A Trial Investigating the Pharmacodynamic and Pharmacokinetic Properties of Insulin Degludec/Insulin Aspart 15 in Subjects With Type 1 Diabetes - Full Text View

Purpose

This trial is conducted in Europe. The aim of the trial is to investigate the pharmacodynamic (the effect of the investigated drug on the body) and the pharmacokinetic (exposure of the trial drug in the body) properties of insulin degludec/insulin aspart 15 in subjects with type 1 diabetes.

Condition	Intervention	Phase
Diabetes Diabetes Mellitus, Type 1	Drug: IDegAsp 15 Drug: IDegAsp Drug: IDeg Drug: insulin aspart Drug: placebo	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 and Pharmacokinetic Properties of Insulin Degludec/Insulin Aspart 15 in Subjects With Type 1 Diabetes

Resource links provided by NLM:

Genetics Home Reference related topics: type 1 diabetes

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 1

Drug Information available for: Insulin human Insulin aspart

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

Area under the glucose infusion rate curve [ Time Frame: From 0 to 6 hours after single dose (IDegAsp 15, IDeg and IDegAsp) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Area under the serum IDeg concentration-time curve [ Time Frame: From 0 to 120 hours after single dose ] [ Designated as safety issue: No ]
Area under the serum IAsp concentration-time curve [ Time Frame: From 0 to 12 hours after single dose ] [ Designated as safety issue: No ]

Estimated Enrollment:	33
Study Start Date:	January 2013
Estimated Study Completion Date:	August 2013
Estimated Primary Completion Date:	August 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: IDegAsp 15	Drug: IDegAsp 15 Each subject subject will be randomly allocated to five single doses. Administered subcutaneously (s.c, under the skin) on five dosing visits separated by 15-25 days. The dose level will be 0.5 U/kg Body Weight (BW). Drug: placebo Each subject subject will be randomly allocated to five single doses. Administered subcutaneously (s.c, under the skin) on five dosing visits separated by 15-25 days.
Experimental: IDegAsp	Drug: IDegAsp Each subject subject will be randomly allocated to five single doses. Administered subcutaneously (s.c, under the skin) on five dosing visits separated by 15-25 days. The dose level will be 0.5 U/kg Body Weight (BW). Drug: placebo Each subject subject will be randomly allocated to five single doses. Administered subcutaneously (s.c, under the skin) on five dosing visits separated by 15-25 days.
Experimental: IDeg	Drug: IDeg Each subject subject will be randomly allocated to five single doses. Administered subcutaneously (s.c, under the skin) on five dosing visits separated by 15-25 days. The dose level will be 0.425 U/kg Body Weight (BW).
Active Comparator: IAsp	Drug: insulin aspart Each subject subject will be randomly allocated to five single doses. Administered subcutaneously (s.c, under the skin) on five dosing visits separated by 15-25 days. The dose level will be 0.075 U/kg Body Weight (BW).
Experimental: IDeg + IAsp	Drug: IDeg Each subject subject will be randomly allocated to five single doses. Administered subcutaneously (s.c, under the skin) on five dosing visits separated by 15-25 days. The dose level will be 0.425 U/kg Body Weight (BW). Drug: insulin aspart Each subject subject will be randomly allocated to five single doses. Administered subcutaneously (s.c, under the skin) on five dosing visits separated by 15-25 days. The dose level will be 0.075 U/kg Body Weight (BW).

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 at least 12 months
Body mass index 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 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, use of nicotine substitute products or transdermal nicotine patches during the inpatient period
Female of childbearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods (adequate contraceptive measures include sterilisation, hormonal intrauterine devices, oral contraceptives, condom with spermizide, sexual abstinence or vasectomised partner)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01773798

Contacts

Contact: Novo Nordisk

clinicaltrials@novonordisk.com

Locations

Austria
	Recruiting
Graz, Austria, 8010

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Hanne Hastrup-Nielsen

Novo Nordisk

More Information

Additional Information:

Clinical Trials at Novo Nordisk This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT01773798 History of Changes
Other Study ID Numbers:	NN1050-4008, 2012-004215-31, U1111-1134-6222
Study First Received:	January 18, 2013
Last Updated:	January 30, 2013
Health Authority:	Austria: Agency for Health and Food Safety

Additional relevant MeSH terms:

Diabetes Mellitus, Type 1
Diabetes Mellitus
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 16, 2013