CClinicalTrials.gg
CompletedNCT00071422Updated Jul 11, 2014

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

A Phase 2 interventional study of INGAP-Peptide and INGAP-Peptide in Diabetes Mellitus, Non-Insulin-Dependent, sponsored by Exsulin Corporation. Completed at 17 sites in United States. Open to participants aged 35 Years to 70 Years. Per ClinicalTrials.gov, last updated 2014-07-11.

Sponsored by Exsulin Corporation · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
126
Allocation
Randomized
Ages
35 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Diabetes Mellitus, Non-Insulin-Dependent

Keywords

  • Type 2 diabetes
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 126 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Exsulin Corporation is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 70 Years
Sexes eligible
All
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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
126 participants (actual)

Study arms

  • Placebo comparator
    placebo

    1.5 mL SC injection, once daily for 90 days

    Drug: placebo

  • Experimental
    300 mg INGAP Peptide

    1.5 mL SC injection, once daily for 90 days

    Drug: INGAP-Peptide

  • Experimental
    600 mg INGAP Peptide

    1.5 mL SC injection, once daily for 90 days

    Drug: INGAP-Peptide

Interventions

  • DrugINGAP-Peptide

    1.5 mL, once daily, self-administered SC injection for 90 days

  • DrugINGAP-Peptide

    1.5 mL, once daily, self-administered SC injection for 90 days

  • Drugplacebo

    1.5 mL, once daily, self-administered SC injection for 90 days

06

Study locations

17 sites
  • Diabetes and Endocrine Associates
    La Jolla, California 92037, United States
  • VA Hospital UCSD
    San Diego, California 92161, United States
  • Diablo Clinical Research
    Walnut Creek, California 94598, United States
  • Denver, Colorado 80209, United States
  • Longmont Medical Research Network
    Longmont, Colorado 80501, United States
  • MedStar Clinical Research Center
    Washington, District of Columbia 20003, United States
  • Future Care Studies
    Springfield, Massachusetts 01107, United States
  • Mercury Street Medical
    Butte, Montana 59701, United States
  • Diabetes-Endocrinology Center of WNY
    Buffalo, New York 14209, United States
  • UNC Diabetes Care Center
    Durham, North Carolina 27713, United States
  • Piedmont Medical Group
    Winston-Salem, North Carolina 27103, United States
  • Clinical Research Institute of Southern Oregon
    Medford, Oregon 97504, United States
  • Mountain View Clinical Research
    Greer, South Carolina 29651, United States
  • Dallas Diabetes and Endocrine Center
    Dallas, Texas 75230, United States
  • University of Texas Health Science Center - Texas Diabetes Institute
    San Antonio, Texas 78207, United States
  • DGD Research Associates
    San Antonio, Texas 78229, United States
  • Charlottesville Medical Research
    Charlottesville, Virginia 22911, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 11, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00071422
Lead sponsor
Exsulin Corporation
First posted
Oct 23, 2003
Start date
Oct 2003
Primary completion
Jun 2004
Completion
Jun 2004
Last update
Jul 11, 2014
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2011. You cannot join it, but the record below documents what was studied.

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