Last updated: 11/07/2018 05:12:52
A study to determine the safety and efficacy of albiglutide in subjects with type 2 diabetes
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Randomized, Double-blind, Placebo and Active-Controlled, Parallel-group, Multicenter Study to Determine the Efficacy and Safety of Albiglutide Administered in Combination With Metformin and Glimepiride Compared With Metformin Plus Glimepiride and Placebo and with Metformin plus Glimepiride and Pioglitazone in Subjects With Type 2 Diabetes Mellitus
Trial description: The purpose of this study is to determine the safety and efficacy of albiglutide in subjects with type 2 diabetes
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Change from Baseline (BL) in glycosylated hemoglobin (HbA1c) at Week 52
Timeframe: Baseline and Week 52
Secondary outcomes:
Change from Baseline in HbA1c at Week 104 and Week 156
Timeframe: Baseline, Week 104, and Week 156
Change from Baseline in fasting plasma glucose (FPG) at Week 52
Timeframe: Baseline and Week 52
Change from Baseline in FPG at Week 104 and Week 156
Timeframe: Baseline, Week 104, and Week 156
Time to hyperglycemia rescue
Timeframe: From the start of study medication until the end of the treatment (up to Week 156)
Number of participants who achieved clinically meaningful HbA1c response levels of <6.5%, <7%, and <7.5% at Week 52
Timeframe: Week 52
Number of participants who achieved clinically meaningful HbA1c response levels of <6.5%, <7%, and <7.5% at Week 156
Timeframe: Week 156
Change from Baseline in body weight at Week 52
Timeframe: Baseline and Week 52
Change from Baseline in body weight at Week 104 and Week 156
Timeframe: Baseline, Week 104, and Week 156
Interventions:
Drug: placebo to match albiglutide
Biological/vaccine: albiglutide
Drug: metformin
Drug: glimepiride
Drug: pioglitazone
Drug: placebo to match pioglitazone
Enrollment:
685
Observational study model:
Not applicable
Primary completion date:
2012-28-01
Time perspective:
Not applicable
Clinical publications:
Home P, Stewart M, Carr M, Miller M, Yang F, Shamanna P.Harmony 5 PRIMARY ENDPOINT PUBLICATION: HARMONY 5: 52 week efficacy of albiglutide versus placebo and versus pioglitazone in patients with type 2 diabetes currently taking metformin and glimepiride.Diabetes Obes Metab.2015;17(2):179-87
Medical condition
Diabetes Mellitus, Type 2
Product
albiglutide, glimepiride, metformin, pioglitazone
Collaborators
Not applicable
Study date(s)
February 2009 to April 2013
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- type 2 diabetes
- BMI 20-45kg/m2 inclusive
- females who are pregnant, lactating, or less than 6 weeks post-partum
- current symptomatic heart failure (NYHA Class II-IV)
Inclusion and exclusion criteria
Inclusion criteria:
- type 2 diabetes
- BMI 20-45kg/m2 inclusive
Exclusion criteria:
- females who are pregnant, lactating, or less than 6 weeks post-partum
- current symptomatic heart failure (NYHA Class II-IV)
Trial location(s)
Location
GSK Investigational Site
Pune, India, 411011
73.9 miles (118.2 km) away from your location
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2012-28-01
Actual study completion date
2013-02-04
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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