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

Tracking Information
First Received Date ^ICMJE	April 24, 2002
Last Updated Date	June 23, 2005
Start Date ^ICMJE	December 2001
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00034255 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Single Dose and 34-Day Tolerance Study of INGAP Peptide in Insulin Deficient Patients
Official Title ^ICMJE	Single Dose and 34-Day Tolerance Study of INGAP Peptide in Insulin Deficient Patients
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.
Detailed Description
Study Phase	Phase I, Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Condition ^ICMJE	Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2
Intervention ^ICMJE	Drug: INGAP Peptide
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	62
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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: 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. Exclusion Criteria: Patients meeting any of the following exclusion criteria at screening will not be enrolled in the study: 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.
Gender	Both
Ages	18 Years to 70 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00034255
Responsible Party
Study ID Numbers ^ICMJE	INGAP-01-001
Study Sponsor ^ICMJE	GMP Endotherapeutics
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	GMP Endotherapeutics
Verification Date	June 2003
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP