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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
November 10, 2008
June 23, 2017
April 2009
July 2012   (Final data collection date for primary outcome measure)
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 [ Time Frame: Baseline, Week 24 ]
mean change from baseline in HbA1C [ Time Frame: 24 weeks ]
Complete list of historical versions of study NCT00789750 on ClinicalTrials.gov Archive Site
  • 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.
  • mean change from baseline in fasting plasma glucose [ Time Frame: 24 weeks ]
  • Subjects with a decrease of >= 0.7 percentage units in HbA1C [ Time Frame: 24 weeks ]
  • Subjects achieving an HbA1C goal of <7.0% [ Time Frame: 24 weeks ]
  • Subjects with a reduction of FPG of >= 30 mg/dL [ Time Frame: 24 weeks ]
  • change from baseline and percent change from baseline in TC [ Time Frame: 24 weeks ]
  • change from baseline and percent change from baseline in LDL-C [ Time Frame: 24 weeks ]
  • change from baseline and percent change from baseline in HDL-C [ Time Frame: 24 weeks ]
  • change from baseline and percent change from baseline in non-HDL-C [ Time Frame: 24 weeks ]
  • change from baseline and percent change from baseline in TG [ Time Frame: 24 weeks ]
  • change from baseline and percent change from baseline in apoA-I [ Time Frame: 24 weeks ]
  • change from baseline and percent change from baseline in apoB [ Time Frame: 24 weeks ]
  • effects on insulin levels [ Time Frame: 24 weeks ]
  • effects on HOMA indices [ Time Frame: 24 weeks ]
  • effects on hs-CRP. [ Time Frame: 24 weeks ]
Not Provided
Not Provided
 
Colesevelam as Add-on to Pioglitazone Therapy for Type 2 Diabetes Mellitus
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)
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: Colesevelam
    Colesevelam 625 mg tablets
    Other Name: Welchol
  • Drug: Placebo
    Placebo tablets appearing to be colesevelam
    Other Name: No drug
  • Drug: Pioglitazone
    30 mg or 45 mg pioglitazone therapy
    Other Name: Actos
  • Experimental: Colesevelam
    Participants receive six colesevelam tablets (3.8 grams/day) in addition to pioglitazone-based therapy (30 mg or 45 mg)
    Interventions:
    • Drug: Colesevelam
    • Drug: Pioglitazone
  • Placebo Comparator: Placebo
    Participants receive six placebo tablets in addition to pioglitazone-based therapy (30 mg or 45 mg)
    Interventions:
    • Drug: Placebo
    • Drug: Pioglitazone
Rosenstock J, Truitt KE, Baz-Hecht M, Ford DM, Tao B, Chou HS. Efficacy and safety of colesevelam in combination with pioglitazone in patients with type 2 diabetes mellitus. Horm Metab Res. 2014 Dec;46(13):943-9. doi: 10.1055/s-0034-1383648. Epub 2014 Jul 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
562
July 2012
July 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00789750
WEL-A-U306
No
Not Provided
Not Provided
Not Provided
Daiichi Sankyo Inc.
Daiichi Sankyo Inc.
Not Provided
Study Director: Global Clinical Leader Daiichi Sankyo Inc.
Daiichi Sankyo Inc.
June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP