Colesevelam Pediatric Type 2 Diabetes Mellitus Study (WELKid DM)

This study is currently recruiting participants.
Verified November 2013 by Daiichi Sankyo Inc.
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT01258075
First received: December 9, 2010
Last updated: November 20, 2013
Last verified: November 2013

December 9, 2010
November 20, 2013
November 2010
November 2015   (final data collection date for primary outcome measure)
mean change in hemoglobin A1c from baseline (day 1) to 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01258075 on ClinicalTrials.gov Archive Site
  • 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).
Same as current
Not Provided
Not Provided
 
Colesevelam Pediatric Type 2 Diabetes Mellitus Study
Colesevelam Oral Suspension as Monotherapy or Add-on to Metformin Therapy in Pediatric Subjects With Type 2 Diabetes Mellitus

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]).

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: Welchol for oral suspension placebo proxy
    placebo proxy for Welchol for oral suspension, 0.625 grams colesevelam hydrochloride
    Other Name: colesevelam hydrochloride
  • Drug: Welchol for oral suspension
    Welchol for oral suspension, 3.75 grams colesevelam hydrochloride
    Other Name: colesevelam hydrochloride
  • Sham Comparator: placebo proxy
    Intervention: Drug: Welchol for oral suspension placebo proxy
  • Experimental: Welchol oral suspension
    Intervention: Drug: Welchol for oral suspension
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
November 2015
November 2015   (final data collection date for primary outcome measure)

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.
Both
10 Years to 17 Years
No
Contact: Ray Martodam, PhD 800-730-5779 R.Martodam@Medpace.com
Contact: Ray Martodam, PhD 513-579-9911 ext 2567 R.Martodam@Medpace.com
United States
 
NCT01258075
WEL-307
Yes
Daiichi Sankyo Inc.
Daiichi Sankyo Inc.
Not Provided
Study Director: Daiichi Sankyo Medical Monitor Daiichi-Sankyo Pharma Development
Daiichi Sankyo Inc.
November 2013

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