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

Ligand Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Placebo; Drug: MB07803

Study type: Interventional

Funder types: Industry

Identifiers

NCT00458016

MB07803-202

Details and patient eligibility

About

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

Enrollment: 105 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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105 participants in 5 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: MB07803

2

Experimental group

Treatment:

Drug: MB07803

3

Experimental group

Treatment:

Drug: MB07803

4

Experimental group

Treatment:

Drug: MB07803

5

Placebo Comparator group

Treatment:

Drug: Placebo