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Safety and Efficacy of INGAP-Peptide in Patients With Type 2 Diabetes

Primary Purpose

Diabetes Mellitus, Non-Insulin-Dependent

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
INGAP-Peptide
INGAP-Peptide
placebo
Sponsored by
Exsulin Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Non-Insulin-Dependent focused on measuring Type 2 diabetes

Eligibility Criteria

35 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria Age 35-70 Using >20 Units of insulin per day HbA1c from 6.5% to 10% No islet antibodies Otherwise healthy

Sites / Locations

  • Diabetes and Endocrine Associates
  • VA Hospital UCSD
  • Diablo Clinical Research
  • Longmont Medical Research Network
  • MedStar Clinical Research Center
  • Future Care Studies
  • Mercury Street Medical
  • Diabetes-Endocrinology Center of WNY
  • UNC Diabetes Care Center
  • Piedmont Medical Group
  • Clinical Research Institute of Southern Oregon
  • Mountain View Clinical Research
  • Dallas Diabetes and Endocrine Center
  • University of Texas Health Science Center - Texas Diabetes Institute
  • DGD Research Associates
  • Charlottesville Medical Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

placebo

300 mg INGAP Peptide

600 mg INGAP Peptide

Arm Description

1.5 mL SC injection, once daily for 90 days

1.5 mL SC injection, once daily for 90 days

1.5 mL SC injection, once daily for 90 days

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
October 22, 2003
Last Updated
July 10, 2014
Sponsor
Exsulin Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00071422
Brief Title
Safety and Efficacy of INGAP-Peptide in Patients With Type 2 Diabetes
Official Title
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 Insulin-using Type 2 Diabetes Mellitus Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
June 2004 (Actual)
Study Completion Date
June 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Exsulin Corporation

4. Oversight

5. Study Description

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 2 diabetes is a disease where the beta cells are unable to meet a person's insulin needs. 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 improve the ability to produce insulin in type 2 diabetic patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Non-Insulin-Dependent
Keywords
Type 2 diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
1.5 mL SC injection, once daily for 90 days
Arm Title
300 mg INGAP Peptide
Arm Type
Experimental
Arm Description
1.5 mL SC injection, once daily for 90 days
Arm Title
600 mg INGAP Peptide
Arm Type
Experimental
Arm Description
1.5 mL SC injection, once daily for 90 days
Intervention Type
Drug
Intervention Name(s)
INGAP-Peptide
Intervention Description
1.5 mL, once daily, self-administered SC injection for 90 days
Intervention Type
Drug
Intervention Name(s)
INGAP-Peptide
Intervention Description
1.5 mL, once daily, self-administered SC injection for 90 days
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
1.5 mL, once daily, self-administered SC injection for 90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Age 35-70 Using >20 Units of insulin per day HbA1c from 6.5% to 10% No islet antibodies Otherwise healthy
Facility Information:
Facility Name
Diabetes and Endocrine Associates
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
VA Hospital UCSD
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
Facility Name
Diablo Clinical Research
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
City
Denver
State/Province
Colorado
ZIP/Postal Code
80209
Country
United States
Facility Name
Longmont Medical Research Network
City
Longmont
State/Province
Colorado
ZIP/Postal Code
80501
Country
United States
Facility Name
MedStar Clinical Research Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20003
Country
United States
Facility Name
Future Care Studies
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01107
Country
United States
Facility Name
Mercury Street Medical
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Facility Name
Diabetes-Endocrinology Center of WNY
City
Buffalo
State/Province
New York
ZIP/Postal Code
14209
Country
United States
Facility Name
UNC Diabetes Care Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27713
Country
United States
Facility Name
Piedmont Medical Group
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Clinical Research Institute of Southern Oregon
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Mountain View Clinical Research
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
Dallas Diabetes and Endocrine Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
University of Texas Health Science Center - Texas Diabetes Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78207
Country
United States
Facility Name
DGD Research Associates
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Charlottesville Medical Research
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22911
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Safety and Efficacy of INGAP-Peptide in Patients With Type 2 Diabetes

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