- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01258075
Colesevelam for Children With Type 2 Diabetes (WELKid DM)
Colesevelam Oral Suspension as Monotherapy or Add-on to Metformin Therapy in Pediatric Subjects With Type 2 Diabetes Mellitus
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.
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Arizona
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Tucson, Arizona, United States, 85724
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Arkansas
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Little Rock, Arkansas, United States, 72202
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California
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Los Angeles, California, United States, 90027
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Oakland, California, United States, 94609
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San Diego, California, United States, 92123
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Colorado
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Aurora, Colorado, United States, 80045
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Connecticut
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Hartford, Connecticut, United States, 06106
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Florida
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Tampa, Florida, United States, 33612
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Georgia
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Atlanta, Georgia, United States, 30322
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Illinois
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Chicago, Illinois, United States, 60637
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Kansas
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Kansas City, Kansas, United States, 66160
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Maryland
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Baltimore, Maryland, United States, 21229
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Massachusetts
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Springfield, Massachusetts, United States, 01199
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New York
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New York, New York, United States, 10032
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North Carolina
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Raleigh, North Carolina, United States, 27610
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Ohio
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Cincinnati, Ohio, United States, 45229
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73112
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Oklahoma City, Oklahoma, United States, 73104
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
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South Carolina
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Greenville, South Carolina, United States, 29615
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Tennessee
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Nashville, Tennessee, United States, 37232
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Texas
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Dallas, Texas, United States, 75235
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Houston, Texas, United States, 77030
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San Antonio, Texas, United States, 78207
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Colesevelam
High-dose colesevelam suspended in a drink for oral administration once daily with dinner
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3.75 grams colesevelam hydrochloride in oral suspension
Other Names:
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EXPERIMENTAL: Placebo proxy
Low-dose colesevelam suspended in a drink for oral administration once daily with dinner
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0.625 grams colesevelam hydrochloride in oral suspension
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent Change in Hemoglobin A1c (HbA1c) From Baseline to Month 6
Time Frame: Baseline to Month 6 post-dose
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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.
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Baseline to Month 6 post-dose
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent Change in Hemoglobin A1c (HbA1c) From Baseline to Month 12
Time Frame: Baseline to Month 12 post-dose
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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.
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Baseline to Month 12 post-dose
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Change in Fasting Plasma Glucose (FPG) From Baseline to Month 12
Time Frame: Baseline to Month 12 post-dose
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Change from baseline was assessed for FPG values at Month 6 and Month 12 categorical time points.
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Baseline to Month 12 post-dose
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Number of Participants Achieving a Response to Therapy to Month 12
Time Frame: Baseline to Month 12 post-dose
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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.
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Baseline to Month 12 post-dose
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Percent Change From Baseline to Month 6 in Plasma Lipids
Time Frame: Baseline to Month 6 post-dose
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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.
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Baseline to Month 6 post-dose
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Percent Change From Baseline to Month 6 in Triglycerides
Time Frame: Baseline to Month 6 post-dose
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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.
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Baseline to Month 6 post-dose
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Number of Participants Requiring Rescue Medication Who Initially Met Rescue Criteria
Time Frame: Baseline to Month 12 post-dose
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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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Baseline to Month 12 post-dose
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Global Clinical Leader/Medical Monitor, Daiichi Sankyo, Inc.
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- WEL-A-U307
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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