Single Dose and 34-Day Tolerance Study of INGAP Peptide in Insulin Deficient Patients

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Single Dose and 34-Day Tolerance Study of INGAP Peptide in Insulin Deficient Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00034255
• Other study ID #: INGAP-01-001
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: April 24, 2002
• Last updated: June 23, 2005
• Start date: December 2001

Study information

• Verified date: June 2003
• Source: GMP Endotherapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and tolerability of single and multiple doses of intramuscular INGAP Peptide given for the first time in humans as a potential treatment for diabetes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

Patients meeting all of the following inclusion criteria at screening can be considered for admission to the study.

Stage 1 and Stage 2:

1. Male and female patients with, type 1 diabetes mellitus that are 18 through 70 years of age, or type 2 diabetes mellitus that are 30 through 70 years of age.

2. Patients who are insulin deficient and are diagnosed with type 1 or type 2 diabetes mellitus, and are currently well managed with insulin, with or without metformin.

3. Patients who have been on stable doses of insulin treatment for 90 days prior to study randomization.

Exclusion Criteria:

Patients meeting any of the following exclusion criteria at screening will not be enrolled in the study:

1. Patients with a history of any clinically significant retinopathy, symptomatic autonomic neuropathy, unstable angina, or kidney problems.

2. Patients with an uncontrolled or untreated significant pulmonary, neurological condition, or cardiovascular disease, including hypertension, congestive heart failure, angina, or peripheral vascular disease.

3. Patients who have received any investigational product within 30 days of admission into the study.

4. Patients with a history or clinical evidence of multiple organ autoimmune disorders.

5. Patients with a medical condition, serious intercurrent illness, or extenuating circumstance that would significantly decrease study compliance, including all prescribed follow-up.

6. Patients who are lactating and breastfeeding.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2

Intervention

Drug:
• INGAP Peptide

Locations

Country	Name	City	State
United States	UNC Diabetes, Endocrinology, Metabolism Clinic	Durham	North Carolina
United States	Texas Diabetes Institute	San Antonio	Texas
United States	VASDHS Medical Center	San Diego	California
United States	MedStar Research Institute - Clinical Research Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
GMP Endotherapeutics

Country where clinical trial is conducted

United States,