Status:
COMPLETED
Safety, Tolerability, and Efficacy Study of MB07803 Administered to Patients With Type 2 Diabetes Mellitus
Lead Sponsor:
Ligand Pharmaceuticals
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT00458016
Start Date
March 1 2007
End Date
March 1 2008
Last Update
October 3 2011
Active Locations (25)
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1
Los Angeles, California, United States, 90057
2
Walnut Creek, California, United States, 94598
3
Miami, Florida, United States, 33169
4
Miami Gardens, Florida, United States, 33169