A Pilot Study of the Efficacy and Safety of BMS-512148 on Glycemic Control in Participants with Type 2 Diabetes Treated Aggressively but not Controlled on Combination Antihyperglycemic Therapy with Metformin and/or Thiazolidinedione (TZD) and Insulin IRBMED # HUM00008535
Trial Objective:
The primary objective of this pilot study is to evaluate the efficacy and safety of an investigational medication in subjects with type 2 diabetes, whose disease is not controlled even though they are currently on combination antihyperglycemic therapy.
Research Abstract:
The treatment of diabetes is an important health concern and despite a wide range of available therapies, the epidemic continues. Worldwide, there are an estimated 150 million people who have type 2 diabetes. The currently available therapies to treat type 2 diabetes augment the action or delivery of insulin to lower blood glucose. Nonetheless, despite therapy, many patients do not achieve control of their diabetes. In an effort to treat type 2 diabetes, aggressive therapy with multiple pharmacologic agents may be prescribed. However, even with the increased use in aggressive therapy, there has been a decline in glycemic control. Therefore, additional therapies are warranted.
Our study drug, BMS-512148 is an inhibitor of sodium-glucose re-absorption by the kidney, which results in an increased excretion of glucose in the urine. This effect lowers plasma glucose in an insulin-independent manner, and thus our study drug displays a novel mechanism of action. The aim of this pilot study is to support the proof of concept that BMS-512148 is effective in lowering blood glucose in insulin-resistant subjects who do not respond well to therapies which act through an insulin-dependant mechanism. The use of BMS-512148, which acts via an insulin-independent mechanism, may result in lower plasma glucose levels in these insulin-resistant subjects, and bring the management of their type 2 diabetes to therapeutic goal. The population chosen for this study is uncontrolled despite aggressive treatment with an insulin-sensitizing therapy (with metformin and/or a Thiazolidinedione (TZD)) and insulin therapy. They define a population that does not respond to either mechanism of the two currently available therapies to treat diabetes and are therefore a population of patients with an unmet need. They are characteristic of subjects with substantial insulin resistance and unresponsive type 2 diabetes. Two doses of BMS-512148 (10mg and 20mg, both administered once a day) will be evaluated in order to determine if BMS-512148 is an efficacious compound in the treatment of hyperglycemia and if there is a dose-dependent trend in glycemic efficacy.
Study Design:
This phase IIb, 12-week, randomized, double-blind, triple-arm, parallel group, placebo-controlled, multicenter trial will assess subjects' changes from baseline in glycosylated hemoglobin (A1C).
Eligibility Criteria:
We are seeking to enroll subjects with the following key eligibility criteria:
Inclusion Criteria
- Males and females, 18 to 75 years old, with type 2 diabetes and with inadequate glycemic control
- Subjects receiving insulin and metformin and/or a thiazolidinedione
- Body Mass Index = 40 kg/m2
Exclusion Criteria
- Symptoms of severely uncontrolled diabetes, and history of hypoglycemic unawareness
- Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases
Qualified subjects may receive, at no cost, study-related: medical care, research medication, laboratory work, evaluations, glucose monitoring supplies, and nutritional and diabetic counseling.
Compensation: $30 per completed visit
Duration of study: 19 weeks
Contact Us
If you are interested in participating as a subject in this study, please contact Dr. Oral's study coordinator, Annie Boullion, at (734) 615-0539.
We are located on the 3rd floor of the Taubman Center,
in the University of Michigan Hospital.
Our address is:
The Department of Internal Medicine
Division of Metabolism, Endocrinology and Diabetes
3920 Taubman Center, SPC 5354
1500 E. Medical Center Drive
Ann Arbor, MI 48109
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