Colesevelam for Children With Type 2 Diabetes (WELKid DM)

Daiichi Sankyo

Status and phase

Completed

Phase 4

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: Low-dose colesevelam

Drug: High-dose colesevelam

Study type

Interventional

Funder types

Industry

Identifiers

NCT01258075

WEL-A-U307

Details and patient eligibility

About

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.

Full 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]).

Enrollment

236 patients

Sex

All

Ages

10 to 17 years old

Volunteers

No Healthy Volunteers

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