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Colesevelam for Children With Type 2 Diabetes (WELKid DM)

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ClinicalTrials.gov Identifier: NCT01258075
Recruitment Status : Completed
First Posted : December 10, 2010
Results First Posted : December 22, 2020
Last Update Posted : May 13, 2021
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

Brief Summary:

This study will evaluate the efficacy and safety of the study drug in treating type 2 diabetes in children 10 to 17 years old.

The groups will be low-dose (0.625 g Welchol) and high-dose (3.75 g Welchol). The children will have a 2 in 5 chance of being assigned to the low-dose group. They will have a 3 in 5 chance of being assigned to the high-dose group.

We believe the study drug will be safe, well tolerated, and improve blood sugar control in children 10 to 17 years old.


Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: High-dose colesevelam Drug: Low-dose colesevelam Phase 4

Detailed Description:

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]).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 236 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
Actual Study Start Date : February 24, 2011
Actual Primary Completion Date : November 1, 2019
Actual Study Completion Date : April 21, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Colesevelam
High-dose colesevelam suspended in a drink for oral administration once daily with dinner
Drug: High-dose colesevelam
3.75 grams colesevelam hydrochloride in oral suspension
Other Name: Welchol oral suspension

Experimental: Placebo proxy
Low-dose colesevelam suspended in a drink for oral administration once daily with dinner
Drug: Low-dose colesevelam
0.625 grams colesevelam hydrochloride in oral suspension
Other Name: Welchol oral suspension




Primary Outcome Measures :
  1. Percent Change in Hemoglobin A1c (HbA1c) From Baseline to Month 6 [ Time Frame: Baseline to Month 6 post-dose ]
    The percent change in HbA1c from baseline to Month 6 was assessed with the last observation after 1 month before any rescue therapy carried forward.


Secondary Outcome Measures :
  1. Percent Change in Hemoglobin A1c (HbA1c) From Baseline to Month 12 [ Time Frame: Baseline to Month 12 post-dose ]
    The percent change in HbA1c from baseline to Month 6 was assessed with the last observation after 1 month before any rescue therapy carried forward.

  2. Change in Fasting Plasma Glucose (FPG) From Baseline to Month 12 [ Time Frame: Baseline to Month 12 post-dose ]
    Change from baseline was assessed for FPG values at Month 6 and Month 12 categorical time points.

  3. Number of Participants Achieving a Response to Therapy to Month 12 [ Time Frame: Baseline to Month 12 post-dose ]
    Participants achieving a response to therapy, ie, glycemic control, were assessed with the last observation after 1 month before any rescue therapy carried forward at Month 6 and Month 12. Response to therapy was defined as HbA1c <7.0% or <6.5%, reduction in HbA1c ≥0.7% or ≥0.5% from baseline, and/or reduction in FPG ≥30 mg/dL from baseline.

  4. Percent Change From Baseline to Month 6 in Plasma Lipids [ Time Frame: Baseline to Month 6 post-dose ]
    The percent change in plasma lipids from baseline to Month 6 was assessed with the last observation after 1 month before any rescue therapy carried forward.

  5. Percent Change From Baseline to Month 6 in Triglycerides [ Time Frame: Baseline to Month 6 post-dose ]
    The percent change in triglycerides from baseline to Month 6 was assessed with the last observation after 1 month before any rescue therapy carried forward.

  6. Number of Participants Requiring Rescue Medication Who Initially Met Rescue Criteria [ Time Frame: Baseline to Month 12 post-dose ]
    Rescue criteria was defined as HbA1c levels ≥8.5% after 3 months or ≥7.5% after 6 months (≥173 days) (confirmed persistent hyperglycemia) of study medication treatment, as measured by the central laboratory.



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

Inclusion Criteria:

  • Diagnosis of type 2 diabetes mellitus, as defined by the American Diabetes Association;
  • Written informed consent of study participation
  • 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;
  • Clinical laboratory assessments/evaluations, eg. autoimmune markers, aminotransferases, triglycerides, creatinine clearance, and Hb variants, that are not within the protocol-defined parameters
  • Systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥95 mmHg
  • Use of medications not allowed by protocol-defined parameters, eg. insulin or any medication that affects insulin sensitivity or secretion, growth hormones/somatotropin, or anabolic steroids
  • Genetic syndrome or disorder known to affect glucose
  • Participation in a weight loss program or another interventional research study within 60 days;
  • Female participants who are lactating, pregnant, or plan to become pregnant within 1 year of screening;
  • Female participants 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

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 ClinicalTrials.gov identifier (NCT number): NCT01258075


Locations
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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.
Investigators
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Study Director: Global Clinical Leader/Medical Monitor Daiichi Sankyo, Inc.
  Study Documents (Full-Text)

Documents provided by Daiichi Sankyo, Inc.:
Additional Information:
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Responsible Party: Daiichi Sankyo, Inc.
ClinicalTrials.gov Identifier: NCT01258075    
Other Study ID Numbers: WEL-A-U307
First Posted: December 10, 2010    Key Record Dates
Results First Posted: December 22, 2020
Last Update Posted: May 13, 2021
Last Verified: April 2021
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 https://vivli.org/. 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: https://vivli.org/ourmember/daiichi-sankyo/
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all 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, the European Union and/or Japan 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.
URL: https://vivli.org/ourmember/daiichi-sankyo/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Daiichi Sankyo, Inc.:
Type 2 diabetes mellitus
Blood glucose
Anti-diabetic
Bile acid sequestrant
Colesevelam HCl
Oral suspension
Pediatric
Add-on therapy
Add-on to metformin
Metformin
Adolescent
Lipid
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Colesevelam Hydrochloride
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents