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

NCT00115570 | Completed Phase 3

• 2 other identifiers: EFC6096HMR 1964
• Study Type: interventional
• Target: 572
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Insulin-Dependent

Keywords

Diabetes,Insulin-Dependent, pediatric,rapid acting injection

Outcome Measures

Primary Outcomes (1)

• Change in total glycated hemoglobin measured as HbA1c equivalents (GHb )from baseline to endpoint

  week 26 or last observed treatment

Secondary Outcomes (4)

• 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;

Study Arms (2)

Insulin Glulisine

EXPERIMENTAL

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

Drug: Insulin glulisine; Drug: insulin glargine; Drug: NPH insulin

Insulin Lispro

ACTIVE COMPARATOR

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

Drug: insulin lispro; Drug: insulin glargine; Drug: NPH insulin

Interventions

Insulin glulisine DRUG

Subcutaneous injection

Also known as: apidra

Insulin Glulisine

insulin lispro DRUG

Subcutaneous injection

Insulin Lispro

insulin glargine DRUG

Subcutaneous injection once daily

Insulin Glulisine; Insulin Lispro

NPH insulin DRUG

subcutaneous injection twice daily

Insulin Glulisine; Insulin Lispro

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Childrens Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus

Interventions

insulin glulisine; Insulin Lispro; Insulin Glargine; Insulin, Isophane

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Insulin, Long-Acting

Study Officials

• Dr Arethi PHILOTHEOU

  UCT Diabetes Clinical Trials Unit - Faculty of Health Sciences - South-Africa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2005
• First Posted: June 24, 2005
• Study Start: April 1, 2005
• Primary Completion: November 1, 2006
• Study Completion: November 1, 2006
• Last Updated: May 20, 2016

Record last verified: 2016-05

Locations

US (1)