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Colesevelam for Children With Type 2 Diabetes (WELKid DM)

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
High-dose colesevelam
Low-dose colesevelam
Sponsored by
Daiichi Sankyo, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring 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

Eligibility Criteria

10 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Colesevelam

Placebo proxy

Arm Description

High-dose colesevelam suspended in a drink for oral administration once daily with dinner

Low-dose colesevelam suspended in a drink for oral administration once daily with dinner

Outcomes

Primary Outcome Measures

Percent Change in Hemoglobin A1c (HbA1c) From Baseline to Month 6
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

Percent Change in Hemoglobin A1c (HbA1c) From Baseline to Month 12
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.
Change in Fasting Plasma Glucose (FPG) From Baseline to Month 12
Change from baseline was assessed for FPG values at Month 6 and Month 12 categorical time points.
Number of Participants Achieving a Response to Therapy to Month 12
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.
Percent Change From Baseline to Month 6 in Plasma Lipids
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.
Percent Change From Baseline to Month 6 in Triglycerides
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.
Number of Participants Requiring Rescue Medication Who Initially Met Rescue Criteria
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.

Full Information

First Posted
December 9, 2010
Last Updated
April 16, 2021
Sponsor
Daiichi Sankyo, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01258075
Brief Title
Colesevelam for Children With Type 2 Diabetes
Acronym
WELKid DM
Official Title
Colesevelam Oral Suspension as Monotherapy or Add-on to Metformin Therapy in Pediatric Subjects With Type 2 Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
February 24, 2011 (Actual)
Primary Completion Date
November 1, 2019 (Actual)
Study Completion Date
April 21, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daiichi Sankyo, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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]).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
236 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Colesevelam
Arm Type
Experimental
Arm Description
High-dose colesevelam suspended in a drink for oral administration once daily with dinner
Arm Title
Placebo proxy
Arm Type
Experimental
Arm Description
Low-dose colesevelam suspended in a drink for oral administration once daily with dinner
Intervention Type
Drug
Intervention Name(s)
High-dose colesevelam
Other Intervention Name(s)
Welchol oral suspension
Intervention Description
3.75 grams colesevelam hydrochloride in oral suspension
Intervention Type
Drug
Intervention Name(s)
Low-dose colesevelam
Other Intervention Name(s)
Welchol oral suspension
Intervention Description
0.625 grams colesevelam hydrochloride in oral suspension
Primary Outcome Measure Information:
Title
Percent Change in Hemoglobin A1c (HbA1c) From Baseline to Month 6
Description
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.
Time Frame
Baseline to Month 6 post-dose
Secondary Outcome Measure Information:
Title
Percent Change in Hemoglobin A1c (HbA1c) From Baseline to Month 12
Description
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.
Time Frame
Baseline to Month 12 post-dose
Title
Change in Fasting Plasma Glucose (FPG) From Baseline to Month 12
Description
Change from baseline was assessed for FPG values at Month 6 and Month 12 categorical time points.
Time Frame
Baseline to Month 12 post-dose
Title
Number of Participants Achieving a Response to Therapy to Month 12
Description
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.
Time Frame
Baseline to Month 12 post-dose
Title
Percent Change From Baseline to Month 6 in Plasma Lipids
Description
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.
Time Frame
Baseline to Month 6 post-dose
Title
Percent Change From Baseline to Month 6 in Triglycerides
Description
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.
Time Frame
Baseline to Month 6 post-dose
Title
Number of Participants Requiring Rescue Medication Who Initially Met Rescue Criteria
Description
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.
Time Frame
Baseline to Month 12 post-dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Leader/Medical Monitor
Organizational Affiliation
Daiichi Sankyo, Inc.
Official's Role
Study Director
Facility Information:
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21229
Country
United States
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27610
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78207
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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/
IPD Sharing 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.
IPD Sharing 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.
IPD Sharing URL
https://vivli.org/ourmember/daiichi-sankyo/
Links:
URL
http://www.welchol.com
Description
product information, FDA-approved labeling, usage instructions, dosage forms available

Learn more about this trial

Colesevelam for Children With Type 2 Diabetes

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