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Welchol 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: August 27, 2013
Last verified: August 2013
  Purpose

The current study investigates Welchol 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 Welchol 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: Welchol
Drug: placebo
Drug: Pioglitazone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:
  • mean change from baseline in HbA1C [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • mean change from baseline in fasting plasma glucose [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Subjects with a decrease of >= 0.7 percentage units in HbA1C [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Subjects achieving an HbA1C goal of <7.0% [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Subjects with a reduction of FPG of >= 30 mg/dL [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • change from baseline and percent change from baseline in TC [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • change from baseline and percent change from baseline in LDL-C [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • change from baseline and percent change from baseline in HDL-C [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • change from baseline and percent change from baseline in non-HDL-C [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • change from baseline and percent change from baseline in TG [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • change from baseline and percent change from baseline in apoA-I [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • change from baseline and percent change from baseline in apoB [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • effects on insulin levels [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • effects on HOMA indices [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • effects on hs-CRP. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

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: Welchol
Welchol 625 mg Tablets patients will be on stable pioglitazone 30mg or 45 mg
Drug: Welchol
Welchol 625 mg Tablets
Drug: Pioglitazone
patients will be on stable pioglitazone 30mg or 45 mg
Other Name: Actos
Placebo Comparator: placebo
placebo patients will be on stable pioglitazone 30mg or 45 mg
Drug: placebo
placebo tablets
Drug: Pioglitazone
patients will be on stable pioglitazone 30mg or 45 mg
Other Name: Actos

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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 DPP-IV inhibitor)
  • A1C >= 7.5% and =< 9.5% at screening.
  • Fasting plasma glucose =<240 mg/dL at randomization (Week0/Day 1).
  • Male or female >= 18 years of age.
  • Women of childbearing potential (WOCBP) 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
  • Two or more fasting self-monitored blood glucose (SMBG) levels >240 mg/dL during the placebo lead-in period
  • Body mass index >40 kg/m2 at screening
  • Weight loss >3% in the 3 months prior to screening
  • Treatment with bile acid sequestrants, including Welchol within 3 months prior to screening
  • LDL level <60 mg/dL
  • Female subject who is pregnant or breastfeeding
  • SBP >= 180 mmHg and/or DBP >= 110 mmHg
  • History of unstable angina, myocardial infarction, cerebrovascular accident, transient ischemic attack, or any revascularization within 6 months prior to screening
  • History of malignancy, except subjects who have been disease-free for >10 years or whose malignancy was a basal or squamous cell skin carcinoma. Women with a history of cervical dysplasia (CIN2 or higher) should be excluded unless 2 consecutive normal cervical smears have subsequently been recorded prior to enrollment
  • Known (or evidence of) infection with human immunodeficiency virus (HIV)
  • History of alcohol or drug abuse within 1 year prior to screening
  • History of untreated major psychiatric disorders that could inhibit abilities to comply with the protocol
  • Any condition, lab abnormality or concomitant therapy which, in the opinion of the investigator, might pose a risk to the subject or make participation not in the subject's best interest
  • Known or suspected allergy, hypersensitivity or intolerance to the excipients of the investigational study medication
  • Participation in an interventional medical, surgical, or pharmaceutical study within 30 days prior to the screening visit
  • A direct or familial relationship with the sponsor, investigator, or site personnel affiliated with the study.
  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, 35294
Birmingham, Alabama, United States, 35216
Birmingham, Alabama, United States, 35205
Montgomery, Alabama, United States, 36117
Montgomery, Alabama, United States, 36106
United States, Arizona
Green Valley, Arizona, United States, 85614
Mesa, Arizona, United States, 85210
Phoenix, Arizona, United States, 85050
Tempe, Arizona, United States, 85284
Tempe, Arizona, United States, 85282
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, 33175
Miami, Florida, United States, 33156
Miami, Florida, United States, 33135
Miami, Florida, United States, 33183
Miami, Florida, United States, 33169
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, 32792
Winter Park, Florida, United States, 32789
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
St. 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, 45245
Cincinnati, Ohio, United States, 45227
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, 73159
Oklahoma City, Oklahoma, United States, 73103
Oklahoma City, Oklahoma, United States, 73132
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, 75235
Dallas, Texas, United States, 75231
Dallas, Texas, United States, 75230
Fort Worth, Texas, United States, 76117
Grand Prairie, Texas, United States, 75052
Houston, Texas, United States, 77074
Houston, Texas, United States, 77008
Houston, Texas, United States, 77081
Houston, Texas, United States, 77083
San Antonio, Texas, United States, 78229
San Antonio, Texas, United States, 78209
Sugar Land, Texas, United States, 77479
Sugar Land, Texas, United States, 77478
Tomball, Texas, United States, 77375
United States, Utah
Salt Lake City, Utah, United States, 84107
Salt Lake City, Utah, United States, 84102
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.
  More Information

No publications provided

Responsible Party: Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier: NCT00789750     History of Changes
Other Study ID Numbers: WEL-306
Study First Received: November 10, 2008
Last Updated: August 27, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Colesevelam
Pioglitazone
Anticholesteremic Agents
Antimetabolites
Hypoglycemic Agents
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014