Effect of GLP-1 on Insulin Biosynthesis and Turnover Rates

NCT00609154 | Terminated Phase 1 Results DMC

• 3 other identifiers: 1999-041, Sub-study #4Sub-study 4R01DK061644-09
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes

Keywords

Type 2 diabetes; Insulin; biosynthesis; Non diabetic control

Outcome Measures

Primary Outcomes (1)

• Insulin Biosynthesis Rate

  Blood insulin biosynthesis rate

  24 hours

Study Arms (2)

Diabetic Group

EXPERIMENTAL

Participants with Type 2 diabetes

Drug: glucagon like peptide-1; Dietary Supplement: glucose control

Non-diabetic Group

ACTIVE COMPARATOR

Participants who are non-diabetic will serve as control. treatment is matched to experimental group

Drug: glucagon like peptide-1; Dietary Supplement: glucose control

Interventions

glucagon like peptide-1 DRUG

GLP-1 1 pmole/kg/min

Also known as: incretin

Diabetic Group; Non-diabetic Group

glucose control DIETARY_SUPPLEMENT

glucose without GLP-1

Diabetic Group; Non-diabetic Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 Diabetes
• Non diabetic

You may not qualify if:

• Currently taking medication such as thiazolidinediones, metformin, Exenatide, or sitagliptin
• Chronic condition such as chronic heart failure CHF), Coronary Artery Disease (CAD), or chronic renal failure (CRF)
• Anemia

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead
• Merck Sharp & Dohme LLC: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Albert Einstein College of Medicinie

The Bronx, New York, 10461, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Insulin Resistance

Interventions

Glucagon-Like Peptide 1; Incretins; Glycemic Control

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Therapeutics

Results Point of Contact

• Title: Dr. Daniel Stein
• Organization: Albert Einstein College of Medicine

daniel.stein@einsteinmed.edu

718-430-2237

Study Officials

• Daniel T Stein, MD

  Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2008
• First Posted: February 6, 2008
• Study Start: August 12, 2010
• Primary Completion: May 13, 2014
• Study Completion: May 13, 2014
• Last Updated: February 28, 2024
• Results First Posted: February 28, 2024

Record last verified: 2024-02

Locations

US (1)