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 - HMR1964D/3001

Aventis Pharmaceuticals, Inc.0 sites560 target enrollmentMay 18, 2005

Overview

No summary available.

Registry

who.int

Start Date

May 18, 2005

End Date

TBD

Last Updated

12 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•\- 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…),
•. Glutamic Acid Decarboxylase (GAD) antibody indicative for type 1 diabetes measured at any time before the study,
•. 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 \<\=11\.0 %;

•\- 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;