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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.

Tracking Information
First Submitted Date  ICMJE December 9, 2010
First Posted Date  ICMJE December 10, 2010
Last Update Posted Date July 16, 2020
Actual Study Start Date  ICMJE February 24, 2011
Actual Primary Completion Date November 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2019)
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)
Original Primary Outcome Measures  ICMJE
 (submitted: December 9, 2010)
Mean change in hemoglobin A1c from baseline (day 1) to 6 months [ Time Frame: 6 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2019)
  • 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
  • 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
  • Percentage of participants achieving HbA1c targets at Month 6 [ Time Frame: 6 months ]
    HbA1c categorical targets are <7.0% and <6.5%
  • 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%
  • 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%
  • 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
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • Proportion of participants requiring rescue medication within 12 months [ Time Frame: Within 12 months ]
  • Time (months) from randomization to initiation of rescue medication [ Time Frame: Within 12 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 9, 2010)
  • Mean change in fasting plasma glucose from baseline (day 1) to 6 months [ Time Frame: 6 months ]
  • percentage of subjects with HbA1c decreasing >= 0.7% from baseline (day 1) to 6 months [ Time Frame: 6 months ]
  • percentage of subjects with final HbA1c < 7.0% at 6 months [ Time Frame: 6 months ]
  • percentage of subjects with decrease in fasting plasma glucose >= 30 mg/dL from baseline (day 1) to 6 months [ Time Frame: 6 months ]
  • 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).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Colesevelam for Children With Type 2 Diabetes
Official Title  ICMJE Colesevelam Oral Suspension as Monotherapy or Add-on to Metformin Therapy in Pediatric Subjects With Type 2 Diabetes Mellitus
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.

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]).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes Mellitus
Intervention  ICMJE
  • Drug: High-dose colesevelam
    3.75 grams colesevelam hydrochloride in oral suspension
    Other Name: Welchol oral suspension
  • Drug: Low-dose colesevelam
    0.625 grams colesevelam hydrochloride in oral suspension
    Other Name: Welchol oral suspension
Study Arms  ICMJE
  • Experimental: Colesevelam
    High-dose colesevelam suspended in a drink for oral administration once daily with dinner
    Intervention: Drug: High-dose colesevelam
  • Experimental: Placebo proxy
    Low-dose colesevelam suspended in a drink for oral administration once daily with dinner
    Intervention: Drug: Low-dose colesevelam
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: April 30, 2015)
230
Original Estimated Enrollment  ICMJE
 (submitted: December 9, 2010)
200
Actual Study Completion Date  ICMJE April 21, 2020
Actual Primary Completion Date November 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01258075
Other Study ID Numbers  ICMJE WEL-A-U307
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: 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/
Responsible Party Daiichi Sankyo, Inc.
Study Sponsor  ICMJE Daiichi Sankyo, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Global Clinical Leader/Medical Monitor Daiichi Sankyo, Inc.
PRS Account Daiichi Sankyo, Inc.
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP