NCT00034255

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P75+ for phase_1

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2001

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 25, 2002

Completed
Last Updated

June 24, 2005

Status Verified

June 1, 2003

First QC Date

April 24, 2002

Last Update Submit

June 23, 2005

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus, Type 2

Interventions

INGAP PeptideDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Stage 1 and Stage 2:
  • 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.
  • 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.
  • Patients who have been on stable doses of insulin treatment for 90 days prior to study randomization.

You may not qualify if:

  • Patients with a history of any clinically significant retinopathy, symptomatic autonomic neuropathy, unstable angina, or kidney problems.
  • Patients with an uncontrolled or untreated significant pulmonary, neurological condition, or cardiovascular disease, including hypertension, congestive heart failure, angina, or peripheral vascular disease.
  • Patients who have received any investigational product within 30 days of admission into the study.
  • Patients with a history or clinical evidence of multiple organ autoimmune disorders.
  • Patients with a medical condition, serious intercurrent illness, or extenuating circumstance that would significantly decrease study compliance, including all prescribed follow-up.
  • Patients who are lactating and breastfeeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

VASDHS Medical Center

San Diego, California, 92161, United States

Location

MedStar Research Institute - Clinical Research Center

Washington D.C., District of Columbia, 20003, United States

Location

UNC Diabetes, Endocrinology, Metabolism Clinic

Durham, North Carolina, 27713, United States

Location

Texas Diabetes Institute

San Antonio, Texas, 78284, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus, Type 2

Interventions

INGAP peptide

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 24, 2002

First Posted

April 25, 2002

Study Start

December 1, 2001

Last Updated

June 24, 2005

Record last verified: 2003-06

Locations

US(4)