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

Completed · Phase 2 · Has a placebo group

Conditions studied: Type 2 Diabetes Mellitus

In brief

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

Key facts

Study ID

NCT00458016

Run by

Ligand Pharmaceuticals

People needed

105

Starts

2007-03-01

Expected to finish

2008-03-01

Last updated by the study team

2011-10-03

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Los Angeles, California, United States
• Study site — Walnut Creek, California, United States
• Study site — Miami, Florida, United States
• Study site — Miami Gardens, Florida, United States
• Study site — Chicago, Illinois, United States
• Study site — Chicago, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Butte, Montana, United States
• Study site — Las Vegas, Nevada, United States
• Study site — Charlotte, North Carolina, United States
• Study site — Statesville, North Carolina, United States
• Study site — Winston-Salem, North Carolina, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Delaware, Ohio, United States
• Study site — Marion, Ohio, United States
• Study site — Willoughby Hills, Ohio, United States
• Study site — Tulsa, Oklahoma, United States
• Study site — Charleston, South Carolina, United States
• Study site — Bristol, Tennessee, United States
• Study site — Corpus Christi, Texas, United States
• Study site — Dallas, Texas, United States
• Study site — Houston, Texas, United States
• Study site — San Antonio, Texas, United States
• Study site — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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