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Sponsored by: |
Daiichi Sankyo Inc. |
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Information provided by: | Daiichi Sankyo Inc. |
ClinicalTrials.gov Identifier: | NCT00570739 |
This is a 16-week double-blind, placebo-controlled study (for colesevelam HCl); in the type 2 diabetes group, subjects will also be treated with open label background,metformin HCl. Two-hundred sixty subjects with type 2 DM and 200 subjects with pre-diabetes will be enrolled. Qualified subjects with T2DM will be randomized 1:1 to receive metformin HCl plus colesevelam HCl or metformin HCl plus placebo matching colesevelam HCl. Qualified subjects with pre diabetes will be randomized 1:1 to receive colesevelam HCl or matching placebo.
Condition | Intervention | Phase |
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Type 2 Diabetes Mellitus Hypercholesterolemia Pre-Diabetes |
Drug: Colesevelam HCl Drug: Metformin HCl |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Effects of Metformin HCl in Combination With Colesevelam HCl, Compared to Metformin HCl Alone, as Initial Therapy in Drug naïve Subjects With Type 2 Diabetes Mellitus, and the Effects of Colesevelam HCl on the Lipid Profile in Subjects With Pre Diabetes |
Estimated Enrollment: | 460 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | February 2009 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator |
Drug: Colesevelam HCl
3.75 g/day as 6 unbranded tablets, 16 weeks
Drug: Metformin HCl
currently marketed tablets. 850mg qd for 1 week, increased to 850 mg bid (1700 mg/day) on the second week. The latter dosage would then be maintained for an additional 14 weeks.
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2: Placebo Comparator |
Drug: Colesevelam HCl
3.75 g/day as 6 unbranded tablets, 16 weeks
Drug: Metformin HCl
currently marketed tablets. 850mg qd for 1 week, increased to 850 mg bid (1700 mg/day) on the second week. The latter dosage would then be maintained for an additional 14 weeks.
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3: Experimental |
Drug: Colesevelam HCl
3.75 g/day as 6 unbranded tablets, 16 weeks
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4: Active Comparator |
Drug: Colesevelam HCl
3.75 g/day as 6 unbranded tablets, 16 weeks
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This is a 16-week, double-blinded, placebo-controlled, randomized, parallel-group, multi-center study in pre-diabetic subjects and drug-naive subjects with T2DM.
Ages Eligible for Study: | 18 Years to 79 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
2-hour post 75 g OGTT glucose levels in the range of:
FPG levels in the range of:
Previous diagnosis of:
Women may be enrolled if all 3 of the following criteria (in addition to the above criteria)are met:
In addition to all of the above criteria, women must also meet 1 of the following 3 criteria to be enrolled:
Exclusion Criteria:
Contact: Mary Martini, RN, BSN | 513-345-4017 | martini.maryl@kendle.com |
Contact: Erin Dineen, RN | 513-345-4017 | dineen.erina@kendle.com |
Study Director: | Michael Jones | DSI |
Responsible Party: | Daiichi Sankyo, Inc. ( Michael Jones, Sr. Director, Medical Affairs ) |
Study ID Numbers: | WEL-411, IND 68,466 |
Study First Received: | December 10, 2007 |
Last Updated: | December 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00570739 |
Health Authority: | United States: Food and Drug Administration |
Colesevelam Type 2 Diabetes Mellitus Pre diabetes Metformin |
Colesevelam Metabolic Diseases Hyperlipidemias Metformin Glucose Intolerance Diabetes Mellitus Prediabetic State Endocrine System Diseases |
Hyperglycemia Diabetes Mellitus, Type 2 Endocrinopathy Glucose Metabolism Disorders Metabolic disorder Hypercholesterolemia Dyslipidemias Lipid Metabolism Disorders |
Antimetabolites Hypoglycemic Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses |
Antilipemic Agents Physiological Effects of Drugs Anticholesteremic Agents Pharmacologic Actions |