A Trial Investigating the Pharmacodynamic Properties of NN1218 in Subjects With Type 1 Diabetes
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ClinicalTrials.gov Identifier: NCT01618188 |
Recruitment Status :
Completed
First Posted : June 13, 2012
Last Update Posted : December 11, 2018
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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 : | 52 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Trial Investigating the Pharmacodynamic Properties of NN1218 in Subjects With Type 1 Diabetes |
Actual Study Start Date : | June 11, 2012 |
Actual Primary Completion Date : | September 7, 2012 |
Actual Study Completion Date : | September 7, 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: Formulation A |
Drug: Faster-acting insulin aspart
A single dose of 0.2 U/kg body weight for subcutaneous (s.c., under the skin) administration.
Other Name: NN1218 |
Experimental: Formulation B |
Drug: Faster-acting insulin aspart
A single dose of 0.2 U/kg body weight for subcutaneous (s.c., under the skin) administration.
Other Name: NN1218 |
Active Comparator: Insulin Aspart |
Drug: insulin aspart
A single dose of 0.2 U/kg body weight for subcutaneous (s.c., under the skin) administration. |
- Area under the glucose infusion rate curve [ Time Frame: From 0 to 2 hours ]
- Area under the glucose infusion rate curve [ Time Frame: From 0 to 12 hours ]
- Maximum glucose infusion rate [ Time Frame: Within 0 to 12 hours after dosing ]
- Time to maximum glucose infusion rate [ 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:
- Type 1 diabetes mellitus for more than 12 months
- Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion for more than 12 months
- Body mass index (BMI) between 18.0-28.0 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 trial start
- 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 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): NCT01618188
Germany | |
Novo Nordisk Investigational Site | |
Neuss, Germany, 41460 |
Study Director: | Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S |
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Novo Nordisk A/S |
ClinicalTrials.gov Identifier: | NCT01618188 |
Other Study ID Numbers: |
NN1218-3978 U1111-1126-0900 ( Other Identifier: WHO ) 2011-005796-16 ( EudraCT Number ) |
First Posted: | June 13, 2012 Key Record Dates |
Last Update Posted: | December 11, 2018 |
Last Verified: | December 2018 |
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 |