Diabetes Mellitus, Insulin-DependentPhase 2NCT00071409
Safety and Efficacy of INGAP-Peptide in Patients With Type 1 Diabetes
A Phase 2 study testing INGAP-Peptide in people with Diabetes Mellitus, Insulin-Dependent, run by Exsulin Corporation at 10 sites in United States.
Trial 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 1 diabetes is a disease where the beta cells have been destroyed so that little or no insulin is made. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Insulin-Dependent
- 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
- 63 participants
- Where
- 10 sitesUnited States
- Study dates
- Oct 2003to May 2004
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65
- fasting C-peptide <0.3 ng/ml.
- HbA1c <10%
- history of onset of type 1 DM at or before 20 years of age.
- Otherwise healthy
Who cannot join
None listed.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Mercury Street Medical
Butte, Montana, 59701
UNC Diabetes Care Center
Durham, North Carolina, 27713
Radiant Research
Irvine, California, 92618
Clinical Research Institute of Southern Oregon
Medford, Oregon, 97504
University of Texas Health Science Center - Texas Diabetes Institute
San Antonio, Texas, 78207
DGD Research Associates
San Antonio, Texas, 78229
VA Hospital UCSD
San Diego, California, 92161
Springfield Diabetes and Endocrine Center
Springfield, Illinois, 62704
Diablo Clinical Research
Walnut Creek, California, 94598
MedStar Clinical Research Center
Washington D.C., District of Columbia, 20003
About this study
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 Type I Diabetes Mellitus Patients
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 1 diabetes is a disease where the beta cells have been destroyed so that little or no insulin is made. 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 restore the ability to produce insulin in type 1 diabetic patients.
- Conditions
- Diabetes Mellitus, Insulin-Dependent
- Being tested
- INGAP-Peptide, placebo
- Keywords
- Type 1 diabetes
- 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
1.5 mL, once daily, self-administered SC injection for 90 days
INGAP-PeptideDrug
1.5 mL, once daily, self-administered SC injection for 90 days
placeboDrug
1.5 mL, once daily, self-administered SC injection for 90 days
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | 1.5 mL SC injection Receives: Drug: placebo |
| 300 mg INGAP Peptide | Experimental | 1.5 mL SC injection, once daily for 90 days Receives: Drug: INGAP-Peptide |
| 600 mg INGAP Peptide | Experimental | 1.5 mL SC injection, once daily for 90 days Receives: Drug: INGAP-Peptide |
What is being measured
The primary outcome is the main question the study is designed to answer.
assess efficacy and safety based on arginine stimulated C peptide, fasting C peptide, average daily insulin dose, fasting glucose, glycosylated hemoglobin (Hb A1c), and AEs
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2003 (estimated)
- Study startOct 2003
- Primary completionMay 2004
- Study completionMay 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Insulin-DependentStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Exsulin Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00071409
- Sponsor's protocol ID
- 2003068
- Status last verified
- Aug 2011
- First submitted
- 22 Oct 2003
- Last updated
- 11 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 Type I Diabetes Mellitus Patients
- ClinicalTrials.gov ID
- NCT00071409
- Acronym / sponsor ID
- 2003068
- Conditions
- Diabetes Mellitus, Insulin-Dependent
- Keywords
- Type 1 diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Exsulin CorporationIndustry (pharma, biotech, devices)
- Study start
- Oct 2003
- Primary completion
- May 2004 (actual)
- Study completion
- May 2004 (actual)
- First posted
- 23 Oct 2003 (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.
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 1 diabetes is a disease where the beta cells have been destroyed so that little or no insulin is made. 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 restore the ability to produce insulin in type 1 diabetic patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: placebo1.5 mL SC injection |
| 300 mg INGAP Peptide | Experimental | Drug: INGAP-Peptide1.5 mL SC injection, once daily for 90 days |
| 600 mg INGAP Peptide | Experimental | Drug: INGAP-Peptide1.5 mL SC injection, once daily for 90 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-65
- fasting C-peptide <0.3 ng/ml.
- HbA1c <10%
- history of onset of type 1 DM at or before 20 years of age.
- Otherwise healthy
Key exclusion criteria (0 listed)
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-Peptide1.5 mL, once daily, self-administered SC injection for 90 days | Drug | 300 mg INGAP Peptide |
| INGAP-Peptide1.5 mL, once daily, self-administered SC injection for 90 days | Drug | 600 mg INGAP Peptide |
| placebo1.5 mL, once daily, self-administered SC injection for 90 days | Drug | placebo |
Primary outcome
assess efficacy and safety based on arginine stimulated C peptide, fasting C peptide, average daily insulin dose, fasting glucose, glycosylated hemoglobin (Hb A1c), and AEs
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: 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 Diabetes Mellitus, Insulin-Dependent, run by Exsulin Corporation at 10 sites in United States.
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 5 inclusion and 0 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: finished, as of the sponsor's last update on 11 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
assess efficacy and safety based on arginine stimulated C peptide, fasting C peptide, average daily insulin dose, fasting glucose, glycosylated hemoglobin (Hb A1c), and AEs (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jul 2014.