Last updated: 11/07/2018 07:15:01
A study of the efficacy and safety of albiglutide in subjects with type 2 diabetes with renal impairment.
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A Randomized, Double-Blind, Active-Controlled, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of Albiglutide as Compared With Sitagliptin in Subjects With Type 2 Diabetes Mellitus With Renal Impairment
Trial description: This randomized, double-blind, active-controlled study evaluates the efficacy and safety of a weekly dose of albiglutide as compared with sitagliptin. Subjects who are renally impaired with a historical diagnosis of type 2 diabetes mellitus and whose glycemia is inadequately controlled on their current regimen of diet and exercise or their antidiabetic therapy of metformin, thiazolidinedione, sulfonylurea, or any combination of these oral antidiabetic medications will be recruited into the study.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Change from Baseline in glycosylated hemoglobin (HbA1c) at Week 26
Timeframe: Baseline; Week 26
Secondary outcomes:
Mean change from Baseline in HbA1c at Weeks 4, 8, 12, 16, and 20: LOCF
Timeframe: Baseline; Weeks 4, 8, 12, 16, and 20
Mean change from Baseline in HbA1c at Weeks 4, 8, 12, 16, 20, 26, 36, 48, and Week 52: Observed Cases
Timeframe: Baseline; Weeks 4, 8, 12, 16, 20, 26, 36, 48, and 52
Change from Baseline in fasting plasma glucose (FPG) at Week 26
Timeframe: Baseline; Week 26
Mean change from Baseline in FPG at Weeks 4, 8, 12, 16, 20, and 26: LOCF
Timeframe: Baseline; Weeks 4, 8, 12, 16, 20, and 26
Mean change from Baseline in fasting plasma glucose (FPG) at Weeks 1, 2, 3, 4, 8, 12, 16, 20, 26, 36, 48, and Week 52: OC
Timeframe: Baseline; Weeks 1, 2, 3, 4, 8, 12, 16, 20, 26, 36, 48, Week 52
Number of participants who achieved clinically meaningful HbA1c response levels of <6.5% and <7.0% at Week 26: LOCF
Timeframe: Week 26
Number of participants who achieved a clinically meaningful improvement in the HbA1c response level of >=1.0%, >=1.5%, and >=2.0% at Week 26: LOCF
Timeframe: Week 26
Number of participants who achieved a clinically meaningful HbA1c response level of <6.5% and <7.0% at Week 52: OC
Timeframe: Week 52
Number of participants who achieved a clinically meaningful improvement in the HbA1c response level of >=1.0%, >=1.5%, and >=2.0% at Week 52: OC
Timeframe: Week 52
Number of participants with the indicated time to hyperglycemic rescue through Week 52
Timeframe: Week 2 to Week 52
Time to hyperglycemic rescue through Week 52
Timeframe: Week 2 to Week 52
Change from Baseline in body weight at Week 26: LOCF
Timeframe: Baseline; Week 26
Change from Baseline in body weight through Week 26: LOCF
Timeframe: Baseline; Week 1, Week 2 , Week 3, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 26
Change from Baseline in body weight through Week 52: OC
Timeframe: Baseline; Week 1, Week 2 , Week 3, Week 4, Week 8, Week 12, Week 16, Week 20, Week 26, Week 36, Week 48, and Week 52
Plasma concentrations (conc.) of albiglutide at Week 8 and Week 16
Timeframe: Week 8 Pre-dose (immediately prior to dose), Week 8 Post-dose (at least 2 days after a dose of medication), Week 16 Pre-dose (immediately prior to dose), and Week 16 Post-dose (at least 2 days after previous dose of albiglutide)
Interventions:
Enrollment:
507
Primary completion date:
2012-05-11
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Malcolm A. Young, PhD, Jeffrey A. Wald, PhD, Jessica E. Matthews, BS, Rickey Reinhardt, MD, PhD .Effect of Renal Impairment on the Pharmacokinetics, Efficacy, and Safety of Albiglutide.Postgrad Med.2014;126(3):36-46.
Medical condition
Diabetes Mellitus, Type 2
Product
albiglutide
Collaborators
GSK
Study date(s)
May 2010 to November 2012
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Renally impaired with a historical diagnosis of type 2 diabetes mellitus and is experiencing inadequate glycemic control on their current regime of diet and exercise or their antidiabetic therapy of metformin, TZD, SU, or any combination of these oral antidiabetic medications
- BMI >/=20 kg/m2 and </=45 kg/m2
- History of cancer
- History of treated diabetic gastroparesis
Inclusion and exclusion criteria
Inclusion criteria:
- Renally impaired with a historical diagnosis of type 2 diabetes mellitus and is experiencing inadequate glycemic control on their current regime of diet and exercise or their antidiabetic therapy of metformin, TZD, SU, or any combination of these oral antidiabetic medications
- BMI >/=20 kg/m2 and
- Fasting C-peptide >/=0.8 ng/mL (>/=0.26 nmol/L)
- HbA1c between 7.0% and 10.0%, inclusive.
Exclusion criteria:
- History of cancer
- History of treated diabetic gastroparesis
- Current biliary disease or history of pancreatitis
- History of significant gastrointestinal surgery
- Recent clinically significant cardiovascular and/or cerebrovascular disease
- History of human immunodeficiency virus infection
- Abnormal liver function or acute symptomatic infection with hepatitis B or hepatitis C
- Female subject is pregnant (confirmed by laboratory testing), lactating, or <6 weeks postpartum
- Known allergy to any GLP 1 analogue, sitagliptin, other study medications’ excipients, excipients of albiglutide, or Baker’s yeast
- Receipt of any investigational drug or sitagliptin 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
Trial location(s)
Location
GSK Investigational Site
Richardson, Texas, United States, 75080
Status
Study Complete
Location
GSK Investigational Site
Cleveland, Ohio, United States, 44195
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Asheville, North Carolina, United States, 28801
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Winston-Salem, North Carolina, United States, 27103
Status
Study Complete
Showing 1 - 6 of 214 Results
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
Study complete
Actual primary completion date
2012-05-11
Actual study completion date
2012-05-11
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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