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Comparison of NN1250 With Insulin Glargine in Subjects With Type 2 Diabetes (BEGIN™)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01068678
First received: February 12, 2010
Last updated: September 22, 2011
Last verified: September 2011
History of Changes

February 12, 2010
September 22, 2011
February 2010
November 2010   (final data collection date for primary outcome measure)
HbA1c change from baseline [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01068678 on ClinicalTrials.gov Archive Site
Body weight change from baseline [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Comparison of NN1250 With Insulin Glargine in Subjects With Type 2 Diabetes
A Trial Comparing Efficacy and Safety of NN1250 and Insulin Glargine in Subjects With Type 2 Diabetes (BEGIN™: EASY AM)

This trial will be conducted in Africa, Asia, Europe, and North America. The aim of this clinical trial is to compare NN1250 with insulin glargine in subjects with type 2 diabetes currently treated with metformin alone or with metformin combined with an oral anti-diabetic drug (OAD) qualifying for intensified treatment.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: NN1250
    NN1250 will be injected subcutaneously (under the skin) three times weekly. The dose will be individually adjusted.
  • Drug: insulin glargine
    Insulin glargine will be injected subcutaneously (under the skin) once daily. The dose will be individually adjusted.
  • Experimental: A
    Intervention: Drug: NN1250
  • Active Comparator: B
    Intervention: Drug: insulin glargine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
460
November 2010
November 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Insulin naïve subjects
  • Currently treated with metformin alone or metformin combined with OADs (oral anti-diabetic drugs): insulin secretagogue (sulfonylurea (SU) or glinide), insulin DPP-4 inhibitor, a-glucosidase-inhibitor with unchanged dosing for at least three months prior to trial start
  • HbA1c: 7.0-10.0 % (both inclusive)
  • BMI (Body Mass Index) below or equal to 45.0 kg/m2

Exclusion Criteria:

  • Treatment with thiazoledinediones, exenatide or liraglutide within the last 3 months before trial start
  • Cardiovascular disease within the last 6 months prior to trial start
  • Uncontrolled treated/untreated severe hypertension
  • Pregnant, breast-feeding, intention of becoming pregnant or not using adequate contraceptive methods
  • Cancer and medical history of cancer
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Czech Republic,   Israel,   Puerto Rico,   Slovakia,   South Africa,   United Kingdom
 
NCT01068678
NN1250-3724, 2009-011398-33, U1111-1113-2412
No
Novo Nordisk
Novo Nordisk
Not Provided
Study Director: Dorthe Lyngsoe Vuylsteke Novo Nordisk
Novo Nordisk
September 2011

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