NCT00995540

Brief Summary

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2009

Geographic Reach
2 countries

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 13, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 15, 2009

Completed
17 days until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

February 12, 2014

Status Verified

February 1, 2014

Enrollment Period

2.1 years

First QC Date

October 13, 2009

Last Update Submit

February 11, 2014

Conditions

Type 1 Diabetes Mellitus

Keywords

T1DMRegenerationIsletBeta cellINGAP Peptide

Outcome Measures

Primary Outcomes (1)

  • Injection tolerability

    Local injection site

    4-8-12-16 weeks

Secondary Outcomes (1)

  • C-peptide

    4-8-12-16 weeks

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo subcutaneous injection tid for 12 weeks

Drug: Placebo

100 mg INGAP Peptide tid

ACTIVE COMPARATOR

100 mg INGAP Peptide tid subcutaneous injection for 12 weeks

Drug: INGAP Peptide

200 mg INGAP Peptide tid

ACTIVE COMPARATOR

200 mg INGAP Peptide tid subcutaneous injection for 12 weeks

Drug: INGAP Peptide

Interventions

INGAP PeptideDRUG

100 mg INGAP Peptide tid subcutaneous injection for 12 weeks

Also known as: Exsulin
100 mg INGAP Peptide tid
PlaceboDRUG

Placebo tid subcutaneous injection for 12 weeks

Placebo

Eligibility Criteria

Age19 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients meeting all of the following criteria will be eligible for enrollment in the study:
  • Male and female patients between the ages of 19 and 60 years old, inclusive, with a history of T1DM for \>2 years and ≤40 years;
  • Receiving multiple daily insulin injections or insulin pump therapy for \>2 years;
  • Body mass index (BMI) ≤32 kg/m2;
  • HbA1c ≤7.7%;
  • Fasting C-peptide levels \<0.6 ng/mL
  • Willing to sign the study informed consent document;
  • In good general health with no late severe complications or concomitant medical conditions that would influence the outcome of the trial, at the discretion of the Investigator and the Sponsor;
  • If treated with angiotensin-converting enzymes/angiotensin II receptor blockers (ACE/ARB), the doses should be unchanged for a month prior to enrollment; and
  • Females of child bearing potential must have a negative urine pregnancy test on Day 0 prior to dispensing drug and should additionally fulfill one of the following criteria:
  • Willing to use oral, implantable, transdermal, or injectable contraceptives for 21 days prior to the first dose and until 28 days after the last dose; or,
  • Willing to use another reliable means of contraception approved by the Investigator (intrauterine device, female condom, diaphragm with spermicide, cervical cap, use of condom by sexual partner, or a sterile sexual partner) from Screening until after the last blood sample (at Week 16).

You may not qualify if:

  • Patients meeting any of the following criteria will be excluded from study participation:
  • Total daily insulin dosage exceeding 1.0 U/kg/day or a change in total daily insulin dose level of more than 50% (increase or decrease) within the past 3 months;
  • Treatment with any diabetes medication other than insulin;
  • A score of 4 or more restricted responses on the Clarke Hypoglycemia Awareness Survey;
  • Systolic or diastolic blood pressure \>180 mmHg or \>110 mmHg, respectively;
  • Clinical worsening of retinopathy or neuropathy in the previous 3 months;
  • Clinical worsening of nephropathy in the previous 3 months, or blood urea nitrogen (BUN) and serum creatinine exceeding 50 mg/dL and 2.0 mg/dL, respectively;
  • History or presence of acute or chronic pancreatitis, including a serum amylase level \>1.5 times the upper limit of normal (ULN) or a serum lipase level \>2 times ULN;
  • A history or presence of any illness, disease, or condition that could impact patient safety or evaluability of drug effect, in the Investigator's opinion;
  • An episode of severe hypoglycemia (change in mental status requiring assistance) during the previous 30 days;
  • An episode of acute glycemic decompensation with associated hyperosmolar non-ketotic state or diabetic ketoacidosis during the past 6 months;
  • A serum aspartate aminotransferase (AST), alanine aminotransferase (ALT), or total bilirubin level \>2 times ULN;
  • Received any investigational product within 30 days of admission into this study or had any prior or existing exposure to INGAP Peptide or glucagon-like peptides (GLP 1, GLP 2, or analogs);
  • Concurrent or planned participation in any other clinical study during the conduct of this study;
  • Positive urine test for cocaine, opiates, amphetamines, or cannabinoids;
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

McGill University - Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

INGAP peptide

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Yogish Kudva, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

  • George Tsoukas, MD

    McGill University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2009

First Posted

October 15, 2009

Study Start

November 1, 2009

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

February 12, 2014

Record last verified: 2014-02

Locations

CA(1)US(1)