|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT00034255 |
|
Date of registration:
|
24/04/2002 |
|
Primary sponsor: |
|
|
Public title:
|
Single Dose and 34-Day Tolerance Study of INGAP Peptide in Insulin Deficient Patients
|
|
Scientific title:
|
Single Dose and 34-Day Tolerance Study of INGAP Peptide in Insulin Deficient Patients |
|
Date of first enrolment:
|
December 2001 |
|
Target sample size:
|
62 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00034255 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Key inclusion & exclusion criteria
|
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.
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Diabetes Mellitus, Type 1
|
|
Diabetes Mellitus, Type 2
|
|
Intervention(s)
|
|
Drug: INGAP Peptide
|
|
Secondary ID(s)
|
|
INGAP-01-001
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|