Phase 4
Completed N=236
Colesevelam for Children With Type 2 Diabetes
Source: ClinicalTrials.gov NCT01258075 ↗Enrolled (actual)
236
Serious AEs
8.1%
Results posted
Dec 2020
Primary outcomePrimary: Percent Change in Hemoglobin A1c (HbA1c) From Baseline to Month 6 — 0.09; 0.21 percent change — p=0.5494
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Hemoglobin A1c (HbA1c) From Baseline to Month 6 |
0.09; 0.21 | 0.5494 |
| SECONDARY Percent Change in Hemoglobin A1c (HbA1c) From Baseline to Month 12 |
-0.27; -0.05; -0.12; -0.06; -0.06; -0.16 | — |
| SECONDARY Change in Fasting Plasma Glucose (FPG) From Baseline to Month 12 |
11.6; 16.7; 15.5; 10.6; 14.6; 11.6 | — |
| SECONDARY Number of Participants Achieving a Response to Therapy to Month 12 |
39; 26; 26; 11; 32; 20 | — |
| SECONDARY Percent Change From Baseline to Month 6 in Plasma Lipids |
1.0; 3.2; -1.1; 4.4; 1.9; 2.3 | — |
| SECONDARY Percent Change From Baseline to Month 6 in Triglycerides |
10.0; 6.4 | — |
| SECONDARY Number of Participants Requiring Rescue Medication Who Initially Met Rescue Criteria |
16; 8; 4; 0; 12; 8 | — |
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
Data sourced from ClinicalTrials.gov (NCT01258075). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.