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To define the relative efficacy, safety and tolerability profiles of oral daily MBX-2982 at three different daily doses vs. placebo and sitagliptin 100 mg when administered for up to 4 weeks in patients that are treatment-naive or taking a single anti-diabetic medication (non-TZD, non-injectable).
Approximately 100 patients will be randomized in this study, 20 to each of of the three MBX-2982 treatment groups, 20 to placebo, and 20 to the sitagliptin group. Patients will be taking 3 tablets and 1 capsule daily. This sample size provides the minimum number expected to ensure a power of at least 80% to detect a 20% decrease in the weighted mean glucose level associated with an extended mixed meal tolerance test (with 2 standardized meals) relative to placebo after 4 weeks of daily treatment with MBX-2982, assuming a drop-out rate of 20% and a common SD of 25%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MBX-2982 25 mg | Experimental |
| |
| MBX-2982 100 mg | Experimental |
| |
| MBX-2982 300 mg | Experimental |
| |
| Sitagliptin 100 mg | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MBX-2982 | Drug | tablets and capsule once daily |
| |
| MBX-2982 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the effect of MBX-2982 on the absolute and percent change from baseline and placebo in mean weighted average of 14-point blood glucose levels associated with a standardized breakfast and lunch | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the effect of MBX-2982 on additional glycemic parameters. | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian Roberts, MD | Metabolex, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Impact Clinical Trials | Los Angeles | California | 90036 | United States | ||
| Nevada Alliance Against Diabetes |
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| Drug |
tablets and capsule once daily |
|
| MBX-2982 | Drug | tablets and capsule once daily |
|
| Sitagliptin | Drug | tablets and capsule once daily |
|
| placebo | Drug | tablets and capsule once daily |
|
| Las Vegas |
| Nevada |
| 89101 |
| United States |
| United Medical Associates | Binghamton | New York | 13901 | United States |
| dgd Research, Inc., a Cetero Research Co. | San Antonio | Texas | 78229 | United States |
| Healthy Life Clinical Diagnostic Center | Tbilisi | 0144 | Georgia |
| Georgian Diabetes Center | Tbilisi | 0159 | Georgia |
| Medulla Chemotherapy and Immunotherapy Clinic | Tbilisi | 0186 | Georgia |
| Bharti Research Institute of Diabetes and Endocrinology | Karnāl | Haryana | 132001 | India |
| Diabetes Thyroid Hormone Research Institute Pvt Ltd | Indore | M.p. | 452001 | India |
| Gandhi Endocrinology & Diabetes Centre | Rāmdaspeth | Nagpur | 10 | India |
| Gokula Metropolis Research, MS Ramaiah Memorial Hospital | Bangalore | 560 054 | India |
| Medisys Clinisearch India Pvt Ltd | Bangalore | 560043 | India |
| Hormone Care Research Centre | Ghaziabad | 201002 | India |
| Bangalore Endocrinology & Diabetes Research Centre | Malleshwaram | 560 003 | India |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C000608114 | MBX-2982 |
| D000068900 | Sitagliptin Phosphate |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011719 | Pyrazines |
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