Colesevelam Pediatric Type 2 Diabetes Mellitus Study (WELKid DM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01258075
Recruitment Status : Recruiting
First Posted : December 10, 2010
Last Update Posted : December 27, 2017
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

Brief Summary:

Colesevelam oral suspension will be studied as treatment of type 2 diabetes mellitus (T2DM) to evaluate clinical safety and efficacy in patients aged 10-17 years. The patients may have been treated with Metformin or have had no antidiabetic drug treatment in the previous three months.

Study Hypothesis: Colesevelam oral suspension for pediatric subjects with T2DM is safe, well tolerated, and shows improved blood sugar control (as evidenced by a significant change from baseline in hemoglobin A1C [HbA1c]).

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Welchol for oral suspension placebo proxy Drug: Welchol for oral suspension Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Colesevelam Oral Suspension as Monotherapy or Add-on to Metformin Therapy in Pediatric Subjects With Type 2 Diabetes Mellitus
Study Start Date : November 2010
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Sham Comparator: Placebo proxy Drug: Welchol for oral suspension placebo proxy
placebo proxy for Welchol for oral suspension, 0.625 grams colesevelam hydrochloride
Other Name: colesevelam hydrochloride
Experimental: Welchol oral suspension Drug: Welchol for oral suspension
Welchol for oral suspension, 3.75 grams colesevelam hydrochloride
Other Name: colesevelam hydrochloride

Primary Outcome Measures :
  1. Mean change in hemoglobin A1c from baseline (day 1) to 6 months [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Mean change in fasting plasma glucose from baseline (day 1) to 6 months [ Time Frame: 6 months ]
  2. Percentage of participants with HbA1c decreasing >= 0.7% from baseline (day 1) to 6 months [ Time Frame: 6 months ]
  3. Percentage of participants with final HbA1c < 7.0% at 6 months [ Time Frame: 6 months ]
  4. Percentage of participants with decrease in fasting plasma glucose >= 30 mg/dL from baseline (day 1) to 6 months [ Time Frame: 6 months ]
  5. Mean change in plasma lipids from baseline (day 1) to 6 months [ Time Frame: 6 months ]
    To assess the effects of colesevelam HCl oral suspension on changes in plasma lipids including total cholesterol (TC), low-density lipoprotein cholesterol, (LDL-C), high-density lipoprotein cholesterol (HDL-C), non-high-density lipoprotein cholesterol (non-HDL-C), triglycerides (TG), apolipoprotein A-1 (apo A-1), and apolipoprotein B (apo B).

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis of type 2 diabetes mellitus, as defined by the American Diabetes Association;
  • Understand study procedures and agree to participate by giving written assent and obtaining written consent from a parent or legal guardian at screening;
  • Males and females aged 10 to 17 years, inclusive, at randomization (randomization must occur before 18th birthday);
  • HbA1c at screening between 7.0% and 10.0%, inclusive;
  • Fasting C-peptide >0.6 ng/mL; and
  • Anti-diabetic treatment at screening:

    • Treatment-naïve or untreated; OR
    • On metformin monotherapy: Metformin monotherapy has been initiated prior to screening.

Exclusion Criteria:

  • Fasting plasma glucose >270 mg/dL;
  • Diagnosis of type 1 diabetes;
  • History of more than one episode of ketoacidosis after the initial diagnosis of type 2 diabetes mellitus;
  • Positive autoimmune markers;
  • Creatinine clearance <70 mL/min;
  • Alanine transaminase or aspartate aminotransferase elevation >2.5 X upper limit of normal;
  • Participation in another interventional research study protocol in the past 60 days;
  • Female subjects who are lactating, pregnant, or plan to become pregnant within 1 year of screening;
  • Female subjects who are sexually active and unwilling to use appropriate contraception for the duration of the study;
  • History of bowel obstruction;
  • Other significant organ system illness or condition (including psychiatric or developmental disorder) that, in the opinion of the Investigator, would prevent full participation;
  • Triglycerides >500 mg/dL.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01258075

Contact: Tina Roberts, PhD 800-730-5779
Contact: Jayeeta Roychoudhury, PhD 513-579-9911 ext 12537

  Hide Study Locations
United States, Arizona
Tucson, Arizona, United States, 85724
United States, Arkansas
Little Rock, Arkansas, United States, 72202
United States, California
Los Angeles, California, United States, 90027
Oakland, California, United States, 94609
San Diego, California, United States, 92123
United States, Colorado
Aurora, Colorado, United States, 80045
United States, Connecticut
Hartford, Connecticut, United States, 06106
United States, Florida
Tampa, Florida, United States, 33612
United States, Georgia
Atlanta, Georgia, United States, 30322
United States, Illinois
Chicago, Illinois, United States, 60637
United States, Kansas
Kansas City, Kansas, United States, 66160
United States, Maryland
Baltimore, Maryland, United States, 21229
United States, Massachusetts
Springfield, Massachusetts, United States, 01199
United States, New York
New York, New York, United States, 10032
United States, North Carolina
Raleigh, North Carolina, United States, 27610
United States, Ohio
Cincinnati, Ohio, United States, 45229
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73104
Oklahoma City, Oklahoma, United States, 73112
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
Greenville, South Carolina, United States, 29615
United States, Tennessee
Nashville, Tennessee, United States, 37232
United States, Texas
Dallas, Texas, United States, 75235
Houston, Texas, United States, 77030
San Antonio, Texas, United States, 78207
Sponsors and Collaborators
Daiichi Sankyo, Inc.
Study Director: Global Clinical Leader/Medical Monitor Daiichi Sankyo, Inc.

Additional Information:
Responsible Party: Daiichi Sankyo, Inc. Identifier: NCT01258075     History of Changes
Other Study ID Numbers: WEL-A-U307
First Posted: December 10, 2010    Key Record Dates
Last Update Posted: December 27, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address:
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Studies for which the medicine and indication have received EU and US marketing approval on or after 01 January 2014 or by the US or EU Health Authorities when regulatory submissions in both regions are not planned and after the primary study results have been accepted for publication.
Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States and the European Union from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.

Keywords provided by Daiichi Sankyo, Inc.:
colesevelam HCl
type 2 diabetes mellitus
blood glucose
bile acid sequestrant
oral suspension
add-on therapy
add-on to metformin

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