Efficacy and Safety of Albiglutide in Treatment of Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00838903
First received: February 5, 2009
Last updated: August 11, 2014
Last verified: August 2014

February 5, 2009
August 11, 2014
February 2009
January 2012   (final data collection date for primary outcome measure)
Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 104 [ Time Frame: Baseline and Week 104 ] [ Designated as safety issue: No ]
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 value is defined as the last non-missing value before the start of treatment. Change from BL was calculated as the value at Week 104 minus the value at BL. Based on analysis of covariance (ANCOVA): change = treatment + BL HbA1c + prior myocardial infarction history + age category + region. Difference of least squares means (albiglutide - placebo, albiglutide - sitagliptin, albiglutide - glimepiride) is from the ANCOVA model. The last observation carried forward (LOCF) method was used to impute missing post-Baseline 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.
HbA1 c change from baseline [ Time Frame: two years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00838903 on ClinicalTrials.gov Archive Site
  • Change From Baseline in HbA1c at Week 156 [ Time Frame: Baseline and Week 156 ] [ Designated as safety issue: No ]
    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 .
  • Change From Baseline in Fasting Plasma Glucose (FPG) at Week 104 [ Time Frame: Baseline and Week 104 ] [ Designated as safety issue: No ]
    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 FPG + Baseline HbA1c category + prior myocardial infarction history + age category + region.
  • Change From Baseline in FPG at Week 156 [ Time Frame: Baseline and Week 156 ] [ Designated as safety issue: No ]
    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 Baseline value. This analysis used observed FPG values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.
  • Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 104 [ Time Frame: Week 104 ] [ Designated as safety issue: No ]
    The number of participants who achieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <7%, and <7.5% at Week 52) were assessed.
  • Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 156 [ Time Frame: Week 156 ] [ Designated as safety issue: No ]
    The number of participants who achieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <7%, and <7.5% at Week 156) were assessed.
  • Time to Hyperglycemia Rescue [ Time Frame: From the start of study medication until the end of the treatment (up to Week 156) ] [ Designated as safety issue: No ]
    Participants who experienced persistent hyperglycemia (high blood glucose) could have qualified for hyperglycemia rescue.The conditions for hyperglycemic rescue were as follows: FPG >=280 milligrams/deciliter (mg/dL) between >=Week 2 and <Week 4; FPG >=250 mg/dL between >=Week 4 and <Week 12; HbA1c >=8.5% and a <=0.5% reduction from Baseline between >=Week 12 and <Week 24; HbA1c >=8.5% between >=Week 24 and <Week 48; HbA1c >=8.0% between >= Week 48 and <Week 156. Participants could have been rescued at any time on or after Week 2. Time to hyperglycemia rescue is defined as the time between the date of the first dose of study medication and the date of hyperglycemia rescue plus 1 day, or the time between the date of the first dose of study medication and the date of the last visit during the active treatment period plus 1 day for participants not requiring rescue. This time was divided by 7 to express the result in week
  • Change From Baseline in Body Weight at Week 104 [ Time Frame: Baseline and Week 104 ] [ Designated as safety issue: No ]
    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 + Baseline HbA1c category + prior myocardial infarction history + age category + region.
  • Change From Baseline in Body Weight at Week 156 [ Time Frame: Baseline and Week 156 ] [ Designated as safety issue: No ]
    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. This analysis used observed body weight values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.
  • FPG change from baseline [ Time Frame: two years ] [ Designated as safety issue: No ]
  • body weight change from baseline [ Time Frame: two years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Efficacy and Safety of Albiglutide in Treatment of Type 2 Diabetes
A Randomized, Double-Blind, Placebo and Active-Controlled, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of Albiglutide When Used in Combination With Metformin Compared With Metformin Plus Sitagliptin, Metformin Plus Glimepiride, and Metformin Plus Placebo in Subjects With Type 2 Diabetes Mellitus

The purpose of this study is to determine if albiglutide is safe and effective in the treatment of type 2 diabetes.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Biological: albiglutide
    albiglutide
  • Drug: sitagliptin
    sitagliptin
  • Drug: glimepiride
    Glimepiride
  • Drug: metformin
    Metformin
  • Biological: placebo albiglutide
    placebo to match albiglutide
  • Drug: placebo sitagliptin
    placebo to match sitagliptin
  • Drug: placebo glimepiride
    placebo to match glimepiride
  • Experimental: albiglutide + metformin
    Albiglutide + metformin + placebo sitagliptin + placebo glimepiride
    Interventions:
    • Biological: albiglutide
    • Drug: metformin
    • Drug: placebo sitagliptin
    • Drug: placebo glimepiride
  • Active Comparator: sitagliptin + metformin
    Sitagliptin + metformin + placebo albiglutide + placebo glimepiride
    Interventions:
    • Drug: sitagliptin
    • Drug: metformin
    • Biological: placebo albiglutide
    • Drug: placebo glimepiride
  • Active Comparator: glimepiride + metformin
    Glimepiride + metformin + placebo albiglutide + placebo sitagliptin
    Interventions:
    • Drug: glimepiride
    • Drug: metformin
    • Biological: placebo albiglutide
    • Drug: placebo sitagliptin
  • Active Comparator: metformin + placebo
    Metformin + placebo albiglutide + placebo sitagliptin + placebo glimepiride
    Interventions:
    • Drug: metformin
    • Biological: placebo albiglutide
    • Drug: placebo sitagliptin
    • Drug: placebo glimepiride
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1049
March 2013
January 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • type 2 diabetes
  • BMI 20-45kg/m2 inclusive

Exclusion Criteria:

  • females who are pregnant, lactating or <6 weeks post-partum
  • current symptomatic heart failure (NYHA Class III or IV)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   United Kingdom,   Albania,   Germany,   Hong Kong,   Mexico,   Peru,   Philippines,   Russian Federation,   South Africa,   Spain
 
NCT00838903
112753
Yes
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP