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Safety, Tolerability, and Efficacy Study of MB07803 Administered to Patients With Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ligand Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00458016
First received: April 5, 2007
Last updated: September 29, 2011
Last verified: September 2011
History of Changes
  Purpose

The purpose of this study is to collect important information regarding the safety, tolerability, and efficacy of MB07803 when administered for 28 days in patients with type 2 diabetes mellitus


Condition Intervention Phase
Type 2 Diabetes Mellitus
 Drug: MB07803
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, 28-day, Multicenter, Double-Blind,Randomized, Placebo-Controlled Study to Assess the Safety, Tolerability and Efficacy of MB07803 in Patients With Type 2 Diabetes Mellitus

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ligand Pharmaceuticals:

Primary Outcome Measures:
  • Fasting Plasma Glucose Concentration [ Time Frame: Change from baseline to Day 28 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fasting serum triglycerides and free fatty acids, fasting serum insulin. [ Time Frame: Change from baseline to Day 28 ] [ Designated as safety issue: No ]

Enrollment: 105
Study Start Date: March 2007
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: MB07803
Daily oral administration
Experimental: 2 Drug: MB07803
Daily oral administration
Experimental: 3 Drug: MB07803
Daily oral administration
Experimental: 4 Drug: MB07803
Daily oral administration
Placebo Comparator: 5 Drug: Placebo
Daily oral administration

  Eligibility

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

Inclusion Criteria:

  • Fasting plasma glucose between 120 - 270 mg/dL at screening
  • HbA1c measurements between 6.0 - 10% at screening
  • Females who are surgically sterile (i.e. women who have had a hysterectomy or tubal ligation). Females who are postmenopausal for at least 12 consecutive months and documented by blood follicular stimulating hormone (FSH) greater than or equal to 40 mlU/mL.Females of childbearing potential must be willing to use an approved double-barrier method of birth control (e.g. condom plus spermicide ;IUD plus spermicide) from the time of signing the informed consent form through 4 weeks following the last dose of study drug.
  • Body mass index (BMI) in the range of 18.5 - 37 kg/m2 Patients with a BMI in the range of 37.5 - 40 kg/m2 who in the Investigator's opinion, are in good health and satisfy the eligibility criteria, will be considered on a case-by case basis
  • Written informed consent

Exclusion Criteria:

  • Type 1 diabetes mellitus
  • Type 2 diabetes mellitus with a history of diabetic ketoacidosis or ketosis-prone
  • Use of thiazolidinediones (TZDs)
  • Currently on more than two oral hypoglycemic agent
  • History of outpatient insulin use
  • Clinically significant history of cardiac disease within 6 months of informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00458016

  Show 25 Study Locations
Sponsors and Collaborators
Ligand Pharmaceuticals
  More Information

No publications provided

Responsible Party: Ligand Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00458016     History of Changes
Other Study ID Numbers: MB07803-202
Study First Received: April 5, 2007
Last Updated: September 29, 2011
Health Authority: United States: Food and Drug Administration

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 21, 2013