NCT00806338

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at P25-P50 for phase_1 diabetes-mellitus

Timeline
Completed

Started Nov 2008

Geographic Reach
1 country

2 active sites

Status
completed

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

January 21, 2008

Completed
10 months until next milestone

Study Start

First participant enrolled

November 1, 2008

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 10, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

April 15, 2009

Status Verified

April 1, 2009

Enrollment Period

5 months

First QC Date

January 21, 2008

Last Update Submit

April 14, 2009

Conditions

Diabetes MellitusObesity

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 months

Secondary Outcomes (4)

  • Effect on glucose tolerance or glucose/insulin relationships

    6 months

  • Effect on appetite and food consumption

    6 months

  • Effect on behavior and mood

    6 months

  • Effect on exploratory biomarkers

    6 months

Study Arms (4)

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

Interventions

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.

Trodusquemine (MSI-1436) 10mg/m2Trodusquemine (MSI-1436) 3mg/m2Trodusquemine (MSI-1436) 6mg/m2
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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;
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cetero Research

Miami Gardens, Florida, 33169, United States

Location

dgd Research

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Diabetes MellitusObesity

Interventions

3-N-1(spermine)-7, 24-dihydroxy-5-cholestane 24-sulfate

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mark Kipnes, MD

    dgd Research

    PRINCIPAL INVESTIGATOR

  • Gilbert Weiner, D.O. AOBFP

    Cetero Research, San Antonio

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 21, 2008

First Posted

December 10, 2008

Study Start

November 1, 2008

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

April 15, 2009

Record last verified: 2009-04

Locations

US(2)