Clinical trial NCT00458016: Safety, Tolerability, and Efficacy Study of MB07803 Administered to Patients With Type 2 Diabetes Mellitus
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Ligand Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2007-04-09
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Fasting Plasma Glucose Concentration
timeFrame: Change from baseline to Day 28
Secondary outcomes:
measure: Fasting serum triglycerides and free fatty acids, fasting serum insulin.
timeFrame: Change from baseline to Day 28
Other outcomes:
Locations:
city: Los Angeles
country: United States
state: California
city: Walnut Creek
country: United States
state: California
city: Miami Gardens
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Chicago
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Indianapolis
country: United States
state: Indiana
city: Butte
country: United States
state: Montana
city: Las Vegas
country: United States
state: Nevada
city: Charlotte
country: United States
state: North Carolina
city: Statesville
country: United States
state: North Carolina
city: Winston- Salem
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Delaware
country: United States
state: Ohio
city: Marion
country: United States
state: Ohio
city: Willoughby Hills
country: United States
state: Ohio
city: Tulsa
country: United States
state: Oklahoma
city: Charleston
country: United States
state: South Carolina
city: Bristol
country: United States
state: Tennessee
city: Corpus Christi
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Richmond
country: United States
state: Virginia
Study officials:
References: