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.
NCT ID: NCT00570739
Last Updated: 2010-07-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
502 participants
INTERVENTIONAL
2007-11-30
2009-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
Metformin HCl and Colesevelam Placebo
One or two Metformin HCl tablets 850 mg (depending on tolerability) and 6 colesevelam 625 mg placebo tablets once daily for 16 weeks
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.
Metformin HCl tablets and Colesevelam tablets
One or two Metformin HCl tablets 850 mg (depending on tolerability) and 6 colesevelam 625 mg tablets once daily for 16 weeks
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.
Colesevelam placebo
Six colesevelam 625 mg placebo tablets will be given once a day for 16 weeks
Pre-diabetes Participants: Colesevelam
Participants will receive 6 colesevelam tablets, 625 mg. Study medication is to be administered once daily for 16 weeks.
Colesevelam
Six colesevelam 625 mg tablets will be given once a day for 16 weeks.
Interventions
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Metformin HCl and Colesevelam Placebo
One or two Metformin HCl tablets 850 mg (depending on tolerability) and 6 colesevelam 625 mg placebo tablets once daily for 16 weeks
Metformin HCl tablets and Colesevelam tablets
One or two Metformin HCl tablets 850 mg (depending on tolerability) and 6 colesevelam 625 mg tablets once daily for 16 weeks
Colesevelam placebo
Six colesevelam 625 mg placebo tablets will be given once a day for 16 weeks
Colesevelam
Six colesevelam 625 mg tablets will be given once a day for 16 weeks.
Eligibility Criteria
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Inclusion Criteria
* 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 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 .
18 Years
79 Years
ALL
No
Sponsors
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Daiichi Sankyo
INDUSTRY
Responsible Party
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Daiichi Sankyo, Inc.
Principal Investigators
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Michael Jones
Role: STUDY_DIRECTOR
DSI
Locations
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Birmingham, Alabama, United States
Los Gatos, California, United States
Tarzana, California, United States
Ocala, Florida, United States
Pocatello, Idaho, United States
Gary, Indiana, United States
New Orleans, Louisiana, United States
Olive Branch, Mississippi, United States
Dundee, New York, United States
West Seneca, New York, United States
Statesville, North Carolina, United States
Kent, Ohio, United States
Marion, Ohio, United States
Portland, Oregon, United States
Corpus Christi, Texas, United States
Dallas, Texas, United States
San Antonio, Texas, United States
Barranquilla, Atlántico, Colombia
Bogota, Cundinamarca, Colombia
Bucaramanga, Santander Department, Colombia
Mumbai, Dadar, India
Durgāpura, Jaipur, India
Bangalore, Karnataka, India
Kochi, Kerala, India
Nashik, Maharashtra, India
Las Palmas, Chihuahua, Mexico
Delegacion, Cuauhtemoc, Mexico
Guadalajara, Jalisco, Mexico
Monterrey, Nuevo León, Mexico
Hermosillo, Sonora, Mexico
Mérida, Yucatán, Mexico
Countries
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References
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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.
Other Identifiers
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IND 68,466
Identifier Type: -
Identifier Source: secondary_id
WEL-411
Identifier Type: -
Identifier Source: org_study_id
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