Comparison of NN1250 With Insulin Glargine in Type 1 Diabetes - Full Text View

Sponsor:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT01079234

Purpose

This trial is conducted in Europe and in the United States of America (USA). The aim of the trial is to investigate the efficacy and safety of NN1250 in subjects with type 1 diabetes.

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Control: Active Control Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A 26-week Trial Investigating the Efficacy and Safety of Different Dosing Regimens in Subjects With Type 1 Diabetes

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 1

Drug Information available for: Insulin Insulin aspart Insulin glargine

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

HbA1c change from baseline [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in FPG (fasting plasma glucose) [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]
Hypoglycaemic episodes [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	486
Study Start Date:	March 2010
Estimated Study Completion Date:	May 2011
Estimated Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: NN1250 NN1250 injected subcutaneously (under the skin) once daily (alternative regimens) Drug: insulin aspart At least three daily doses at meal-time
B: Active Comparator	Drug: insulin glargine Insulin glargine injected subcutaneously (under the skin) once daily Drug: insulin aspart At least three daily doses at meal-time
C: Experimental	Drug: NN1250 NN1250 injected subcutaneously (under the skin) once daily Drug: insulin aspart At least three daily doses at meal-time

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Type 1 diabetes for 12 months or longer, hereof the last 3 months with injection based therapies
Current treatment with any basal insulin using one or two daily injections and with three or more daily meal-time insulin injections used as bolus insulin therapy
HbA1c below or equal to 10.0 %
BMI (Body Mass Index) below or equal to 35.0 kg/m2
Ability to self-manage insulin therapy of a changed insulin dose in the preceding two months prior to trial entry
Ability and willingness to adhere to the protocol including performance of SMPG (self-measured plasma glucose) profiles and self-adjustment of insulin doses

Exclusion Criteria:

Use of any antidiabetic glucose lowering drug other than insulin within the last 3 months prior to trial entry
Cardiovascular disease within the last 6 months prior to trial entry
Uncontrolled treated/untreated severe hypertension
Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate
Cancer and medical history of cancer

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01079234

Show 49 Study Locations

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Anette Skov Pedersen

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 A/S ( Public Access to Clinical Trials )
ClinicalTrials.gov Identifier:	NCT01079234 History of Changes
Other Study ID Numbers:	NN1250-3770, U1111-1112-8813, 2009-012923-27
Study First Received:	March 2, 2010
Last Updated:	July 12, 2010
Health Authority:	Belgium: Federal Agency for Medicines and Health Products; Germany: Federal Institute for Drugs and Medical Devices; Norway: Norwegian Medicines Agency; United Kingdom: Medicines and Healthcare Products Regulatory Agency; United States: Food and Drug Administration; Poland: The Drug Institute in Warsaw; Greece: Ministry of Health

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

Insulin, Asp(B28)-
Glargine
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 01, 2010