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

Ligand Pharmaceuticals0 sites105 target enrollmentMarch 2007

ConditionsType 2 Diabetes Mellitus

InterventionsMB07803 Placebo

DrugsMB07803 Placebo

Overview

Phase: Phase 2
Intervention: MB07803
Conditions: Type 2 Diabetes Mellitus
Sponsor: Ligand Pharmaceuticals
Enrollment: 105
Primary Endpoint: Fasting Plasma Glucose Concentration
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

March 2007

End Date

March 2008

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Ligand Pharmaceuticals

Responsible Party

Sponsor

Eligibility 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