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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.

Primary Purpose

Type 2 Diabetes Mellitus, Hypercholesterolemia, Pre-diabetes

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Metformin HCl and Colesevelam Placebo
Metformin HCl tablets and Colesevelam tablets
Colesevelam placebo
Colesevelam
Sponsored by
Daiichi Sankyo, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Colesevelam, Type 2 Diabetes Mellitus, Pre-diabetes, Metformin

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 .

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Arm Label

Diabetic Participants: Metformin HCl+Placebo for Colesevelam

Diabetic participants: Metformin HCl + Colesevelam

Pre-diabetic Participants: Colesevelam Placebo

Pre-diabetes Participants: Colesevelam

Arm Description

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.

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.

Participants will receive 6 placebo tablets matching colesevelam 625 mg. Study medication is to be administered once daily for 16 weeks.

Participants will receive 6 colesevelam tablets, 625 mg. Study medication is to be administered once daily for 16 weeks.

Outcomes

Primary Outcome Measures

Percent Change of Hemoglobin A1C (HbA1C) From Baseline to 16 Weeks When Given as Initial Therapy to Drug-naïve, Diabetic Subjects.
Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) in Pre-Diabetic Subjects From Baseline to 16 Weeks

Secondary Outcome Measures

Percent Change in Hemoglobin A1C (HbA1C) When Given to Drug-naïve, Diabetic Subjects From 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
Fasting Insulin When Given to Drug-naïve, Diabetic Subjects From Baseline to 4, 8, 12, and 16 Weeks
Fasting C-Peptide Levels When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks
30 Minute Post-Meal Glucose Levels When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks
1 Hour Post-Meal Glucose Levels When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks
2 Hour Post-Meal Glucose Levels to in Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks
2 Hour Post-Meal Insulin Levels When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks
2 Hour Post-Meal C-Peptide Levels When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks
The Percent Change of Low Density Lipoprotein Cholesterol (LDL-C) When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks
Percent Change of Non-High Density Lipoprotein (Non-HDL) Levels When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks
Percent Change of High Density Lipoprotein Cholesterol(HDL-C) When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks
Percent Change of Total Cholesterol (TC) When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks
Percent Change of Triglycerides (TG)When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks
Percent Change of Apolipoprotein A-1 (Apo A-1) When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks
Percent Change of Apolipoprotein B (Apo B)When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks
Percent Change of Apolipoprotein C3 (Apo C3)When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks
Change in the Levels of Various Lipoprotein Particles When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks
Change in the Size of Various Lipoprotein Particles When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks
Change in the Calculated Total Triglycerides When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks
Change in the Calculated Very Low Density Lipoprotein Triglycerides When Given to Drug-naïve, Diabetic Subjects From 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.
Change in the Calculated High Density Lipoprotein Cholesterol When Given to Drug-naïve, Diabetic Subjects From 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.
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
Percent of Subject Achieving HbA1c Goal of <6.5% at Weeks 4, 8, 12, and 16 When Given to Drug-naïve, Diabetic Subjects
Percent of Subjects Achieving Low Density Lipoprotein-Cholesterol of <100 mg/dL at Weeks 8, 16 When Given to Drug-naïve, Diabetic Subjects
Percent of Subjects Achieving Low Density Lipoprotein-Cholesterol Goal of <70 mg/dL at Weeks 8, 16 When Given as to Drug-naïve, Diabetics
Change in Body Weight When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks
Change in Waist-to-Hip Ratio When Given to Drug-Naive Diabetic Subjects From Baseline to 16 Weeks
Change in Plasma Glucose Area Under the Curve (0 to 120 Minutes) From the Baseline Glucose Tolerance Test (GTT) to the 16 Week GTT
Percent Change of Various Calculated Lipid Parameters When Given as Initial Therapy to Drug-naïve, Diabetic From Baseline to 16 Weeks Subjects
These calculated values are reported as part of an NMR analysis. The calculations are done by LipoScience, Inc., and are proprietary.
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
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
Percent Change in Low Density Lipoprotein-Cholesterol in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks
Percent Change in Non-High Density Lipoprotein-Cholesterol in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks
Percent Change in High Density Lipoprotein-Cholesterol in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks
Percent Change in Total Cholesterol in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks
Percent Change in Apolipoprotein A-1 in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks
Percent Change in Apolipoprotein B in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks
Percent Change in Apolipoprotein CIII in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks
Percent Change in Triglycerides in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks
Percent Change in Hs-C-Reactive Protein in Pre-Diabetic Subjects From Baseline to 16 Weeks
Level of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks
Particle Size of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks
Change of Various Calculated Lipid Parameters in Pre-Diabetic Subjects From 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.
Percent Change of HbA1c in Pre-Diabetic Subjects From Baseline to 4, 8, 12, and 16 Weeks
Percent Change of Fasting Plasma Glucose in Pre-Diabetic Subjects From Baseline to 4, 8, 12, and 16 Weeks
Percent Change of Fasting Insulin in Pre-Diabetic Subjects From Baseline to 4, 8, 12, and 16 Weeks
Change of Fasting C-peptide Levels in Pre-Diabetic Subjects From Baseline to 16 Weeks
Change of Glucose Levels 30 Minutes Post Oral Glucose Tolerance Test in Pre-Diabetic Subjects From Baseline to 16 Weeks
Change of Glucose Levels 1 Hour Post Oral Glucose Tolerance Test in Pre-Diabetic Subjects From Baseline to 16 Weeks
Change of Glucose Levels 2 Hours Post Oral Glucose Tolerance Test in Pre-Diabetic Subjects From Baseline to 16 Weeks
Change of Insulin Levels 2 Hours Post Oral Glucose Tolerance Test in Pre-Diabetic Subjects From 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
Percent of Subjects Achieving Low Density Lipoprotein-Cholesterol of <100 mg/dL at Weeks 8, 16 in Pre-Diabetic Subjects
Percent of Subjects Achieving Low Density Lipoprotein-Cholesterol of <70 mg/dL at Weeks 8, 16 in Pre-Diabetic Subjects
Change in Body Weight in Pre-Diabetic Subjects From Baseline to 16 Weeks
Change in Waist-to-Hip Ratio in Pre-Diabetic Subjects From 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
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
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
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
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
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
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

Full Information

First Posted
December 10, 2007
Last Updated
July 19, 2010
Sponsor
Daiichi Sankyo, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00570739
Brief Title
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.
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 Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Daiichi Sankyo, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Hypercholesterolemia, Pre-diabetes
Keywords
Colesevelam, Type 2 Diabetes Mellitus, Pre-diabetes, Metformin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
502 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diabetic Participants: Metformin HCl+Placebo for Colesevelam
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Diabetic participants: Metformin HCl + Colesevelam
Arm Type
Experimental
Arm Description
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.
Arm Title
Pre-diabetic Participants: Colesevelam Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive 6 placebo tablets matching colesevelam 625 mg. Study medication is to be administered once daily for 16 weeks.
Arm Title
Pre-diabetes Participants: Colesevelam
Arm Type
Experimental
Arm Description
Participants will receive 6 colesevelam tablets, 625 mg. Study medication is to be administered once daily for 16 weeks.
Intervention Type
Drug
Intervention Name(s)
Metformin HCl and Colesevelam Placebo
Intervention Description
One or two Metformin HCl tablets 850 mg (depending on tolerability) and 6 colesevelam 625 mg placebo tablets once daily for 16 weeks
Intervention Type
Drug
Intervention Name(s)
Metformin HCl tablets and Colesevelam tablets
Intervention Description
One or two Metformin HCl tablets 850 mg (depending on tolerability) and 6 colesevelam 625 mg tablets once daily for 16 weeks
Intervention Type
Drug
Intervention Name(s)
Colesevelam placebo
Intervention Description
Six colesevelam 625 mg placebo tablets will be given once a day for 16 weeks
Intervention Type
Drug
Intervention Name(s)
Colesevelam
Intervention Description
Six colesevelam 625 mg tablets will be given once a day for 16 weeks.
Primary Outcome Measure Information:
Title
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
Title
Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) in Pre-Diabetic Subjects From Baseline to 16 Weeks
Time Frame
Baseline to 16 Weeks
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
Fasting C-Peptide Levels When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks
Time Frame
Baseline to 16 weeks
Title
30 Minute Post-Meal Glucose Levels When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks
Time Frame
Baseline to 16 weeks
Title
1 Hour Post-Meal Glucose Levels When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks
Time Frame
Baseline to 16 weeks
Title
2 Hour Post-Meal Glucose Levels to in Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks
Time Frame
Baseline to 16 weeks
Title
2 Hour Post-Meal Insulin Levels When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks
Time Frame
Baseline to 16 weeks
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
Change in the Calculated Total Triglycerides When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks
Time Frame
Baseline to 16 Weeks
Title
Change in the Calculated Very Low Density Lipoprotein Triglycerides When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks
Description
These calculated values are reported as part of an NMR analysis. The calculations are done by LipoScience, Inc., and are proprietary.
Time Frame
Baseline to 16 Weeks
Title
Change in the Calculated High Density Lipoprotein Cholesterol When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks
Description
These calculated values are reported as part of an NMR analysis. The calculations are done by LipoScience, Inc., and are proprietary.
Time Frame
Baseline to 16 Weeks
Title
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
Title
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
Title
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
Title
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
Title
Change in Body Weight When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks
Time Frame
Baseline to 16 Weeks
Title
Change in Waist-to-Hip Ratio When Given to Drug-Naive Diabetic Subjects From Baseline to 16 Weeks
Time Frame
Baseline to 16 Weeks
Title
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
Title
Percent Change of Various Calculated Lipid Parameters When Given as Initial Therapy to Drug-naïve, Diabetic From Baseline to 16 Weeks Subjects
Description
These calculated values are reported as part of an NMR analysis. The calculations are done by LipoScience, Inc., and are proprietary.
Time Frame
Baseline to 16 Weeks
Title
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
Title
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
Title
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
Title
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
Title
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
Title
Percent Change in Total Cholesterol in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks
Time Frame
Baseline to 8, and 16 Weeks
Title
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
Title
Percent Change in Apolipoprotein B in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks
Time Frame
Baseline to 8, and 16 Weeks
Title
Percent Change in Apolipoprotein CIII in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks
Time Frame
Baseline to 8, and 16 Weeks
Title
Percent Change in Triglycerides in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks
Time Frame
Baseline to 8, and 16 Weeks
Title
Percent Change in Hs-C-Reactive Protein in Pre-Diabetic Subjects From Baseline to 16 Weeks
Time Frame
Baseline 16 Weeks
Title
Level of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks
Time Frame
Baseline to 16 Weeks
Title
Particle Size of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks
Time Frame
Baseline to 16 Weeks
Title
Change of Various Calculated Lipid Parameters in Pre-Diabetic Subjects From Baseline to 16 Weeks
Description
These calculated values are reported as part of an NMR analysis. The calculations are done by LipoScience, Inc., and are proprietary.
Time Frame
Baseline to 16 Weeks
Title
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
Title
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
Title
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
Title
Change of Fasting C-peptide Levels in Pre-Diabetic Subjects From Baseline to 16 Weeks
Time Frame
Baseline to 16 Weeks
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
Change in Body Weight in Pre-Diabetic Subjects From Baseline to 16 Weeks
Time Frame
Baseline to 16 Weeks
Title
Change in Waist-to-Hip Ratio in Pre-Diabetic Subjects From Baseline to 16 Weeks
Time Frame
Baseline to 16 Weeks
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility 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 .
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Jones
Organizational Affiliation
DSI
Official's Role
Study Director
Facility Information:
City
Birmingham
State/Province
Alabama
Country
United States
City
Los Gatos
State/Province
California
Country
United States
City
Tarzana
State/Province
California
Country
United States
City
Ocala
State/Province
Florida
Country
United States
City
Pocatello
State/Province
Idaho
Country
United States
City
Gary
State/Province
Indiana
Country
United States
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
City
Olive Branch
State/Province
Mississippi
Country
United States
City
Dundee
State/Province
New York
Country
United States
City
West Seneca
State/Province
New York
Country
United States
City
Statesville
State/Province
North Carolina
Country
United States
City
Kent
State/Province
Ohio
Country
United States
City
Marion
State/Province
Ohio
Country
United States
City
Portland
State/Province
Oregon
Country
United States
City
Corpus Christi
State/Province
Texas
Country
United States
City
Dallas
State/Province
Texas
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
City
Barranquilla
State/Province
Atlántico
Country
Colombia
City
Bogota
State/Province
Cundinamarca
Country
Colombia
City
Bucaramanga
State/Province
Santander
Country
Colombia
City
Mumbai
State/Province
Dadar
Country
India
City
Durgapura
State/Province
Jaipur
Country
India
City
Bangalore
State/Province
Karnataka
Country
India
City
Cochin
State/Province
Kerala
Country
India
City
Nasik
State/Province
Mahārāshtra
Country
India
City
Las Palmas
State/Province
Chihuahua
Country
Mexico
City
Delegacion
State/Province
Cuauhtemoc
Country
Mexico
City
Guadalajara
State/Province
Jalisco
Country
Mexico
City
Monterrey
State/Province
Nuevo Leon
Country
Mexico
City
Hermosillo
State/Province
Sonora
Country
Mexico
City
Merida
State/Province
Yucatan
Country
Mexico

12. IPD Sharing Statement

Citations:
PubMed Identifier
22913890
Citation
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.
Results Reference
derived
PubMed Identifier
22836068
Citation
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.
Results Reference
derived
PubMed Identifier
20634176
Citation
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.
Results Reference
derived
PubMed Identifier
20634175
Citation
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.
Results Reference
derived

Learn more about this trial

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.

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