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Type 2 Diabetes MellitusPhase 3NCT00789750

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

A Phase 3 study testing Colesevelam and Pioglitazone in people with Type 2 Diabetes Mellitus, run by Daiichi Sankyo at 141 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Colesevelam and Pioglitazone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
562 participants
Where
141 sitesUnited States
Study dates
Apr 2009to Jul 2012
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

141 sites in 1 country.

141 sites in 1 country

United States141 sites

  • Study site

    Alexandria, Virginia, 22304

  • Study site

    Arlington, Texas, 76012

  • Study site

    Arlington Heights, Illinois, 60004

  • Study site

    Belvidere, New Jersey, 07823

  • Study site

    Berlin, New Jersey, 08009

  • Study site

    Billings, Montana, 59101

  • Study site

    Birmingham, Alabama, 35205

  • Study site

    Birmingham, Alabama, 35216

  • Study site

    Birmingham, Alabama, 35294

  • Study site

    Bloomington, Indiana, 47403

  • Study site

    Brooklyn Center, Minnesota, 55430

  • Study site

    Buena Park, California, 90620

  • Study site

    Burbank, California, 91505

  • Study site

    Charleston, South Carolina, 29412

  • Study site

    Charleston, South Carolina, 29414

  • Study site

    Chicago, Illinois, 60607

  • Study site

    Chino, California, 91710

  • Study site

    Cincinnati, Ohio, 45219

  • Study site

    Cincinnati, Ohio, 45227

  • Study site

    Cincinnati, Ohio, 45245

  • Study site

    Cleveland, Ohio, 44122

  • Study site

    Clifton, New Jersey, 07013

  • Study site

    Columbia, South Carolina, 29201

  • Study site

    Columbus, Georgia, 31904

  • Study site

    Columbus, Ohio, 43213

  • Study site

    Coral Gables, Florida, 33134

  • Study site

    Crestview Hills, Kentucky, 41017

  • Study site

    Cuyahoga Falls, Ohio, 44223

  • Study site

    Dallas, Texas, 75230

  • Study site

    Dallas, Texas, 75231

  • Study site

    Dallas, Texas, 75235

  • Study site

    Danville, Virginia, 24541

  • Study site

    Decatur, Georgia, 30035

  • Study site

    DeLand, Florida, 32720

  • Study site

    Delray Beach, Florida, 33484

  • Study site

    East Point, Georgia, 30344

  • Study site

    Evansville, Indiana, 47714

  • Study site

    Fort Worth, Texas, 76117

  • Study site

    Garden Grove, California, 92844

  • Study site

    Germantown, Tennessee, 38138

  • Study site

    Grand Prairie, Texas, 75052

  • Study site

    Green Valley, Arizona, 85614

  • Study site

    Greer, South Carolina, 29651

  • Study site

    Gulf Breeze, Florida, 32561

  • Study site

    Harrisburg, Pennsylvania, 17112

  • Study site

    Hialeah, Florida, 33012

  • Study site

    Houston, Texas, 77008

  • Study site

    Houston, Texas, 77074

  • Study site

    Houston, Texas, 77081

  • Study site

    Houston, Texas, 77083

  • Study site

    Huntington Park, California, 90255

  • Study site

    Jackson, Mississippi, 39216

  • Study site

    Jackson, Tennessee, 38305

  • Study site

    Jacksonville, Florida, 32223

  • Study site

    Jersey Shore, Pennsylvania, 17740

  • Study site

    Kansas City, Missouri, 64111

  • Study site

    Kenosha, Wisconsin, 53142

  • Study site

    Kissimmee, Florida, 34741

  • Study site

    La Mirada, California, 90638

  • Study site

    La Porte, Indiana, 46350

  • Study site

    Lafayette, Louisiana, 70503

  • Study site

    Lakewood, Washington, 98499

  • Study site

    Las Vegas, Nevada, 89123

  • Study site

    Lexington, North Carolina, 27293

  • Study site

    Lincoln, California, 95648

  • Study site

    Lomita, California, 90717

  • Study site

    Los Gatos, California, 95032

  • Study site

    Lumberton, New Jersey, 08048

  • Study site

    Manassas, Virginia, 20110

  • Study site

    Marietta, Georgia, 30066

  • Study site

    Marion, Ohio, 43302

  • Study site

    Mesa, Arizona, 85210

  • Study site

    Miami, Florida, 33135

  • Study site

    Miami, Florida, 33156

  • Study site

    Miami, Florida, 33169

  • Study site

    Miami, Florida, 33175

  • Study site

    Miami, Florida, 33183

  • Study site

    Mine Hill, New Jersey, 07803

  • Study site

    Modesto, California, 95355

  • Study site

    Montgomery, Alabama, 36106

  • Study site

    Montgomery, Alabama, 36117

  • Study site

    Murfreesboro, Tennessee, 37130

  • Study site

    Nampa, Idaho, 83686

  • Study site

    New Bedford, Massachusetts, 02740

  • Study site

    New Port Richey, Florida, 34652

  • Study site

    New Tazewell, Tennessee, 37825

  • Study site

    New Windsor, New York, 12553

  • Study site

    North Massapequa, New York, 11758

  • Study site

    Ocala, Florida, 34471

  • Study site

    Oklahoma City, Oklahoma, 73103

  • Study site

    Oklahoma City, Oklahoma, 73132

  • Study site

    Oklahoma City, Oklahoma, 73159

  • Study site

    Ormond Beach, Florida, 32174

  • Study site

    Paducah, Kentucky, 42003

  • Study site

    Pembroke Pines, Florida, 33026

  • Study site

    Pembroke Pines, Florida, 33027

  • Study site

    Philadelphia, Pennsylvania, 19140

  • Study site

    Philadelphia, Pennsylvania, 19153

  • Study site

    Phoenix, Arizona, 85050

  • Study site

    Pinellas Park, Florida, 33781

  • Study site

    Port Gibson, Mississippi, 39150

  • Study site

    Portland, Oregon, 97220

  • Study site

    Prince Frederick, Maryland, 20678

  • Study site

    Richmond, Virginia, 23225

  • Study site

    Roswell, Georgia, 30076

  • Study site

    Salem, Virginia, 24153

  • Study site

    Salt Lake City, Utah, 84102

  • Study site

    Salt Lake City, Utah, 84107

  • Study site

    San Antonio, Texas, 78209

  • Study site

    San Antonio, Texas, 78229

  • Study site

    San Diego, California, 92161

  • Study site

    Sanford, Florida, 32771

  • Study site

    Santa Ana, California, 92701

  • Study site

    Searcy, Arkansas, 72143

  • Study site

    Shaker Heights, Ohio, 44120

  • Study site

    Silver Spring, Maryland, 20910

  • Study site

    South Bend, Indiana, 46614

  • Study site

    Southfield, Michigan, 48034

  • Study site

    St Louis, Missouri, 63141

  • Study site

    Statesville, North Carolina, 28625

  • Study site

    Stockbridge, Georgia, 30281

  • Study site

    Stow, Ohio, 44224

  • Study site

    Suffolk, Virginia, 23435

  • Study site

    Sugar Land, Texas, 77478

  • Study site

    Sugar Land, Texas, 77479

  • Study site

    Tampa, Florida, 33607

  • Study site

    Tempe, Arizona, 85282

  • Study site

    Tempe, Arizona, 85284

  • Study site

    Tomball, Texas, 77375

  • Study site

    Tonawanda, New York, 14150

  • Study site

    Tucker, Georgia, 30084

  • Study site

    Tustin, California, 92780

  • Study site

    Upper Saint Clair, Pennsylvania, 15241

  • Study site

    Vero Beach, Florida, 32960

  • Study site

    Walnut Creek, California, 94598

  • Study site

    Waycross, Georgia, 31501

  • Study site

    Wellington, Florida, 33449

  • Study site

    West Seneca, New York, 14224

  • Study site

    Winter Haven, Florida, 33880

  • Study site

    Winter Park, Florida, 32789

  • Study site

    Winter Park, Florida, 32792

Other trials in United States

About this study

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)

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.

Being tested
Colesevelam, Placebo, Pioglitazone
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ColesevelamDrug

    Also called Welchol

    Colesevelam 625 mg tablets

  • PlaceboDrug

    Also called No drug

    Placebo tablets appearing to be colesevelam

  • PioglitazoneDrug

    Also called Actos

    30 mg or 45 mg pioglitazone therapy

Study groups in NCT00789750
Study groupRoleWhat they receive
ColesevelamExperimentalParticipants receive six colesevelam tablets (3.8 grams/day) in addition to pioglitazone-based therapy (30 mg or 45 mg)
Receives: Drug: Colesevelam; Drug: Pioglitazone
PlaceboPlacebo comparatorParticipants receive six placebo tablets in addition to pioglitazone-based therapy (30 mg or 45 mg)
Receives: Drug: Placebo; Drug: Pioglitazone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24

    Measured: Baseline, Week 24

Secondary outcomes (18)

  1. Change From Baseline in HbA1c at Week 4

    Measured: Baseline, Week 4

  2. Change From Baseline in HbA1c at Week 8

    Measured: Baseline, Week 8

  3. Change From Baseline in HbA1c at Week 16

    Measured: Baseline, Week 16

  4. Number of Participants Achieving an HbA1c Goal of <7.0%

    Measured: Week 24

  5. Change From Baseline in Fasting Plasma Glucose (FPG)

    In this study a reduction in FPG of at least 30 mg/dL is considered glycemic response.

    Measured: Baseline, Week 24

  6. Number of Participants With a Decrease of >= 0.7 Percent in HbA1c

    Measured: Week 24

  7. Number of Participants With a Decrease of >= 0.5 Percent in HbA1c

    Measured: Week 24

  8. Number of Participants With a Reduction in FPG of >= 30 mg/dL

    Measured: Week 24

  9. Percent Change From Baseline in Total Cholesterol (TC)

    TC is measured in milligrams per deciliter (mg/dL)

    Measured: Baseline, Week 24

  10. Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)

    LDL-C is measured in mg/dL

    Measured: Baseline, Week 24

  11. Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C)

    HDL-C is measured in mg/dL

    Measured: Baseline, Week 24

  12. Percent Change From Baseline in Non-HDL-C

    Non-HDL-C is measured in mg/dL

    Measured: Baseline, Week 24

  13. Percent Change From Baseline in Triglycerides (TG)

    TG are measured in mg/dL

    Measured: Baseline, Week 24

  14. Percent Change From Baseline in Apolipoprotein A-1 (Apo A-I)

    Apo A-1 is measured in mg/dL

    Measured: Baseline, Week 24

  15. Percent Change From Baseline in Apolipoprotein B (Apo B)

    Apo B is measured in mg/dL

    Measured: Baseline, Week 24

  16. Change From Baseline in Fasting Insulin Levels

    Measured: Baseline, Week 24

  17. Change From Baseline in Fasting C-peptide

    Measured: Baseline, Week 24

  18. Change From Baseline in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)

    HOMA-IR is a calculation of fasting insulin and fasting glucose that shows the level of insulin resistance. Lower numbers are better.

    Measured: Baseline, Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2008 (estimated)
  2. Study startApr 2009
  3. Primary completionJul 2012
  4. Study completionJul 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
562 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00789750
Sponsor's protocol ID
WEL-A-U306
Status last verified
Jun 2017
First submitted
10 Nov 2008
Last updated
26 Jun 2017
Data monitoring committee
No

Publications

  • 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.

    PubMed 25054436

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Colesevelam and Pioglitazone in people with Type 2 Diabetes Mellitus, run by Daiichi Sankyo at 141 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 141 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 (time frame: Baseline, Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00789750, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2017.

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