A Study to Determine the Efficacy and Safety of Albiglutide as Compared With Liraglutide.

Diabetes Mellitus Clinical Trial

Official title:

A Randomized, Open-Label, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of Albiglutide as Compared With Liraglutide in Subjects With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01128894
• Other study ID #: 114179
• Status: Completed
• Phase: Phase 3
• First received: April 29, 2010
• Last updated: May 22, 2014
• Start date: May 2010
• Est. completion date: September 2011

Study information

• Verified date: April 2014
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This open-label study examines the efficacy and safety of albiglutide as compared with liraglutide in subjects with type 2 diabetes.

Description:

This randomized, open-label, multicenter, 2 parallel-group study evaluates the efficacy and safety of a weekly subcutaneously injected dose of albiglutide as compared with liraglutide. Subjects with a historical diagnosis of type 2 diabetes mellitus and whose glycemia is inadequately controlled on their current regimen of metformin, thiazolidinedione, sulfonylurea, or any combination of these oral antidiabetics will be recruited into the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 841
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of type 2 diabetes mellitus and experiencing inadequate glycemic control on their current regimen of metformin, TZD, SU, or any combination of these oral antidiabetic medications

• BMI >/=20kg/m2 and </=45 kg/m2

• Fasting C-peptide >/=0.8 ng/mL (>/=0.26 nmol/L)

• HbA1c between 7.0% and 10.0%, inclusive

• Female subjects of childbearing potential must be practicing adequate contraception.

Exclusion Criteria:

• History of cancer

• History of treated diabetic gastroparesis

• Current biliary disease or history of pancreatitis

• History of significant GI surgery

• Recent clinically significant cardiovascular and/or cerebrovascular disease

• Hypertension

• History of human immunodeficiency virus infection

• History of or current liver disease or acute symptomatic infection with hepatitis B or hepatitis C

• History of alcohol or substance abuse

• Female subject is pregnant, lactating, or <6 weeks postpartum

• Known allergy to any GLP 1 analogue, liraglutide, other study medications' excipients, excipients of albiglutide, or Baker's yeast

• History of type 1 diabetes mellitus

• Contraindications (as per the prescribing information) for the use of either background or potential randomized study medications (e.g., liraglutide)

• Receipt of any investigational drug or liraglutide 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

• History or family history of thyroid disease

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Biological:
• albiglutide
albiglutide weekly subcutaneous injection

Drug:
• liraglutide
liraglutide daily subcutaneous injection, starting at 0.6mg, then up-titrating to 1.2mg then 1.8mg in accordance with prescribing information.

Locations

Country	Name	City	State
Australia	GSK Investigational Site	Box Hill	Victoria
Australia	GSK Investigational Site	Camperdown	New South Wales
Australia	GSK Investigational Site	Fremantle	Western Australia
Australia	GSK Investigational Site	Garran	Australian Capital Territory
Australia	GSK Investigational Site	Geelong	Victoria
Australia	GSK Investigational Site	Heidelberg	Victoria
Australia	GSK Investigational Site	Herston	Queensland
Australia	GSK Investigational Site	Ringwood East	Victoria
Australia	GSK Investigational Site	St Leonards	New South Wales
Israel	GSK Investigational Site	Beer-Sheva
Israel	GSK Investigational Site	Haifa
Israel	GSK Investigational Site	Kfar Saba
Israel	GSK Investigational Site	Nahariya
Korea, Republic of	GSK Investigational Site	Goyang
Korea, Republic of	GSK Investigational Site	Seongnam-si
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
Peru	GSK Investigational Site	Callao	Lima
Peru	GSK Investigational Site	Huacho	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
Philippines	GSK Investigational Site	Cebu City
Philippines	GSK Investigational Site	Iloilo City
Philippines	GSK Investigational Site	Makati City
Philippines	GSK Investigational Site	Marikina City
Philippines	GSK Investigational Site	Pasay
Philippines	GSK Investigational Site	Pasig
Philippines	GSK Investigational Site	Pasig City
Spain	GSK Investigational Site	Alicante
Spain	GSK Investigational Site	La Coruña
Spain	GSK Investigational Site	Majadahonda (Madrid)
Spain	GSK Investigational Site	Modulo H
Spain	GSK Investigational Site	Sabadell
Spain	GSK Investigational Site	Torrevieja (Alicante)
United Kingdom	GSK Investigational Site	Birmingham
United Kingdom	GSK Investigational Site	Hertfordshire
United Kingdom	GSK Investigational Site	Livingston
United Kingdom	GSK Investigational Site	London
United Kingdom	GSK Investigational Site	Swansea
United States	GSK Investigational Site	Arlington	Texas
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	Birmingham	Alabama
United States	GSK Investigational Site	Bloomfield Hills	Michigan
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	Burlington	North Carolina
United States	GSK Investigational Site	Canal Fulton	Ohio
United States	GSK Investigational Site	Chandler	Arizona
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	Cleveland	Ohio
United States	GSK Investigational Site	Cocoa	Florida
United States	GSK Investigational Site	Columbus	Ohio
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	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	Dearborn	Michigan
United States	GSK Investigational Site	Detroit	Michigan
United States	GSK Investigational Site	Downington	Pennsylvania
United States	GSK Investigational Site	Draper	Utah
United States	GSK Investigational Site	Dubuque	Iowa
United States	GSK Investigational Site	Durham	North Carolina
United States	GSK Investigational Site	Elizabeth	New Jersey
United States	GSK Investigational Site	Escondido	California
United States	GSK Investigational Site	Evansville	Indiana
United States	GSK Investigational Site	Fort Worth	Texas
United States	GSK Investigational Site	Fresno	California
United States	GSK Investigational Site	Gallipolis	Ohio
United States	GSK Investigational Site	Gilbert	Arizona
United States	GSK Investigational Site	Greensboro	North Carolina
United States	GSK Investigational Site	Greer	South Carolina
United States	GSK Investigational Site	Haddon Heights	New Jersey
United States	GSK Investigational Site	Haverhill	Massachusetts
United States	GSK Investigational Site	Honolulu	Hawaii
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	Hurst	Texas
United States	GSK Investigational Site	Idaho Falls	Idaho
United States	GSK Investigational Site	Indio	California
United States	GSK Investigational Site	Irvine	California
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	Las Vegas	Nevada
United States	GSK Investigational Site	Las Vegas	Nevada
United States	GSK Investigational Site	Lenoir	North Carolina
United States	GSK Investigational Site	Lexington	Kentucky
United States	GSK Investigational Site	Lincoln	Nebraska
United States	GSK Investigational Site	Los Angeles	California
United States	GSK Investigational Site	Los Angeles	California
United States	GSK Investigational Site	Manassas	Virginia
United States	GSK Investigational Site	Memphis	Tennessee
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	Midland	Texas
United States	GSK Investigational Site	Minneapolis	Minnesota
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	North Massapequa	New York
United States	GSK Investigational Site	North Miami	Florida
United States	GSK Investigational Site	North Richland Hills	Texas
United States	GSK Investigational Site	Ocala	Florida
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	Orlando	Florida
United States	GSK Investigational Site	Paducah	Kentucky
United States	GSK Investigational Site	Palm Desert	California
United States	GSK Investigational Site	Pembroke Pines	Florida
United States	GSK Investigational Site	Phoenix	Arizona
United States	GSK Investigational Site	Picayune	Mississippi
United States	GSK Investigational Site	Portland	Oregon
United States	GSK Investigational Site	Richmond	Virginia
United States	GSK Investigational Site	Richmond	Virginia
United States	GSK Investigational Site	Riverside	California
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 Antonio	Texas
United States	GSK Investigational Site	San Diego	California
United States	GSK Investigational Site	San Diego	California
United States	GSK Investigational Site	Satna Monica	California
United States	GSK Investigational Site	Schertz	Texas
United States	GSK Investigational Site	Searcy	Arkansas
United States	GSK Investigational Site	Shelby	North Carolina
United States	GSK Investigational Site	Shreveport	Louisiana
United States	GSK Investigational Site	Simpsonville	South Carolina
United States	GSK Investigational Site	South Burlington	Vermont
United States	GSK Investigational Site	Spokane	Washington
United States	GSK Investigational Site	Spokane	Washington
United States	GSK Investigational Site	Spring Valley	California
United States	GSK Investigational Site	St Clair Shores	Michigan
United States	GSK Investigational Site	St. Louis	Missouri
United States	GSK Investigational Site	St. Louis	Missouri
United States	GSK Investigational Site	St. Petersburg	Florida
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	Tacoma	Washington
United States	GSK Investigational Site	Tampa	Florida
United States	GSK Investigational Site	Tarzana	California
United States	GSK Investigational Site	Tucson	Arizona
United States	GSK Investigational Site	Tullahoma	Tennessee
United States	GSK Investigational Site	Tustin	California
United States	GSK Investigational Site	Valparaiso	Indiana
United States	GSK Investigational Site	Walnut Creek	California
United States	GSK Investigational Site	West Hills	California
United States	GSK Investigational Site	West Jordan	Utah
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,  Israel,  Korea, Republic of,  Peru,  Philippines,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 32	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 32 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 and Week 32	No
Secondary	Mean Change From Baseline in HbA1c at Weeks 4, 6, 12, 18 and 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 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 considered in the treatment week if they had received at least one dose in that treatment week.	Baseline, Weeks 4, 6, 12, 18 and 26	No
Secondary	Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 32	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 was calculated as the post-Baseline value minus the value at Baseline. The analysis was performed using an Analysis of Covariance (ANCOVA) model with treatment group, region, Baseline HbA1c category, history of prior myocardial infarction (yes versus no), and age category (<65 years versus =65 years) as factors and Baseline FPG as a continuous covariate. 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 considered in the treatment week if they had received at least one dose in that treatment week.	Baseline and Week 32	No
Secondary	Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 1, 2, 3, 4, 6, 12, 18 and 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 the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. 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 considered in the treatment week if they had received at least one dose in that treatment week.	Baseline, Weeks 1, 2, 3, 4, 6, 12, 18 and 26	No
Secondary	Number of Participants Who Achieved HbA1c Response Level of <6.5% and <7.0% at Week 32	Number of participants who achieved HbA1c response levels of <6.5% and <7.0% at Week 32 were assessed. 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.	Week 32	No
Secondary	Time to Hyperglycemia Rescue at Week 32	Participants who experienced persistent hyperglycemia (high blood glucose) could have qualified for hyperglycemia rescue. The conditions for hyperglycemia rescue were as follows: fasting plasma glucose (FPG) >=280 milligram/decilitre (mg/dL) >= Week 2 and < Week 4, FPG >=250 mg/dL >= Week 4 and	Week 32	No
Secondary	Mean Change From Baseline in Body Weight at Week 32	The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the value at Week 32 minus the value at Baseline. The analysis was performed using an Analysis of Covariance (ANCOVA) model with treatment group, region, Baseline HbA1c category, history of prior myocardial infarction (yes versus no), and age category (<65 years versus =65 years) as factors and Baseline weight as a continuous covariate. 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. Weight values obtained after hyperglycemia rescue were treated as missing and replaced with pre-rescue values.	Baseline and Week 32	No