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.
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
2 other identifiers
interventional
502
4 countries
31
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 type-2-diabetes-mellitus
Started Nov 2007
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 10, 2007
CompletedFirst Posted
Study publicly available on registry
December 11, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedResults Posted
Study results publicly available
July 13, 2010
CompletedJuly 27, 2010
July 1, 2010
1.4 years
December 10, 2007
April 6, 2010
July 19, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percent Change of Hemoglobin A1C (HbA1C) From Baseline to 16 Weeks When Given as Initial Therapy to Drug-naïve, Diabetic Subjects.
Baseline to 16 weeks
Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) in Pre-Diabetic Subjects From Baseline to 16 Weeks
Baseline to 16 Weeks
Secondary Outcomes (64)
Percent Change in Hemoglobin A1C (HbA1C) When Given to Drug-naïve, Diabetic Subjects From Baseline to 4, 8, 12 and 16 Weeks.
Baseline to 4, 8, 12, and 16 weeks
Fasting Plasma Glucose When Given to Drug-naïve, Diabetic Subjects From Baseline to 4, 8, 12, and 16 Weeks
Baseline to 4, 8, 12, and 16 weeks
Fasting Insulin When Given to Drug-naïve, Diabetic Subjects From Baseline to 4, 8, 12, and 16 Weeks
Baseline to 4, 8, 12, and 16 weeks
Fasting C-Peptide Levels When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks
Baseline to 16 weeks
30 Minute Post-Meal Glucose Levels When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks
Baseline to 16 weeks
- +59 more secondary outcomes
Study Arms (4)
Diabetic Participants: Metformin HCl+Placebo for Colesevelam
PLACEBO COMPARATORParticipants 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.
Diabetic participants: Metformin HCl + Colesevelam
EXPERIMENTALParticipants 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.
Pre-diabetic Participants: Colesevelam Placebo
PLACEBO COMPARATORParticipants will receive 6 placebo tablets matching colesevelam 625 mg. Study medication is to be administered once daily for 16 weeks.
Pre-diabetes Participants: Colesevelam
EXPERIMENTALParticipants will receive 6 colesevelam tablets, 625 mg. Study medication is to be administered once daily for 16 weeks.
Interventions
One or two Metformin HCl tablets 850 mg (depending on tolerability) and 6 colesevelam 625 mg placebo tablets once daily for 16 weeks
One or two Metformin HCl tablets 850 mg (depending on tolerability) and 6 colesevelam 625 mg tablets once daily for 16 weeks
Six colesevelam 625 mg placebo tablets will be given once a day for 16 weeks
Six colesevelam 625 mg tablets will be given once a day for 16 weeks.
Eligibility Criteria
You may qualify if:
- 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.
- 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:
- +6 more criteria
You may not qualify if:
- 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 .
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Daiichi Sankyolead
Study Sites (31)
Unknown Facility
Birmingham, Alabama, United States
Unknown Facility
Los Gatos, California, United States
Unknown Facility
Tarzana, California, United States
Unknown Facility
Ocala, Florida, United States
Unknown Facility
Pocatello, Idaho, United States
Unknown Facility
Gary, Indiana, United States
Unknown Facility
New Orleans, Louisiana, 70112, United States
Unknown Facility
Olive Branch, Mississippi, United States
Unknown Facility
Dundee, New York, United States
Unknown Facility
West Seneca, New York, United States
Unknown Facility
Statesville, North Carolina, United States
Unknown Facility
Kent, Ohio, United States
Unknown Facility
Marion, Ohio, United States
Unknown Facility
Portland, Oregon, United States
Unknown Facility
Corpus Christi, Texas, United States
Unknown Facility
Dallas, Texas, United States
Unknown Facility
San Antonio, Texas, United States
Unknown Facility
Barranquilla, Atlántico, Colombia
Unknown Facility
Bogota, Cundinamarca, Colombia
Unknown Facility
Bucaramanga, Santander Department, Colombia
Unknown Facility
Mumbai, Dadar, India
Unknown Facility
Durgāpura, Jaipur, India
Unknown Facility
Bangalore, Karnataka, India
Unknown Facility
Kochi, Kerala, India
Unknown Facility
Nashik, Maharashtra, India
Unknown Facility
Las Palmas, Chihuahua, Mexico
Unknown Facility
Delegacion, Cuauhtemoc, Mexico
Unknown Facility
Guadalajara, Jalisco, Mexico
Unknown Facility
Monterrey, Nuevo León, Mexico
Unknown Facility
Hermosillo, Sonora, Mexico
Unknown Facility
Mérida, Yucatán, Mexico
Related Publications (4)
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.
PMID: 22913890DERIVEDGoldberg 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.
PMID: 22836068DERIVEDHandelsman 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.
PMID: 20634176DERIVEDRosenstock 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.
PMID: 20634175DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- John Raia, Senior Director Professional Affairs
- Organization
- Daiichi Sankyo, Inc.
Study Officials
- STUDY DIRECTOR
Michael Jones
DSI
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 10, 2007
First Posted
December 11, 2007
Study Start
November 1, 2007
Primary Completion
April 1, 2009
Study Completion
May 1, 2009
Last Updated
July 27, 2010
Results First Posted
July 13, 2010
Record last verified: 2010-07