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

• Status: Completed
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ligand Pharmaceuticals

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