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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00458016

Enrollment

105

Registered

2007-04-09

Start date

2007-03-31

Completion date

2008-03-31

Last updated

2011-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

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

Interventions

DRUGMB07803

Daily oral administration

DRUGPlacebo

Daily oral administration

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026