Bioequivalence of Two Insulatard® Formulations in Healthy Subjects
This study has been completed.
Sponsor:
Novo Nordisk
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01486901
First received: December 5, 2011
Last updated: NA
Last verified: December 2011
History: No changes posted
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Purpose
This trial is conducted in Europe. The aim of this trial is to test for bioequivalence between two formulations of Insulatard® in healthy subjects.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Healthy |
Drug: isophane human insulin |
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 Randomised, Single Centre, Double-blind, Two-period Cross-over, Glucose Clamp Trial to Test for Bioequivalence Between Insulatard® (600 Nmol/ml) and Insulatard® (1998 Nmol/ml) in Healthy Subjects |
Resource links provided by NLM:
Further study details as provided by Novo Nordisk:
Primary Outcome Measures:
- Area under the serum insulin concentration-time curve (AUC 0-24 hours) [ Designated as safety issue: No ]
- Maximum serum insulin concentration (Cmax) [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Area under the serum insulin concentration-time curve (AUC 0-inifinity hours) [ Designated as safety issue: No ]
- Time to maximum serum insulin concentration (tmax) [ Designated as safety issue: No ]
- Terminal serum insulin half life (t½) [ Designated as safety issue: No ]
- Adverse events [ Designated as safety issue: No ]
| Enrollment: | 44 |
| Study Start Date: | May 2006 |
| Study Completion Date: | July 2006 |
| Primary Completion Date: | July 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Formulation A |
Drug: isophane human insulin
Single dose of each formulation, administered subcutaneously (s.c., under the skin) on two separate dosing visits
|
| Active Comparator: Formulation B |
Drug: isophane human insulin
Single dose of each formulation, administered subcutaneously (s.c., under the skin) on two separate dosing visits
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Considered generally healthy upon completion of medical history and physical examination as judged by the Investigator
- Body Mass Index (BMI) between 18.0 and 27.0 kg/m^2, inclusive
- Non-smoker, defined as no nicotine consumption for at least one year
- Fasting plasma glucose below or equal to 100 mg/dL (5.6 mmol/L)
Exclusion Criteria:
- Previous participation in this trial or other clinical trials within the last 3 months
- Body weight above 87.5 kg
- Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures (intrauterine device (IUD) that has been in place for at least 3 months, or sterilisation, or the oral contraceptive pill, which should have been taken without difficulty for at least 3 months, an approved hormonal implant)
- History of alcohol or drug abuse
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Public Access to Clinical Trials, Novo Nordisk A/S |
| ClinicalTrials.gov Identifier: | NCT01486901 History of Changes |
| Other Study ID Numbers: | EX1000-1736, 2005-006049-18 |
| Study First Received: | December 5, 2011 |
| Last Updated: | December 5, 2011 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Additional relevant MeSH terms:
|
Insulin Insulin, NPH Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013