Comparison of NN1250 With Insulin Glargine in Type 1 Diabetes (BEGIN™)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Novo Nordisk

ClinicalTrials.gov Identifier:

NCT01079234

First received: March 2, 2010

Last updated: December 8, 2011

Last verified: December 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

March 2, 2010

Last Updated Date

December 8, 2011

Start Date ^ICMJE

March 2010

Primary Completion Date

November 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01079234 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Comparison of NN1250 With Insulin Glargine in Type 1 Diabetes

Official Title ^ICMJE

A 26-week Trial Investigating the Dosing Flexibility, Efficacy and Safety of NN1250 in Subjects With Type 1 Diabetes - With a 26 Week Extension

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Diabetes Mellitus, Type 1

Intervention ^ICMJE

Drug: NN1250
NN1250 injected subcutaneously (under the skin) once daily (alternative regimens)
Drug: insulin glargine
Insulin glargine injected subcutaneously (under the skin) once daily
Drug: NN1250
NN1250 injected subcutaneously (under the skin) once daily
Drug: insulin aspart
At least three daily doses at meal-time

Study Arm (s)

Experimental: A
Interventions:
- Drug: NN1250
- Drug: insulin aspart
Active Comparator: B
Interventions:
- Drug: insulin glargine
- Drug: insulin aspart
Experimental: C
Interventions:
- Drug: NN1250
- Drug: insulin aspart

Publications *

Mathieu C, Hollander P, Miranda-Palma B, Cooper J, Franek E, Russell-Jones D, Larsen J, Tamer SC, Bain SC; NN1250-3770 (BEGIN: Flex T1) Trial Investigators. Efficacy and safety of insulin degludec in a flexible dosing regimen vs insulin glargine in patients with type 1 diabetes (BEGIN: Flex T1): a 26-week randomized, treat-to-target trial with a 26-week extension. J Clin Endocrinol Metab. 2013 Mar;98(3):1154-62. doi: 10.1210/jc.2012-3249. Epub 2013 Feb 7.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

493

Completion Date

May 2011

Primary Completion Date

November 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Belgium, Germany, Norway, Poland, United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT01079234

Other Study ID Numbers ^ICMJE

NN1250-3770, U1111-1112-8813, 2009-012923-27

Has Data Monitoring Committee

Responsible Party

Novo Nordisk

Study Sponsor ^ICMJE

Novo Nordisk

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Anette Skov Pedersen

Novo Nordisk

Information Provided By

Novo Nordisk

Verification Date

December 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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