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.
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.
Brief Title
Colesevelam for Children With Type 2 Diabetes
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 \[HbA1c\]).
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 \[HbA1c\]).
Categories
Completion Date
Completion Date Type
Actual
Conditions
Type 2 Diabetes Mellitus
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
* 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
Inclusion 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.
* 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.
Gender
All
Gender Based
false
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
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
17 Years
Minimum Age
10 Years
NCT Id
NCT01258075
Org Class
Industry
Org Full Name
Daiichi Sankyo
Org Study Id
WEL-A-U307
Overall Status
Completed
Phases
Phase 4
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Colesevelam Oral Suspension as Monotherapy or Add-on to Metformin Therapy in Pediatric Subjects With Type 2 Diabetes Mellitus
Primary Outcomes
Outcome Description
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.
Outcome Measure
Percent Change in Hemoglobin A1c (HbA1c) From Baseline to Month 6
Outcome Time Frame
Baseline to Month 6 post-dose
Secondary Outcomes
Outcome Description
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.
Outcome Time Frame
Baseline to Month 12 post-dose
Outcome Measure
Percent Change in Hemoglobin A1c (HbA1c) From Baseline to Month 12
Outcome Description
Change from baseline was assessed for FPG values at Month 6 and Month 12 categorical time points.
Outcome Time Frame
Baseline to Month 12 post-dose
Outcome Measure
Change in Fasting Plasma Glucose (FPG) From Baseline to Month 12
Outcome Description
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.
Outcome Time Frame
Baseline to Month 12 post-dose
Outcome Measure
Number of Participants Achieving a Response to Therapy to Month 12
Outcome Description
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.
Outcome Time Frame
Baseline to Month 6 post-dose
Outcome Measure
Percent Change From Baseline to Month 6 in Plasma Lipids
Outcome Description
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.
Outcome Time Frame
Baseline to Month 6 post-dose
Outcome Measure
Percent Change From Baseline to Month 6 in Triglycerides
Outcome Description
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.
Outcome Time Frame
Baseline to Month 12 post-dose
Outcome Measure
Number of Participants Requiring Rescue Medication Who Initially Met Rescue Criteria
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Child
Maximum Age Number (converted to Years and rounded down)
17
Minimum Age Number (converted to Years and rounded down)
10
Investigators
Investigator Type
Principal Investigator
Investigator Name
Rubina Heptulla
Investigator Email
RHEPTULL@montefiore.org
Investigator Phone
718-920-6542 / 718-920-5473/ 718-920-4664