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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: 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

  Hide Study Locations
Locations
United States, Alabama
Birmingham, Alabama, United States, 35205
Birmingham, Alabama, United States, 35216
Birmingham, Alabama, United States, 35294
Montgomery, Alabama, United States, 36106
Montgomery, Alabama, United States, 36117
United States, Arizona
Green Valley, Arizona, United States, 85614
Mesa, Arizona, United States, 85210
Phoenix, Arizona, United States, 85050
Tempe, Arizona, United States, 85282
Tempe, Arizona, United States, 85284
United States, Arkansas
Searcy, Arkansas, United States, 72143
United States, California
Buena Park, California, United States, 90620
Burbank, California, United States, 91505
Chino, California, United States, 91710
Garden Grove, California, United States, 92844
Huntington Park, California, United States, 90255
La Mirada, California, United States, 90638
Lincoln, California, United States, 95648
Lomita, California, United States, 90717
Los Gatos, California, United States, 95032
Modesto, California, United States, 95355
San Diego, California, United States, 92161
Santa Ana, California, United States, 92701
Tustin, California, United States, 92780
Walnut Creek, California, United States, 94598
United States, Florida
Coral Gables, Florida, United States, 33134
DeLand, Florida, United States, 32720
Delray Beach, Florida, United States, 33484
Gulf Breeze, Florida, United States, 32561
Hialeah, Florida, United States, 33012
Jacksonville, Florida, United States, 32223
Kissimmee, Florida, United States, 34741
Miami, Florida, United States, 33135
Miami, Florida, United States, 33156
Miami, Florida, United States, 33169
Miami, Florida, United States, 33175
Miami, Florida, United States, 33183
New Port Richey, Florida, United States, 34652
Ocala, Florida, United States, 34471
Ormond Beach, Florida, United States, 32174
Pembroke Pines, Florida, United States, 33026
Pembroke Pines, Florida, United States, 33027
Pinellas Park, Florida, United States, 33781
Sanford, Florida, United States, 32771
Tampa, Florida, United States, 33607
Vero Beach, Florida, United States, 32960
Wellington, Florida, United States, 33449
Winter Haven, Florida, United States, 33880
Winter Park, Florida, United States, 32789
Winter Park, Florida, United States, 32792
United States, Georgia
Columbus, Georgia, United States, 31904
Decatur, Georgia, United States, 30035
East Point, Georgia, United States, 30344
Marietta, Georgia, United States, 30066
Roswell, Georgia, United States, 30076
Stockbridge, Georgia, United States, 30281
Tucker, Georgia, United States, 30084
Waycross, Georgia, United States, 31501
United States, Idaho
Nampa, Idaho, United States, 83686
United States, Illinois
Arlington Heights, Illinois, United States, 60004
Chicago, Illinois, United States, 60607
United States, Indiana
Bloomington, Indiana, United States, 47403
Evansville, Indiana, United States, 47714
LaPorte, Indiana, United States, 46350
South Bend, Indiana, United States, 46614
United States, Kentucky
Crestview Hills, Kentucky, United States, 41017
Paducah, Kentucky, United States, 42003
United States, Louisiana
Lafayette, Louisiana, United States, 70503
United States, Maryland
Prince Frederick, Maryland, United States, 20678
Silver Spring, Maryland, United States, 20910
United States, Massachusetts
New Bedford, Massachusetts, United States, 02740
United States, Michigan
Southfield, Michigan, United States, 48034
United States, Minnesota
Brooklyn Center, Minnesota, United States, 55430
United States, Mississippi
Jackson, Mississippi, United States, 39216
Port Gibson, Mississippi, United States, 39150
United States, Missouri
Kansas City, Missouri, United States, 64111
Saint Louis, Missouri, United States, 63141
United States, Montana
Billings, Montana, United States, 59101
United States, Nevada
Las Vegas, Nevada, United States, 89123
United States, New Jersey
Belvidere, New Jersey, United States, 07823
Berlin, New Jersey, United States, 08009
Clifton, New Jersey, United States, 07013
Lumberton, New Jersey, United States, 08048
Mine Hill, New Jersey, United States, 07803
United States, New York
New Windsor, New York, United States, 12553
North Massapequa, New York, United States, 11758
Tonawanda, New York, United States, 14150
West Seneca, New York, United States, 14224
United States, North Carolina
Lexington, North Carolina, United States, 27293
Statesville, North Carolina, United States, 28625
United States, Ohio
Cincinnati, Ohio, United States, 45219
Cincinnati, Ohio, United States, 45227
Cincinnati, Ohio, United States, 45245
Cleveland, Ohio, United States, 44122
Columbus, Ohio, United States, 43213
Cuyahoga Falls, Ohio, United States, 44223
Marion, Ohio, United States, 43302
Shaker Heights, Ohio, United States, 44120
Stow, Ohio, United States, 44224
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73103
Oklahoma City, Oklahoma, United States, 73132
Oklahoma City, Oklahoma, United States, 73159
United States, Oregon
Portland, Oregon, United States, 97220
United States, Pennsylvania
Harrisburg, Pennsylvania, United States, 17112
Jersey Shore, Pennsylvania, United States, 17740
Philadelphia, Pennsylvania, United States, 19140
Philadelphia, Pennsylvania, United States, 19153
Upper Saint Clair, Pennsylvania, United States, 15241
United States, South Carolina
Charleston, South Carolina, United States, 29412
Charleston, South Carolina, United States, 29414
Columbia, South Carolina, United States, 29201
Greer, South Carolina, United States, 29651
United States, Tennessee
Germantown, Tennessee, United States, 38138
Jackson, Tennessee, United States, 38305
Murfreesboro, Tennessee, United States, 37130
New Tazewell, Tennessee, United States, 37825
United States, Texas
Arlington, Texas, United States, 76012
Dallas, Texas, United States, 75230
Dallas, Texas, United States, 75231
Dallas, Texas, United States, 75235
Fort Worth, Texas, United States, 76117
Grand Prairie, Texas, United States, 75052
Houston, Texas, United States, 77008
Houston, Texas, United States, 77074
Houston, Texas, United States, 77081
Houston, Texas, United States, 77083
San Antonio, Texas, United States, 78209
San Antonio, Texas, United States, 78229
Sugar Land, Texas, United States, 77478
Sugar Land, Texas, United States, 77479
Tomball, Texas, United States, 77375
United States, Utah
Salt Lake City, Utah, United States, 84102
Salt Lake City, Utah, United States, 84107
United States, Virginia
Alexandria, Virginia, United States, 22304
Danville, Virginia, United States, 24541
Manassas, Virginia, United States, 20110
Richmond, Virginia, United States, 23225
Salem, Virginia, United States, 24153
Suffolk, Virginia, United States, 23435
United States, Washington
Lakewood, Washington, United States, 98499
United States, Wisconsin
Kenosha, Wisconsin, United States, 53142
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 July 21, 2017