Safety and Efficacy Study of Albiglutide in Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of Two Dose Levels of Albiglutide Compared With Placebo in Subjects With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00849017
• Other study ID #: 112756
• Status: Completed
• Phase: Phase 3
• First received: February 19, 2009
• Last updated: May 29, 2014
• Start date: January 2009
• Est. completion date: January 2013

Study information

• Verified date: April 2014
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Africa: Medicines Control CouncilMexico: Ministry of HealthUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether albiglutide is effective in the treament of patients with type 2 diabetes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 309
• Est. completion date: January 2013
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• type 2 diabetes

• BMI 20-45kg/m2 inclusive

Exclusion Criteria:

• females who are pregnant, lactating, or <6 weeks post-partum

• CHF NYHA class III-IV

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

Intervention

Biological:
• albiglutide
albiglutide weekly injection
• albiglutide uptitration
albiglutide uptitration at week 12
• placebo
matching albiglutide placebo weekly injection

Locations

Country	Name	City	State
Mexico	GSK Investigational Site	Cuernavaca
Mexico	GSK Investigational Site	Distrito Federal
Mexico	GSK Investigational Site	Guadalajara
Mexico	GSK Investigational Site	Guadalajara
Mexico	GSK Investigational Site	Merida	Yucatán
Mexico	GSK Investigational Site	Mexico City
Mexico	GSK Investigational Site	Mexico City
Mexico	GSK Investigational Site	Morelia	Michoacán
Mexico	GSK Investigational Site	Nezahualcoyotl
Mexico	GSK Investigational Site	Pachuca	Hidalgo
Mexico	GSK Investigational Site	Puebla
Mexico	GSK Investigational Site	Tijuana	Baja California Norte
Mexico	GSK Investigational Site	Torreón
Mexico	GSK Investigational Site	Zapopan	Jalisco
South Africa	GSK Investigational Site	Parow
United States	GSK Investigational Site	Akron	Ohio
United States	GSK Investigational Site	Alabaster	Alabama
United States	GSK Investigational Site	Arkansas City	Kansas
United States	GSK Investigational Site	Arlington	Texas
United States	GSK Investigational Site	Arvada	Colorado
United States	GSK Investigational Site	Asheville	North Carolina
United States	GSK Investigational Site	Ashland	Oregon
United States	GSK Investigational Site	Atlanta	Georgia
United States	GSK Investigational Site	Atlanta	Georgia
United States	GSK Investigational Site	Atlanta	Georgia
United States	GSK Investigational Site	Atlanta	Georgia
United States	GSK Investigational Site	Avon	Indiana
United States	GSK Investigational Site	Baltimore	Maryland
United States	GSK Investigational Site	Bay City	Michigan
United States	GSK Investigational Site	Bensalem	Pennsylvania
United States	GSK Investigational Site	Benzonia	Michigan
United States	GSK Investigational Site	Berlin	New Jersey
United States	GSK Investigational Site	Birmingham	Alabama
United States	GSK Investigational Site	Birmingham	Alabama
United States	GSK Investigational Site	Blue Ridge	Georgia
United States	GSK Investigational Site	Bristol	Tennessee
United States	GSK Investigational Site	Broken Bow	Nebraska
United States	GSK Investigational Site	Bull Shoals	Arkansas
United States	GSK Investigational Site	Burke	Virginia
United States	GSK Investigational Site	Burlington	North Carolina
United States	GSK Investigational Site	Calabash	North Carolina
United States	GSK Investigational Site	Canal Fulton	Ohio
United States	GSK Investigational Site	Carmichael	California
United States	GSK Investigational Site	Chadbourn	North Carolina
United States	GSK Investigational Site	Chandler	Arizona
United States	GSK Investigational Site	Chesterfield	Missouri
United States	GSK Investigational Site	Chicago	Illinois
United States	GSK Investigational Site	Chula Vista	California
United States	GSK Investigational Site	Clarksville	Tennessee
United States	GSK Investigational Site	Clearwater	Florida
United States	GSK Investigational Site	Cleburne	Texas
United States	GSK Investigational Site	Cleveland	Ohio
United States	GSK Investigational Site	Cocoa	Florida
United States	GSK Investigational Site	Columbia	Tennessee
United States	GSK Investigational Site	Columbia	South Carolina
United States	GSK Investigational Site	Columbus	Ohio
United States	GSK Investigational Site	Columbus	Georgia
United States	GSK Investigational Site	Corpus Christi	Texas
United States	GSK Investigational Site	Council Bluffs	Iowa
United States	GSK Investigational Site	Covington	Louisiana
United States	GSK Investigational Site	Crescent Springs	Kentucky
United States	GSK Investigational Site	Crossville	Tennessee
United States	GSK Investigational Site	Cutler Bay	Florida
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	Dallas	Texas
United States	GSK Investigational Site	Dayton	Ohio
United States	GSK Investigational Site	Dayton	Ohio
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	Deerfield Beach	Florida
United States	GSK Investigational Site	Delray Beach	Florida
United States	GSK Investigational Site	Dothan	Alabama
United States	GSK Investigational Site	Downington	Pennsylvania
United States	GSK Investigational Site	Dubuque	Iowa
United States	GSK Investigational Site	East Providence	Rhode Island
United States	GSK Investigational Site	El Paso	Texas
United States	GSK Investigational Site	Elizabeth	New Jersey
United States	GSK Investigational Site	Evansville	Indiana
United States	GSK Investigational Site	Evergreen Park	Illinois
United States	GSK Investigational Site	Fayetteville	North Carolina
United States	GSK Investigational Site	Foothill Ranch	California
United States	GSK Investigational Site	Fort Lauderdale	Florida
United States	GSK Investigational Site	Fort Worth	Texas
United States	GSK Investigational Site	Fresno	California
United States	GSK Investigational Site	Gilbert	Arizona
United States	GSK Investigational Site	Great Falls	Montana
United States	GSK Investigational Site	Green Valley	Arizona
United States	GSK Investigational Site	Greensboro	North Carolina
United States	GSK Investigational Site	Greenville	South Carolina
United States	GSK Investigational Site	Greenville	South Carolina
United States	GSK Investigational Site	Greer	South Carolina
United States	GSK Investigational Site	Haddon Heights	New Jersey
United States	GSK Investigational Site	Hainesport	New Jersey
United States	GSK Investigational Site	Hallandale Beach	Florida
United States	GSK Investigational Site	Harrisburg	Pennsylvania
United States	GSK Investigational Site	Haverhill	Massachusetts
United States	GSK Investigational Site	Hialeah	Florida
United States	GSK Investigational Site	Hickory	North Carolina
United States	GSK Investigational Site	Hollywood	Florida
United States	GSK Investigational Site	Honolulu	Hawaii
United States	GSK Investigational Site	Honolulu	Hawaii
United States	GSK Investigational Site	Hot Springs	Arkansas
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	Huntington Beach	California
United States	GSK Investigational Site	Huntington Beach	California
United States	GSK Investigational Site	Hurst	Texas
United States	GSK Investigational Site	Idaho Falls	Idaho
United States	GSK Investigational Site	Indianapolis	Indiana
United States	GSK Investigational Site	Indio	California
United States	GSK Investigational Site	Interlochen	Michigan
United States	GSK Investigational Site	Iowa City	Iowa
United States	GSK Investigational Site	Irvine	California
United States	GSK Investigational Site	Jefferson City	Missouri
United States	GSK Investigational Site	Johnson City	Tennessee
United States	GSK Investigational Site	Jonesboro	Arkansas
United States	GSK Investigational Site	Kalamazoo	Michigan
United States	GSK Investigational Site	Kalamazoo	Michigan
United States	GSK Investigational Site	Kansas City	Missouri
United States	GSK Investigational Site	Katy	Texas
United States	GSK Investigational Site	Kettering	Ohio
United States	GSK Investigational Site	La Grange	Illinois
United States	GSK Investigational Site	La Porte	Indiana
United States	GSK Investigational Site	Lake Charles	Louisiana
United States	GSK Investigational Site	Lakewood	California
United States	GSK Investigational Site	Lansdale	Pennsylvania
United States	GSK Investigational Site	Las Vegas	Nevada
United States	GSK Investigational Site	Las Vegas	Nevada
United States	GSK Investigational Site	Las Vegas	Nevada
United States	GSK Investigational Site	Lauderdale Lakes	Florida
United States	GSK Investigational Site	Lenoir	North Carolina
United States	GSK Investigational Site	Lewisburg	West Virginia
United States	GSK Investigational Site	Lewisville	Texas
United States	GSK Investigational Site	Lexington	Kentucky
United States	GSK Investigational Site	Lincoln	Nebraska
United States	GSK Investigational Site	Little Rock	Arkansas
United States	GSK Investigational Site	Long Beach	California
United States	GSK Investigational Site	Los Alamitos	California
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	Madisonville	Kentucky
United States	GSK Investigational Site	Manassas	Virginia
United States	GSK Investigational Site	Marianna	Florida
United States	GSK Investigational Site	Mason	Ohio
United States	GSK Investigational Site	Maumee	Ohio
United States	GSK Investigational Site	McKenzie	Tennessee
United States	GSK Investigational Site	Melrose Park	Pennsylvania
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	Middletown	Delaware
United States	GSK Investigational Site	Midland	Texas
United States	GSK Investigational Site	Milwaukee	Wisconsin
United States	GSK Investigational Site	Mint Hill	North Carolina
United States	GSK Investigational Site	Mission Viejo	California
United States	GSK Investigational Site	Morehead City	North Carolina
United States	GSK Investigational Site	Murrells Inlet	South Carolina
United States	GSK Investigational Site	Naperville	Illinois
United States	GSK Investigational Site	Nashville	Tennessee
United States	GSK Investigational Site	New Britain	Connecticut
United States	GSK Investigational Site	Newton	Kansas
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	Northridge	California
United States	GSK Investigational Site	Ocala	Florida
United States	GSK Investigational Site	Odessa	Texas
United States	GSK Investigational Site	Oklahoma City	Oklahoma
United States	GSK Investigational Site	Omaha	Nebraska
United States	GSK Investigational Site	Omaha	Nebraska
United States	GSK Investigational Site	Omaha	Nebraska
United States	GSK Investigational Site	Orangeburg	South Carolina
United States	GSK Investigational Site	Orlando	Florida
United States	GSK Investigational Site	Ormond Beach	Florida
United States	GSK Investigational Site	Overland Park	Kansas
United States	GSK Investigational Site	Oviedo	Florida
United States	GSK Investigational Site	Oxon Hill	Maryland
United States	GSK Investigational Site	Paducah	Kentucky
United States	GSK Investigational Site	Palm Desert	California
United States	GSK Investigational Site	Panama City	Florida
United States	GSK Investigational Site	Pasadena	California
United States	GSK Investigational Site	Pembroke Pines	Florida
United States	GSK Investigational Site	Pembroke Pines	Florida
United States	GSK Investigational Site	Peoria	Illinois
United States	GSK Investigational Site	Phoenix	Arizona
United States	GSK Investigational Site	Picayune	Mississippi
United States	GSK Investigational Site	Pittsburgh	Pennsylvania
United States	GSK Investigational Site	Plantation	Florida
United States	GSK Investigational Site	Richland	Washington
United States	GSK Investigational Site	Riverside	California
United States	GSK Investigational Site	Rolling Fork	Mississippi
United States	GSK Investigational Site	Sacramento	California
United States	GSK Investigational Site	Salt Lake City	Utah
United States	GSK Investigational Site	Salt Lake City	Utah
United States	GSK Investigational Site	Salt Lake City	Utah
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 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 Diego	California
United States	GSK Investigational Site	San Diego	California
United States	GSK Investigational Site	Santa Ana	California
United States	GSK Investigational Site	Satna Monica	California
United States	GSK Investigational Site	Savannah	Georgia
United States	GSK Investigational Site	Savannah	Georgia
United States	GSK Investigational Site	Schertz	Texas
United States	GSK Investigational Site	Searcy	Arkansas
United States	GSK Investigational Site	Selah	Washington
United States	GSK Investigational Site	Shelby	North Carolina
United States	GSK Investigational Site	Shreveport	Louisiana
United States	GSK Investigational Site	Shreveport	Louisiana
United States	GSK Investigational Site	Simpsonville	South Carolina
United States	GSK Investigational Site	Snellville	Georgia
United States	GSK Investigational Site	South Bend	Indiana
United States	GSK Investigational Site	South Burlington	Vermont
United States	GSK Investigational Site	Spokane	Washington
United States	GSK Investigational Site	Spring Valley	California
United States	GSK Investigational Site	Springfield	Missouri
United States	GSK Investigational Site	St Clair Shores	Michigan
United States	GSK Investigational Site	St. Cloud	Florida
United States	GSK Investigational Site	St. Louis	Missouri
United States	GSK Investigational Site	Stratford	New Jersey
United States	GSK Investigational Site	Suffolk	Virginia
United States	GSK Investigational Site	Sugar Land	Texas
United States	GSK Investigational Site	Sugarland	Texas
United States	GSK Investigational Site	Tabor City	North Carolina
United States	GSK Investigational Site	Tarzana	California
United States	GSK Investigational Site	Taylors	South Carolina
United States	GSK Investigational Site	Thornville	Ohio
United States	GSK Investigational Site	Tipton	Pennsylvania
United States	GSK Investigational Site	Topeka	Kansas
United States	GSK Investigational Site	Torrance	California
United States	GSK Investigational Site	Tucker	Georgia
United States	GSK Investigational Site	Tucson	Arizona
United States	GSK Investigational Site	Tullahoma	Tennessee
United States	GSK Investigational Site	Tulsa	Oklahoma
United States	GSK Investigational Site	Tulsa	Oklahoma
United States	GSK Investigational Site	Uniontown	Pennsylvania
United States	GSK Investigational Site	Victorville	California
United States	GSK Investigational Site	Virgina Beach	Virginia
United States	GSK Investigational Site	Vista	California
United States	GSK Investigational Site	Walnut Creek	California
United States	GSK Investigational Site	Waterloo	Iowa
United States	GSK Investigational Site	Weber City	Virginia
United States	GSK Investigational Site	West Hills	California
United States	GSK Investigational Site	West Jordan	Utah
United States	GSK Investigational Site	West Palm Beach	Florida
United States	GSK Investigational Site	West Plains	Missouri
United States	GSK Investigational Site	West Valley City	Utah
United States	GSK Investigational Site	Zanesville	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Mexico,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 52	Glycated hemoglobin (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 BL HbA1c is defined as the last non-missing value before the start of treatment. Change from BL was calculated as the value at Week 52 minus the value at BL. 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 post-BL HbA1c values; the last non-missing post-BL on-treatment measurement was used to impute the missing measurement. HbA1c values obtained after hyperglycemic rescue were treated as missing and were replaced with pre-rescue values.	Baseline and Week 52	No
Secondary	Change From Baseline in HbA1c at Weeks 104 and 156	HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. This analysis used observed HbA1c values, excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.	Baseline and Weeks 104 and 156	No
Secondary	Time to Hyperglycemia Rescue	Participants who experienced persistent hyperglycemia (high blood glucose) could have qualified for hyperglycemia rescue. The conditions for hyperglycemia rescue were as follows: FPG >=280 milligrams/deciliter (mg/dL) between >=Week 2 and	From the start of study medication until the end of the treatment (up to Week 156)	No
Secondary	Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52	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. FPG values obtained after hyperglycemia rescue were treated as missing and replaced with pre-rescue values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Based on ANCOVA: change = treatment + Baseline weight + prior myocardial infarction history + age category + region + current antidiabetic therapy.	Baseline and Week 52	No
Secondary	Change From Baseline in Fasting Plasma Glucose (FPG) at Week 156	The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline FPG minus the Baseline FPG.	Baseline and Week 156	No
Secondary	Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 52	The number of participants who acheieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <7%, and <7.5% at Week 52) were assessed.	Week 52	No
Secondary	Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 156	The number of participants who acheieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <7%, and <7.5% at Week 156) were assessed.	Week 156	No
Secondary	Change From Baseline in Body Weight at Week 52	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. Weight values obtained after hyperglycemia rescue were treated as missing and replaced with prerescue values. Based on ANCOVA: change = treatment + Baseline weight + prior myocardial infarction history + age category + region + current antidiabetic therapy.	Baseline and Week 52	No
Secondary	Change From Baseline in Body Weight at Week 156	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.	Baseline and Week 156	No
Secondary	Change From Baseline in Postprandial Blood Glucose Profile Parameter-4 Hour C-peptide AUC	Changes from Baseline at Week 52 in postprandial parameters after a mixed-meal (MM) tolerance test were analyzed. Post prandial blood glucose parameter analyzed was 4 hour c-peptide AUC. The AUC was determined using the trapezoidal method using measurements until 4 hours following the meal. The standardized AUC is the total AUC divided by elapsed time. Those parameters were analyzed analogous to the primary endpoint using an ANCOVA model with treatment group as a factor, and corresponding Baseline postprandial profile as a continuous covariate. This analysis used observed values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.	Baseline and Week 52	No
Secondary	Change From Baseline in Postprandial Blood Glucose Profile Parameter- 4 Hour Blood Glucose AUC	Changes from Baseline at Week 52 in postprandial parameters after a mixed-meal (MM) tolerance test were analyzed. Post prandial blood glucose parameter analyzed was: 4 hour blood glucose area under urve AUC The AUC was determined using the trapezoidal method using measurements until 4 hours following the meal. The standardized AUC is the total AUC divided by elapsed time. Those parameters were analyzed analogous to the primary endpoint using an ANCOVA model with treatment group as a factor, and corresponding Baseline postprandial profile as a continuous covariate. This analysis used observed values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.	Baseline and Week 52	No
Secondary	Change From Baseline in Postprandial Blood Glucose Profile Parameters-4 Hour Insulin AUC and 4 Hour Proinsulin AUC	Changes from Baseline at Week 52 in postprandial parameters after a mixed-meal (MM) tolerance test were analyzed. Post prandial blood glucose parameters analyzed were: 4-hour insulin AUC (4 hr Ins AUC), and 4-hour proinsulin AUC (4 hr pro-Ins AUC). The AUC was determined using the trapezoidal method using measurements until 4 hours following the meal. The standardized AUC is the total AUC divided by elapsed time. Those parameters were analyzed analogous to the primary endpoint using an ANCOVA model with treatment group as a factor, and corresponding Baseline postprandial profile as a continuous covariate. This analysis used observed values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.	Baseline and Week 52	No
Secondary	Albiglutide Plasma Concentration at Weeks 8 and 24	Albiglutide plasma concentration data was analyzed at Week 8 pre-dose, Week 8 post dose, Week 24 pre-dose and Week 24 post-dose. All participants who received albiglutide were initiated on a 30mg weekly dosing regimen; however, beginning at Week 12, participants in the albiglutide 50 mg treatment group were uptitrated to receive albiglutide 50 mg for the remainder of the study.	Weeks 8 and 24	No