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


Tracking Information

Start Date  ICMJENovember 2009
Estimated Primary Completion DateSeptember 2010   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: October 30, 2009)		HbA1c change from baseline [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]
Original Primary Outcome Measures  ICMJESame as current
Change HistoryComplete list of historical versions of study NCT01006291 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: October 30, 2009)
  • 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 ]
Original Secondary Outcome Measures  ICMJESame as current

Descriptive Information

Brief Title  ICMJEComparison of NN1250 With Insulin Glargine in Type 2 Diabetes
Official Title  ICMJEA 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
Brief Summary

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.

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Condition  ICMJEDiabetes Mellitus, Type 2
Intervention  ICMJE
  • 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
Study Arms / Comparison Groups
  • A: Experimental
    Intervention: Drug: NN1250
  • B: Experimental
    Intervention: Drug: NN1250
  • C: Active Comparator
    Intervention: Drug: insulin glargine

Recruitment Information

Estimated Enrollment  ICMJE675
Estimated Completion DateSeptember 2010
Estimated Primary Completion DateSeptember 2010   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
GenderBoth
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Public Access to Clinical Trials - Novo NordiskPlease Contact NN via emailclinicaltrials@novonordisk.com
Location Countries  ICMJEArgentina,   Finland,   Hungary,   India,   Israel,   Macedonia, The Former Yugoslav Republic of,   Malaysia,   Mexico,   Norway,   Russian Federation,   Serbia,   South Africa,   Taiwan,   United Kingdom

Administrative Information

NCT ID  ICMJENCT01006291
Responsible PartyPublic Access to Clinical Trials, Novo Nordisk A/S
Study ID Numbers  ICMJENN1250-3668, UTN: U1111-1111-7084, EudraCT No: 2008-005771-10
Study Sponsor  ICMJENovo Nordisk
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Lise Brandt, MSc.PhD.Novo Nordisk
Information Provided ByNovo Nordisk