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

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

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

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: MB07803; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90057
    • Walnut Creek, California, United States, 94598
  • Florida
    • Miami, Florida, United States, 33169
    • Miami Gardens, Florida, United States, 33169
  • Illinois
    • Chicago, Illinois, United States, 60611
    • Chicago, Illinois, United States, 60607
  • Indiana
    • Indianapolis, Indiana, United States, 46260
    • Indianapolis, Indiana, United States, 46254
  • Montana
    • Butte, Montana, United States, 59701
  • Nevada
    • Las Vegas, Nevada, United States, 89123
  • North Carolina
    • Charlotte, North Carolina, United States, 28209
    • Statesville, North Carolina, United States, 28677
    • Winston- Salem, North Carolina, United States, 27103
  • Ohio
    • Cincinnati, Ohio, United States, 45246
    • Delaware, Ohio, United States, 43015
    • Marion, Ohio, United States, 43302
    • Willoughby Hills, Ohio, United States, 44094
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74104
  • South Carolina
    • Charleston, South Carolina, United States, 29407
  • Tennessee
    • Bristol, Tennessee, United States, 37620
  • Texas
    • Corpus Christi, Texas, United States, 78404
    • Dallas, Texas, United States, 75231
    • Houston, Texas, United States, 77030
    • San Antonio, Texas, United States, 78229
  • Virginia
    • Richmond, Virginia, United States, 23249

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: MB07803; Daily oral administration
Experimental: 2	Drug: MB07803; Daily oral administration
Experimental: 3	Drug: MB07803; Daily oral administration
Experimental: 4	Drug: MB07803; Daily oral administration
Placebo Comparator: 5	Drug: Placebo; Daily oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Fasting Plasma Glucose Concentration	Change from baseline to Day 28

Secondary Outcome Measures

Outcome Measure	Time Frame
Fasting serum triglycerides and free fatty acids, fasting serum insulin.	Change from baseline to Day 28

Collaborators and Investigators

• Sponsor: Ligand Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: March 1, 2007
• Primary Completion (Actual): March 1, 2008
• Study Completion (Actual): March 1, 2008

Study Registration Dates

• First Submitted: April 5, 2007
• First Submitted That Met QC Criteria: April 5, 2007
• First Posted (Estimate): April 9, 2007

Study Record Updates

• Last Update Posted (Estimate): October 3, 2011
• Last Update Submitted That Met QC Criteria: September 29, 2011
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: MB07803-202