- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00570739
Effects of Metformin Hydrochloride (HCl) in Combination With Colesevelam HCl, Compared to Metformin HCl Alone, in Patients With Type 2 Diabetes Mellitus and the Effects of Colesevelam HCl on Lipids and Glucose on Pre-diabetic Patients.
July 19, 2010 updated by: Daiichi Sankyo, Inc.
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
This is a 16-week double-blind, placebo-controlled (for colesevelam hydrochloride (HCl)) study in the type 2 diabetic subjects and pre-diabetic subjects.
Diabetic participants will also be treated with open label, background,metformin HCl.
Two-hundred sixty subjects with type 2 diabetes (T2DM) and 200 pre-diabetic subjects are planned to be 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 pre-diabetic subjects will be randomized 1:1 to receive colesevelam HCl or matching placebo.
Study Overview
Status
Completed
Study Type
Interventional
Enrollment (Actual)
502
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Atlántico
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Barranquilla, Atlántico, Colombia
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Cundinamarca
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Bogota, Cundinamarca, Colombia
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Santander
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Bucaramanga, Santander, Colombia
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Dadar
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Mumbai, Dadar, India
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Jaipur
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Durgapura, Jaipur, India
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Karnataka
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Bangalore, Karnataka, India
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Kerala
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Cochin, Kerala, India
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Mahārāshtra
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Nasik, Mahārāshtra, India
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Chihuahua
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Las Palmas, Chihuahua, Mexico
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Cuauhtemoc
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Delegacion, Cuauhtemoc, Mexico
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Jalisco
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Guadalajara, Jalisco, Mexico
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Nuevo Leon
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Monterrey, Nuevo Leon, Mexico
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Sonora
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Hermosillo, Sonora, Mexico
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Yucatan
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Merida, Yucatan, Mexico
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Alabama
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Birmingham, Alabama, United States
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California
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Los Gatos, California, United States
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Tarzana, California, United States
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Florida
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Ocala, Florida, United States
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Idaho
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Pocatello, Idaho, United States
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Indiana
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Gary, Indiana, United States
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Louisiana
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New Orleans, Louisiana, United States, 70112
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Mississippi
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Olive Branch, Mississippi, United States
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New York
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Dundee, New York, United States
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West Seneca, New York, United States
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North Carolina
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Statesville, North Carolina, United States
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Ohio
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Kent, Ohio, United States
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Marion, Ohio, United States
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Oregon
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Portland, Oregon, United States
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Texas
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Corpus Christi, Texas, United States
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Dallas, Texas, United States
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San Antonio, Texas, United States
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 79 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 18 to 79 years, inclusive.
- HbA1C in the range of greater than or equal to 6.5 percent to small than or equal to 10.0 percent, to be enrolled in the T2DM cohort.
2-hour post 75 g OGTT glucose levels in the range of:
- greater than or equal to 200 mg/dL to be enrolled in the T2DM cohort, or
- greater than or equal to 140 to 200 mg/dL to be enrolled in the pre-diabetes cohort.
FPG levels in the range of:
- greater than or equal to 126 mg/dL to be enrolled in the T2DM cohort, or
- greater than or equal to 110 to smaller than or equal to 125 mg/dL to be enrolled in the pre-diabetes cohort.
- LDL-C levels greater than or equal to 100 mg/dL.
- Drug-naïve, defined as having never received treatment for T2DM or not having received antidiabetic drug therapy during the 3 months prior to screening visit.
Previous diagnosis of:
- T2DM or prediabetes, to be enrolled in the respective cohorts, or
- CHD, CVD, and/or primary hypercholesterolemia + BMI greater than or equal to 25 mg/kg2 to be screened for T2DM or pre-diabetes.
- Understanding of the study procedures and agreement to participate in the study by giving written informed consent at screening visit.
Women may be enrolled if all 3 of the following criteria (in addition to the above criteria)are met:
- They are not pregnant (women of childbearing potential must have a negative serum pregnancy test [serum beta human chorionic gonadotropin )] at screening visit);
- They are not breast-feeding; and
- They do not plan to become pregnant during the study.
In addition to all of the above criteria, women must also meet 1 of the following 3 criteria to be enrolled:
- They have been post-menopausal for at least 1 year; or
- They are of childbearing potential and will practice 1 of the following methods of birth control throughout the study: oral, injectable, or implantable hormonal contraceptives; intrauterine device; diaphragm plus spermicide; or female condom plus spermicide. Methods of contraception that are not acceptable are partner's use of condoms or partner's vasectomy.
Exclusion Criteria:
- History of type 1 diabetes and/or history of acute or chronic metabolic acidosis, including diabetic ketoacidosis.
- History of chronic (requiring daily for greater than 2 months) use of insulin therapy, except for the treatment of gestational diabetes.
- Current or prior (within the past 3 months) treatment with an oral antidiabetic drug.
- Current or prior (within the past 3 months) treatment with colesevelam HCl (WelChol), colestipol, colestimide, or cholestyramine.
- History of dysphagia, swallowing disorders, or intestinal motility disorder.
- Any serious disorder, including pulmonary, hepatic, gastrointestinal (including clinically significant malabsorption), uncontrolled endocrine/metabolic, hematologic/oncologic (within the last 5 years), neurologic, and psychiatric diseases, that would interfere with the conduct of the study or interpretation of the data.
- Acute coronary syndrome (eg, myocardial infarction or unstable angina), coronary intervention (coronary artery bypass graft or percutaneous transluminal coronary angioplasty or similar procedure), congestive heart failure (requiring pharmacological treatment), or transient ischemic attack within 3 months of screening visit.
- History of pancreatitis.
- History of acquired immune deficiency syndrome or human immunodeficiency virus.
- History of drug or alcohol abuse within the past 2 years.
- Hospitalization for any cause within 14 days prior to screening visit.
- History of an allergic or toxic response to colesevelam HCl or any of its components.
- Known hypersensitivity to metformin HCl.
- Serum TG greater than or equal to 500 mg/dL.
- Body mass index (BMI) greater than 40 kg/m2 .
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: Diabetic Participants: Metformin HCl+Placebo for Colesevelam
Participants will receive either 850 mg or 1700 mg of metformin HCl, depending on tolerability + 6 placebo tablets matching colesevelam 625 mg.
Study medication is to be administered once daily for 16 weeks.
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One or two Metformin HCl tablets 850 mg (depending on tolerability) and 6 colesevelam 625 mg placebo tablets once daily for 16 weeks
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Experimental: Diabetic participants: Metformin HCl + Colesevelam
Participants will receive either 850 mg or 1700 mg of metformin HCl, depending on tolerability + 6 colesevelam tablets, 625 mg.
Study medication is to be administered once daily for 16 weeks.
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One or two Metformin HCl tablets 850 mg (depending on tolerability) and 6 colesevelam 625 mg tablets once daily for 16 weeks
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Placebo Comparator: Pre-diabetic Participants: Colesevelam Placebo
Participants will receive 6 placebo tablets matching colesevelam 625 mg.
Study medication is to be administered once daily for 16 weeks.
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Six colesevelam 625 mg placebo tablets will be given once a day for 16 weeks
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Experimental: Pre-diabetes Participants: Colesevelam
Participants will receive 6 colesevelam tablets, 625 mg.
Study medication is to be administered once daily for 16 weeks.
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Six colesevelam 625 mg tablets will be given once a day for 16 weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Percent Change of Hemoglobin A1C (HbA1C) From Baseline to 16 Weeks When Given as Initial Therapy to Drug-naïve, Diabetic Subjects.
Time Frame: Baseline to 16 weeks
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Baseline to 16 weeks
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Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) in Pre-Diabetic Subjects From Baseline to 16 Weeks
Time Frame: Baseline to 16 Weeks
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Baseline to 16 Weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent Change in Hemoglobin A1C (HbA1C) When Given to Drug-naïve, Diabetic Subjects From Baseline to 4, 8, 12 and 16 Weeks.
Time Frame: Baseline to 4, 8, 12, and 16 weeks
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Baseline to 4, 8, 12, and 16 weeks
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Fasting Plasma Glucose When Given to Drug-naïve, Diabetic Subjects From Baseline to 4, 8, 12, and 16 Weeks
Time Frame: Baseline to 4, 8, 12, and 16 weeks
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Baseline to 4, 8, 12, and 16 weeks
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Fasting Insulin When Given to Drug-naïve, Diabetic Subjects From Baseline to 4, 8, 12, and 16 Weeks
Time Frame: Baseline to 4, 8, 12, and 16 weeks
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Baseline to 4, 8, 12, and 16 weeks
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Fasting C-Peptide Levels When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks
Time Frame: Baseline to 16 weeks
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Baseline to 16 weeks
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30 Minute Post-Meal Glucose Levels When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks
Time Frame: Baseline to 16 weeks
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Baseline to 16 weeks
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1 Hour Post-Meal Glucose Levels When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks
Time Frame: Baseline to 16 weeks
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Baseline to 16 weeks
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2 Hour Post-Meal Glucose Levels to in Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks
Time Frame: Baseline to 16 weeks
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Baseline to 16 weeks
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2 Hour Post-Meal Insulin Levels When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks
Time Frame: Baseline to 16 weeks
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Baseline to 16 weeks
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2 Hour Post-Meal C-Peptide Levels When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks
Time Frame: Baseline to 16 weeks
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Baseline to 16 weeks
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The Percent Change of Low Density Lipoprotein Cholesterol (LDL-C) When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks
Time Frame: Baseline to 8, and 16 weeks
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Baseline to 8, and 16 weeks
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Percent Change of Non-High Density Lipoprotein (Non-HDL) Levels When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks
Time Frame: Baseline to 8, and 16 weeks
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Baseline to 8, and 16 weeks
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Percent Change of High Density Lipoprotein Cholesterol(HDL-C) When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks
Time Frame: Baseline to 8, and 16 weeks
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Baseline to 8, and 16 weeks
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Percent Change of Total Cholesterol (TC) When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks
Time Frame: Baseline to 8, and 16 weeks
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Baseline to 8, and 16 weeks
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Percent Change of Triglycerides (TG)When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks
Time Frame: Baseline to 8, and 16 weeks
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Baseline to 8, and 16 weeks
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Percent Change of Apolipoprotein A-1 (Apo A-1) When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks
Time Frame: Baseline to 8, and 16 weeks
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Baseline to 8, and 16 weeks
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Percent Change of Apolipoprotein B (Apo B)When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks
Time Frame: Baseline to 8, and 16 weeks
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Baseline to 8, and 16 weeks
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Percent Change of Apolipoprotein C3 (Apo C3)When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks
Time Frame: Baseline to 8, and 16 weeks
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Baseline to 8, and 16 weeks
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Change in the Levels of Various Lipoprotein Particles When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks
Time Frame: Baseline to 16 weeks
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Baseline to 16 weeks
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Change in the Size of Various Lipoprotein Particles When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks
Time Frame: Baseline to 16 Weeks
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Baseline to 16 Weeks
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Change in the Calculated Total Triglycerides When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks
Time Frame: Baseline to 16 Weeks
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Baseline to 16 Weeks
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Change in the Calculated Very Low Density Lipoprotein Triglycerides When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks
Time Frame: Baseline to 16 Weeks
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These calculated values are reported as part of an NMR analysis.
The calculations are done by LipoScience, Inc., and are proprietary.
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Baseline to 16 Weeks
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Change in the Calculated High Density Lipoprotein Cholesterol When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks
Time Frame: Baseline to 16 Weeks
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These calculated values are reported as part of an NMR analysis.
The calculations are done by LipoScience, Inc., and are proprietary.
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Baseline to 16 Weeks
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Percent of Subjects Achieving HbA1c Goal of <7.0% at Weeks 4, 8, 12, and 16 if Baseline HbA1c Was > or = to 7.0% When Given to Drug-naïve, Diabetics
Time Frame: Baseline to 4, 8, 12, and 16 Weeks
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Baseline to 4, 8, 12, and 16 Weeks
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Percent of Subject Achieving HbA1c Goal of <6.5% at Weeks 4, 8, 12, and 16 When Given to Drug-naïve, Diabetic Subjects
Time Frame: Baseline to 4, 8, 12 and 16 weeks
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Baseline to 4, 8, 12 and 16 weeks
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Percent of Subjects Achieving Low Density Lipoprotein-Cholesterol of <100 mg/dL at Weeks 8, 16 When Given to Drug-naïve, Diabetic Subjects
Time Frame: Baseline to Weeks 8, and 16
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Baseline to Weeks 8, and 16
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Percent of Subjects Achieving Low Density Lipoprotein-Cholesterol Goal of <70 mg/dL at Weeks 8, 16 When Given as to Drug-naïve, Diabetics
Time Frame: Baseline to Weeks 8, and 16
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Baseline to Weeks 8, and 16
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Change in Body Weight When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks
Time Frame: Baseline to 16 Weeks
|
Baseline to 16 Weeks
|
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Change in Waist-to-Hip Ratio When Given to Drug-Naive Diabetic Subjects From Baseline to 16 Weeks
Time Frame: Baseline to 16 Weeks
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Baseline to 16 Weeks
|
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Change in Plasma Glucose Area Under the Curve (0 to 120 Minutes) From the Baseline Glucose Tolerance Test (GTT) to the 16 Week GTT
Time Frame: Baseline vs. 16 Weeks
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Baseline vs. 16 Weeks
|
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Percent Change of Various Calculated Lipid Parameters When Given as Initial Therapy to Drug-naïve, Diabetic From Baseline to 16 Weeks Subjects
Time Frame: Baseline to 16 Weeks
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These calculated values are reported as part of an NMR analysis.
The calculations are done by LipoScience, Inc., and are proprietary.
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Baseline to 16 Weeks
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Percent of Subjects Achieving 2-Hr. Post Meal Glucose Goal of <180 mg/dL When Given to Drug-naïve, Diabetic Subjects From Baseline to Week 16
Time Frame: Baseline to Week 16
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Baseline to Week 16
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Percent of Subjects Achieving Hs-C-Reactive Protein Goal of <2.0 mg/L When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks
Time Frame: Baseline to 16 Weeks
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Baseline to 16 Weeks
|
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Percent Change in Low Density Lipoprotein-Cholesterol in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks
Time Frame: Baseline to 8, and 16 Weeks
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Baseline to 8, and 16 Weeks
|
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Percent Change in Non-High Density Lipoprotein-Cholesterol in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks
Time Frame: Baseline to 8, and 16 Weeks
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Baseline to 8, and 16 Weeks
|
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Percent Change in High Density Lipoprotein-Cholesterol in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks
Time Frame: Baseline to 8, and 16 Weeks
|
Baseline to 8, and 16 Weeks
|
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Percent Change in Total Cholesterol in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks
Time Frame: Baseline to 8, and 16 Weeks
|
Baseline to 8, and 16 Weeks
|
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Percent Change in Apolipoprotein A-1 in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks
Time Frame: Baseline to 8, and 16 Weeks
|
Baseline to 8, and 16 Weeks
|
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Percent Change in Apolipoprotein B in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks
Time Frame: Baseline to 8, and 16 Weeks
|
Baseline to 8, and 16 Weeks
|
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Percent Change in Apolipoprotein CIII in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks
Time Frame: Baseline to 8, and 16 Weeks
|
Baseline to 8, and 16 Weeks
|
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Percent Change in Triglycerides in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks
Time Frame: Baseline to 8, and 16 Weeks
|
Baseline to 8, and 16 Weeks
|
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Percent Change in Hs-C-Reactive Protein in Pre-Diabetic Subjects From Baseline to 16 Weeks
Time Frame: Baseline 16 Weeks
|
Baseline 16 Weeks
|
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Level of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks
Time Frame: Baseline to 16 Weeks
|
Baseline to 16 Weeks
|
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Particle Size of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks
Time Frame: Baseline to 16 Weeks
|
Baseline to 16 Weeks
|
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Change of Various Calculated Lipid Parameters in Pre-Diabetic Subjects From Baseline to 16 Weeks
Time Frame: Baseline to 16 Weeks
|
These calculated values are reported as part of an NMR analysis.
The calculations are done by LipoScience, Inc., and are proprietary.
|
Baseline to 16 Weeks
|
Percent Change of HbA1c in Pre-Diabetic Subjects From Baseline to 4, 8, 12, and 16 Weeks
Time Frame: Baseline to 4, 8, 12, and 16 Weeks
|
Baseline to 4, 8, 12, and 16 Weeks
|
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Percent Change of Fasting Plasma Glucose in Pre-Diabetic Subjects From Baseline to 4, 8, 12, and 16 Weeks
Time Frame: Baseline to 4, 8, 12, and 16 weeks
|
Baseline to 4, 8, 12, and 16 weeks
|
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Percent Change of Fasting Insulin in Pre-Diabetic Subjects From Baseline to 4, 8, 12, and 16 Weeks
Time Frame: Baseline to 4, 8, 12, and 16 Weeks
|
Baseline to 4, 8, 12, and 16 Weeks
|
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Change of Fasting C-peptide Levels in Pre-Diabetic Subjects From Baseline to 16 Weeks
Time Frame: Baseline to 16 Weeks
|
Baseline to 16 Weeks
|
|
Change of Glucose Levels 30 Minutes Post Oral Glucose Tolerance Test in Pre-Diabetic Subjects From Baseline to 16 Weeks
Time Frame: Baseline to 16 Weeks
|
Baseline to 16 Weeks
|
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Change of Glucose Levels 1 Hour Post Oral Glucose Tolerance Test in Pre-Diabetic Subjects From Baseline to 16 Weeks
Time Frame: Baseline to 16 Weeks
|
Baseline to 16 Weeks
|
|
Change of Glucose Levels 2 Hours Post Oral Glucose Tolerance Test in Pre-Diabetic Subjects From Baseline to 16 Weeks
Time Frame: Baseline to 16 Weeks
|
Baseline to 16 Weeks
|
|
Change of Insulin Levels 2 Hours Post Oral Glucose Tolerance Test in Pre-Diabetic Subjects From Baseline to 16 Weeks
Time Frame: Baseline to 16 Weeks
|
Baseline to 16 Weeks
|
|
Change of C-Peptide Levels 2 Hours Post Oral Glucose Tolerance Test in Pre-Diabetic Subjects From Baseline to 16 Weeks
Time Frame: Baseline to 16 Weeks
|
Baseline to 16 Weeks
|
|
Percent of Subjects Achieving Low Density Lipoprotein-Cholesterol of <100 mg/dL at Weeks 8, 16 in Pre-Diabetic Subjects
Time Frame: Baseline to 8, and 16 Weeks
|
Baseline to 8, and 16 Weeks
|
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Percent of Subjects Achieving Low Density Lipoprotein-Cholesterol of <70 mg/dL at Weeks 8, 16 in Pre-Diabetic Subjects
Time Frame: Baseline to 8, and 16 Weeks
|
Baseline to 8, and 16 Weeks
|
|
Change in Body Weight in Pre-Diabetic Subjects From Baseline to 16 Weeks
Time Frame: Baseline to 16 Weeks
|
Baseline to 16 Weeks
|
|
Change in Waist-to-Hip Ratio in Pre-Diabetic Subjects From Baseline to 16 Weeks
Time Frame: Baseline to 16 Weeks
|
Baseline to 16 Weeks
|
|
Area Under the Curve for Plasma Glucose From 0 to 120 Minutes During the Oral Glucose Tolerance Tests in Pre-Diabetic Subjects From Baseline to 16 Weeks
Time Frame: Baseline to 16 Weeks
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Baseline to 16 Weeks
|
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Percent Achievement of <140 mg/dL Plasma Glucose 2 Hours Post the Oral Glucose Tolerance Test in Pre-Diabetic Subjects Whose Corresponding Baseline Value Was >or= to 140 mg/dL From Baseline to 16 Weeks
Time Frame: Baseline to 16 Weeks
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Baseline to 16 Weeks
|
|
Percent Achievement of <110 mg/dL Fasting Plasma Glucose in Pre-Diabetic Subjects Whose Corresponding Baseline Value Was > or = to 110 mg/dL From Baseline to 4, 8, 12, and 16 Weeks
Time Frame: Baseline to 4, 8, 12, and 16 Weeks
|
Baseline to 4, 8, 12, and 16 Weeks
|
|
Percent Achievement of <100 mg/dL Fasting Plasma Glucose in Pre-Diabetic Subjects Whose Corresponding Baseline Value Was > or = to 100 mg/dL From Baseline to 4, 8, 12 and 16 Weeks
Time Frame: Baseline to 4, 8, 12 and 16 weeks
|
Baseline to 4, 8, 12 and 16 weeks
|
|
Percent Achievement of <140 mg/dL Plasma Glucose Post 2 Hour Glucose Tolerance Test and Fasting Plasma Glucose <110 mg/dL in Pre-Diabetic Subjects From Baseline to 16 Weeks
Time Frame: Baseline to 16 Weeks
|
Baseline to 16 Weeks
|
|
Percent Achievement of Hs-C-Reactive Protein <2.0 mg/L in Pre-Diabetic Subjects Whose Corresponding Baseline Value Was > or = to 2.0 mg/L From Baseline to 16 Weeks
Time Frame: Baseline to 16 Weeks
|
Baseline to 16 Weeks
|
|
Percent of Subjects Meeting Type 2 Diabetes Criteria (Fasting Plasma Glucose >or= to 126 mg/dL or Plasma Glucose >or= to 200 mg/dL Post 2 Hr Glucose Tolerance Test in Pre-Diabetic Subjects From Baseline to 16 Weeks
Time Frame: Baseline to 16 Weeks
|
Baseline to 16 Weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Michael Jones, DSI
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Rosenstock J, Hernandez-Triana E, Handelsman Y, Misir S, Jones MR. Clinical effects of colesevelam in Hispanic subjects with primary hyperlipidemia and prediabetes. Postgrad Med. 2012 Jul;124(4):14-20. doi: 10.3810/pgm.2012.07.2564.
- Goldberg RB, Rosenson RS, Hernandez-Triana E, Misir S, Jones MR. Initial combination therapy with metformin plus colesevelam improves lipoprotein particles in patients with early type 2 diabetes mellitus. J Clin Lipidol. 2012 Jul-Aug;6(4):318-24. doi: 10.1016/j.jacl.2012.05.005. Epub 2012 May 29.
- Handelsman Y, Goldberg RB, Garvey WT, Fonseca VA, Rosenstock J, Jones MR, Lai YL, Jin X, Misir S, Nagendran S, Abby SL. Colesevelam hydrochloride to treat hypercholesterolemia and improve glycemia in prediabetes: a randomized, prospective study. Endocr Pract. 2010 Jul-Aug;16(4):617-28. doi: 10.4158/EP10129.OR.
- Rosenstock J, Fonseca VA, Garvey WT, Goldberg RB, Handelsman Y, Abby SL, Lai YL, Jin X, Misir S, Nagendran S, Jones MR. Initial combination therapy with metformin and colesevelam for achievement of glycemic and lipid goals in early type 2 diabetes. Endocr Pract. 2010 Jul-Aug;16(4):629-40. doi: 10.4158/EP10130.OR.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2007
Primary Completion (Actual)
April 1, 2009
Study Completion (Actual)
May 1, 2009
Study Registration Dates
First Submitted
December 10, 2007
First Submitted That Met QC Criteria
December 10, 2007
First Posted (Estimate)
December 11, 2007
Study Record Updates
Last Update Posted (Estimate)
July 27, 2010
Last Update Submitted That Met QC Criteria
July 19, 2010
Last Verified
July 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Hyperglycemia
- Lipid Metabolism Disorders
- Hyperlipidemias
- Dyslipidemias
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Prediabetic State
- Glucose Intolerance
- Hypercholesterolemia
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Metformin
- Colesevelam Hydrochloride
Other Study ID Numbers
- WEL-411
- IND 68,466
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Daiichi Sankyo, Inc.CompletedHypercholesterolemiaUnited States, South Africa, Israel, Netherlands, Canada, Norway, Austria, Australia
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HealthPartners InstituteDaiichi Sankyo, Inc.; International Diabetes Center at Park NicolletCompletedType 2 DiabetesUnited States
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Carine BeysenCompleted
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Daiichi Sankyo, Inc.TerminatedType 2 Diabetes MellitusUnited States
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KineMedUniversity Medical Center Groningen; Daiichi Sankyo, Inc.; Diabetes & Glandular...CompletedType 2 Diabetes Mellitus | Impaired Glucose ToleranceUnited States
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University of California, San DiegoDaiichi Sankyo, Inc.CompletedNonalcoholic SteatohepatitisUnited States