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Colesevelam Pediatric Type 2 Diabetes Mellitus Study (WELKid DM)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Daiichi Sankyo Inc.
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT01258075
First received: December 9, 2010
Last updated: May 21, 2014
Last verified: May 2014
  Purpose

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]).


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: Welchol for oral suspension placebo proxy
Drug: Welchol for oral suspension
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:
  • mean change in hemoglobin A1c from baseline (day 1) to 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • mean change in fasting plasma glucose from baseline (day 1) to 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • percentage of subjects with HbA1c decreasing >= 0.7% from baseline (day 1) to 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • percentage of subjects with final HbA1c < 7.0% at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • percentage of subjects with decrease in fasting plasma glucose >= 30 mg/dL from baseline (day 1) to 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • mean change in plasma lipids from baseline (day 1) to 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 200
Study Start Date: November 2010
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: placebo proxy Drug: Welchol for oral suspension placebo proxy
placebo proxy for Welchol for oral suspension, 0.625 grams colesevelam hydrochloride
Other Name: colesevelam hydrochloride
Experimental: Welchol oral suspension Drug: Welchol for oral suspension
Welchol for oral suspension, 3.75 grams colesevelam hydrochloride
Other Name: colesevelam hydrochloride

  Eligibility

Ages Eligible for Study:   10 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of type 2 diabetes mellitus, as defined by the American Diabetes Association;
  • Understand study procedures and agree to participate by giving written assent and obtaining written consent from a parent or legal guardian at screening;
  • 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;
  • Positive autoimmune markers;
  • Creatinine clearance <70 mL/min;
  • Alanine transaminase or aspartate aminotransferase elevation >2.5 X upper limit of normal;
  • Participation in another interventional research study protocol in the past 60 days;
  • Female subjects who are lactating, pregnant, or plan to become pregnant within 1 year of screening;
  • Female subjects 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;
  • Triglycerides >500 mg/dL.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01258075

Contacts
Contact: Ray Martodam, PhD 800-730-5779 R.Martodam@Medpace.com
Contact: Ray Martodam, PhD 513-579-9911 ext 2567 R.Martodam@Medpace.com

  Show 22 Study Locations
Sponsors and Collaborators
Daiichi Sankyo Inc.
Investigators
Study Director: Daiichi Sankyo Medical Monitor Daiichi-Sankyo Pharma Development
  More Information

Additional Information:
No publications provided

Responsible Party: Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier: NCT01258075     History of Changes
Other Study ID Numbers: WEL-307
Study First Received: December 9, 2010
Last Updated: May 21, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Daiichi Sankyo Inc.:
colesevelam HCl
type 2 diabetes mellitus
blood glucose
anti-diabetic
bile acid sequestrant
oral suspension
pediatric
add-on therapy
add-on to metformin
metformin
adolescent
lipid

Additional relevant MeSH terms:
Colesevelam
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Metformin
Anticholesteremic Agents
Antimetabolites
Hypoglycemic Agents
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014