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Colesevelam as Add-on to Pioglitazone Therapy for Type 2 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT00789750
Recruitment Status : Completed
First Posted : November 13, 2008
Results First Posted : June 26, 2017
Last Update Posted : June 26, 2017
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

Study Description
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Brief Summary:
The current study investigates colesevelam as add-on therapy to pioglitazone to improve glycemic control in subjects with type 2 diabetes mellitus not adequately controlled with pioglitazone monotherapy or pioglitazone in combination with either metformin or a sulfonylurea. The study will evaluate if colesevelam add-on to pioglitazone therapy for type 2 diabetes mellitus will be safe, well tolerated, and efficacious.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Colesevelam Drug: Placebo Drug: Pioglitazone Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 562 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo Controlled, Parallel Group Study of the Efficacy and Safety of WELCHOL as Add-on to Pioglitazone Therapy for Type 2 Diabetes Mellitus (T2DM)
Study Start Date : April 2009
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Colesevelam
Participants receive six colesevelam tablets (3.8 grams/day) in addition to pioglitazone-based therapy (30 mg or 45 mg)
 Drug: Colesevelam
Colesevelam 625 mg tablets
Other Name: Welchol

Drug: Pioglitazone
30 mg or 45 mg pioglitazone therapy
Other Name: Actos
Placebo Comparator: Placebo
Participants receive six placebo tablets in addition to pioglitazone-based therapy (30 mg or 45 mg)
 Drug: Placebo
Placebo tablets appearing to be colesevelam
Other Name: No drug

Drug: Pioglitazone
30 mg or 45 mg pioglitazone therapy
Other Name: Actos


Outcome Measures
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Primary Outcome Measures :
  1. Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 [ Time Frame: Baseline, Week 24 ]

Secondary Outcome Measures :
  1. Change From Baseline in HbA1c at Week 4 [ Time Frame: Baseline, Week 4 ]
  2. Change From Baseline in HbA1c at Week 8 [ Time Frame: Baseline, Week 8 ]
  3. Change From Baseline in HbA1c at Week 16 [ Time Frame: Baseline, Week 16 ]
  4. Number of Participants Achieving an HbA1c Goal of <7.0% [ Time Frame: Week 24 ]
  5. Change From Baseline in Fasting Plasma Glucose (FPG) [ Time Frame: Baseline, Week 24 ]
    In this study a reduction in FPG of at least 30 mg/dL is considered glycemic response.

  6. Number of Participants With a Decrease of >= 0.7 Percent in HbA1c [ Time Frame: Week 24 ]
  7. Number of Participants With a Decrease of >= 0.5 Percent in HbA1c [ Time Frame: Week 24 ]
  8. Number of Participants With a Reduction in FPG of >= 30 mg/dL [ Time Frame: Week 24 ]
  9. Percent Change From Baseline in Total Cholesterol (TC) [ Time Frame: Baseline, Week 24 ]
    TC is measured in milligrams per deciliter (mg/dL)

  10. Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) [ Time Frame: Baseline, Week 24 ]
    LDL-C is measured in mg/dL

  11. Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) [ Time Frame: Baseline, Week 24 ]
    HDL-C is measured in mg/dL

  12. Percent Change From Baseline in Non-HDL-C [ Time Frame: Baseline, Week 24 ]
    Non-HDL-C is measured in mg/dL

  13. Percent Change From Baseline in Triglycerides (TG) [ Time Frame: Baseline, Week 24 ]
    TG are measured in mg/dL

  14. Percent Change From Baseline in Apolipoprotein A-1 (Apo A-I) [ Time Frame: Baseline, Week 24 ]
    Apo A-1 is measured in mg/dL

  15. Percent Change From Baseline in Apolipoprotein B (Apo B) [ Time Frame: Baseline, Week 24 ]
    Apo B is measured in mg/dL

  16. Change From Baseline in Fasting Insulin Levels [ Time Frame: Baseline, Week 24 ]
  17. Change From Baseline in Fasting C-peptide [ Time Frame: Baseline, Week 24 ]
  18. Change From Baseline in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) [ Time Frame: Baseline, Week 24 ]
    HOMA-IR is a calculation of fasting insulin and fasting glucose that shows the level of insulin resistance. Lower numbers are better.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of Type 2 diabetes mellitus
  • Inadequate glycemic control on a stable dose (at least 2 months prior to screening) of pioglitazone at 30 or 45 mg/day, with or without one or two other oral antidiabetic medications [metformin or a sulfonylurea, or dipeptidyl peptidase (DPP-IV) inhibitor]
  • Hemoglobin A1c (HbA1c) >= 7.5% and =< 9.5% at screening
  • Fasting plasma glucose =<240 mg/dL at randomization (Week 0/Day 1).
  • Male or female >= 18 years of age.
  • Women of childbearing potential must be using an adequate method of contraception as detailed per-protocol
  • Fasting C-peptide level >0.5 ng/mL at screening
  • Clinically stable in regards to medical conditions other than type 2 diabetes
  • Concomitant medications are at stable doses for at least 30 days prior to enrollment, and are not anticipated to need adjustment during the study period

Exclusion Criteria:

  • History of Type 1 diabetes and/or history of ketoacidosis
  • History of bowel obstruction
  • History of hypertriglyceridemia-induced pancreatitis
  • Fasting serum triglyceride concentration >500 mg/dL
  • History of dysphagia, swallowing disorders, gastroparesis, other gastrointestinal motility disorders, major gastrointestinal surgery
  • History of insulin use >= 2 weeks duration during the previous 3 months or a total of >2 months insulin therapy at any time prior to screening
  • Treatment with bile acid sequestrants, including colesevelam within 3 months prior to screening
  • Female subject who is pregnant or breastfeeding
  • History of unstable angina, myocardial infarction, cerebrovascular accident, transient ischemic attack, or any revascularization within 6 months prior to screening
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00789750


Locations
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Sponsors and Collaborators
Daiichi Sankyo, Inc.
Investigators
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Study Director: Global Clinical Leader Daiichi Sankyo, Inc.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Daiichi Sankyo, Inc.
ClinicalTrials.gov Identifier: NCT00789750    
Other Study ID Numbers: WEL-A-U306
First Posted: November 13, 2008    Key Record Dates
Results First Posted: June 26, 2017
Last Update Posted: June 26, 2017
Last Verified: June 2017
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pioglitazone
Colesevelam Hydrochloride
 Hypoglycemic Agents
Physiological Effects of Drugs
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents