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
  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:


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 April 20, 2014