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 · Type: INTERVENTIONAL · Enrollment: 33
Last updated 2017-01-18
Summary
This trial is conducted in Europe. The aim of the trial is to investigate the pharmacokinetic (the exposure of the trial drug in the body) and pharmacodynamic (the effect of the investigated drug on the body) properties of faster-acting insulin aspart in subjects with Type 1 diabetes.
Conditions
- Diabetes
- Diabetes Mellitus, Type 1
Interventions
- DRUG
-
Faster-acting insulin aspart
Subjects will receive a single dose of either Faster-acting insulin aspart or NovoRapid® at a predefined fixed dose level in connection to intake of a standardised meal. Administered subcutaneously (s.c., under the skin)
- DRUG
-
insulin aspart
Subjects will receive a single dose of either Faster-acting insulin aspart or NovoRapid® at a predefined fixed dose level in connection to intake of a standardised meal. Administered subcutaneously (s.c., under the skin)
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
- 18 Years
- Max Age
- 64 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-05-31
- Primary Completion
- 2014-07-31
- Completion
- 2014-07-31
Countries
- Austria
Study Locations
More Related Trials
-
A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of Faster-acting Insulin Aspart in Subjects With Type 2 Diabetes Mellitus
NCT02933853 ·Status: COMPLETED ·Phase: PHASE1
-
A Trial Investigating the Pharmacokinetic Properties of Formulations of NN1218 in Subjects With Type 1 Diabetes
NCT01469143 ·Status: COMPLETED ·Phase: PHASE1
-
A Trial Investigating the Pharmacokinetic Properties of NN1218 in Subjects With Diabetes Mellitus, Type 1
NCT01296438 ·Status: COMPLETED ·Phase: PHASE1
-
Comparing Insulin Aspart With Fast-acting Insulin Human in Subjects With Type 1 Diabetes
NCT01269606 ·Status: COMPLETED ·Phase: PHASE1
-
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
-
Comparison of Pharmacodynamics and Pharmacokinetics of Biphasic Insulin Aspart 30 and Insulin Glargine and Insulin Glulisine Therapy in Subjects With Type 2 Diabetes
NCT00824668 ·Status: COMPLETED ·Phase: PHASE1
-
A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of FIAsp in Geriatric and Younger Adult Subjects With Type 1 Diabetes
NCT02003677 ·Status: COMPLETED ·Phase: PHASE1
-
A Trial Comparing the Pharmacokinetic Properties of Faster-acting Insulin Aspart (FIAsp) After Different Injection Regions and Routes of Administration in Healthy Subjects
NCT02089451 ·Status: COMPLETED ·Phase: PHASE1
-
Comparing Pharmacodynamic and Pharmacokinetic Properties of Insulin Degludec and Insulin Glargine 300 U/mL at Steady-state Conditions in Subjects With Type 1 Diabetes Mellitus
NCT02536859 ·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 to Investigate Different Needle Features Assessed by Comparing Insulin Aspart Pharmacokinetic Profiles
NCT02594033 ·Status: COMPLETED ·Phase: PHASE1
-
A Trial Investigating the Pharmacodynamic Properties of NN1218 in Subjects With Type 1 Diabetes
NCT01618188 ·Status: COMPLETED ·Phase: PHASE1
-
A Trial Investigating the Pharmacodynamic Properties of NN5401 in Subjects With Type 1 Diabetes
NCT01590836 ·Status: COMPLETED ·Phase: PHASE1
-
Comparison of the Pharmacodynamics and Pharmacokinetics of Insulin Aspart and Human Insulin in Elderly People With Type 2 Diabetes
NCT00676819 ·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
-
Comparison of the Effect of NN5401 With the Effect of NN1250 and Insulin Aspart in Subjects With Type 1 Diabetes
NCT01173926 ·Status: COMPLETED ·Phase: PHASE1
-
A Comparison of Pharmacodynamics and Pharmacokinetics of Insulin Aspart, Biphasic Insulin Aspart 30, 50 and 70.
NCT00283218 ·Status: COMPLETED ·Phase: NA
-
Comparison of Insulin Aspart Produced by the NN2000 Process to the Current Process in Type 1 Diabetes
NCT00604656 ·Status: COMPLETED ·Phase: PHASE3
-
A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Insulin 320 in Healthy Subjects
NCT02479022 ·Status: COMPLETED ·Phase: PHASE1
-
Examining the Long-term Safety of Insulin Aspart When Used as a Part of the Treatment for Type 1 Diabetes
NCT00832182 ·Status: COMPLETED ·Phase: PHASE3
-
Comparison of Insulin Glargine Against Insulin Aspart Infused Under the Skin in Patients With Type 2 Diabetes
NCT00184613 ·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
-
Safety and Efficacy of Insulin Aspart in Children With Type 1 Diabetes
NCT01467141 ·Status: COMPLETED ·Phase: PHASE4
-
Comparison of Pharmacodynamics and Pharmacokinetics of Biphasic Insulin Aspart 50 to Biphasic Insulin Aspart 70 in Type 2 Diabetes
NCT00612599 ·Status: COMPLETED ·Phase: PHASE3
-
A Trial Investigating the Exposure of NN5401 in Young Adults and Elderly Subjects With Type 1 Diabetes
NCT01174303 ·Status: COMPLETED ·Phase: PHASE1