Comparison of Insulin Aspart Produced by Current Process and the NN2000 Process in Healthy Japanese
This study has been completed.
Sponsor:
Novo Nordisk
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01620450
First received: June 13, 2012
Last updated: NA
Last verified: June 2012
History: No changes posted
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Purpose
This trial is conducted in Japan. The aim of this trial is to compare insulin aspart produced by current process and the NN2000 process in healthy Japanese subjects.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Healthy |
Drug: biphasic human insulin 30 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Single-centre, Randomised, Double Blind, Cross-over Trial Demonstrating the Bioequivalence Between NN2000-Mix30 and NN-X14Mix30 (NovoRapid® 30 Mix) in Healthy Japanese Subjects |
Resource links provided by NLM:
Further study details as provided by Novo Nordisk:
Primary Outcome Measures:
- Area under the curve of insulin aspart concentration (AUC IAsp, 0-16h) [ Designated as safety issue: No ]
- Maximum insulin aspart concentration (Cmax IAsp) [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Area under the curve of insulin aspart concentration (AUC IAsp) [ Designated as safety issue: No ]
- Time to maximum insulin aspart concentration (tmax IAsp) [ Designated as safety issue: No ]
- Terminal elimination half life (t½) [ Designated as safety issue: No ]
- Body weight [ Designated as safety issue: No ]
- Adverse events [ Designated as safety issue: No ]
| Enrollment: | 34 |
| Study Start Date: | November 2004 |
| Study Completion Date: | February 2005 |
| Primary Completion Date: | February 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: NN2000 |
Drug: biphasic human insulin 30
Single dose of each formulation administered subcutaneously (s.c., under the skin) on two separate visits
|
| Active Comparator: NN-X14 |
Drug: biphasic human insulin 30
Single dose of each formulation administered subcutaneously (s.c., under the skin) on two separate visits
|
Eligibility| Ages Eligible for Study: | 20 Years to 50 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Japanese
- Considered generally healthy based on medical history and physical examination
- Body Mass Index (BMI) between 18 and 27 kg/m^2 (both inclusive)
- Fasting plasma glucose between 3.8 mmol/L (68.4 mg/dL) and 6.0 mmol/L (108.0 mg/dL)
Exclusion Criteria:
- Clinically significant abnormal values in clinical laboratory tests of haematology, biochemistry, fasting plasma glucose and urinalysis
- Any serious systemic infectious disease that occurred during the last 4 weeks before trial
- Any inter-current illness that may affect blood glucose
- Subject with a first degree relative with diabetes mellitus
- Blood donation of more than 400 mL (inclusive) in total within the last 12 weeks or more than 200 mL (inclusive) in total within the last 4 weeks
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Public Access to Clinical Trials, Novo Nordisk A/S |
| ClinicalTrials.gov Identifier: | NCT01620450 History of Changes |
| Other Study ID Numbers: | NN2000-1612 |
| Study First Received: | June 13, 2012 |
| Last Updated: | June 13, 2012 |
| Health Authority: | Japan: Ministry of Health, Labour and Welfare (MHLW) |
Additional relevant MeSH terms:
|
Insulin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013