Diabetes MellitusPhase 1NCT00606112
A Single Dose, Tolerance and Pharmacokinetic Study in Obese or Overweight Type 2 Diabetic Volunteers
A Phase 1 study testing Trodusquemine (MSI-1436) in people with Diabetes Mellitus and Obesity, run by Genaera Corporation at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety and tolerance of a single intravenous (through a vein) dose of trodusquemine (MSI-1436) in obese, type 2 diabetics. Different amounts of trodusquemine (MSI-1436) will be given to each volunteer group throughout the study. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Diabetes Mellitus, Obesity
- What is being tested?
- Trodusquemine (MSI-1436)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Apr 2009
- Phase
- Phase 1
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- male or female obese or overweight type 2 diabetic subjects, between 18 and 55 years old (inclusive)
- either treatment naive or who are inadequately controlled on either metformin alone or metformin in combination with a sulfonylurea. Subjects on metformin in combination with a sulfonylurea will be allowed a 2 week period to wash out the sulfonylurea before dosing.
- have a fasting blood sugar of ≥ 100 mg/dL, hemoglobin A1C ≥ 7.5% (but ≤ 11.0%). Subjects on a combination of metformin and sulfonylurea must have a hemoglobin A1C ≥ 7.5% (but ≤ 10.0%);
- non-smoker
- body mass index (BMI) of 27-40 kg/m2
Who cannot join
- likely allergy or sensitivity to any components of Trodusquemine (MSI-1436) for Injection based on known allergies to drugs of the same class;
- any subject with a history of allergy (rash, hives, breathing difficulty, etc.) to any medications, either prescription or nonprescription, including dietary supplements or herbal medications;
- any subject with a history of severe allergy or bronchial asthma;
- a clinically significant history of or current abnormality or disease of any organ system, including renal, hepatic, gastrointestinal, cardiovascular (except hyperlipidemia or controlled hypertension), pulmonary (including chronic asthma), endocrine (except diabetes), central nervous, or hematologic systems, or recent clinically significant surgery;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Double-Blind, Randomized, Placebo-Controlled Ascending IV Single-Dose Tolerance and Pharmacokinetic Study of Trodusquemine (MSI-1436) in Obese Type 2 Diabetics
The purpose of this study is to evaluate the safety and tolerance of a single intravenous (through a vein) dose of trodusquemine (MSI-1436) in obese, type 2 diabetics.
Different amounts of trodusquemine (MSI-1436) will be given to each volunteer group throughout the study.
Another purpose is to evaluate the pharmacokinetics (PK - the study of the way the drug enters and leaves the blood and tissues over time) of trodusquemine (MSI-1436).
Finally, this study will also determine whether trodusquemine (MSI-1436) has any effect on appetite, mood or behavior, and selective biomarkers (substances in your blood that may change in response to the study drug).
- Conditions
- Diabetes Mellitus, Obesity
- Being tested
- Trodusquemine (MSI-1436)
- Medical subject headings
- Diabetes Mellitus, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trodusquemine (MSI-1436)Drug
A single dose will be administered on Day 0. Doses are 3mg/m2 in cohort 1, 6mg/m2 in cohort 2, 10mg/m2 in cohort 3 and 15mg/m2 in cohort 4/
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Not described Receives: Drug: Trodusquemine (MSI-1436) |
| 2 | Placebo comparator | Not described Receives: Drug: Trodusquemine (MSI-1436) |
| 3 | Placebo comparator | Not described Receives: Drug: Trodusquemine (MSI-1436) |
| 4 | Placebo comparator | Not described Receives: Drug: Trodusquemine (MSI-1436) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerance of a single intravenous dose of trodusquemine (MSI-1436) in obese, type 2 diabetics
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionJun 2008
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genaera Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Mark Kipnes, MD, Principal investigator, dgd ResearchGilbert R. Weiner, D.O. AOBFP, Principal investigator, Allied Research International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00606112
- Sponsor's protocol ID
- MSI-1436C-103
- Status last verified
- Apr 2009
- First submitted
- 21 Jan 2008
- Last updated
- 15 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Double-Blind, Randomized, Placebo-Controlled Ascending IV Single-Dose Tolerance and Pharmacokinetic Study of Trodusquemine (MSI-1436) in Obese Type 2 Diabetics
- ClinicalTrials.gov ID
- NCT00606112
- Acronym / sponsor ID
- MSI-1436C-103
- Conditions
- Diabetes Mellitus, Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Genaera CorporationIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Jun 2008 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 1 Feb 2008 (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.
The purpose of this study is to evaluate the safety and tolerance of a single intravenous (through a vein) dose of trodusquemine (MSI-1436) in obese, type 2 diabetics.
Different amounts of trodusquemine (MSI-1436) will be given to each volunteer group throughout the study.
Another purpose is to evaluate the pharmacokinetics (PK - the study of the way the drug enters and leaves the blood and tissues over time) of trodusquemine (MSI-1436).
Finally, this study will also determine whether trodusquemine (MSI-1436) has any effect on appetite, mood or behavior, and selective biomarkers (substances in your blood that may change in response to the study drug).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: Trodusquemine (MSI-1436) |
| 2 | Placebo comparator | Drug: Trodusquemine (MSI-1436) |
| 3 | Placebo comparator | Drug: Trodusquemine (MSI-1436) |
| 4 | Placebo comparator | Drug: Trodusquemine (MSI-1436) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- male or female obese or overweight type 2 diabetic subjects, between 18 and 55 years old (inclusive)
- either treatment naive or who are inadequately controlled on either metformin alone or metformin in combination with a sulfonylurea. Subjects on metformin in combination with a sulfonylurea will be allowed a 2 week period to wash out the sulfonylurea before dosing.
- have a fasting blood sugar of ≥ 100 mg/dL, hemoglobin A1C ≥ 7.5% (but ≤ 11.0%). Subjects on a combination of metformin and sulfonylurea must have a hemoglobin A1C ≥ 7.5% (but ≤ 10.0%);
- non-smoker
- body mass index (BMI) of 27-40 kg/m2
Key exclusion criteria (4 listed)
- likely allergy or sensitivity to any components of Trodusquemine (MSI-1436) for Injection based on known allergies to drugs of the same class;
- any subject with a history of allergy (rash, hives, breathing difficulty, etc.) to any medications, either prescription or nonprescription, including dietary supplements or herbal medications;
- any subject with a history of severe allergy or bronchial asthma;
- a clinically significant history of or current abnormality or disease of any organ system, including renal, hepatic, gastrointestinal, cardiovascular (except hyperlipidemia or controlled hypertension), pulmonary (including chronic asthma), endocrine (except diabetes), central nervous, or hematologic systems, or recent clinically significant surgery;
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 |
|---|---|---|
| Trodusquemine (MSI-1436)A single dose will be administered on Day 0. Doses are 3mg/m2 in cohort 1, 6mg/m2 in cohort 2, 10mg/m2 in cohort 3 and 15mg/m2 in cohort 4/ | Drug | 1, 2, 3, 4 |
Primary outcome
Safety and Tolerance of a single intravenous dose of trodusquemine (MSI-1436) in obese, type 2 diabetics
Time frame: 6 months
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 15 Apr 2009.
Related trials for Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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.
Mark Kipnes, MD principal investigator
dgd Research
Gilbert R. Weiner, D.O. AOBFP principal investigator
Allied Research International
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Trodusquemine (MSI-1436) in people with Diabetes Mellitus and Obesity, run by Genaera Corporation at 1 site 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 4 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 15 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Safety and Tolerance of a single intravenous dose of trodusquemine (MSI-1436) in obese, type 2 diabetics (time frame: 6 months). 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 15 Apr 2009.