Pharmacokinetics and Pharmacodynamics of Biphasic Insulin Aspart 30 and Biphasic Human Insulin 30 in Type 2 Diabetes
NCT00825253 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2017-01-06
Summary
This trial is conducted in Europe. The aim of this clinical trial is to compare the pharmacodynamics (i.e. the glucose-lowering effect of the study medication over the entire observation phase from the time of administration and the efficacy period) and the pharmacokinetics (i.e. amount of the study insulin that can be determined in the blood) of a treatment with biphasic insulin aspart 30 (BiAsp 30) administered once, twice or thrice daily and biphasic human insulin 30 administered once daily in type 2 diabetic subjects
Conditions
- Diabetes
- Diabetes Mellitus, Type 2
Interventions
- DRUG
-
biphasic insulin aspart 30
- DRUG
-
biphasic human insulin 30
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
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-03-31
- Primary Completion
- 2007-05-31
- Completion
- 2007-05-31
Countries
- Germany
Study Locations
More Related Trials
-
Comparison of Biphasic Insulin Aspart (30, 50 and 70) and Insulin Aspart in Healthy Subjects
NCT01520831 ·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
-
Pharmacokinetics and Pharmacodynamics of Biphasic Insulin Aspart 30 in Healthy Volunteers
NCT01707160 ·Status: COMPLETED ·Phase: PHASE1
-
Frequency of Episodes of Hypoglycaemia During Treatment With Biphasic Insulin Aspart 30 in Type 2 Diabetes
NCT01487798 ·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 Pharmacodynamics and Pharmacokinetics of Biphasic Insulin Aspart 50 to Biphasic Insulin Aspart 70 in Type 2 Diabetes
NCT00612599 ·Status: COMPLETED ·Phase: PHASE3
-
Comparison of Subject-driven Titration of Biphasic Insulin Aspart (BIAsp) 30 Twice Daily Versus Investigator-driven Titration of BIAsp 30 Twice Daily Both in Combination With Oral Antidiabetic Drugs in Subjects With Type 2 Diabetes
NCT01618214 ·Status: COMPLETED ·Phase: PHASE4
-
Effect of Biphasic Insulin Compared to Biphasic Insulin Combined With Insulin Aspart, With or Without Metformin in Type 2 Diabetes
NCT00282451 ·Status: COMPLETED ·Phase: PHASE4
-
Bioequivalence of Two Formulations of Biphasic Insulin Aspart 50 in Healthy Subjects
NCT01527643 ·Status: COMPLETED ·Phase: PHASE1
-
A Trial Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart and BIAsp 30 in Insulin naïve Subjects With Type 2 Diabetes
NCT01513590 ·Status: COMPLETED ·Phase: PHASE3
-
A Comparison of Pharmacodynamics and Pharmacokinetics of Insulin Aspart, BIAsp70, BIAsp50 and Fast-acting Human Insulin
NCT00888732 ·Status: COMPLETED ·Phase: PHASE3
-
Insulin Profile of Biphasic Insulin Aspart 70 to That of Biphasic Insulin Aspart 30 in Healthy Volunteers
NCT01538511 ·Status: COMPLETED ·Phase: PHASE1
-
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
-
Comparison of Two Formulations of Biphasic Insulin Aspart 70
NCT01523041 ·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
-
Efficacy of Biphasic Insulin Aspart 30 in Type 2 Diabetics Failing on OADs
NCT00791895 ·Status: COMPLETED ·Phase: PHASE4
-
Prandial Orientated Biphasic Insulin Aspart 30 Therapy - the Physiological Premix Insulin Therapy for Type 2 Diabetes
NCT01536652 ·Status: COMPLETED
-
Efficacy and Safety of Biphasic Insulin Aspart 30 in Type 2 Diabetes Mellitus When Failing on OADs
NCT00537277 ·Status: COMPLETED ·Phase: PHASE4
-
Comparison of NN5401 With Biphasic Insulin Aspart 30 in Type 2 Diabetes
NCT01009580 ·Status: COMPLETED ·Phase: PHASE3
-
Comparison of Explorative Formulation of Insulin Degludec and Insulin Aspart Co-formulation Versus Explorative Formulation of Insulin Degludec and Insulin Aspart Separately Compared With Biphasic Insulin Aspart 30 in Male Subjects With Diabetes
NCT01865305 ·Status: COMPLETED ·Phase: PHASE1
-
Efficacy and Safety of Biphasic Insulin Aspart 30 FlexPen™ in Subjects With Type 2 Diabetes
NCT01704378 ·Status: COMPLETED ·Phase: PHASE4
-
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 Biphasic Insulin Aspart 30 FlexPen® in Insulin Naive Subjects With Type 2 Diabetes
NCT00600366 ·Status: COMPLETED ·Phase: PHASE4
-
Effect of Biphasic Insulin Aspart 30 on Blood Glucose Control in Subjects With Type 2 Diabetes
NCT00280046 ·Status: COMPLETED ·Phase: PHASE3
-
Long Term Safety and Efficacy of Biphasic Insulin Aspart 30 in Subjects With Type 2 Diabetes
NCT01527539 ·Status: COMPLETED ·Phase: PHASE3