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Safety and Tolerability Study of MBX-2044 in Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Metabolex
ClinicalTrials.gov Identifier:
NCT00422487
First received: January 15, 2007
Last updated: September 11, 2007
Last verified: November 2006
History of Changes
  Purpose

The purpose of this study is to collect important information regarding the glucose-lowering efficacy of MBX-2044 and the safety of MBX-2044 (especially weight gain and edema) in diabetics. It will also provide important information about the appropriate doses to be used in subsequent longer-term studies to evaluate the safety and efficacy of MBX-2044 alone and in combination with other anti-diabetic agents.


Condition Intervention Phase
Type 2 Diabetes Mellitus
 Drug: MBX-2044
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Phase 2a, Randomized, Double-Blind, Placebo-Controlled Multiple Ascending Dose Study of MBX-2044 to Evaluate the Multiple-Dose Pharmacokinetics, Safety and Tolerability When Administered Orally in Patients With Type 2 Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Metabolex:

Primary Outcome Measures:
  • Evaluate the multiple-dose pharmacokinetics of MBX-2044 administered as monotherapy at the protocol-specified daily dose orally for 14 days
  • Evaluate the clinical safety and tolerability of MBX-2044 after 14 days administration, including the parameters of weight gain and edema
  • Determine the maximum tolerated dose (MTD) of MBX-2044, after 14 days administration
  • Determine the effect of MBX-2044 after 14 days administration, on efficacy parameters

Estimated Enrollment: 50
Study Start Date: October 2006
Study Completion Date: September 2007
Detailed Description:

The current study is designed to test the short-term effectiveness and tolerability of MBX-2044 in patients with type 2 diabetes who are currently being controlled with up to one or two non-TZD hypoglycemic agent(s) including sulfonylureas, meglitinides, metformin, α-glucosidase inhibitors or Byetta®. Eligible patients will be enrolled into one of the following treatment cohorts receiving either placebo or MBX-2044 at 1.5, 4.5, 15, 30, or 60 mg/day in a double-blinded study for a 14-day treatment period. Patients will be evaluated for adverse events and vital signs daily. All efficacy and laboratory safety measures will be assessed after 2 weeks. This study will provide important information regarding the glucose-lowering efficacy of MBX-2044 and the safety of MBX-2044 (especially weight gain and edema) in diabetics. It will also provide important information about the appropriate doses to be used in subsequent longer-term studies to evaluate the safety and efficacy of MBX-2044 alone and in combination with other anti-diabetic agents.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes previously controlled with up to one or two non-TZD hypoglycemic agents including sulfonylureas (e.g., glyburide, glipizide, glimeprimide), meglitinides (e.g., Prandin®, Starlix®), metformin (e.g., Glucophage®), α-glucosidase inhibitors (e.g.,acarbose, miglitol) or Byetta®
  • All female patients must be either surgically sterile or post-menopausal.
  • Male patients with female partners of childbearing potential must agree to use condoms, or their partner must use a medically acceptable form of contraception.
  • BMI 24-44 kg/m2.
  • Patients must have a FPG ≤ 200 mg/dL at screening.
  • Patients must have Hemoglobin A1c ≥ 6.5%, ≤ 10.0% at screening.
  • Electrocardiogram (ECG) and chest x-ray must be normal, or considered not clinically significant, for participation in this study.
  • Patients must have a blood pressure ≤ 160/90 mm/hg including hypertensive patients controlled with medication.

Exclusion Criteria:

  • History of Type 1 diabetes or diabetes secondary to pancreatitis or pancreatectomy.
  • History of TZD use (Actos or Avandia) within 6 months of Screening Visit.
  • History of TZD discontinuation due to lack of efficacy.
  • History of congestive heart failure within last 5 years.
  • History of significant pulmonary disease, myocardial infarction, cerebrovascular accident, or nephrotic syndrome within last 1 year.
  • Malignancy within the last 5 years (except resected basal cell carcinoma).
  • Ongoing active infection.
  • Change in treatment with lipid-lowering agent within 7 days of screening visit.
  • Current or expected requirement for anticoagulant therapy [except for low-dose aspirin ≤ 325 mg/d or Plavix® ≤ 75 mg/d].
  • Current or expected treatment with phenytoin for the duration of the study.
  • Known hypersensitivity to NSAIDs.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00422487

Locations
United States, Texas
Diabetes and Glandular Disease Research Associates
San Antonio, Texas, United States, 78229-4801
Sponsors and Collaborators
Metabolex
Investigators
Principal Investigator: Sherwyn Schwartz, MD Diabetes and Glandular Research Associates
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00422487     History of Changes
Other Study ID Numbers: M2044-20610
Study First Received: January 15, 2007
Last Updated: September 11, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Metabolex:
Type 2 Diabetes Mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 23, 2013