Effect of GLP-1 on Insulin Biosynthesis and Turnover Rates

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2008 by Albert Einstein College of Medicine of Yeshiva University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier:
NCT00609154
First received: January 23, 2008
Last updated: February 5, 2008
Last verified: January 2008

January 23, 2008
February 5, 2008
November 2007
November 2008   (final data collection date for primary outcome measure)
Insulin biosynthesis rate [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00609154 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Effect of GLP-1 on Insulin Biosynthesis and Turnover Rates
Effect of GLP-1 on Insulin Biosynthesis and Turnover Rates

The gut hormone glucagon like peptide-1 (GLP-1) has been shown to have important effects on maintaining the function and health of the insulin producing beta cells. This hormone is known to increase the production rate of new insulin as well as increase the release of insulin into the blood. We will measure the rate of new insulin production in subjects with Type 2 diabetes compared to non diabetic subjects. We hypothesize that subjects with Type 2 diabetes make less insulin in response to GLP-1 compared to non diabetic subjects.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Type 2 Diabetes
  • Drug: glucagon like peptide-1
    GLP-1 1 pmole/kg/min
  • Drug: glucose control
    glucose without GLP-1
  • Experimental: A
    Type 2 diabetes
    Interventions:
    • Drug: glucagon like peptide-1
    • Drug: glucose control
  • Experimental: B
    non diabetic control, matched
    Interventions:
    • Drug: glucagon like peptide-1
    • Drug: glucose control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
16
November 2008
November 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

Type 2 Diabetes Non diabetic, weight, sex, age matched

Exclusion Criteria:

TZD, metformin, Exenatide, sitagliptin CHF, CAD CRF Anemia

Both
18 Years to 65 Years
Yes
Contact: Cynthia Rivera, RN 718-430-2446 carivera@aecom.yu.edu
United States
 
NCT00609154
1999-041, Sub-study 4
Yes
Daniel T. Stein, MD, Albert Einstein College of Medicine
Albert Einstein College of Medicine of Yeshiva University
Merck Sharp & Dohme Corp.
Principal Investigator: Daniel Stein, MD Albert Einstein College of Medicine of Yeshiva University
Albert Einstein College of Medicine of Yeshiva University
January 2008

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