Effects of Metformin HCl in Combination With Colesevelam HCl, Compared to Metformin HCl Alone, in Patients With Type 2 Diabetes Mellitus Not Previously Treated With Drug Therapy, and the Effects of Colesevelam HCl on Lipids and Glucose in Patients With Pre Diabetes
Information source: Daiichi Sankyo Inc.
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes Mellitus; Hypercholesterolemia; Pre-Diabetes
Intervention: Colesevelam HCl (Drug); Metformin HCl (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Daiichi Sankyo Inc. Official(s) and/or principal investigator(s):
Michael Jones, Study Director, Affiliation: DSI
Overall contact:
Mary Martini, RN, BSN, Phone: 513-345-4017, Email: martini.maryl@kendle.com
Summary
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.
Clinical Details
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
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: To evaluate the effects of metformin HCl plus colesevelam HCl combination therapy compared to metformin HCl alone on hemoglobin A1C (HbA1C) when given as initial therapy in drug-naïve subjects
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 79 Years.
Gender(s): Both.
Criteria:
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 .
Locations and Contacts
Mary Martini, RN, BSN, Phone: 513-345-4017, Email: martini.maryl@kendle.com
Birmingham, Alabama, United States; Recruiting
Barranquilla, Atlántico, Colombia; Recruiting
Los Gatos, California, United States; Recruiting
Tarzana, California, United States; Recruiting
Las Palmas, Chihuahua, Mexico; Recruiting
Delegacion, Cuauhtemoc, Mexico; Recruiting
Bogota, Cundinamarca, Colombia; Recruiting
Mumbai, Dadar, India; Recruiting
Ocala, Florida, United States; Recruiting
Pocatello, Idaho, United States; Recruiting
Gary, Indiana, United States; Recruiting
Durgapura, Jaipur, India; Recruiting
Guadalajara, Jalisco, Mexico; Recruiting
Bangalore, Karnataka, India; Recruiting
Cochin, Kerala, India; Recruiting
New Orleans, Louisiana 70112, United States; Recruiting
Nasik, Mahārāshtra, India; Recruiting
Olive Branch, Mississippi, United States; Recruiting
Dundee, New York, United States; Recruiting
West Seneca, New York, United States; Recruiting
Statesville, North Carolina, United States; Recruiting
Monterrey, Nuevo Leon, Mexico; Recruiting
Marion, Ohio, United States; Recruiting
Kent, Ohio, United States; Recruiting
Portland, Oregon, United States; Recruiting
Bucaramanga, Santander, Colombia; Recruiting
Hermosillo, Sonora, Mexico; Recruiting
Dallas, Texas, United States; Recruiting
Corpus Christi, Texas, United States; Recruiting
San Antonio, Texas, United States; Recruiting
Merida, Yucatan, Mexico; Recruiting
Additional Information
Starting date: November 2007
Ending date: February 2009
Last updated: December 1, 2008
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