Safety and Efficacy of Insulin Aspart in Children With Type 1 Diabetes
NCT01467141 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 26
Last updated 2017-02-23
Summary
This trial is conducted in Europe. The aim of this trial is to evaluate safety and efficacy in children with type 1 diabetes.
Conditions
- Diabetes
- Diabetes Mellitus, Type 1
Interventions
- DRUG
-
insulin aspart
Injected s.c. (under the skin) three times a day
- DRUG
-
human insulin
Injected s.c. (under the skin) 30 minutes before the meals
- DRUG
-
isophane human insulin
May be administered s.c. (under the skin) in both treatment groups thrice daily
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Global Clinical Registry (GCR, 1452) · Novo Nordisk A/S
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 2 Years
- Max Age
- 6 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2002-06-19
- Primary Completion
- 2003-10-15
- Completion
- 2003-10-15
Countries
- Germany
Study Locations
More Related Trials
-
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
-
Safety and Efficacy of Insulin Detemir Plus Insulin Aspart Against Insulin Glargine Plus Insulin Aspart as Mealtime Insulin in Type 1 Diabetes
NCT00095082 ·Status: COMPLETED ·Phase: PHASE3
-
A Randomised Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of Faster-acting Insulin Aspart in Subjects With Type 1 Diabetes
NCT02131246 ·Status: COMPLETED ·Phase: PHASE1
-
Efficacy and Safety of a Fixed or a Flexible Supplementary Insulin Therapy in Type 2 Diabetes
NCT00274274 ·Status: COMPLETED ·Phase: PHASE4
-
Efficacy and Safety of Biphasic Insulin Aspart 30 in Type 1 or Type 2 Diabetes
NCT01467323 ·Status: COMPLETED ·Phase: PHASE3
-
Comparison of Single Dose and Steady State Pharmacodynamics of Biphasic Insulin Aspart 30 and 70 in Subjects With Type 1 Diabetes
NCT01526941 ·Status: COMPLETED ·Phase: PHASE1
-
Special Survey for Paediatric Subjects
NCT01487382 ·Status: COMPLETED
-
Long Term Safety of Biphasic Insulin Aspart 30 in Juveniles With Type 1 Diabetes
NCT01486381 ·Status: COMPLETED ·Phase: PHASE3
-
A Randomised Proof-of-Principle Trial Investigating Pharmacodynamics, Pharmacokinetics, and Safety of NNC0143-0406 in Subjects With Type 1 Diabetes Mellitus
NCT02938572 ·Status: COMPLETED ·Phase: PHASE1
-
The Effect of Insulin Glulisine Compared With Insulin Aspart on Breakfast Post Prandial Glucose Levels in Prepubertal Children
NCT00913497 ·Status: COMPLETED ·Phase: PHASE4
-
Comparison of the Ability of Glulisine With Lispro to Control Type 1 Diabetes Mellitus in Children and Adolescents
NCT00115570 ·Status: COMPLETED ·Phase: PHASE3
-
A Trial Comparing the Safety and Efficacy of Insulin Degludec and Insulin Glargine, Both With Insulin Aspart as Mealtime Insulin in Subjects With Type 1 Diabetes
NCT02034513 ·Status: COMPLETED ·Phase: PHASE3
-
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
-
Investigating the Postprandial Glucose Metabolism After Treatment With Faster-acting Insulin Aspart in Subjects With Type 1 Diabetes
NCT02568280 ·Status: COMPLETED ·Phase: PHASE1
-
Comparison of IDegAsp (Inclusive Three Explorative Formulations) With Insulin Degludec and Insulin Aspart Separately Injected in Subjects With Type 1 Diabetes
NCT01868568 ·Status: COMPLETED ·Phase: PHASE1
-
Treatment Satisfaction of Insulin Glargine Plus Insulin Apidra Compared With NPH Insulin Plus Insulin Apidra in Recently Diagnosed Type 1 Diabetes Children and Adolescents
NCT00925977 ·Status: TERMINATED ·Phase: NA
-
Investigation of the Response Relationship of NN5401 in Type 1 Diabetics
NCT00993096 ·Status: COMPLETED ·Phase: PHASE1
-
A Trial Investigating the Pharmacodynamic Response of Faster Acting Insulin Aspart in Subjects With Type 1 Diabetes
NCT02033239 ·Status: COMPLETED ·Phase: PHASE1
-
Comparison of the Pharmacodynamics and Pharmacokinetics of Biphasic Insulin Aspart 30, 50, 70 and Insulin Aspart in Subjects With Type 1 Diabetes
NCT01536028 ·Status: COMPLETED ·Phase: PHASE1
-
A Trial Investigating the Pharmacodynamic Properties of NN5401 in Subjects With Type 1 Diabetes
NCT01590836 ·Status: COMPLETED ·Phase: PHASE1
-
Efficacy and Safety of Insulin Aspart in Subjects With Type 1 or Type 2 Diabetes
NCT00593255 ·Status: COMPLETED ·Phase: PHASE4
-
A Trial Investigating the Pharmacodynamic and Pharmacokinetic Properties of Insulin Degludec/Insulin Aspart 15 in Subjects With Type 1 Diabetes
NCT01773798 ·Status: COMPLETED ·Phase: PHASE1
-
Evaluation of Pharmacokinetics , Safety, Tolerability and Pharmacodynamics of Biocon Insulin Tregopil
NCT04141423 ·Status: TERMINATED ·Phase: PHASE1
-
Comparing Insulin Aspart With Fast-acting Insulin Human in Subjects With Type 1 Diabetes
NCT01269606 ·Status: COMPLETED ·Phase: PHASE1
-
Comparison of the Blood Sugar Lowering Effect and Safety of Two Insulin Treatments in Type 2 Diabetes
NCT00537303 ·Status: COMPLETED ·Phase: PHASE4