Tolerability, Safety, and Efficacy Study of INGAP Peptide to Treat Type 1 Diabetes Mellitus in Adults
INGAP Peptide acetate is the active ingredient of INGAP Peptide Solution for Injection. It is being developed as an antidiabetic agent for the restoration of endogenous insulin secretion in patients with type 1 diabetes mellitus (T1DM) and in insulin-deficient patients with type 2 diabetes mellitus (T2DM). This clinical study is designed to generate additional data regarding the appropriate dose and dosing regimen and to evaluate safety and efficacy in patients with T1DM.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||A Multiple-center, Randomized, Double-blind, Placebo-controlled, Parallel Study to Assess the Tolerability, Safety, and Efficacy of INGAP Peptide Given Subcutaneously as Injections t.i.d. for 12 Weeks in Adult Patients With Type 1 Diabetes Mellitus|
- Severity of adverse events (AEs) recorded by the Medical Dictionary for Regulatory Activities (MedDRA) [ Time Frame: 4-8-12-16 weeks ] [ Designated as safety issue: Yes ]
- Efficacy measured by maximal C-peptide (Cmax) and C-peptide AUC during mixed meal test [ Time Frame: 4-8-12-16 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||November 2009|
|Estimated Study Completion Date:||March 2013|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
|Placebo Comparator: Placebo||
Placebo tid subcutaneous injection for 12 weeks
|Active Comparator: 100 mg INGAP Peptide tid||
Drug: INGAP Peptide
100 mg INGAP Peptide tid subcutaneous injection for 12 weeks
Other Name: Exsulin
|Active Comparator: 200 mg INGAP Peptide tid||
Drug: INGAP Peptide
200 mg INGAP Peptide tid subcutaneous injection for 12 weeks
Other Name: Exsulin
In contrast to currently approved therapies that are directed at controlling either the metabolic abnormalities or tissue complications of diabetes, INGAP Peptide therapy is intended to restore ß cell mass and islet cell function. INGAP Peptide has been identified as a substance that induces islet cell regeneration from progenitor cells resident in the pancreas in a manner that recapitulates islet development during normal embryogenesis.
INGAP Peptide therapy has been evaluated in phase 1 and 2 studies of both T1DM and T2DM patients (Dungan K, Diab Met Res Rev 2009; 25:558-565). Once daily injections of INGAP Peptide for 3 months caused a statistically significant increase in C peptide secretion in T1DM patients, and a trend towards increased C-peptide levels was seen in T2DM patients. Glycosylated hemoglobin (HbA1c) decreased by -0.6% (p<0.0125) in T2DM patients and by -0.4% (p<0.06) in T1DM patients.
Given the very short half-life or INGAP Peptide (i.e., <1 hour), the findings of these earlier phase 2 studies in patients with T1DM and T2DM are very encouraging in that despite suboptimal exposure to the drug, there was evidence of efficacy. Local injection site reactions observed in those studies may have been due to relatively large doses of formulations that were not optimized for tonicity and patient comfort.
This study has been designed such that the dose of INGAP Peptide will be divided across three daily administrations using a formulation that has been improved with respect to tonicity. The study will evaluate the safety, tolerability and C-peptide response associated with this dosing regimen in patients with T1DM.
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|McGill University - Montreal General Hospital|
|Montreal, Quebec, Canada, H3G 1A4|
|Principal Investigator:||Yogish Kudva, M.D.||Mayo Clinic|
|Principal Investigator:||George Tsoukas, MD||McGill University|