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Safety and Efficacy of Albiglutide in Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT00849056
Recruitment Status : Completed
First Posted : February 23, 2009
Results First Posted : July 1, 2014
Last Update Posted : January 9, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date  ICMJE February 19, 2009
First Posted Date  ICMJE February 23, 2009
Results First Submitted Date  ICMJE April 24, 2014
Results First Posted Date  ICMJE July 1, 2014
Last Update Posted Date January 9, 2017
Study Start Date  ICMJE January 2009
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 29, 2014)
Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 52 [ Time Frame: Baseline and 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 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 52 minus the value at BL. Based on analysis of covariance (ANCOVA): change = treatment + BL HbA1c + prior myocardial infarction history + age category + region + current antidiabetic therapy. 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. One Intent-to-Treat (ITT) participant (par.) had all post-BL HbA1c measurements occur after hyperglycemic rescue. This par. is included in the ITT Population counts but did not contribute to this analysis.
Original Primary Outcome Measures  ICMJE
 (submitted: February 19, 2009)
HbA1c change from baseline [ Time Frame: one year ]
Change History Complete list of historical versions of study NCT00849056 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 29, 2014)
  • Change From Baseline in HbA1c at Weeks 104 and 156 [ Time Frame: Baseline and 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.
  • Time to Hyperglycemia Rescue [ Time Frame: From the start of study medication until the end of the treatment (up to Week 156) ]
    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 <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 weeks.
  • Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52 [ Time Frame: Baseline and 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.
  • Change From Baseline in Fasting Plasma Glucose (FPG) at Week 156 [ Time Frame: Baseline and 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.
  • Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 52 [ Time Frame: Week 52 ]
    The number of participants who achieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <6.5%, and <7.0% 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 ]
    The number of participants who achieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <6.5%, and <7.0% at Week 156) were assessed.
  • Change From Baseline in Body Weight at Week 52 [ Time Frame: Baseline and 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.
  • Change From Baseline in Body Weight at Week 156 [ Time Frame: Baseline and 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 19, 2009)
  • FPG change from baseline [ Time Frame: one year ]
  • body weight change from baseline [ Time Frame: one year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Albiglutide in Type 2 Diabetes
Official Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of Albiglutide When Used in Combination With Pioglitazone With or Without Metformin in Subjects With Type 2 Diabetes Mellitus
Brief Summary The purpose of this study is to determine the safety, tolerability and efficacy of albiglutide in the treatment of type 2 diabetes.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus, Type 2
Intervention  ICMJE
  • Biological: albiglutide
    albiglutide weekly subcutaneous injection
  • Drug: placebo
    placebo weekly subcutaneous injection
Study Arms  ICMJE
  • Placebo Comparator: placebo + pioglitazone (with or without metformin)
    Placebo albiglutide weekly injection + pioglitazone (with or without metformin)
    Intervention: Drug: placebo
  • Experimental: albiglutide + pioglitazone (with or without metformin)
    albiglutide weekly injection + pioglitazone (with or without meformin)
    Intervention: Biological: albiglutide
Publications * Home PD, Ahrén B, Reusch JEB, Rendell M, Weissman PN, Cirkel DT, Miller D, Ambery P, Carr MC, Nauck MA. Three-year data from 5 HARMONY phase 3 clinical trials of albiglutide in type 2 diabetes mellitus: Long-term efficacy with or without rescue therapy. Diabetes Res Clin Pract. 2017 Sep;131:49-60. doi: 10.1016/j.diabres.2017.06.013. Epub 2017 Jun 15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 9, 2011)
310
Original Estimated Enrollment  ICMJE
 (submitted: February 19, 2009)
300
Actual Study Completion Date  ICMJE January 2013
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • NYHA Class II to IV heart failure
  • females who are pregnant, lactating, or less than 6 weeks post-partum
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India,   Korea, Republic of,   Peru,   South Africa,   United Kingdom,   United States
Removed Location Countries Argentina,   Philippines
 
Administrative Information
NCT Number  ICMJE NCT00849056
Other Study ID Numbers  ICMJE 112755
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
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.
Responsible Party GlaxoSmithKline
Study Sponsor  ICMJE GlaxoSmithKline
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date November 2016

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