Albiglutide Glucose Clamp Study in Subjects With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01475734
First received: November 17, 2011
Last updated: November 21, 2012
Last verified: August 2012

November 17, 2011
November 21, 2012
December 2011
July 2012   (final data collection date for primary outcome measure)
Glucagon concentration (nmol/L) [ Time Frame: Day 4 ] [ Designated as safety issue: No ]
Glucagon concentration (nmol/L) during the hypoglycemic periods after treatment with albiglutide or placebo
Same as current
Complete list of historical versions of study NCT01475734 on ClinicalTrials.gov Archive Site
  • Plasma C-peptide concentration during hypoglycemic periods [ Time Frame: Day 4 ] [ Designated as safety issue: No ]
    Insulin secretion rate (measured by mathematical analysis of C-peptide concentration) during the hypogycemic periods
  • Glucagon concentration [ Time Frame: Day 4 ] [ Designated as safety issue: No ]
    Glucagon concentration at all stages of glycemia
  • Plasma C-peptide concentration during all stages of glycemia [ Time Frame: Day 4 ] [ Designated as safety issue: No ]
    Insulin secretion rate (measured by mathematical analysis of C-peptide concentration) at all stages of glycemia
  • Albiglutide concentration [ Time Frame: Day 4 ] [ Designated as safety issue: No ]
    Average concentration of albiglutide during the clamp period
  • Number of participants with adverse events [ Time Frame: Day 4 ] [ Designated as safety issue: No ]
    Number of participants with adverse events during the clamp period
Same as current
Not Provided
Not Provided
 
Albiglutide Glucose Clamp Study in Subjects With Type 2 Diabetes
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.

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.

This is a Phase II, single-site, randomized, double-blind, parallel-group, placebo-controlled, 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 3 days before employing 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. In particular, this study is being conducted to ensure that albiglutide does not impair counter-regulatory responses during hypoglycemia.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Biological: albiglutide
    subcutaneous injection
  • Biological: placebo
    subcutaneous injection
  • Active Comparator: albiglutide
    single dose of albiglutide
    Intervention: Biological: albiglutide
  • Placebo Comparator: placebo
    single dose of placebo
    Intervention: Biological: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
41
July 2012
July 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01475734
108372
Yes
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
August 2012

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