Comparison of the Ability of Glulisine With Lispro to Control Type 1 Diabetes Mellitus in Children and Adolescents

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00115570
First received: June 23, 2005
Last updated: March 27, 2009
Last verified: March 2009
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Insulin-Dependent
Drug: insulin glulisine
Drug: insulin lispro
Drug: insulin glargine
Drug: NPH insulin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Change in GHb from baseline to endpoint (week 26 or last observed treatment)

Secondary Outcome Measures:
  • Safety (AEs)
  • Serious symptomatic hypoglycemia, clinical chemistry, hematology, insulin antibodies
  • Change in GHb at weeks 12 and 26
  • Self-monitored glucose parameters
  • Symptomatic hypoglycemia and insulin doses

Estimated Enrollment: 560
Study Start Date: March 2005
Estimated Study Completion Date: November 2006
  Eligibility

Ages Eligible for Study:   4 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • Treatment with any investigational drug in last month before V1;
  • 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 emergency ward, 3 months prior to V1;
  • History of hypoglycemia unawareness;
  • History of hypersensitivity to insulin or insulin analogs or any of the excipients in insulin glulisine formulation or any of the excipients in other study insulin preparations formulations;
  • Clinically relevant hepatic, neurologic, endocrine, active cancer, or other major systemic disease making implementation of protocol or interpretation of study results difficult and would, in the opinion of the investigator, preclude safe participation of subject in protocol;
  • History of cardiac abnormalities and/or cardiovascular disorders;
  • History of drug/alcohol abuse;
  • Impaired hepatic function shown by, but not limited to, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than twice the normal upper limit for age at V1;
  • Impaired renal function shown by, but not limited to, serum creatinine greater than 1.5 times upper limit for age at V1;
  • Non fasting triglyceride level of >500 mg/dL (5.7 mmol/L) at V1;
  • Parent/legally authorized representative unable to understand nature, scope, possible consequences of study;
  • Parent/legally authorized representative unable to read/write;
  • Subjects unlikely to comply with protocol, e.g. inability/unwillingness to participate in adequate training, uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing study;
  • Children/relatives of employee of sponsor or of sponsor representatives;
  • Children or relatives of investigator, any sub-investigator, research assistant, pharmacist, study coordinator or other staff directly involved in conduct of protocol;
  • Subjects who have previously been treated with insulin glulisine.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00115570

Locations
United States, Pennsylvania
Childrens Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Sanofi
Investigators
Principal Investigator: Dr Arethi PHILOTHEOU UCT Diabetes Clinical Trials Unit - Faculty of Health Sciences - South-Africa
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00115570     History of Changes
Other Study ID Numbers: EFC6096, HMR 1964
Study First Received: June 23, 2005
Last Updated: March 27, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
Diabetes, Insulin-Dependent, pediatric, rapid acting injection

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin LISPRO
Glargine
Insulin glulisine
Insulin
Insulin, NPH
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014