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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01098539
• Other study ID #: 114130
• Status: Completed
• Phase: Phase 3
• First received: April 1, 2010
• Last updated: January 9, 2017
• Start date: May 2010
• Est. completion date: November 2012

Study information

• Verified date: January 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 507
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Renal Insufficiency

Intervention

Biological:
• albiglutide
albiglutide weekly subcutaneous injection + sitagliptin matching placebo

Drug:
• sitagliptin
albiglutide matching placebo + sitagliptin (25mg, 50mg or 100mg depending on level of renal impairment)

Locations

Country	Name	City	State
Australia	GSK Investigational Site	Auchenflower	Queensland
Australia	GSK Investigational Site	Box Hill	Victoria
Australia	GSK Investigational Site	Caboolture	Queensland
Australia	GSK Investigational Site	Camperdown	New South Wales
Australia	GSK Investigational Site	Clayton	Victoria
Australia	GSK Investigational Site	Fremantle	Western Australia
Australia	GSK Investigational Site	Garran	Australian Capital Territory
Australia	GSK Investigational Site	Heidelberg	Victoria
Australia	GSK Investigational Site	Herston	Queensland
Australia	GSK Investigational Site	Kippa Ring	Queensland
Australia	GSK Investigational Site	Melbourne	Victoria
Australia	GSK Investigational Site	Parkville	Victoria
Brazil	GSK Investigational Site	Brasília
Brazil	GSK Investigational Site	Mogi das Cruzes
Brazil	GSK Investigational Site	Porto Alegre	Rio Grande Do Sul
Brazil	GSK Investigational Site	São Paulo
Colombia	GSK Investigational Site	Barrangquilla
Colombia	GSK Investigational Site	Bogota
Colombia	GSK Investigational Site	Floridablanca-Santander
Germany	GSK Investigational Site	Bad Lauterberg	Niedersachsen
Germany	GSK Investigational Site	Bad Nauheim	Hessen
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Dresden	Sachsen
Germany	GSK Investigational Site	Mainz	Rheinland-Pfalz
India	GSK Investigational Site	Ahmedabad
India	GSK Investigational Site	Bangalore
India	GSK Investigational Site	Bangalore
India	GSK Investigational Site	Bangalore
India	GSK Investigational Site	Bangalore
India	GSK Investigational Site	Bangalore
India	GSK Investigational Site	Belgaum
India	GSK Investigational Site	Belgaum,
India	GSK Investigational Site	Chennai
India	GSK Investigational Site	Lucknow
India	GSK Investigational Site	Manipal
India	GSK Investigational Site	Mumbai
India	GSK Investigational Site	Nasik
Israel	GSK Investigational Site	Ashkelon
Israel	GSK Investigational Site	Beer-Sheva
Israel	GSK Investigational Site	Haifa
Israel	GSK Investigational Site	Haifa
Israel	GSK Investigational Site	Holon
Israel	GSK Investigational Site	Kfar Saba
Israel	GSK Investigational Site	Safed
Korea, Republic of	GSK Investigational Site	Seongnam-si
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Suwon, Kyonggi-do
Peru	GSK Investigational Site	Arequipa
Peru	GSK Investigational Site	Callao	Lima
Peru	GSK Investigational Site	Ica
Peru	GSK Investigational Site	Lima
Peru	GSK Investigational Site	Lima
Peru	GSK Investigational Site	Lima
Peru	GSK Investigational Site	Piura
Peru	GSK Investigational Site	Trujillo
Philippines	GSK Investigational Site	Cebu City
Philippines	GSK Investigational Site	Iloilo City
Philippines	GSK Investigational Site	Makati City
Philippines	GSK Investigational Site	Pasay
Philippines	GSK Investigational Site	Tagbilaran City
Russian Federation	GSK Investigational Site	Nizhniy Novgorod
Russian Federation	GSK Investigational Site	Saratov
Russian Federation	GSK Investigational Site	St'Petersburg
Russian Federation	GSK Investigational Site	Yaroslavl
South Africa	GSK Investigational Site	Durban	KwaZulu- Natal
South Africa	GSK Investigational Site	Houghton
South Africa	GSK Investigational Site	Johannesburg	Gauteng
South Africa	GSK Investigational Site	Johannesburg	Gauteng
South Africa	GSK Investigational Site	Lenasia	Gauteng
South Africa	GSK Investigational Site	Phoenix	KwaZulu- Natal
South Africa	GSK Investigational Site	Port Elizabeth	Eastern Cape
South Africa	GSK Investigational Site	Pretoria	Gauteng
South Africa	GSK Investigational Site	Pretoria
South Africa	GSK Investigational Site	Somerset West
South Africa	GSK Investigational Site	Tygerberg
Spain	GSK Investigational Site	Alicante
Spain	GSK Investigational Site	La Coruña
Spain	GSK Investigational Site	Málaga
Spain	GSK Investigational Site	Palma de Mallorca
Spain	GSK Investigational Site	Santiago de Compostela
Spain	GSK Investigational Site	Sevilla
Spain	GSK Investigational Site	Torrevieja (Alicante)
Taiwan	GSK Investigational Site	Kaohsiung
Taiwan	GSK Investigational Site	Taichung
Taiwan	GSK Investigational Site	Tainan
United Kingdom	GSK Investigational Site	Birmingham
United Kingdom	GSK Investigational Site	Coventry	West Midlands
United Kingdom	GSK Investigational Site	Hertfordshire
United Kingdom	GSK Investigational Site	Hull
United Kingdom	GSK Investigational Site	Liverpool
United Kingdom	GSK Investigational Site	Livingston
United Kingdom	GSK Investigational Site	London
United Kingdom	GSK Investigational Site	Plymouth
United Kingdom	GSK Investigational Site	Swansea
United States	GSK Investigational Site	Alexandria	Louisiana
United States	GSK Investigational Site	Altoona	Pennsylvania
United States	GSK Investigational Site	Arlington	Texas
United States	GSK Investigational Site	Arlington	Texas
United States	GSK Investigational Site	Asheville	North Carolina
United States	GSK Investigational Site	Atlanta	Georgia
United States	GSK Investigational Site	Atlanta	Georgia
United States	GSK Investigational Site	Augusta	Georgia
United States	GSK Investigational Site	Austin	Texas
United States	GSK Investigational Site	Austin	Texas
United States	GSK Investigational Site	Bangor	Maine
United States	GSK Investigational Site	Birmingham	Alabama
United States	GSK Investigational Site	Blue Ridge	Georgia
United States	GSK Investigational Site	Bountiful	Utah
United States	GSK Investigational Site	Bristol	Tennessee
United States	GSK Investigational Site	Burke	Virginia
United States	GSK Investigational Site	Charleston	South Carolina
United States	GSK Investigational Site	Cincinnati	Ohio
United States	GSK Investigational Site	Cleveland	Ohio
United States	GSK Investigational Site	Columbia	South Carolina
United States	GSK Investigational Site	Dallas	Texas
United States	GSK Investigational Site	Dallas	Texas
United States	GSK Investigational Site	Dallas	Texas
United States	GSK Investigational Site	Dearborn	Michigan
United States	GSK Investigational Site	Decatur	Georgia
United States	GSK Investigational Site	Deer Park	Texas
United States	GSK Investigational Site	Des Moines	Iowa
United States	GSK Investigational Site	Detroit	Michigan
United States	GSK Investigational Site	Doral	Florida
United States	GSK Investigational Site	Downington	Pennsylvania
United States	GSK Investigational Site	Flint	Michigan
United States	GSK Investigational Site	Fort Worth	Texas
United States	GSK Investigational Site	Franklin	Tennessee
United States	GSK Investigational Site	Fresno	California
United States	GSK Investigational Site	Gallipolis	Ohio
United States	GSK Investigational Site	Grapevine	Texas
United States	GSK Investigational Site	Greer	South Carolina
United States	GSK Investigational Site	Gulf Shores	Alabama
United States	GSK Investigational Site	Hollywood	Florida
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Humble	Texas
United States	GSK Investigational Site	Huntington Beach	California
United States	GSK Investigational Site	Huntsville	Alabama
United States	GSK Investigational Site	Hurst	North Carolina
United States	GSK Investigational Site	Hurst	Texas
United States	GSK Investigational Site	Hyattsville	Maryland
United States	GSK Investigational Site	Irving	Texas
United States	GSK Investigational Site	Jacksonville	Florida
United States	GSK Investigational Site	Kansas City	Missouri
United States	GSK Investigational Site	Kansas City	Missouri
United States	GSK Investigational Site	Knoxville	Tennessee
United States	GSK Investigational Site	Las Vegas	Nevada
United States	GSK Investigational Site	Las Vegas	Nevada
United States	GSK Investigational Site	Lexington	Kentucky
United States	GSK Investigational Site	Los Angeles	California
United States	GSK Investigational Site	Los Angeles	California
United States	GSK Investigational Site	Los Angeles	California
United States	GSK Investigational Site	Los Gatos	California
United States	GSK Investigational Site	Manassas	Virginia
United States	GSK Investigational Site	Medford	Oregon
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	Miami Beach	Florida
United States	GSK Investigational Site	Midland	Texas
United States	GSK Investigational Site	Mission	Kansas
United States	GSK Investigational Site	New Port Richey	Florida
United States	GSK Investigational Site	Norfolk	Virginia
United States	GSK Investigational Site	North Massapequa	New York
United States	GSK Investigational Site	North Myrtle Beach	South Carolina
United States	GSK Investigational Site	North Richland Hills	Texas
United States	GSK Investigational Site	Oklahoma City	Oklahoma
United States	GSK Investigational Site	Omaha	Nebraska
United States	GSK Investigational Site	Orange	California
United States	GSK Investigational Site	Paducah	Kentucky
United States	GSK Investigational Site	Pearland	Texas
United States	GSK Investigational Site	Pembroke Pines	Florida
United States	GSK Investigational Site	Philadelphia	Pennsylvania
United States	GSK Investigational Site	Phoenix	Arizona
United States	GSK Investigational Site	Plano	Texas
United States	GSK Investigational Site	Plantation	Florida
United States	GSK Investigational Site	Richardson	Texas
United States	GSK Investigational Site	Roswell	Georgia
United States	GSK Investigational Site	Salem	Virginia
United States	GSK Investigational Site	San Antonio	Texas
United States	GSK Investigational Site	San Antonio	Texas
United States	GSK Investigational Site	San Antonio	Texas
United States	GSK Investigational Site	San Diego	California
United States	GSK Investigational Site	San Diego	California
United States	GSK Investigational Site	San Dimas	California
United States	GSK Investigational Site	Schertz	Texas
United States	GSK Investigational Site	Shelby	North Carolina
United States	GSK Investigational Site	South Burlington	Vermont
United States	GSK Investigational Site	Springfield	Missouri
United States	GSK Investigational Site	Springfield	Massachusetts
United States	GSK Investigational Site	St Clair Shores	Michigan
United States	GSK Investigational Site	Staten Island	New York
United States	GSK Investigational Site	Stone Mountain	Georgia
United States	GSK Investigational Site	Sugarland	Texas
United States	GSK Investigational Site	Tabor City	North Carolina
United States	GSK Investigational Site	Tacoma	Washington
United States	GSK Investigational Site	Tampa	Florida
United States	GSK Investigational Site	Tarzana	California
United States	GSK Investigational Site	Taylor	Michigan
United States	GSK Investigational Site	Taylors	South Carolina
United States	GSK Investigational Site	Tomball	Texas
United States	GSK Investigational Site	Toney	Alabama
United States	GSK Investigational Site	Tullahoma	Tennessee
United States	GSK Investigational Site	Valparaiso	Indiana
United States	GSK Investigational Site	West Hills	California
United States	GSK Investigational Site	Whittier	California
United States	GSK Investigational Site	Whittier	California
United States	GSK Investigational Site	Wilmington	North Carolina
United States	GSK Investigational Site	Winston-Salem	North Carolina
United States	GSK Investigational Site	Winter Park	Florida
United States	GSK Investigational Site	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Australia,  Brazil,  Colombia,  Germany,  India,  Israel,  Korea, Republic of,  Peru,  Philippines,  Russian Federation,  South Africa,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline; Week 26	No
Secondary	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.	Baseline; Weeks 4, 8, 12, 16, and 20	No
Secondary	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.	Baseline; Weeks 4, 8, 12, 16, 20, 26, 36, 48, and 52	No
Secondary	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.	Baseline; Week 26	No
Secondary	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.	Baseline; Weeks 4, 8, 12, 16, 20, and 26	No
Secondary	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.	Baseline; Weeks 1, 2, 3, 4, 8, 12, 16, 20, 26, 36, 48, Week 52	No
Secondary	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.	Week 26	No
Secondary	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.	Week 26	No
Secondary	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.	Week 52	No
Secondary	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.	Week 52	No
Secondary	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 2 to Week 52	No
Secondary	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 2 to Week 52	No
Secondary	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.	Baseline; Week 26	No
Secondary	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.	Baseline; Week 1, Week 2 , Week 3, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 26	No
Secondary	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.	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	No
Secondary	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.	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)	No

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