Diabetes MellitusPhase 1NCT00806338
An Ascending Multi-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 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and tolerance of multiple intravenous (through a vein) doses of trodusquemine (MSI-1436) in obese or overweight, type 2 diabetics. Read more about this study
- Who is it for?
- Ages 18 to 65 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
- 22 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male or female obese or overweight type 2 diabetic subjects, between 18 and 65 years old (inclusive) either treatment naïve or who are inadequately controlled on metformin alone;
- subjects receiving metformin should be on stable dose for at least two weeks prior to enrollment;
- have a fasting blood sugar of ≥ 100 mg/dL and hemoglobin A1C ≥ 7.5% (but ≤ 11.0%) at study entry;
- of any race who are in good health (based on medical history, physical examination, electrocardiograms [ECGs], and clinical laboratory tests);
- non-smokers (refrained from any tobacco or nicotine usage, including smokeless tobacco, nicotine patches, etc.,) for 6 months prior to Day 0 of the study. Subjects must have cotinine levels below those measured for smokers based on reference lab values;
- body mass index (BMI) of 27-40 kg/m2;
- able to execute informed written consent;
- willingness to remain in the clinic for the inpatient portion of the study and return for follow-up visits as required by the protocol and as deemed necessary by the Principal Investigator;
Who cannot join
- likely allergy or sensitivity to any components of Trodusquemine (MSI-1436C) for Injection;
- 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;
- history of seizure, epilepsy, severe head injury, multiple sclerosis, or other known neurological conditions;
- abnormal pre-admission vital signs, physical examination, clinical laboratory, or any safety variable which is considered clinically significant for this population by the Principal Investigator or Sponsor (or designee). Subjects with an abnormal serum creatinine should not be enrolled. Subjects with AST (SGOT), ALT (SGPT), GGT, alkaline phosphatase, bilirubin, blood urea nitrogen (BUN), prothrombin time (PT), or activated partial thromboplastin time (aPPT) >1.5 times above the upper limit of normal should not be enrolled;
- any subject with a clinically significant mental or physical illness within 1 year prior to the first dose, including a history of alcohol and/or drug abuse within 1 year prior to the first dose of study medication;
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- Insulin requiring diabetics;
- any subject who has received any known hepatic or renal clearance altering agents (eg, erythromycin, cimetidine, barbiturates, phenothiazines, St. John's Wort, etc.) within a period of 90 days prior to the first dose of study medication;
- any subject who has received any approved prescription anti-obesity drug or has taken any over-the-counter medication for weight loss or who has received a thiazolidinedione or exanatide within a period of 90 days prior to the first dose of study medication;
- ingestion or use of any investigational medication or device within 60 days prior to the first dose of study medication; ingestion or use of any investigational anti-obesity medication is prohibited within 3 months prior to the first dose of study medication;
- any subject with history of malignancy in last 5 years, with exception of basal and squamous cell carcinomas of the skin;
- any subject who is positive for HBsAG, Hepatitis C antibody, Hepatitis A IgM, or Human Immunodeficiency Virus (HIV) Viral Serology tests at the screening visit;
- a positive qualitative urine drug or alcohol test at screening or at check-in;
- mental capacity is limited to the extent that the subject cannot provide legal consent or understand information regarding the study;
- any subject who has had a 10% weight loss in the past 3 months prior to the screening visit.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Cetero Research
Miami Gardens, Florida, 33169
dgd Research
San Antonio, Texas, 78229
About this study
Official title: A Phase I, Double-Blind, Randomized, Placebo-Controlled Ascending IV Multiple Dose Tolerance and Pharmacokinetic Study of Trodusquemine (MSI-1436) in Obese or Overweight Type 2 Diabetic Volunteers
The purpose of this study is to evaluate the safety and tolerance of multiple intravenous (through a vein) doses of trodusquemine (MSI-1436) in obese or overweight, type 2 diabetics.
Read the detailed description
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), Placebo
- 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 of Trodusquemine (MSI-1436) will be administered every 72 hours on Days 0, 3, 6, 9, 12, 15, 18 and 21. Doses are 3mg/m2 in cohort 1, 6mg/m2 in cohort 2 and 10mg/m2 in cohort 3.
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Trodusquemine (MSI-1436) 3mg/m2 | Experimental | Not described Receives: Drug: Trodusquemine (MSI-1436) |
| Trodusquemine (MSI-1436) 6mg/m2 | Experimental | Not described Receives: Drug: Trodusquemine (MSI-1436) |
| Trodusquemine (MSI-1436) 10mg/m2 | Experimental | Not described Receives: Drug: Trodusquemine (MSI-1436) |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerance of multiple intravenous doses of trodusquemine (MSI-1436) in obese or overweight type 2 diabetics. Safety will be evaluated by physical exams, vital signs assessments, 12-lead ECGs, clinical lab tests and adverse event profile.
Measured: 6 months
Secondary outcomes (4)
Effect on glucose tolerance or glucose/insulin relationships
Measured: 6 months
Effect on appetite and food consumption
Measured: 6 months
Effect on behavior and mood
Measured: 6 months
Effect on exploratory biomarkers
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 posted10 Dec 2008 (estimated)
- Study startNov 2008
- Primary completionApr 2009
- 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
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genaera Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Mark Kipnes, MD, Principal investigator, dgd ResearchGilbert Weiner, D.O. AOBFP, Principal investigator, Cetero Research, San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00806338
- Sponsor's protocol ID
- MSI-1436C-102
- 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 Multiple Dose Tolerance and Pharmacokinetic Study of Trodusquemine (MSI-1436) in Obese or Overweight Type 2 Diabetic Volunteers
- ClinicalTrials.gov ID
- NCT00806338
- Acronym / sponsor ID
- MSI-1436C-102
- Conditions
- Diabetes Mellitus, Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Genaera CorporationIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 10 Dec 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 multiple intravenous (through a vein) doses of trodusquemine (MSI-1436) in obese or overweight, type 2 diabetics.
Detailed description
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 |
|---|---|---|
| Trodusquemine (MSI-1436) 3mg/m2 | Experimental | Drug: Trodusquemine (MSI-1436) |
| Trodusquemine (MSI-1436) 6mg/m2 | Experimental | Drug: Trodusquemine (MSI-1436) |
| Trodusquemine (MSI-1436) 10mg/m2 | Experimental | Drug: Trodusquemine (MSI-1436) |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- male or female obese or overweight type 2 diabetic subjects, between 18 and 65 years old (inclusive) either treatment naïve or who are inadequately controlled on metformin alone;
- subjects receiving metformin should be on stable dose for at least two weeks prior to enrollment;
- have a fasting blood sugar of ≥ 100 mg/dL and hemoglobin A1C ≥ 7.5% (but ≤ 11.0%) at study entry;
- of any race who are in good health (based on medical history, physical examination, electrocardiograms [ECGs], and clinical laboratory tests);
- non-smokers (refrained from any tobacco or nicotine usage, including smokeless tobacco, nicotine patches, etc.,) for 6 months prior to Day 0 of the study. Subjects must have cotinine levels below those measured for smokers based on reference lab values;
Key exclusion criteria (15 listed)
- likely allergy or sensitivity to any components of Trodusquemine (MSI-1436C) for Injection;
- 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;
- history of seizure, epilepsy, severe head injury, multiple sclerosis, or other known neurological conditions;
- abnormal pre-admission vital signs, physical examination, clinical laboratory, or any safety variable which is considered clinically significant for this population by the Principal Investigator or Sponsor (or designee). Subjects with an abnormal serum creatinine should not be enrolled. Subjects with AST (SGOT), ALT (SGPT), GGT, alkaline phosphatase, bilirubin, blood urea nitrogen (BUN), prothrombin time (PT), or activated partial thromboplastin time (aPPT) >1.5 times above the upper limit of normal should not be enrolled;
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 of Trodusquemine (MSI-1436) will be administered every 72 hours on Days 0, 3, 6, 9, 12, 15, 18 and 21. Doses are 3mg/m2 in cohort 1, 6mg/m2 in cohort 2 and 10mg/m2 in cohort 3. | Drug | Trodusquemine (MSI-1436) 10mg/m2, Trodusquemine (MSI-1436) 3mg/m2, Trodusquemine (MSI-1436) 6mg/m2 |
| Placebo | Drug | Placebo |
Primary outcome
Safety and Tolerance of multiple intravenous doses of trodusquemine (MSI-1436) in obese or overweight type 2 diabetics. Safety will be evaluated by physical exams, vital signs assessments, 12-lead ECGs, clinical lab tests and adverse event profile.
Time frame: 6 months
4 secondary outcomes
Effect on glucose tolerance or glucose/insulin relationships
Time frame: 6 months
Effect on appetite and food consumption
Time frame: 6 months
Effect on behavior and mood
Time frame: 6 months
Effect on exploratory biomarkers
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.
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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.
Mark Kipnes, MD principal investigator
dgd Research
Gilbert Weiner, D.O. AOBFP principal investigator
Cetero Research, San Antonio
2 sites 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 2 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 8 inclusion and 15 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 2 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 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 multiple intravenous doses of trodusquemine (MSI-1436) in obese or overweight type 2 diabetics. Safety will be evaluated by physical exams, vital signs assessments, 12-lead ECGs, clinical lab tests and adverse event profile. (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.