A Trial to Test for Bioequivalence Between NN1045 and NN5401 in Subjects With Type 1 Diabetes
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ClinicalTrials.gov Identifier: NCT01455142 |
Recruitment Status
:
Completed
First Posted
: October 19, 2011
Last Update Posted
: February 23, 2015
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetes Diabetes Mellitus, Type 1 | Drug: insulin degludec/insulin aspart | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 32 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Trial to Test for Bioequivalence Between NN1045 and NN5401 in Subjects With Type 1 Diabetes |
Study Start Date : | October 2011 |
Actual Primary Completion Date : | January 2012 |
Actual Study Completion Date : | January 2012 |

Arm | Intervention/treatment |
---|---|
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
|
- Area under the serum insulin degludec concentration-time curve [ Time Frame: From 0 to 120 hours after single-dose (SD) ]
- Maximum observed serum insulin degludec concentration [ Time Frame: After single-dose (within 0 to 120 hours after dosing) ]
- Area under the serum insulin aspart concentration-time curve [ Time Frame: From 0 to 12 hours after single-dose ]
- Maximum observed serum insulin aspart concentration [ Time Frame: After single-dose (within 0 to 12 hours after dosing) ]
- Area under the glucose infusion rate curve [ Time Frame: From 0 to 26 hours after single-dose ]
- Maximum glucose infusion rate [ Time Frame: After single-dose (within 0 to 120 hours after dosing) ]

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Ages Eligible for Study: | 18 Years to 64 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01455142
Austria | |
Graz, Austria, 8010 |
Study Director: | Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S |
Additional Information:
Responsible Party: | Novo Nordisk A/S |
ClinicalTrials.gov Identifier: | NCT01455142 History of Changes |
Other Study ID Numbers: |
NN1045-3834 2011-001569-42 ( EudraCT Number ) U1111-1120-3922 ( Other Identifier: WHO ) |
First Posted: | October 19, 2011 Key Record Dates |
Last Update Posted: | February 23, 2015 |
Last Verified: | February 2015 |
Additional relevant MeSH terms:
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Autoimmune Diseases |
Immune System Diseases Insulin Insulin Aspart Hypoglycemic Agents Physiological Effects of Drugs |