A Trial Investigating the Pharmacodynamic Response of Faster Acting Insulin Aspart in Subjects With Type 1 Diabetes
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ClinicalTrials.gov Identifier: NCT02033239 |
Recruitment Status :
Completed
First Posted : January 10, 2014
Last Update Posted : January 18, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetes Diabetes Mellitus, Type 1 | Drug: Faster-acting insulin aspart Drug: insulin aspart | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 46 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Trial Investigating the Pharmacodynamic Response of FIAsp in Subjects With Type 1 Diabetes |
Study Start Date : | January 2014 |
Actual Primary Completion Date : | June 2014 |
Actual Study Completion Date : | June 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: FIAsp
Each subject will be randomised to a treatment sequence consisting of 8 treatment periods
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Drug: Faster-acting insulin aspart
Subjects will receive different dose levels of faster acting insulin aspart and NovoRapid®. Single dose of trial products will be administered subcutaneously (s.c. under the skin). |
Active Comparator: NovoRapid®
Each subject will be randomised to a treatment sequence consisting of 8 treatment periods
|
Drug: insulin aspart
Subjects will receive different dose levels of faster acting insulin aspart and NovoRapid®. Single dose of trial products will be administered subcutaneously (s.c. under the skin). |
- Area under the glucose infusion rate curve [ Time Frame: From 0 to 12 hours ]
- Area under the serum insulin aspart concentration-time curve [ Time Frame: From 0 to 12 hours ]
- Maximum glucose infusion rate [ Time Frame: Within 0 to 12 hours after dosing ]
- Maximum observed serum insulin aspart concentration [ Time Frame: Within 0 to 12 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:
- Male or female aged 18-64 years (both inclusive) at the time of signing informed consent
- Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
- Body mass index 18.5-28.0 kg/m^2 (both inclusive)
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 at least one cigarette, cigar or pipe daily)
- Not able or willing to refrain from smoking and use of nicotine substitute products 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): NCT02033239
Germany | |
Novo Nordisk Investigational Site | |
Neuss, Germany, 41460 |
Study Director: | Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Novo Nordisk A/S |
ClinicalTrials.gov Identifier: | NCT02033239 |
Other Study ID Numbers: |
NN1218-3887 2011-001580-41 ( EudraCT Number ) U1111-1120-3772 ( Other Identifier: WHO ) |
First Posted: | January 10, 2014 Key Record Dates |
Last Update Posted: | January 18, 2017 |
Last Verified: | January 2017 |
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Autoimmune Diseases Immune System Diseases |
Insulin Insulin, Globin Zinc Insulin Aspart Insulin, Long-Acting Insulin degludec, insulin aspart drug combination Hypoglycemic Agents Physiological Effects of Drugs |