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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.
ClinicalTrials.gov Identifier:
NCT00789750
First received: November 10, 2008
Last updated: June 23, 2017
Last verified: June 2017
  Purpose
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 Intervention Phase
Type 2 Diabetes Mellitus Drug: Colesevelam Drug: Placebo Drug: Pioglitazone Phase 3

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Daiichi Sankyo, Inc.:

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

Secondary Outcome Measures:
  • Change From Baseline in HbA1c at Week 4 [ Time Frame: Baseline, Week 4 ]
  • Change From Baseline in HbA1c at Week 8 [ Time Frame: Baseline, Week 8 ]
  • Change From Baseline in HbA1c at Week 16 [ Time Frame: Baseline, Week 16 ]
  • Number of Participants Achieving an HbA1c Goal of <7.0% [ Time Frame: Week 24 ]
  • 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.

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

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

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

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

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

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

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

  • Change From Baseline in Fasting Insulin Levels [ Time Frame: Baseline, Week 24 ]
  • Change From Baseline in Fasting C-peptide [ Time Frame: Baseline, Week 24 ]
  • 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.


Enrollment: 562
Study Start Date: April 2009
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00789750

  Show 141 Study Locations
Sponsors and Collaborators
Daiichi Sankyo, Inc.
Investigators
Study Director: Global Clinical Leader Daiichi Sankyo, Inc.
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Daiichi Sankyo, Inc.
ClinicalTrials.gov Identifier: NCT00789750     History of Changes
Other Study ID Numbers: WEL-A-U306
Study First Received: November 10, 2008
Results First Received: May 24, 2017
Last Updated: June 23, 2017

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on August 18, 2017