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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: MB07803
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: MB07803<br>* Daily oral administration<br>|
| Experimental: 2<br> | Drug: MB07803<br>* Daily oral administration<br>|
| Experimental: 3<br> | Drug: MB07803<br>* Daily oral administration<br>|
| Experimental: 4<br> | Drug: MB07803<br>* Daily oral administration<br>|
| Placebo Comparator: 5<br> | Drug: Placebo<br>* Daily oral administration<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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