Colesevelam for Children With Type 2 Diabetes

NCT01258075 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: WEL-A-U307
• Study Type: interventional
• Target: 236
• Locations: 1 country
• Sites: 24

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to Month 6 post-dose

Secondary Outcomes (6)

• Percent Change in Hemoglobin A1c (HbA1c) From Baseline to Month 12

  Baseline to Month 12 post-dose

• Change in Fasting Plasma Glucose (FPG) From Baseline to Month 12

  Baseline to Month 12 post-dose

• Number of Participants Achieving a Response to Therapy to Month 12

  Baseline to Month 12 post-dose

• Percent Change From Baseline to Month 6 in Plasma Lipids

  Baseline to Month 6 post-dose

• Percent Change From Baseline to Month 6 in Triglycerides

  Baseline to Month 6 post-dose

Study Arms (2)

Colesevelam

EXPERIMENTAL

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

Drug: High-dose colesevelam

Placebo proxy

EXPERIMENTAL

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

Drug: Low-dose colesevelam

Interventions

High-dose colesevelam DRUG

3.75 grams colesevelam hydrochloride in oral suspension

Also known as: Welchol oral suspension

Colesevelam

Low-dose colesevelam DRUG

0.625 grams colesevelam hydrochloride in oral suspension

Also known as: Welchol oral suspension

Placebo proxy

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Daiichi Sankyo: lead

Study Sites (24)

Unknown Facility

Tucson, Arizona, 85724, United States

Location

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Little Rock, Arkansas, 72202, United States

Location

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Los Angeles, California, 90027, United States

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Oakland, California, 94609, United States

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San Diego, California, 92123, United States

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Aurora, Colorado, 80045, United States

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Hartford, Connecticut, 06106, United States

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Tampa, Florida, 33612, United States

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Atlanta, Georgia, 30322, United States

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Chicago, Illinois, 60637, United States

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Kansas City, Kansas, 66160, United States

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Baltimore, Maryland, 21229, United States

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Springfield, Massachusetts, 01199, United States

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New York, New York, 10032, United States

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Raleigh, North Carolina, 27610, United States

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Cincinnati, Ohio, 45229, United States

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Oklahoma City, Oklahoma, 73104, United States

Location

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Oklahoma City, Oklahoma, 73112, United States

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Philadelphia, Pennsylvania, 19104, United States

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Greenville, South Carolina, 29615, United States

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Nashville, Tennessee, 37232, United States

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Dallas, Texas, 75235, United States

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Houston, Texas, 77030, United States

Location

Unknown Facility

San Antonio, Texas, 78207, United States

Location

Related Links

• product information, FDA-approved labeling, usage instructions, dosage forms available

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Colesevelam Hydrochloride

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Allylamine; Amines; Organic Chemicals; Allyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons

Results Point of Contact

• Title: Contact of Clinical Trial Information
• Organization: Daiichi Sankyo

CTRinfo@dsi.com

908-992-6400

Study Officials

• Global Clinical Leader/Medical Monitor

  Daiichi Sankyo

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2010
• First Posted: December 10, 2010
• Study Start: February 24, 2011
• Primary Completion: November 1, 2019
• Study Completion: April 21, 2020
• Last Updated: May 13, 2021
• Results First Posted: December 22, 2020

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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.

Locations

US (24)