Comparison of the Ability of Glulisine With Lispro to Control Type 1 Diabetes Mellitus in Children and Adolescents
NCT00115570 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 572
Last updated 2016-05-20
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
Interventions
- DRUG
-
Insulin glulisine
Subcutaneous injection
- DRUG
-
insulin lispro
Subcutaneous injection
- DRUG
-
insulin glargine
Subcutaneous injection once daily
- DRUG
-
NPH insulin
subcutaneous injection twice daily
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Dr Arethi PHILOTHEOU · UCT Diabetes Clinical Trials Unit - Faculty of Health Sciences - South-Africa
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 4 Years
- Max Age
- 17 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-04-30
- Primary Completion
- 2006-11-30
- Completion
- 2006-11-30
Countries
- United States
Study Locations
More Related Trials
-
Safety and Efficacy of Insulin Aspart in Children With Type 1 Diabetes
NCT01467141 ·Status: COMPLETED ·Phase: PHASE4
-
Efficacy and Safety of Faster-acting Insulin Aspart Compared to NovoRapid® Both in Combination With Insulin Degludec in Adults With Type 1 Diabetes
NCT02500706 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety of Insulin Glargine Versus. Neutral Protamine Hagedorn (NPH) Insulin in Children With Type 1 Diabetes Above 6 Years Old.
NCT01223131 ·Status: COMPLETED ·Phase: PHASE3
-
Apidra Children & Adolescents Study
NCT01202474 ·Status: COMPLETED ·Phase: PHASE4
-
Comparison of Two NN1250 Formulations Versus Insulin Glargine, All in Combination With Insulin Aspart in Subjects With Type 1 Diabetes
NCT00612040 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Demonstrate Bioequivalence Between Insulin Glulisine U300 and Insulin Glulisine U100 After a Single Subcutaneous Dose Using the Euglycemic Clamp Technique, in Patients With Type 1 Diabetes Mellitus
NCT02910518 ·Status: COMPLETED ·Phase: PHASE1
-
Human Versus Analogue Insulin for Youth With Type 1 Diabetes in Low-Resource Settings
NCT05614089 ·Status: COMPLETED ·Phase: PHASE4
-
Insulin Glulisine in Type 1 Diabetes Mellitus
NCT00297583 ·Status: COMPLETED ·Phase: PHASE1
-
Comparison of Efficacy and Safety of Insulin Detemir and Insulin Glargine in Patients With Type 1 Diabetes
NCT00312104 ·Status: COMPLETED ·Phase: PHASE3
-
The Effect of Insulin Glulisine Compared With Insulin Aspart on Breakfast Post Prandial Glucose Levels in Prepubertal Children
NCT00913497 ·Status: COMPLETED ·Phase: PHASE4
-
Evaluation of Insulin Glulisine (GP40321) Compared to Insulin Glulisine (Apidra® SoloStar®) in Type 1 Diabetes Mellitus Patients
NCT07070752 ·Status: COMPLETED ·Phase: PHASE3
-
Investigation of the Response Relationship of NN5401 in Type 1 Diabetics
NCT00993096 ·Status: COMPLETED ·Phase: PHASE1
-
Efficacy and Safety of Insulin Glulisine in Type 1 Diabetes Mellitus
NCT00290979 ·Status: COMPLETED ·Phase: PHASE3
-
A Trial to Assess the Efficacy and Safety of M1 Pram P037 Prandial Insulin in Subjects With Type 1 Diabetes (T1DM)
NCT04816890 ·Status: COMPLETED ·Phase: PHASE2
-
Comparison of Hypoglycaemic Response Between NN1250 and Insulin Glargine in Type 1 Diabetics
NCT01002768 ·Status: COMPLETED ·Phase: PHASE1
-
A Trial Investigating the Total Exposure of NN5401 (Insulin Degludec/Insulin Aspart) in Children, Adolescents and Adult Subjects With Type 1 Diabetes
NCT01138488 ·Status: COMPLETED ·Phase: PHASE1
-
A Trial Investigating the Pharmacodynamic Properties of NN5401 in Subjects With Type 1 Diabetes
NCT01590836 ·Status: COMPLETED ·Phase: PHASE1
-
Insulin Glulisine, Insulin Lispro and Insulin Glargine in Type 1 or 2 Diabetes Mellitus
NCT00467376 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of LY900014 in Elderly and Younger Adult Participants With Type 1 Diabetes Mellitus
NCT03166124 ·Status: COMPLETED ·Phase: PHASE1
-
Insulin Glulisine Administered Pre-meal Versus Post-meal in Adult Subjects With Type 2 Diabetes Mellitus Receiving Insulin Glargine as Basal Insulin
NCT00135096 ·Status: COMPLETED ·Phase: PHASE3
-
6-month Comparison of Morning Lantus Versus Neutral Protamine Hagedorn Insulin in Young Children With Type 1 Diabetes
NCT00993473 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Compare Pharmacokinetics and Pharmacodynamics of SAR342434 to Insulin Lispro in Subjects With Type 1 Diabetes
NCT02273258 ·Status: COMPLETED ·Phase: PHASE1
-
A Meal Test Study of LY900014 in Participants With Type 1 Diabetes Mellitus
NCT03449433 ·Status: COMPLETED ·Phase: PHASE1
-
32 Week, Open, Randomized, 2 Way Cross Over Multicentre Trial to Compare Safety & Efficacy of Combination of HOE901 Insulin Analogue Once Daily at Bedtime + Lispro Insulin Before Meals vs NPH Insulin (Twice a Day) + Regular in Type 1 Diabetes Mellitus
NCT00537251 ·Status: COMPLETED ·Phase: PHASE3
-
Insulin Glulisine in Healthy Lean and Obese Subjects
NCT00311077 ·Status: COMPLETED ·Phase: PHASE1