Safety and Efficacy of INGAP-Peptide in Patients With Type 1 Diabetes - Tabular View

Tracking Information
First Received Date ^ICMJE	October 22, 2003
Last Updated Date	July 22, 2009
Start Date ^ICMJE	October 2003
Primary Completion Date	May 2004 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 22, 2009)	assess efficacy and safety based on arginine stimulated C peptide, fasting C peptide, average daily insulin dose, fasting glucose, glycosylated hemoglobin (Hb A1c), and AEs [ Time Frame: 90 days ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00071409 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Safety and Efficacy of INGAP-Peptide in Patients With Type 1 Diabetes
Official Title ^ICMJE	A Randomized, Double-blind, Placebo-controlled, Rising Dose, Multicenter Study to Evaluate the Efficacy and Safety of 90 Days of 300 or 600 mg Daily Subcutaneous Injections of INGAP Peptide in Type I Diabetes Mellitus Patients
Brief Summary	Insulin is a chemical that the body needs in order to use or store sugar. It is made by a type of cell called a beta cell which resides in an organ known as the pancreas. Type 1 diabetes is a disease where the beta cells have been destroyed so that little or no insulin is made. Sugar levels rise in the blood as a result. INGAP-Peptide is being tested to attempt to create new beta cells in the pancreas, and to restore the ability to produce insulin in type 1 diabetic patients.
Detailed Description
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Diabetes Mellitus, Insulin-Dependent
Intervention ^ICMJE	Drug: INGAP-Peptide Drug: placebo
Study Arms / Comparison Groups	Placebo Comparator: 1.5 mL SC injection Experimental: 1.5 mL SC injection, once daily for 90 days
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	63
Completion Date	May 2004
Primary Completion Date	May 2004 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria Age 18-65 fasting C-peptide <0.3 ng/ml. HbA1c <10% history of onset of type 1 DM at or before 20 years of age. Otherwise healthy
Gender	Both
Ages	18 Years to 65 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	NCT00071409
Responsible Party	Muhammad Rehman, MD, Procter and Gamble Pharmaceuticals
Study ID Numbers ^ICMJE	2003068
Study Sponsor ^ICMJE	Procter and Gamble
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Procter and Gamble
Verification Date	July 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP