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 enrollmentFebruary 14, 2005

Overview

No summary available.

Registry

who.int

Start Date

February 14, 2005

End Date

November 3, 2006

Last Updated

4 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;