Clinical trial NCT01258075: Colesevelam for Children With Type 2 Diabetes
Official title: Colesevelam Oral Suspension as Monotherapy or Add-on to Metformin Therapy in Pediatric Subjects With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
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
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2010-12-10
Enrollment: 236
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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 \[HbA1c\]).

Eligibility criteria: 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

Primary outcomes:
measure: Percent Change in Hemoglobin A1c (HbA1c) From Baseline to Month 6
timeFrame: Baseline to Month 6 post-dose
Secondary outcomes:
measure: Percent Change in Hemoglobin A1c (HbA1c) From Baseline to Month 12
timeFrame: Baseline to Month 12 post-dose
measure: Change in Fasting Plasma Glucose (FPG) From Baseline to Month 12
timeFrame: Baseline to Month 12 post-dose
measure: Number of Participants Achieving a Response to Therapy to Month 12
timeFrame: Baseline to Month 12 post-dose
measure: Percent Change From Baseline to Month 6 in Plasma Lipids
timeFrame: Baseline to Month 6 post-dose
measure: Percent Change From Baseline to Month 6 in Triglycerides
timeFrame: Baseline to Month 6 post-dose
measure: Number of Participants Requiring Rescue Medication Who Initially Met Rescue Criteria
timeFrame: Baseline to Month 12 post-dose
Other outcomes:
Locations:
city: Tucson
country: United States
state: Arizona
city: Little Rock
country: United States
state: Arkansas
city: Los Angeles
country: United States
state: California
city: Oakland
country: United States
state: California
city: San Diego
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: Hartford
country: United States
state: Connecticut
city: Tampa
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Kansas City
country: United States
state: Kansas
city: Baltimore
country: United States
state: Maryland
city: Springfield
country: United States
state: Massachusetts
city: New York
country: United States
state: New York
city: Raleigh
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Oklahoma City
country: United States
state: Oklahoma
city: Philadelphia
country: United States
state: Pennsylvania
city: Greenville
country: United States
state: South Carolina
city: Nashville
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
Study officials:
affiliation: Daiichi Sankyo
name: Global Clinical Leader/Medical Monitor
role: STUDY_DIRECTOR
References: