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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01006291
First received: October 30, 2009
Last updated: September 20, 2011
Last verified: September 2011
History of Changes

October 30, 2009
September 20, 2011
November 2009
September 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 NCT01006291 on ClinicalTrials.gov Archive Site
  • Hypoglycaemic episodes [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]
  • Self-measured 9-point plasma glucose profiles [ 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 ]
  • Plasma glucose profiles [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Comparison of NN1250 With Insulin Glargine in Type 2 Diabetes
A 26 Week Randomised, Controlled, Open Label, Multicentre, Multinational, Three-arm, Treat-to-target Trial Comparing Efficacy and Safety of Three Different Dosing Regimens of Either NN1250 or Insulin Glargine With or Without Combination With OAD Treatment, in Subjects With Type 2 Diabetes Mellitus (BEGIN™ : FLEX)

This trial is conducted in Africa, Asia, Europe and South America. The aim of this clinical trial is to compare NN1250 with insulin glargine in patients with type 2 diabetes.
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 injected s.c. (under the skin) once daily. The doses will be individually adjusted
  • Drug: NN1250
    NN1250 injected s.c. (under the skin) once daily (alternative regimen). The doses will be individually adjusted.
  • Drug: insulin glargine
    Insulin glargine injected s.c. (under the skin) once daily.The dose will be individually adjusted
  • Experimental: A
    Intervention: Drug: NN1250
  • Experimental: B
    Intervention: Drug: NN1250
  • Active Comparator: C
    Intervention: Drug: insulin glargine
Meneghini L, Atkin SL, Gough SC, Raz I, Blonde L, Shestakova M, Bain S, Johansen T, Begtrup K, Birkeland KI; NN1250-3668 (BEGIN FLEX) Trial Investigators. The efficacy and safety of insulin degludec given in variable once-daily dosing intervals compared with insulin glargine and insulin degludec dosed at the same time daily: a 26-week, randomized, open-label, parallel-group, treat-to-target trial in individuals with type 2 diabetes. Diabetes Care. 2013 Apr;36(4):858-64. doi: 10.2337/dc12-1668. Epub 2013 Jan 22.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
687
September 2010
September 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Type 2 diabetes mellitus for at least 6 months
  • Currently treated with oral antidiabetic drugs, treated with insulin or a combination of oral antidiabetic drugs and insulin for at least 3 months
  • For patients currently treated with oral antidiabetic drug: HbA1c 7-11%
  • For patients currently treated with insulin: HbA1c 7-10%
  • Body Mass Index (BMI) below or equal to 40.0 kg/m2

Exclusion Criteria:

  • Use GLP-1 receptor agonist (exenatide, liraglutide), rosiglitazone, DPP-IV inhibitors, a-glucosidase-inhibitors within the last 3 months prior to trial start
  • 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 hereof
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Finland,   Hungary,   India,   Israel,   Macedonia, The Former Yugoslav Republic of,   Malaysia,   Mexico,   Norway,   Russian Federation,   Serbia,   South Africa,   Taiwan,   United Kingdom
 
NCT01006291
NN1250-3668, U1111-1111-7084, 2008-005771-10
No
Novo Nordisk
Novo Nordisk
Not Provided
Study Director: Lise Brandt, MSc.PhD. Novo Nordisk
Novo Nordisk
September 2011

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