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

Phase 2

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: MB07803; Drug: Placebo

• Registration Number: NCT00458016
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2007-04-05
• Study First Submitted QC: 2007-04-05
• Study First Posted: 2007-04-09
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-29
• Last Update Posted: 2011-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
4	MB07803	-
2	MB07803	-
1	MB07803	-
5	Placebo	-
3	MB07803	-

Primary Outcome Measures

Name	Time	Method
Fasting Plasma Glucose Concentration	Change from baseline to Day 28

Secondary Outcome Measures

Name	Time	Method
Fasting serum triglycerides and free fatty acids, fasting serum insulin.	Change from baseline to Day 28