A Trial Investigating the Pharmacodynamic Properties of NN1218 in Subjects With Type 1 Diabetes
This study has been completed.
Sponsor:
Novo Nordisk
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01618188
First received: June 11, 2012
Last updated: September 12, 2012
Last verified: September 2012
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Purpose
This trial is conducted in Europe. The aim of this trial is to investigate the pharmacodynamic properties (the effect of the investigated drug on the body) of NN1218 in subjects with type 1 diabetes.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Diabetes Mellitus, Type 1 |
Drug: NN1218 Drug: insulin aspart |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Trial Investigating the Pharmacodynamic Properties of NN1218 in Subjects With Type 1 Diabetes |
Resource links provided by NLM:
Further study details as provided by Novo Nordisk:
Primary Outcome Measures:
- Area under the glucose infusion rate curve [ Time Frame: From 0 to 2 hours ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Area under the glucose infusion rate curve [ Time Frame: From 0 to 12 hours ] [ Designated as safety issue: No ]
- Maximum glucose infusion rate [ Time Frame: Within 0 to 12 hours after dosing ] [ Designated as safety issue: No ]
- Time to maximum glucose infusion rate [ Time Frame: Within 0 to 12 hours after dosing ] [ Designated as safety issue: No ]
| Enrollment: | 52 |
| Study Start Date: | June 2012 |
| Study Completion Date: | September 2012 |
| Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Formulation A |
Drug: NN1218
A single dose of 0.2 U/kg body weight for subcutaneous (s.c., under the skin) administration.
|
| Experimental: Formulation B |
Drug: NN1218
A single dose of 0.2 U/kg body weight for subcutaneous (s.c., under the skin) administration.
|
| 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.
|
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 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
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Public Access to Clinical Trials, Novo Nordisk A/S |
| ClinicalTrials.gov Identifier: | NCT01618188 History of Changes |
| Other Study ID Numbers: | NN1218-3978, U1111-1126-0900, 2011-005796-16 |
| Study First Received: | June 11, 2012 |
| Last Updated: | September 12, 2012 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Autoimmune Diseases |
Immune System Diseases Insulin aspart Insulin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013