Safety and Tolerability Study of MBX-2044 in Patients With Type 2 Diabetes
NCT00422487 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2015-05-01
Summary
The purpose of this study is to collect important information regarding the glucose-lowering efficacy of MBX-2044 and the safety of MBX-2044 (especially weight gain and edema) in diabetics. It will also provide important information about the appropriate doses to be used in subsequent longer-term studies to evaluate the safety and efficacy of MBX-2044 alone and in combination with other anti-diabetic agents.
Conditions
Interventions
- DRUG
-
MBX-2044
MBX-2044 1.5 mg one capsule daily for 14 days
- DRUG
-
MBX-2044
MBX-2044 4.5 mg three 1.5 mg capsules daily for 14 days
- DRUG
-
MBX-2044
MBX-2044 15 mg one capsule daily for 14 days
- DRUG
-
MBX-2044
MBX-2044 30 mg two 15 mg capsules daily for 14 days
- DRUG
-
MBX-2044
MBX-2044 60 mg one capsule daily for 14 days
- DRUG
-
MBX-2044
MBX-2044 90 mg one 60 mg capsule and two 15 mg capsules daily for 14 days
- DRUG
-
Placebo for MBX-2044
Placebo Intervention
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Sherwyn Schwartz, MD · Diabetes and Glandular Research Associates
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2006-10-31
- Primary Completion
- 2007-08-31
- Completion
- 2007-09-30
Countries
- United States
Study Locations
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