Type 1 Diabetes MellitusPhase 2NCT00995540

Tolerability, Safety, and Efficacy Study of INGAP Peptide to Treat Type 1 Diabetes Mellitus in Adults

A Phase 2 study testing INGAP Peptide in people with Type 1 Diabetes Mellitus, run by Exsulin Corporation at 2 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 19 to 60 years
Conditions the study is for: Type 1 Diabetes Mellitus
What is being tested?: INGAP Peptide
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 23 participants
Where: 2 sitesin 2 countries
Study dates: Nov 2009to Dec 2011
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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

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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).

Who cannot join

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;

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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;
Inability to fill out and maintain a daily diary during the screening period prior to dosing; or,
Human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C seropositivity in blood sample taken during screening.

Trial locations and contacts

2 sites in 2 countries.

Country

City, postcode or hospital

2 sites in 2 countries

United States1 site

Mayo Clinic
Rochester, Minnesota, 55905

Other trials in United States

Canada1 site

McGill University - Montreal General Hospital
Montreal, Quebec, H3G 1A4

Other trials in Canada

About this study

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

Read the detailed description

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.

Conditions: Type 1 Diabetes Mellitus
Being tested: INGAP Peptide, Placebo
Keywords: T1DM, Regeneration, Islet, Beta cell, INGAP Peptide
Medical subject headings: Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

INGAP PeptideDrug
Also called Exsulin
100 mg INGAP Peptide tid subcutaneous injection for 12 weeks
INGAP PeptideDrug
Also called Exsulin
200 mg INGAP Peptide tid subcutaneous injection for 12 weeks
PlaceboDrug
Placebo tid subcutaneous injection for 12 weeks

Study groups in NCT00995540
Study group	Role	What they receive
Placebo	Placebo comparator	Placebo subcutaneous injection tid for 12 weeks Receives: Drug: Placebo
100 mg INGAP Peptide tid	Active comparator	100 mg INGAP Peptide tid subcutaneous injection for 12 weeks Receives: Drug: INGAP Peptide
200 mg INGAP Peptide tid	Active comparator	200 mg INGAP Peptide tid subcutaneous injection for 12 weeks Receives: Drug: INGAP Peptide

What is being measured

The primary outcome is the main question the study is designed to answer.

Injection tolerability
Local injection site
Measured: 4-8-12-16 weeks

Secondary outcomes (1)

C-peptide
Maximal C-peptide (Cmax) and C-peptide AUC during mixed meal test
Measured: 4-8-12-16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2009Dec 2011

First posted15 Oct 2009 (estimated)
Study startNov 2009
Primary completionDec 2011
Study completionDec 2011

Why it stopped: Preserve clinical supplies

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 23 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00995540
Sponsor's protocol ID: E-201
Status last verified: Feb 2014
First submitted: 13 Oct 2009
Last updated: 12 Feb 2014
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Type 1 Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00995540
Acronym / sponsor ID: E-201
Conditions: Type 1 Diabetes Mellitus
Keywords: T1DM, Regeneration, Islet, Beta cell, INGAP Peptide
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Preserve clinical supplies
Enrolment: 23 participants (actual)
Lead sponsor: Exsulin CorporationIndustry (pharma, biotech, devices)
Study start: Nov 2009
Primary completion: Dec 2011 (actual)
Study completion: Dec 2011 (actual)
First posted: 15 Oct 2009 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboPlacebo subcutaneous injection tid for 12 weeks
100 mg INGAP Peptide tid	Active comparator	Drug: INGAP Peptide100 mg INGAP Peptide tid subcutaneous injection for 12 weeks
200 mg INGAP Peptide tid	Active comparator	Drug: INGAP Peptide200 mg INGAP Peptide tid subcutaneous injection for 12 weeks

Who may qualify

Ages: 19 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (12 listed)

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%;

Key exclusion criteria (17 listed)

• 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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
INGAP PeptideAlso: Exsulin100 mg INGAP Peptide tid subcutaneous injection for 12 weeks	Drug	100 mg INGAP Peptide tid
INGAP PeptideAlso: Exsulin200 mg INGAP Peptide tid subcutaneous injection for 12 weeks	Drug	200 mg INGAP Peptide tid
PlaceboPlacebo tid subcutaneous injection for 12 weeks	Drug	Placebo

Primary outcome

Injection tolerability
Time frame: 4-8-12-16 weeks
Local injection site

1 secondary outcome

C-peptide
Time frame: 4-8-12-16 weeks

Results and safety

The study was stopped early (reason given: Preserve clinical supplies). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2014.

Related trials for Type 1 Diabetes Mellitus

Not yet recruitingPhase 3
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RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Yogish Kudva, M.D. principal investigator

Mayo Clinic

George Tsoukas, MD principal investigator

McGill University

2 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing INGAP Peptide in people with Type 1 Diabetes Mellitus, run by Exsulin Corporation at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 12 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Preserve clinical supplies). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Injection tolerability (time frame: 4-8-12-16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00995540.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2014.