Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Colesevelam for Children With Type 2 Diabetes (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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01258075
Recruitment Status : Completed
First Posted : December 10, 2010
Last Update Posted : July 16, 2020
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

Brief Summary:

This study will see if the study drug will be a good treatment for type 2 diabetes in children 10 to 17 years old.

The groups will be low-dose and high-dose. 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.


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]).

Layout table for study information
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
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. Change from baseline in hemoglobin A1c (HbA1c) within 6 months [ Time Frame: Within 6 months ]
    HbA1c at month 6 (with the last observation after 1 month carried forward)


Secondary Outcome Measures :
  1. Change from baseline in fasting plasma glucose (FPG) values within 12 months [ Time Frame: Within 12 months ]
    Change from baseline will be calculated for FPG values at Month 6 and Month 12 categorical time points

  2. Change from baseline in HbA1c within 12 months [ Time Frame: Within 12 months ]
    Change from baseline in HbA1c will be assessed at Month 3 and Month 12 categorical time points

  3. Percentage of participants achieving HbA1c targets at Month 6 [ Time Frame: 6 months ]
    HbA1c categorical targets are <7.0% and <6.5%

  4. Percentage of participants achieving target reduction from baseline in HbA1c within 6 months [ Time Frame: Within 6 months ]
    Categorical reduction from baseline targets are ≥0.7% and ≥0.5%

  5. Percentage of participants achieving target reduction from baseline in HbA1c within 12 months [ Time Frame: Within 12 months ]
    Categorical reduction from baseline targets are ≥0.7% and ≥0.5%

  6. Percentage of participants achieving at least a 30 mg/dL reduction from baseline in FPG within 6 months [ Time Frame: Within 6 months ]
    Categorical reduction from baseline in FPG target is ≥30 mg/dL

  7. Change from baseline in plasma lipids (mg/dL) at Month 3 [ Time Frame: Month 3 ]
    Change from baseline will be calculated for categorical plasma lipids: total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), non-high-density lipoprotein cholesterol (non-HDL-C), and triglycerides (TG)

  8. Change from baseline in plasma lipids (mg/dL) at Month 6 [ Time Frame: Month 6 ]
    Change from baseline will be calculated for categorical plasma lipids: total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), non-high-density lipoprotein cholesterol (non-HDL-C), and triglycerides (TG)

  9. Change from baseline in plasma lipids (mg/dL) at Month 12 [ Time Frame: Month 12 ]
    Change from baseline will be calculated for categorical plasma lipids: total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), non-high-density lipoprotein cholesterol (non-HDL-C), and triglycerides (TG)

  10. Change from baseline in plasma lipids (g/L) at Month 3 [ Time Frame: Month 3 ]
    Change from baseline will be calculated for categorical plasma lipids: Apolipoprotein A-1 (apo A-1) and Apolipoprotein B (apo B)

  11. Change from baseline in plasma lipids (g/L) at Month 6 [ Time Frame: Month 6 ]
    Change from baseline will be calculated for categorical plasma lipids: Apolipoprotein A-1 (apo A-1) and Apolipoprotein B (apo B)

  12. Change from baseline in plasma lipids (g/L) at Month 12 [ Time Frame: Month 12 ]
    Change from baseline will be calculated for categorical plasma lipids: Apolipoprotein A-1 (apo A-1) and Apolipoprotein B (apo B)

  13. Proportion of participants requiring rescue medication within 12 months [ Time Frame: Within 12 months ]
  14. Time (months) from randomization to initiation of rescue medication [ Time Frame: Within 12 months ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
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
Layout table for location information
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
Layout table for investigator information
Study Director: Global Clinical Leader/Medical Monitor Daiichi Sankyo, Inc.
Additional Information:
Layout table for additonal information
Responsible Party: Daiichi Sankyo, Inc.
ClinicalTrials.gov Identifier: NCT01258075    
Other Study ID Numbers: WEL-A-U307
First Posted: December 10, 2010    Key Record Dates
Last Update Posted: July 16, 2020
Last Verified: July 2020
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/

Layout table for additional information
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:
Layout table for MeSH terms
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