A Single Dose, Tolerance and Pharmacokinetic Study in Obese or Overweight Type 2 Diabetic Volunteers

This study has been completed.
Sponsor:
Information provided by:
Genaera Corporation
ClinicalTrials.gov Identifier:
NCT00606112
First received: January 21, 2008
Last updated: April 14, 2009
Last verified: April 2009
  Purpose

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).


Condition Intervention Phase
Diabetes Mellitus
Obesity
Drug: Trodusquemine (MSI-1436)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Genaera Corporation:

Primary Outcome Measures:
  • Safety and Tolerance of a single intravenous dose of trodusquemine (MSI-1436) in obese, type 2 diabetics [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 28
Study Start Date: January 2008
Study Completion Date: April 2009
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1 Drug: 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/
Placebo Comparator: 2 Drug: 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/
Placebo Comparator: 3 Drug: 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/
Placebo Comparator: 4 Drug: 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/

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. male or female obese or overweight type 2 diabetic subjects, between 18 and 55 years old (inclusive)
  2. 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.
  3. 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%);
  4. non-smoker
  5. body mass index (BMI) of 27-40 kg/m2

Exclusion Criteria:

  1. likely allergy or sensitivity to any components of Trodusquemine (MSI-1436) for Injection based on known allergies to drugs of the same class;
  2. 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;
  3. any subject with a history of severe allergy or bronchial asthma;
  4. 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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00606112

Locations
United States, Texas
dgd Research
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Genaera Corporation
Investigators
Principal Investigator: Mark Kipnes, MD dgd Research
Principal Investigator: Gilbert R. Weiner, D.O. AOBFP Allied Research International
  More Information

No publications provided

Responsible Party: Michael Gast, MD, PhD, Genaera Corporation
ClinicalTrials.gov Identifier: NCT00606112     History of Changes
Other Study ID Numbers: MSI-1436C-103
Study First Received: January 21, 2008
Last Updated: April 14, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 23, 2014