Efficacy and Safety of Insulin Glulisine Compared With Insulin Lispro in Children and Adolescents With Type 1 Diabetes Mellitus: A 26 Week, Multicenter, Open, Parallel Clinical Trial
Overview
- Phase
- Phase 3
- Intervention
- NPH insulin
- Conditions
- Diabetes Mellitus, Insulin-Dependent
- Sponsor
- Sanofi
- Enrollment
- 572
- Locations
- 1
- Primary Endpoint
- Change in total glycated hemoglobin measured as HbA1c equivalents (GHb )from baseline to endpoint
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
The purpose of this study is to determine if insulin glulisine (Apidra) is as safe and effective a rapid acting insulin as insulin lispro (Humalog) in children and adolescents with type 1 diabetes mellitus.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Girls/boys, 4-17 years, inclusive;
- •Girls not yet of childbearing potential or, if sexually active, agree to use reliable medically accepted contraceptive measure during study;
- •Type 1 diabetes mellitus established in medical history: for example, but not limited to, clear signs of insulinopenia (polyuria, polydipsia, polyphagia, weight loss, ketonuria, ketoacidosis); or glutamic acid decarboxylase (GAD) antibody indicative of type 1 diabetes measured at any time before study; or requiring continuous insulin therapy from time of diagnosis;
- •Onset of diabetes at least 1 year prior to visit 1 (V1) of study;
- •Uninterrupted insulin therapy for at least 1 year before V1 of study;
- •At V1, on stable insulin regimen of either NPH or insulin glargine as basal insulin and willing to have multiple daily injections of insulin;
- •Glycated hemoglobin at V1 between ≥ 6.0 and ≤11.0 %;
- •Ability/willingness to do blood glucose monitoring using sponsor-provided glucometer and subject diary.
Exclusion Criteria
- •Active proliferative diabetic retinopathy, defined by application of focal or panretinal photocoagulation or vitrectomy, 6 months before V1, or any other unstable/rapidly progressing retinopathy requiring surgical treatment (including laser photocoagulation) during study;
- •Diabetes other than type 1 diabetes mellitus;
- •Pregnancy (positive pregnancy blood test at V1) or breastfeeding;
- •Pancreatectomized subjects;
- •Subjects who have had pancreas and/or islet cell transplants;
- •Treatment with any anti-diabetic oral agent at any time from diabetes diagnosis;
- •Treatment with systemic corticosteroids in last month before V1;
- •Subjects on pump therapy during last 2 months before V1;
- •Subjects requiring excessively high doses of insulin ("resistant" patients), for example, but not limited to, subjects receiving over 150 IU per day;
- •Likelihood of needing treatment during study period with drugs not permitted by protocol
Arms & Interventions
Insulin Glulisine
Insulin Glulisine (100UI/ml), at least twice daily, in association with basal insulin therapy (NPH insulin or insulin glargine for a maximum of 26 weeks
Intervention: NPH insulin
Insulin Glulisine
Insulin Glulisine (100UI/ml), at least twice daily, in association with basal insulin therapy (NPH insulin or insulin glargine for a maximum of 26 weeks
Intervention: Insulin glulisine
Insulin Glulisine
Insulin Glulisine (100UI/ml), at least twice daily, in association with basal insulin therapy (NPH insulin or insulin glargine for a maximum of 26 weeks
Intervention: insulin glargine
Insulin Lispro
Insulin Lispro (100UI/ml) Subcutaneous (SC) injection , at least twice daily, in association with basal insulin therapy (NPH insulin or insulin glargine ) for a maximum of 30 weeks
Intervention: insulin lispro
Insulin Lispro
Insulin Lispro (100UI/ml) Subcutaneous (SC) injection , at least twice daily, in association with basal insulin therapy (NPH insulin or insulin glargine ) for a maximum of 30 weeks
Intervention: insulin glargine
Insulin Lispro
Insulin Lispro (100UI/ml) Subcutaneous (SC) injection , at least twice daily, in association with basal insulin therapy (NPH insulin or insulin glargine ) for a maximum of 30 weeks
Intervention: NPH insulin
Outcomes
Primary Outcomes
Change in total glycated hemoglobin measured as HbA1c equivalents (GHb )from baseline to endpoint
Time Frame: week 26 or last observed treatment
Secondary Outcomes
- Change from Baseline in GHb at weeks 12 and 26(weeks 12 and 26)
- Change from Baseline in Self-monitored glucose parameters(weeks 4, 12, 18, 26, and endpoint;)
- Incidence of Symptomatic hypoglycemia(first dose of study up to last dose)
- Change from Baseline in basal insulin dose(week 4, 12, 18, 26, and endpoint;)