Type 1 diabetes mellitus
Conditions
Interventions
Product Name: Apidra
Product Code: HMR1964
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Insulin glulisine
Current Sponsor code: HMR1964
Concentration unit: IU/ml international unit
Sponsors
Aventis Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Girls or boys, 4 to 17 years of age, inclusive; - Girls are either not yet of childbearing potential (premenarchal) or, if sexually active, agree to use a reliable contraceptive measure for the duration of the study; - Type 1 diabetes mellitus as established in the medical history: for example but not limited to, . characterized by clear signs of insulinopenia (polyuria, polydipsia, polyphagia, weight loss, ketonuria, ketoacidosis…), or . Glutamic Acid Decarboxylase (GAD) antibody indicative for type 1 diabetes measured at any time before the study, or . requiring continuous insulin therapy from the time of diagnosis; - Onset of diabetes at least 1 year prior to visit 1 of the study; - Uninterrupted insulin therapy for at least one year prior to visit 1 of the study; - At visit 1, on a stable insulin regimen that consists of either NPH or insulin glargine as the basal insulin and willing to have multiple daily injections of insulin; - Glycated hemoglobin measured at visit 1 in the range of >= 6.0 and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Active proliferative diabetic retinopathy, as defined by the application of focal or panretinal photocoagulation or vitrectomy, in the 6 months prior to visit 1, or any other unstable (rapidly progressing) retinopathy that may require surgical treatment (including laser photocoagulation) during the study; - Diabetes other than type 1 diabetes mellitus; - Pregnancy (as determined by pregnancy blood test at visit 1) or breast feeding; - Pancreatectomised subjects; - Subjects who have undergone pancreas and/or islet cell transplants; - Treatment with any anti-diabetic oral agent at any time from the diagnosis of diabetes; - Treatment with systemic corticosteroids in the last month before visit 1; - Subjects who have been on pump therapy during the last 2 months before visit 1; - Subjects requiring excessively high doses of insulin ("resistant" patients), for example but not limited to subjects receiving over 150 IU per day; - Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol; - Treatment with any investigational drug in the last month before visit 1; - History of primary seizure disorders; - History of severe hypoglycemic episode accompanied by seizure and/or coma or diabetic ketoacidosis leading to hospitalization or to care in the emergency ward, in the 3 months prior to visit 1; - History of hypoglycemia unawareness; - History of hypersensitivity to insulin or insulin analogs or any of the excipients in the insulin glulisine formulation (see the Global Investigator’s Brochure for a list of excipients) or any of excipients in the other study insulin preparations formulation; - Clinically relevant hepatic, neurologic, endocrine, active cancer, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult and would, in the opinion of the investigator, preclude the safe participation of the subject in this protocol; - History of cardiac abnormalities and/or cardiovascular disorders; - History of drug or alcohol abuse; - Impaired hepatic function, as shown by but not limited to alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than twice the normal upper limit for age measured at visit 1; - Impaired renal function, as shown by but not limited to serum creatinine greater than 1.5 time the upper limit for age measured at visit 1; - Non fasting triglyceride level of >500 mg/dL (5.7 mmol/L) measured at visit 1; - Parent/legally authorized representative* unable to understand the nature, scope and possible consequences of the study; - Parent/legally authorized representative* unable to read and write; - Subjects unlikely to comply with protocol, e.g. an inability and unwillingness to participate in adequate training, an uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study; - Children or relatives of an employee of the sponsor or of sponsor representatives; - Children or relatives of the investigator, any subinvestigator, research assistant, pharmacist, study coordinator or other staff directly involved in the conduct of the protocol; - Subjects who have previously been treated with insulin glulisine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate non-inferiority of insulin glulisine compared to insulin lispro in the change in GHb from baseline to endpoint (week 26 or last observation on treatment) in children and adolescents with type 1 diabetes mellitus.;Secondary Objective: To compare insulin glulisine with insulin lispro in terms of safety (adverse events, serious symptomatic hypoglycemia, clinical chemistry and hematology as well as insulin antibodies), change in GHb at week 12 and week 26, self-monitored blood glucose parameters, symptomatic hypoglycemia and insulin doses in children and adolescents with type 1 diabetes mellitus.;Primary end point(s): Primary: Change in GHb from baseline to endpoint. Secondary: Change in GHb at week 12 and week 26, self-monitored blood glucose parameters, rate, type and incidence of symptomatic hypoglycemic episodes, and dosage of rapid-acting and basal insulin preparations | — |
Countries
Denmark, Finland, Germany, Hungary, Sweden, United Kingdom
Outcome results
None listed