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A Monotherapy Study to Evaluate the Efficacy and Safety of 2 Dose Levels of Albiglutide in Japanese Subjects With Type 2 Diabetes Mellitus (T2DM)

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Albiglutide 30 mg weekly
Albiglutide 50 mg weekly
Placebo
Liraglutide 0.9 mg daily
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 albiglutide, Japanese, GSK716155, Type 2 diabetes mellitus, glucagon-like peptide 1

Eligibility Criteria

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

Inclusion Criteria:

  • Subjects with diagnosis of Type 2 Diabetes Mellitus, treated with diet and exercise or a stable dose of 1 OAD at screening
  • Body mass index (BMI) 17 to 40 kg/ m^2 inclusive
  • Subjects who are OAD naïve, HbA1c between 7.0% and 10.0% at Screening and at Visit 2; for subjects who enter the study with 1 OAD, HbA1c between 6.5% and 9.5% at Screening and HbA1c between 7.0% and 10.0% at Visit 2
  • Creatinine clearance >30 mL/min (calculated using the Cockcroft-Gault formula)

Exclusion Criteria:

  • History of type 1 diabetes mellitus •Female subject is pregnant, lactating, or <6 weeks postpartum•
  • Clinically significant cardiovascular and/or cerebrovascular disease
  • Current ongoing symptomatic biliary disease, clinical signs or symptoms of pancreatitis, or a history of chronic or acute pancreatitis, as determined by the investigator
  • Serum amylase >=3 ×ULN and/or serum lipase >=2 × ULN and/or subject is experiencing any symptoms possibly related to pancreatitis
  • Prior use of a TZD or GLP-1R agonist within 4 months 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
  • 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
  • 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

Experimental

Experimental

Placebo Comparator

Active Comparator

Arm Label

Albiglutide 30 mg weekly

Albiglutide 50 mg weekly

Placebo

Liraglutide 0.9 mg daily

Arm Description

Subjects will be randomly assigned to double blind albiglutide 30 mg weekly treatment for 52 weeks

Subjects will be randomly assigned to double blind albiglutide 50 mg weekly until Week 52

Subjects will be randomly assigned to double blind matching albiglutide placebo administered weekly. Subjects will then cross-over to double-blind treatment with albiglutide 30 mg weekly at Week 24 until Week 52

Subjects will be randomly assigned to open-label liraglutide for 52 weeks

Outcomes

Primary Outcome Measures

Model-adjusted Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24
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 nonmissing value before the start of treatment. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. Based on analysis of covariance (ANCOVA): Change at Week 24 = treatment (placebo, albiglutide 30 mg, albiglutide 50 mg) + Baseline HbA1c + prior diabetes therapy + age category (<65 years versus ≥65 years). Participants who discontinued from study treatment before Week 24 had their last post-Baseline HbA1c carried forward for the analysis unless the value is past 14 days after the last dose of study drug. The open-label liraglutide group was a reference group and not included in the primary endpoint analysis model. Descriptive summary statistics are provided as a separate outcome measure.
Mean HbA1c at Baseline, Week 24, and Change From Baseline at Week 24
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 nonmissing value before the start of treatment. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. Participants who discontinued from study treatment before Week 24 had their last post-Baseline HbA1c value carried forward for the summary, unless the value was past 14 days after the last dose of study drug. The open-label liraglutide group was a reference group; descriptive statistics comparing albiglutide and liraglutide were exploratory endpoints.

Secondary Outcome Measures

Change From Baseline in HbA1c at Week 52
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 on or before the start of treatment. Change from Baseline was calculated as the value at Week 52 minus the value at Baseline.
Percentage of Participants Achieving Clinically Meaningful Levels of HbA1c (i.e., the Percentage of Participants Achieving Treatment Goal of <6.5% and <7.0%) at Week 24
HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3 month period. Clinically meaningful levels of response in HbA1c are defined as <6.5% and <7.0%. Participants who discontinued the study before Week 24 had their last post-Baseline HbA1c value carried forwrad for the summary unless the value was past 14 days after the last dose of study drug.
Percentage of Participants Achieving Clinically Meaningful Levels of HbA1c (i.e., the Percentage of Participants Achieving Treatment Goal of <6.5% and <7.0%) at Week 52
HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3 month period. Clinically meaningful levels of response in HbA1c are defined as <6.5% and <7.0%.
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
FPG is an indicator of efficacy. The Baseline FPG value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the FPG value at Week 24 minus the FPG value at Baseline. Participants who discontinued from study treatment before Week 24 had their last post-Baseline FPG observation carried forward for the summary unless the value was 14 days past the last dose of study drug.
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52
FPG is an indicator of efficacy. The Baseline FPG value is defined as the last non-missing value on or before the start of treatment. Change from Baseline was calculated as the FPG value at Week 52 minus the FPG value at Baseline.
Change From Baseline in Body Weight at Week 24
The Baseline body weight value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the body weight value at Week 24 minus the value at Baseline. Participants who discontinued from the study treatment before Week 24 had their last non-missing weight carried forward for the summary, unless the value is past 14 days after the last dose of study drug.
Change From Baseline in Body Weight at Week 52
The Baseline body weight value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the body weight value at Week 52 minus the value at Baseline.
Time to Study Withdrawal Due to Hyperglycemia
Participants who experienced persistent hyperglycemia after uptitration were to be withdrawn from the study. Hyperglycemia is defined as a fasting plasma glucose (FPG) ≥280 mg/dL (≥15.5 mmol/L) from ≥Week 2 to <Week 4, ≥250 mg/dL (≥13.9 mmol/L) from ≥Week 4 to <Week 12, or ≥230 mg/dL (≥12.8 mmol/L) from ≥Week 12 to <Week 52, confirmed a second evaluation within 7 days.
Time to Study Withdrawal for Any Reason
Time to withdrawal was calculated as the number of days between the date of first dose and the date of withdrawal plus 1. Time to withdrawal was summarized by visit.

Full Information

First Posted
November 21, 2012
Last Updated
August 12, 2016
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT01733758
Brief Title
A Monotherapy Study to Evaluate the Efficacy and Safety of 2 Dose Levels of Albiglutide in Japanese Subjects With Type 2 Diabetes Mellitus (T2DM)
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Monotherapy Study to Determine the Efficacy and Safety of 2 Dose Levels of Albiglutide in Subjects With Type 2 Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
February 2015 (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 study is designed to examine the efficacy and safety of 2 dose levels of weekly subcutaneously injected albiglutide compared with placebo and an open label reference arm of daily subcutaneous injections of liraglutide, in Japanese 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
albiglutide, Japanese, GSK716155, Type 2 diabetes mellitus, glucagon-like peptide 1

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Albiglutide 30 mg weekly
Arm Type
Experimental
Arm Description
Subjects will be randomly assigned to double blind albiglutide 30 mg weekly treatment for 52 weeks
Arm Title
Albiglutide 50 mg weekly
Arm Type
Experimental
Arm Description
Subjects will be randomly assigned to double blind albiglutide 50 mg weekly until Week 52
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects will be randomly assigned to double blind matching albiglutide placebo administered weekly. Subjects will then cross-over to double-blind treatment with albiglutide 30 mg weekly at Week 24 until Week 52
Arm Title
Liraglutide 0.9 mg daily
Arm Type
Active Comparator
Arm Description
Subjects will be randomly assigned to open-label liraglutide for 52 weeks
Intervention Type
Drug
Intervention Name(s)
Albiglutide 30 mg weekly
Intervention Description
Albiglutide will be available as a pen injector that delivers 30mg of albiglutide
Intervention Type
Drug
Intervention Name(s)
Albiglutide 50 mg weekly
Intervention Description
Albiglutide will be available as a pen injector that delivers 50mg of albiglutide
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Albiglutide matching placebo will be available as a pen injector
Intervention Type
Drug
Intervention Name(s)
Liraglutide 0.9 mg daily
Intervention Description
Liraglutide will be available as prefilled multidose pens that can deliver 0.9 mg dose
Primary Outcome Measure Information:
Title
Model-adjusted Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24
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 nonmissing value before the start of treatment. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. Based on analysis of covariance (ANCOVA): Change at Week 24 = treatment (placebo, albiglutide 30 mg, albiglutide 50 mg) + Baseline HbA1c + prior diabetes therapy + age category (<65 years versus ≥65 years). Participants who discontinued from study treatment before Week 24 had their last post-Baseline HbA1c carried forward for the analysis unless the value is past 14 days after the last dose of study drug. The open-label liraglutide group was a reference group and not included in the primary endpoint analysis model. Descriptive summary statistics are provided as a separate outcome measure.
Time Frame
Baseline and Week 24
Title
Mean HbA1c at Baseline, Week 24, and Change From Baseline at Week 24
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 nonmissing value before the start of treatment. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. Participants who discontinued from study treatment before Week 24 had their last post-Baseline HbA1c value carried forward for the summary, unless the value was past 14 days after the last dose of study drug. The open-label liraglutide group was a reference group; descriptive statistics comparing albiglutide and liraglutide were exploratory endpoints.
Time Frame
Baseline and Week 24
Secondary Outcome Measure Information:
Title
Change From Baseline in HbA1c at Week 52
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 on or before the start of treatment. Change from Baseline was calculated as the value at Week 52 minus the value at Baseline.
Time Frame
Baseline and Week 52
Title
Percentage of Participants Achieving Clinically Meaningful Levels of HbA1c (i.e., the Percentage of Participants Achieving Treatment Goal of <6.5% and <7.0%) at Week 24
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. Clinically meaningful levels of response in HbA1c are defined as <6.5% and <7.0%. Participants who discontinued the study before Week 24 had their last post-Baseline HbA1c value carried forwrad for the summary unless the value was past 14 days after the last dose of study drug.
Time Frame
Week 24
Title
Percentage of Participants Achieving Clinically Meaningful Levels of HbA1c (i.e., the Percentage of Participants Achieving Treatment Goal of <6.5% and <7.0%) at Week 52
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. Clinically meaningful levels of response in HbA1c are defined as <6.5% and <7.0%.
Time Frame
Week 52
Title
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
Description
FPG is an indicator of efficacy. The Baseline FPG value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the FPG value at Week 24 minus the FPG value at Baseline. Participants who discontinued from study treatment before Week 24 had their last post-Baseline FPG observation carried forward for the summary unless the value was 14 days past the last dose of study drug.
Time Frame
Baseline and Week 24
Title
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52
Description
FPG is an indicator of efficacy. The Baseline FPG value is defined as the last non-missing value on or before the start of treatment. Change from Baseline was calculated as the FPG value at Week 52 minus the FPG value at Baseline.
Time Frame
Baseline and Week 52
Title
Change From Baseline in Body Weight at Week 24
Description
The Baseline body weight value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the body weight value at Week 24 minus the value at Baseline. Participants who discontinued from the study treatment before Week 24 had their last non-missing weight carried forward for the summary, unless the value is past 14 days after the last dose of study drug.
Time Frame
Baseline and Week 24
Title
Change From Baseline in Body Weight at Week 52
Description
The Baseline body weight value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the body weight value at Week 52 minus the value at Baseline.
Time Frame
Baseline and Week 52
Title
Time to Study Withdrawal Due to Hyperglycemia
Description
Participants who experienced persistent hyperglycemia after uptitration were to be withdrawn from the study. Hyperglycemia is defined as a fasting plasma glucose (FPG) ≥280 mg/dL (≥15.5 mmol/L) from ≥Week 2 to <Week 4, ≥250 mg/dL (≥13.9 mmol/L) from ≥Week 4 to <Week 12, or ≥230 mg/dL (≥12.8 mmol/L) from ≥Week 12 to <Week 52, confirmed a second evaluation within 7 days.
Time Frame
Baseline through Week 52
Title
Time to Study Withdrawal for Any Reason
Description
Time to withdrawal was calculated as the number of days between the date of first dose and the date of withdrawal plus 1. Time to withdrawal was summarized by visit.
Time Frame
Baseline through Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects with diagnosis of Type 2 Diabetes Mellitus, treated with diet and exercise or a stable dose of 1 OAD at screening Body mass index (BMI) 17 to 40 kg/ m^2 inclusive Subjects who are OAD naïve, HbA1c between 7.0% and 10.0% at Screening and at Visit 2; for subjects who enter the study with 1 OAD, HbA1c between 6.5% and 9.5% at Screening and HbA1c between 7.0% and 10.0% at Visit 2 Creatinine clearance >30 mL/min (calculated using the Cockcroft-Gault formula) Exclusion Criteria: History of type 1 diabetes mellitus •Female subject is pregnant, lactating, or <6 weeks postpartum• Clinically significant cardiovascular and/or cerebrovascular disease Current ongoing symptomatic biliary disease, clinical signs or symptoms of pancreatitis, or a history of chronic or acute pancreatitis, as determined by the investigator Serum amylase >=3 ×ULN and/or serum lipase >=2 × ULN and/or subject is experiencing any symptoms possibly related to pancreatitis Prior use of a TZD or GLP-1R agonist within 4 months 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
456-0058
Country
Japan
Facility Name
GSK Investigational Site
City
Chiba
ZIP/Postal Code
263-0043
Country
Japan
Facility Name
GSK Investigational Site
City
Ehime
ZIP/Postal Code
790-0067
Country
Japan
Facility Name
GSK Investigational Site
City
Ehime
ZIP/Postal Code
792-0045
Country
Japan
Facility Name
GSK Investigational Site
City
Ehime
ZIP/Postal Code
792-8586
Country
Japan
Facility Name
GSK Investigational Site
City
Fukuoka
ZIP/Postal Code
810-0014
Country
Japan
Facility Name
GSK Investigational Site
City
Fukuoka
ZIP/Postal Code
812-0053
Country
Japan
Facility Name
GSK Investigational Site
City
Fukuoka
ZIP/Postal Code
815-8588
Country
Japan
Facility Name
GSK Investigational Site
City
Fukuoka
ZIP/Postal Code
819-0168
Country
Japan
Facility Name
GSK Investigational Site
City
Fukushima
ZIP/Postal Code
960-0418
Country
Japan
Facility Name
GSK Investigational Site
City
Fukushima
ZIP/Postal Code
961-0416
Country
Japan
Facility Name
GSK Investigational Site
City
Fukushima
ZIP/Postal Code
963-8851
Country
Japan
Facility Name
GSK Investigational Site
City
Fukushima
ZIP/Postal Code
964-8501
Country
Japan
Facility Name
GSK Investigational Site
City
Gunma
ZIP/Postal Code
370-3573
Country
Japan
Facility Name
GSK Investigational Site
City
Gunma
ZIP/Postal Code
379-0116
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
040-8585
Country
Japan
Facility Name
GSK Investigational Site
City
Hokkaido
ZIP/Postal Code
062-0007
Country
Japan
Facility Name
GSK Investigational Site
City
Hokkaido
ZIP/Postal Code
070-0002
Country
Japan
Facility Name
GSK Investigational Site
City
Hokkaido
ZIP/Postal Code
072-0012
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
Hyogo
ZIP/Postal Code
670-0074
Country
Japan
Facility Name
GSK Investigational Site
City
Ibaraki
ZIP/Postal Code
300-0835
Country
Japan
Facility Name
GSK Investigational Site
City
Ibaraki
ZIP/Postal Code
300-1512
Country
Japan
Facility Name
GSK Investigational Site
City
Ibaraki
ZIP/Postal Code
311-0113
Country
Japan
Facility Name
GSK Investigational Site
City
Kagawa
ZIP/Postal Code
760-0017
Country
Japan
Facility Name
GSK Investigational Site
City
Kagawa
ZIP/Postal Code
760-0076
Country
Japan
Facility Name
GSK Investigational Site
City
Kagoshima
ZIP/Postal Code
890-0061
Country
Japan
Facility Name
GSK Investigational Site
City
Kanagawa
ZIP/Postal Code
212-0024
Country
Japan
Facility Name
GSK Investigational Site
City
Kanagawa
ZIP/Postal Code
232-0064
Country
Japan
Facility Name
GSK Investigational Site
City
Kanagawa
ZIP/Postal Code
235-0045
Country
Japan
Facility Name
GSK Investigational Site
City
Kanagawa
ZIP/Postal Code
238-0011
Country
Japan
Facility Name
GSK Investigational Site
City
Kanagawa
ZIP/Postal Code
242-0004
Country
Japan
Facility Name
GSK Investigational Site
City
Kanagawa
ZIP/Postal Code
253-0044
Country
Japan
Facility Name
GSK Investigational Site
City
Kochi
ZIP/Postal Code
780-0088
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
866-8660
Country
Japan
Facility Name
GSK Investigational Site
City
Kumamoto
ZIP/Postal Code
867-0041
Country
Japan
Facility Name
GSK Investigational Site
City
Kyoto
ZIP/Postal Code
600-8558
Country
Japan
Facility Name
GSK Investigational Site
City
Kyoto
ZIP/Postal Code
601-1495
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
Nagano
ZIP/Postal Code
385-0022
Country
Japan
Facility Name
GSK Investigational Site
City
Nagano
ZIP/Postal Code
399-0006
Country
Japan
Facility Name
GSK Investigational Site
City
Nagano
ZIP/Postal Code
399-0036
Country
Japan
Facility Name
GSK Investigational Site
City
Nara
ZIP/Postal Code
634-0007
Country
Japan
Facility Name
GSK Investigational Site
City
Oita
ZIP/Postal Code
870-0039
Country
Japan
Facility Name
GSK Investigational Site
City
Oita
ZIP/Postal Code
876-0851
Country
Japan
Facility Name
GSK Investigational Site
City
Okinawa
ZIP/Postal Code
901-0243
Country
Japan
Facility Name
GSK Investigational Site
City
Osaka
ZIP/Postal Code
530-0001
Country
Japan
Facility Name
GSK Investigational Site
City
Osaka
ZIP/Postal Code
530-0004
Country
Japan
Facility Name
GSK Investigational Site
City
Osaka
ZIP/Postal Code
530-0012
Country
Japan
Facility Name
GSK Investigational Site
City
Osaka
ZIP/Postal Code
532-0026
Country
Japan
Facility Name
GSK Investigational Site
City
Osaka
ZIP/Postal Code
536-0023
Country
Japan
Facility Name
GSK Investigational Site
City
Osaka
ZIP/Postal Code
538-0044
Country
Japan
Facility Name
GSK Investigational Site
City
Osaka
ZIP/Postal Code
577-0803
Country
Japan
Facility Name
GSK Investigational Site
City
Saitama
ZIP/Postal Code
332-0012
Country
Japan
Facility Name
GSK Investigational Site
City
Saitama
ZIP/Postal Code
350-0035
Country
Japan
Facility Name
GSK Investigational Site
City
Saitama
ZIP/Postal Code
350-0851
Country
Japan
Facility Name
GSK Investigational Site
City
Saitama
ZIP/Postal Code
354-0031
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
358-0011
Country
Japan
Facility Name
GSK Investigational Site
City
Shizuoka
ZIP/Postal Code
424-0855
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
103-0002
Country
Japan
Facility Name
GSK Investigational Site
City
Tokyo
ZIP/Postal Code
103-0027
Country
Japan
Facility Name
GSK Investigational Site
City
Tokyo
ZIP/Postal Code
103-0028
Country
Japan
Facility Name
GSK Investigational Site
City
Tokyo
ZIP/Postal Code
104-0031
Country
Japan
Facility Name
GSK Investigational Site
City
Tokyo
ZIP/Postal Code
104-0061
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
136-0073
Country
Japan
Facility Name
GSK Investigational Site
City
Tokyo
ZIP/Postal Code
143-0015
Country
Japan
Facility Name
GSK Investigational Site
City
Yamaguchi
ZIP/Postal Code
755-0047
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.
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
113121
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
113121
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
113121
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
113121
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
113121
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
113121
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
113121
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

A Monotherapy Study to Evaluate the Efficacy and Safety of 2 Dose Levels of Albiglutide in Japanese Subjects With Type 2 Diabetes Mellitus (T2DM)

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