A Trial to Test for Bioequivalence Between NN1045 and NN5401 in Subjects With Type 1 Diabetes
This study has been completed.
Sponsor:
Novo Nordisk A/S
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01455142
First received: October 17, 2011
Last updated: February 19, 2015
Last verified: February 2015
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
This trial is conducted in Europe. The aim of the trial is to test for bioequivalence between two formulations of insulin degludec/insulin aspart (IDegAsp) to see if the efficacy and safety obtained with formulation 1 can be assumed identical for formulation 2.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Diabetes Mellitus, Type 1 |
Drug: insulin degludec/insulin aspart |
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 Trial to Test for Bioequivalence Between NN1045 and NN5401 in Subjects With Type 1 Diabetes |
Resource links provided by NLM:
Further study details as provided by Novo Nordisk A/S:
Primary Outcome Measures:
- Area under the serum insulin degludec concentration-time curve [ Time Frame: From 0 to 120 hours after single-dose (SD) ] [ Designated as safety issue: No ]
- Maximum observed serum insulin degludec concentration [ Time Frame: After single-dose (within 0 to 120 hours after dosing) ] [ Designated as safety issue: No ]
- Area under the serum insulin aspart concentration-time curve [ Time Frame: From 0 to 12 hours after single-dose ] [ Designated as safety issue: No ]
- Maximum observed serum insulin aspart concentration [ Time Frame: After single-dose (within 0 to 12 hours after dosing) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Area under the glucose infusion rate curve [ Time Frame: From 0 to 26 hours after single-dose ] [ Designated as safety issue: No ]
- Maximum glucose infusion rate [ Time Frame: After single-dose (within 0 to 120 hours after dosing) ] [ Designated as safety issue: No ]
| Enrollment: | 32 |
| Study Start Date: | October 2011 |
| Study Completion Date: | January 2012 |
| Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Formulation 1 |
Drug: insulin degludec/insulin aspart
Single injection of each formulation. The dose level will be 0.5 U/kg body weight (BW). The trial products will be administered subcutaneously (under the skin).
Other Name: IDegAsp
|
| Experimental: Formulation 2 |
Drug: insulin degludec/insulin aspart
Single injection of each formulation. The dose level will be 0.5 U/kg body weight (BW). The trial products will be administered subcutaneously (under the skin).
Other Name: IDegAsp
|
Eligibility| Ages Eligible for Study: | 18 Years to 64 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Type 1 diabetes mellitus (as diagnosed clinically) for 12 months or longer
- Body mass index from 18.0 to 28.0 kg/m^2 (both inclusive)
- HbA1c below or equal to 9.5% by central laboratory analysis
Exclusion Criteria:
- Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
- Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
- Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01455142
Please refer to this study by its ClinicalTrials.gov identifier: NCT01455142
Locations
| Austria | |
| Graz, Austria, 8010 | |
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
| Study Director: | Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S |
More Information
Additional Information:
No publications provided
| Responsible Party: | Novo Nordisk A/S |
| ClinicalTrials.gov Identifier: | NCT01455142 History of Changes |
| Other Study ID Numbers: | NN1045-3834, 2011-001569-42, U1111-1120-3922 |
| Study First Received: | October 17, 2011 |
| Last Updated: | February 19, 2015 |
| Health Authority: | Austria: Agency for Health and Food Safety |
Additional relevant MeSH terms:
|
Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases |
Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases |
ClinicalTrials.gov processed this record on March 03, 2015