Comparison of NN1250 With Insulin Glargine Plus Insulin Aspart With/Without Metformin and With/Without Pioglitazone in Type 2 Diabetes (BEGIN™)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Novo Nordisk

ClinicalTrials.gov Identifier:

NCT00972283

First received: September 3, 2009

Last updated: December 6, 2011

Last verified: December 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

September 3, 2009

Last Updated Date

December 6, 2011

Start Date ^ICMJE

September 2009

Primary Completion Date

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

Current Primary Outcome Measures ^ICMJE

HbA1c change from baseline [ Time Frame: after 52 weeks treatment ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00972283 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Hypoglycaemic episodes [ Time Frame: after 52 weeks treatment ] [ Designated as safety issue: No ]
Plasma glucose profiles [ Time Frame: after 52 weeks 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 Plus Insulin Aspart With/Without Metformin and With/Without Pioglitazone in Type 2 Diabetes

Official Title ^ICMJE

A 52-week Randomised, Controlled, Open Label, Multicentre, Multinational Treat-to-target Trial Comparing Efficacy and Safety of NN1250 and Insulin Glargine Both Administered Once Daily in a Basal-bolus Regimen With Insulin Aspart as Mealtime Insulin ± Treatment With Metformin, ± Pioglitazone in Subjects With Type 2 Diabetes Currently Treated With Insulin Qualifying for Intensified Treatment (BEGIN™: BB)

Brief Summary

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

The aim of this clinical trial is to compare NN1250 with insulin glargine plus insulin aspart with/without metformin and with/without pioglitazone in subjects with type 2 diabetes.

All oral anti-diabetic drug (OAD) treatment will be discontinued, if applicable, when trial participant enters the trial with the exception of metformin and pioglitazone.

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 2

Intervention ^ICMJE

Drug: NN1250
NN1250 injected subcutaneously (under the skin) in connection with main evening meal. The dose will be adjusted individually.
Drug: insulin glargine
Insulin glargine injected according to approved label. The dose will be adjusted individually.
Drug: insulin aspart
Insulin aspart injected subcutaneously (under the skin) at each main meal. The dose will be adjusted individually.

Study Arm (s)

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

Publications *

Garber AJ, King AB, Del Prato S, Sreenan S, Balci MK, Muñoz-Torres M, Rosenstock J, Endahl LA, Francisco AM, Hollander P; NN1250-3582 (BEGIN BB T2D) Trial Investigators. Insulin degludec, an ultra-longacting basal insulin, versus insulin glargine in basal-bolus treatment with mealtime insulin aspart in type 2 diabetes (BEGIN Basal-Bolus Type 2): a phase 3, randomised, open-label, treat-to-target non-inferiority trial. Lancet. 2012 Apr 21;379(9825):1498-507.

* 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

1006

Completion Date

October 2010

Primary Completion Date

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

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Type 2 diabetes mellitus for at least 6 months
Ongoing daily treatment with insulin (premix, self-mix, basal only, basal bolus) for at least 3 months with/without OAD (oral anti-diabetics drug) prior to trial start
HbA1c 7.0 - 10.0 % (both inclusive)
BMI below or equal to 40.0 kg/m2

Exclusion Criteria:

Treatment with other insulin regimens than premix, self-mix, basal only, basal bolus within 3 months
Cardiovascular disease within the last 6 months
Uncontrolled treated/untreated severe hypertension
Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures
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, Bulgaria, Germany, Hong Kong, Ireland, Italy, Romania, Russian Federation, Slovakia, South Africa, Spain, Turkey

Administrative Information

NCT Number ^ICMJE

NCT00972283

Other Study ID Numbers ^ICMJE

NN1250-3582, 2008-005777-35, U1111-1111-8648

Has Data Monitoring Committee

Responsible Party

Novo Nordisk

Study Sponsor ^ICMJE

Novo Nordisk

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Malene Bording Krüger, B.Sc

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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