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

NCT00606112 | Completed Phase 1

• 1 other identifier: MSI-1436C-103
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerance of a single intravenous dose of trodusquemine (MSI-1436) in obese, type 2 diabetics

  6 months

Study Arms (4)

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)

Interventions

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/

1; 2; 3; 4

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Genaera Corporation: lead

Study Sites (1)

dgd Research

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Obesity

Interventions

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

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mark Kipnes, MD

  dgd Research

  PRINCIPAL INVESTIGATOR

• Gilbert R. Weiner, D.O. AOBFP

  Allied Research International

  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: February 1, 2008
• Study Start: January 1, 2008
• Primary Completion: June 1, 2008
• Study Completion: April 1, 2009
• Last Updated: April 15, 2009

Record last verified: 2009-04

Locations

US (1)