Comparison of Two NN1250 Formulations Versus Insulin Glargine, All in Combination With Insulin Aspart in Subjects With Type 1 Diabetes - Full Text View

Purpose

This trial is conducted in Europe, Oceania and the United States of America (USA).

The aim of the trial is to compare two NN1250 formulations with each other and with insulin glargine, all in combination with insulin aspart in subjects with type 1 diabetes

Condition	Intervention	Phase
Diabetes Mellitus, Type 1	Drug: insulin aspart Drug: insulin glargine Drug: NN1250	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Safety and Efficacy Comparison of Two NN1250 Formulations Versus Insulin Glargine All in Combination With Insulin Aspart in Subjects With Type 1 Diabetes, Measured by HbA1c After 16 Weeks of Treatment

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 Insulin glargine

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

HbA1c [ Time Frame: After 16 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Plasma glucose profiles [ Time Frame: For the duration of the trial ] [ Designated as safety issue: No ]
Incidence of hypoglycaemic episodes [ Time Frame: For the duration of the trial ] [ Designated as safety issue: Yes ]
Frequency and severity of adverse events [ Time Frame: For the duration of the trial ] [ Designated as safety issue: Yes ]
Laboratory safety parameters [ Time Frame: For the duration of the trial ] [ Designated as safety issue: Yes ]
Physical examination and vital signs [ Time Frame: For the duration of the trial ] [ Designated as safety issue: Yes ]

Enrollment:	178
Study Start Date:	January 2008
Study Completion Date:	June 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A	Drug: insulin aspart Treat-to-target dose titration scheme, injection s.c., 3 times daily Other Name: NovoRapid® Drug: NN1250 Formulation 1: Treat-to-target dose titration scheme, injection s.c., once daily
Experimental: B	Drug: insulin aspart Treat-to-target dose titration scheme, injection s.c., 3 times daily Other Name: NovoRapid® Drug: NN1250 Formulation 2: Treat-to-target dose titration scheme, injection s.c., once daily
Active Comparator: C	Drug: insulin aspart Treat-to-target dose titration scheme, injection s.c., 3 times daily Other Name: NovoRapid® Drug: insulin glargine Treat-to-target dose titration scheme, injection s.c., once daily

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Type 1 diabetes for at least one year
HbA1c between 7.0% and 11.0% (both inclusive)
Treated with insulin for at least six months - any regimen

Exclusion Criteria:

Any systemic treatment with products which in the investigator's opinion could interfere with glucose or lipid metabolism (e.g. systemic corticosteroids) three months prior to randomisation
Any disease or condition which according to the investigator would interfere with the trial

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00612040

Locations

United States, Hawaii
Novo Nordisk Clinical Trial Call Center
Honolulu, Hawaii, United States, 96814
United States, Iowa
Novo Nordisk Clinical Trial Call Center
Des Moines, Iowa, United States, 50314
United States, Maryland
Novo Nordisk Clinical Trial Call Center
Hyattsville, Maryland, United States, 20782
United States, Tennessee
Novo Nordisk Clinical Trial Call Center
Chattanooga, Tennessee, United States, 37404
United States, Texas
Novo Nordisk Clinical Trial Call Center
Dallas, Texas, United States, 75230
United States, Washington
Novo Nordisk Clinical Trial Call Center
Renton, Washington, United States, 98057
Australia

Miranda, Australia, 2228
Germany

Hamburg, Germany, 22607
Norway

Elverum, Norway, 2408
Sweden

Stockholm, Sweden, 112 81

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Benedikte J. Lertoft, DVM

Novo Nordisk

More Information

Additional Information:

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

No publications provided by Novo Nordisk

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Birkeland KI, Home PD, Wendisch U, Ratner RE, Johansen T, Endahl LA, Lyby K, Jendle JH, Roberts AP, DeVries JH, Meneghini LF. Insulin degludec in type 1 diabetes: a randomized controlled trial of a new-generation ultra-long-acting insulin compared with insulin glargine. Diabetes Care. 2011 Mar;34(3):661-5. Epub 2011 Jan 26.

Responsible Party:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00612040 History of Changes
Other Study ID Numbers:	NN1250-1835, 2007-002474-60
Study First Received:	January 25, 2008
Last Updated:	September 22, 2011
Health Authority:	United States: Food and Drug Administration Australia: Department of Health and Ageing Therapeutic Goods Administration Norway: Norwegian Medicines Agency Sweden: Medical Products Agency 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
Glargine
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013