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
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Biological: albiglutide
Biological: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 41
Study Start Date: December 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: albiglutide
single dose of albiglutide
Biological: albiglutide
subcutaneous injection
Placebo Comparator: placebo
single dose of placebo
Biological: placebo
subcutaneous injection

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01475734

Locations
United States, California
GSK Investigational Site
Chula Vista, California, United States, 91911
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01475734     History of Changes
Other Study ID Numbers: 108372
Study First Received: November 17, 2011
Last Updated: November 21, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
glucose clamp
hypoglycemia

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 17, 2014