Last updated: 11/07/2018 02:12:25
Albiglutide glucose clamp study in subjects with Type 2 diabetes
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A single-site, randomized, double-blind, placebo-controlled, parallel-group, stepped glucose clamp study to assess the effects of albiglutide on counter-regulatory hormone responses and recovery from hypoglycemia in subjects with Type 2 diabetes mellitus.
Trial description: This is a stepped glucose clamp study designed to investigate the effect of treatment with albiglutide on counter-regulatory hormone responses and recovery from hypoglycemia in subjects with Type 2 diabetes mellitus. A single dose of albiglutide or placebo will be given prior to a stepped hyper- and hypoglycemic clamp. The goal of this study is to demonstrate that albiglutide increases insulin secretion and decreases glucagon levels in a glucose-dependent manner.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Glucagon concentration (nanomoles per liter [nmol/L]) during the hypoglycemic periods of the glucose clamp procedure
Timeframe: Day 4
Secondary outcomes:
Insulin secretion rate (measured by mathematical analysis of C-peptide concentrations) during the glucose clamp period
Timeframe: Day 4
Epinephrine values during the glucose clamp period
Timeframe: Day 4
Norepinephrine values during the glucose clamp period
Timeframe: Day 4
Growth hormone values during the glucose clamp period
Timeframe: Day 4
Insulin values during the glucose clamp period
Timeframe: Day 4
Cortisol values during the glucose clamp period
Timeframe: Day 4
C-peptide values during the glucose clamp period
Timeframe: Day 4
Recovery time of plasma glucose levels to >=3.9 mmol/L (>=70 mg/dL) from the hypoglycemic clamp level of 2.8 nmol/L (50.4 mg/dL)
Timeframe: Day 4
Average albiglutide concentration on the day of the clamp procedure
Timeframe: Day 4
Number of participants with any treatment-emergent serious adverse event (SAE) and treatment-emergent non-serious adverse event (AE) during the clamp period
Timeframe: From the time the participant consented to participate in the study through the end of the study, or the final follow-up visit for participants who discontinued active participation in the study (up to 8 study weeks)
Interventions:
Biological/vaccine: albiglutide
Biological/vaccine: placebo
Enrollment:
44
Observational study model:
Not applicable
Primary completion date:
2012-16-07
Time perspective:
Not applicable
Clinical publications:
M. Hompesch, A. Jones-Leone, M. C. Carr, J. Matthews, H. Zhi, M. Young, L. Morrow and R. R. Reinhardt.Albiglutide does not impair the counter-regulatory hormone response to hypoglycaemia: a randomized, double-blind, placebo-controlled, stepped glucose clamp study in subjects with type 2 diabetes mellitus .Diabetes Obes Metab.2015;17(1):82-90
Medical condition
Diabetes Mellitus, Type 2
Product
albiglutide
Collaborators
Not applicable
Study date(s)
December 2011 to July 2012
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18 - 60 years
Accepts healthy volunteers
No
- Historical diagnosis of type 2 diabetes mellitus for at least 6 months and less than 10 years before Screening
- HbA1c <10% at Screening for subjects who do not require washout of existing OAD or <9% at Screening for subjects who do require washout from existing OAD
- History of pancreatitis or current ongoing symptomatic biliary disease or pancreatitis
- History of significant gastrointestinal surgery,
Inclusion and exclusion criteria
Inclusion criteria:
- Historical diagnosis of type 2 diabetes mellitus for at least 6 months and less than 10 years before Screening
- HbA1c <10% at Screening for subjects who do not require washout of existing OAD or <9% at Screening for subjects who do require washout from existing OAD
- Body mass index in range 28 kg/m2 to40 kg/m2
Exclusion criteria:
- History of pancreatitis or current ongoing symptomatic biliary disease or pancreatitis
- History of significant gastrointestinal surgery,
- History of significant cardiovascular disease
- History of a seizure disorder
- Documented hypertension or hypotension
- Use of oral antidiabetic agents, except for metformin, within 14 days before investigational product administration.
- Current hepatic disease or abnormal liver function tests
- Positive test result for hepatitis B, hepatitis C, or human immunodeficiency virus infection 1 or 2
- History of regular alcohol consumption (exceeding 7 drinks/week for women or 14 drinks/week for men)
- Female subject is pregnant (confirmed by laboratory testing), lactating, or less than 6 weeks postpartum
- Known allergy to any GLP-1 analog or excipients of albiglutide, Baker’s yeast, or insulin
- History of type 1 diabetes,
- Prior exposure to GLP-1 agents, including albiglutide
- Blood donation over 500 mL within 8 weeks before Screening
Trial location(s)
Location
GSK Investigational Site
Chula Vista, California, United States, 91911
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
2012-16-07
Actual study completion date
2012-16-07
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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