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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00458016
Recruitment Status : Completed
First Posted : April 9, 2007
Last Update Posted : October 3, 2011
Information provided by (Responsible Party):
Ligand Pharmaceuticals

Brief Summary:
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 or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: MB07803 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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
Study Start Date : March 2007
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Fasting Plasma Glucose Concentration [ Time Frame: Change from baseline to Day 28 ]

Secondary Outcome Measures :
  1. Fasting serum triglycerides and free fatty acids, fasting serum insulin. [ Time Frame: Change from baseline to Day 28 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00458016

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Sponsors and Collaborators
Ligand Pharmaceuticals

Responsible Party: Ligand Pharmaceuticals Identifier: NCT00458016     History of Changes
Other Study ID Numbers: MB07803-202
First Posted: April 9, 2007    Key Record Dates
Last Update Posted: October 3, 2011
Last Verified: September 2011

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