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Completed

NCT Number: NCT01258075

Colesevelam for Children With Type 2 Diabetes

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

10 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Tucson, Arizona, United States

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About this study

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]).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High-dose colesevelam

Drug

3.75 grams colesevelam hydrochloride in oral suspension

Other names: Welchol oral suspension

Low-dose colesevelam

Drug

0.625 grams colesevelam hydrochloride in oral suspension

Other names: Welchol oral suspension

Primary outcomes

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

    Time frame: Baseline to Month 6 post-dose

    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 outcomes

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

    Time frame: Baseline to Month 12 post-dose

    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.

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

    Time frame: Baseline to Month 12 post-dose

    Change from baseline was assessed for FPG values at Month 6 and Month 12 categorical time points.

  3. Number of Participants Achieving a Response to Therapy to Month 12

    Time frame: Baseline to Month 12 post-dose

    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.

  4. Percent Change From Baseline to Month 6 in Plasma Lipids

    Time frame: Baseline to Month 6 post-dose

    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.

  5. Percent Change From Baseline to Month 6 in Triglycerides

    Time frame: Baseline to Month 6 post-dose

    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.

  6. Number of Participants Requiring Rescue Medication Who Initially Met Rescue Criteria

    Time frame: Baseline to Month 12 post-dose

    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.

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo

Industry

Registry information

Official study title

Colesevelam Oral Suspension as Monotherapy or Add-on to Metformin Therapy in Pediatric Subjects With Type 2 Diabetes Mellitus

Acronym: WELKid DM

Important dates

Study start
2011
Primary completion
2019
Study completion
2020
First posted
Dec 10, 2010
Registry last updated
May 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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