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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00458016
• Other study ID #: MB07803-202
• Status: Completed
• Phase: Phase 2
• First received: April 5, 2007
• Last updated: September 29, 2011
• Start date: March 2007
• Est. completion date: March 2008

Study information

• Verified date: September 2011
• Source: Ligand Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• MB07803
Daily oral administration
• Placebo
Daily oral administration

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ligand Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fasting Plasma Glucose Concentration		Change from baseline to Day 28	No
Secondary	Fasting serum triglycerides and free fatty acids, fasting serum insulin.		Change from baseline to Day 28	No