scheduled for that week. At Weeks 16, 20, and 24, PK samples were collected at any time during the visit. The Week 5 post-dose PK sampling was performed any time between Weeks 4 and 6, within 2 to 5 days after administration of a dose; Week 13 post-dose PK sampling was performed any time between Weeks 12 and 14, within 2 to 5 days after administration of a dose of study medication. Modeled population PK data are presented; data were analyzed using a non-linear mixed effect modeling approach. A one-compartment PK model with first-order absorption and elimination processes was selected to describe GSK716155 PK.
Time Frame
Weeks 0, 1, 4, 5, 8, 12, 13, 16, 20, and 24
Title
Mean Half-maximal Effective Concentration (EC50) of Albiglutide for HbA1c and FPG
Description
EC50 is defined as the concentration of albiglutide that give a half-maximal HbA1c and FPG response. Samples were collected prior to the administration of study medication on dosing days (Weeks 0, 1, 4, 5, 8, 12, and 13) and on the day of the clinic visit at Weeks 16, 20, and 24. At Weeks 0, 1, 4, 8, and 12, PK samples were collected immediately prior to dosing if a dose was scheduled for that week. At Weeks 16, 20, and 24, PK samples were collected at any time during the visit. The Week 5 post-dose PK sampling was performed any time between Weeks 4 and 6, within 2 to 5 days after administration of a dose; Week 13 post-dose PK sampling was performed any time between Weeks 12 and 14, within 2 to 5 days after administration of a dose of study medication. EC50 estimates used PK data as well as HbA1c and FPG efficacy data. EC50 was estimated from an inhibitory Emax (maximal possible effect of albiglutide) model.
Time Frame
Weeks 0, 1, 4, 5, 8, 12, 13, 16, 20, and 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject with a historical diagnosis of type 2 diabetes mellitus who is currently treated with diet and exercise only or one OAD BMI ≥18 kg/m2 and <35 kg/m2 at Screening HbA1c between 7.0% and 10.0%, inclusive Fasting C-peptide ≥0.8 ng/mL (≥0.26 nmol/L) Female subjects of childbearing potential must be practicing adequate contraception . Able and willing to monitor his/her own blood glucose concentrations with a home glucose monitor. Able and willing to provide written informed consent Exclusion Criteria: Diagnosis of type 1 diabetes mellitus Uncorrected thyroid dysfunction Previous use of insulin within one month prior to screening, or more than seven total days of insulin treatment within three months prior to screening Clinically significantly cardiovascular and/or cerebrovascular disease including, but not limited to the following: Previous history of stroke or transient ischemic attack Active, unstable coronary heart disease within the past six months before Screening Documented myocardial infarction within one year before Screening Any cardiac surgery including percutaneous transluminal coronary angioplasty, coronary stent placement, or coronary artery bypass graft surgery within one year before Screening Unstable angina Clinically significant arrhythmia or valvular heart disease Current heart failure NYHA class II to IV Resting systolic pressure >160 mm Hg or diastolic pressure >95 mm Hg at Screening ECG criteria at Screening Heart rate: <40 and >110 bpm PR interval: <120 and > 210 msec QRS interval: <70 and >120 msec QTc interval (Bazett): >450 msec or >480 msec with bundle branch block Fasting triglyceride level >400 mg/dL at Screening AST or ALT >2xULN, ALP and bilirubin >1.5xULN (except known Gilbert's syndrome and a fractionated bilirubin that shows conjugated bilirubin <35% of total bilirubin) If female, is currently lactating, within 6 weeks post-partum, pregnant, or actively trying to become pregnant Has significant renal disease as manifested by one or more of the following: Creatinine clearance at screening <60 mL/min (calculated by Cockcroft-Gault formula) at Screening Known loss of a kidney either by surgical ablation, injury or disease level A hemoglobinopathy that may affect determination of HbA1c level History of treated diabetic gastroparesis History of significant gastrointestinal surgery, including gastric bypass and banding, or surgeries thought to significantly affect upper gastrointestinal function Current ongoing symptomatic biliary disease or history of acute/chronic pancreatitis. Lipase and amylase at Screening > ULN Severe diabetic neuropathy, preproliferative retinopathy or proliferative retinopathy, history of ketoacidosis or hyperosmolar coma History of cancer, other than squamous cell or basal cell carcinoma of the skin, that has not been in full remission for at least 3 years before Screening. (A history of treated cervical intraepithelial neoplasia I or cervical intraepithelial neoplasia II is allowed) Acute or chronic history of liver disease, positive hepatitis B surface antigen (HBsAg) or positive hepatitis C testing at Screening Current and history of alcohol or substance abuse Clinically significant anaemia or any other abnormal haematological profile that is considered by the investigator to be clinically significant Prior use of a GLP-1 analog Known allergy to any formulation excipients, or Baker's yeast, or history of drug, or other allergy which, in the opinion of the responsible study physician, contradicts participation History of or family history of medullary carcinoma of the thyroid. History of or family history of multiple endocrine neoplasia type 2 Receipt of any investigational drug within the 12 weeks before Screening
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
Aichi
ZIP/Postal Code
466-0815
Country
Japan
Facility Name
GSK Investigational Site
City
Ehime
ZIP/Postal Code
790-0067
Country
Japan
Facility Name
GSK Investigational Site
City
Fukuoka
ZIP/Postal Code
810-0001
Country
Japan
Facility Name
GSK Investigational Site
City
Fukuoka
ZIP/Postal Code
811-1346
Country
Japan
Facility Name
GSK Investigational Site
City
Fukuoka
ZIP/Postal Code
815-8555
Country
Japan
Facility Name
GSK Investigational Site
City
Fukuoka
ZIP/Postal Code
819-0168
Country
Japan
Facility Name
GSK Investigational Site
City
Hiroshima
ZIP/Postal Code
731-0103
Country
Japan
Facility Name
GSK Investigational Site
City
Hokkaido
ZIP/Postal Code
003-0023
Country
Japan
Facility Name
GSK Investigational Site
City
Hokkaido
ZIP/Postal Code
044-0053
Country
Japan
Facility Name
GSK Investigational Site
City
Hokkaido
ZIP/Postal Code
061-1395
Country
Japan
Facility Name
GSK Investigational Site
City
Hokkaido
ZIP/Postal Code
080-0010
Country
Japan
Facility Name
GSK Investigational Site
City
Hokkaido
ZIP/Postal Code
080-0016
Country
Japan
Facility Name
GSK Investigational Site
City
Ibaraki
ZIP/Postal Code
310-0826
Country
Japan
Facility Name
GSK Investigational Site
City
Ibaraki
ZIP/Postal Code
311-0113
Country
Japan
Facility Name
GSK Investigational Site
City
Kagoshima
ZIP/Postal Code
891-0401
Country
Japan
Facility Name
GSK Investigational Site
City
Kanagawa
ZIP/Postal Code
210-0852
Country
Japan
Facility Name
GSK Investigational Site
City
Kanagawa
ZIP/Postal Code
235-0045
Country
Japan
Facility Name
GSK Investigational Site
City
Kumamoto
ZIP/Postal Code
862-0976
Country
Japan
Facility Name
GSK Investigational Site
City
Kumamoto
ZIP/Postal Code
866-0862
Country
Japan
Facility Name
GSK Investigational Site
City
Miyagi
ZIP/Postal Code
980-0021
Country
Japan
Facility Name
GSK Investigational Site
City
Miyagi
ZIP/Postal Code
985-0852
Country
Japan
Facility Name
GSK Investigational Site
City
Nagasaki
ZIP/Postal Code
856-0831
Country
Japan
Facility Name
GSK Investigational Site
City
Saitama
ZIP/Postal Code
355-0321
Country
Japan
Facility Name
GSK Investigational Site
City
Saitama
ZIP/Postal Code
362-0021
Country
Japan
Facility Name
GSK Investigational Site
City
Tochigi
ZIP/Postal Code
329-0101
Country
Japan
Facility Name
GSK Investigational Site
City
Tochigi
ZIP/Postal Code
329-0433
Country
Japan
Facility Name
GSK Investigational Site
City
Tokyo
ZIP/Postal Code
125-0054
Country
Japan
Facility Name
GSK Investigational Site
City
Tokyo
ZIP/Postal Code
154-0015
Country
Japan
Facility Name
GSK Investigational Site
City
Tokyo
ZIP/Postal Code
177-0041
Country
Japan
Facility Name
GSK Investigational Site
City
Yamagata
ZIP/Postal Code
990-0885
Country
Japan

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
PubMed Identifier
24552155
Citation
Seino Y, Inagaki N, Miyahara H, Okuda I, Bush M, Ye J, Holland MC, Johnson S, Lewis E, Nakajima H. A randomized dose-finding study demonstrating the efficacy and tolerability of albiglutide in Japanese patients with type 2 diabetes mellitus. Curr Med Res Opin. 2014 Jun;30(6):1095-106. doi: 10.1185/03007995.2014.896327. Epub 2014 Mar 11.
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
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
110932
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
110932
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
110932
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
110932
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
110932
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
110932
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
110932
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

Dose Ranging Study of Albiglutide in Japanese Subjects

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