Comparison of NN5401 Versus Insulin Glargine, Both Combined With Metformin Treatment, in Subjects With Type 2 Diabetes (BOOST™)


Tracking Information

Start Date  ICMJEJanuary 2010
Estimated Primary Completion DateOctober 2010   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: January 8, 2010)		HbA1c change from baseline [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]
Original Primary Outcome Measures  ICMJESame as current
Change HistoryNo Changes Posted
Current Secondary Outcome Measures  ICMJE 
 (submitted: January 8, 2010)		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 NN5401 Versus Insulin Glargine, Both Combined With Metformin Treatment, in Subjects With Type 2 Diabetes
Official Title  ICMJEA Trial Comparing Efficacy and Safety of NN5401 With Insulin Glargine in Insulin Naive Subjects With Type 2 Diabetes
Brief Summary

This trial will be conducted in Asia, Europe and the United states of America (USA).

The aim of this clinical trial is to compare NN5401 with insulin glargine, as add-on to subject's ongoing treatment with metformin + at least one OAD (oral anti-diabetic drug) in subjects 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: NN5401
    NN5401 injected s.c. (under the skin) once daily with the breakfast meal. Dose will be individually adjusted.
  • Drug: insulin glargine
    Insulin glargine injected s.c. (under the skin) once daily. Dose will be individually adjusted.
Study Arms / Comparison Groups
  • A: Experimental
    Intervention: Drug: NN5401
  • B: Active Comparator
    Intervention: Drug: insulin glargine

Recruitment Information

Estimated Enrollment  ICMJE526
Estimated Completion DateOctober 2010
Estimated Primary Completion DateOctober 2010   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of type 2 diabetes mellitus for at least 6 months
  • Insulin naïve subjects
  • Treatment with metformin and at least one other oral antidiabetic drug for at least 3 months before trial start
  • HbA1c between 7.5 - 11.0% (both inclusive)
  • BMI (Body Mass Index) no higher than 40.0 kg/m2

Exclusion Criteria:

  • Treatment with GLP-1 receptor agonists and/or thiazolidinedione(s) within the last 3 months prior to trial start
  • Cardiovascular disease diagnosed within 6 months before trial start
GenderBoth
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Novo Nordisk Clinical Trial Call Center866-867-7178
Location Countries  ICMJEUnited States,   Austria,   India,   Korea, Republic of,   Poland,   Puerto Rico,   Russian Federation,   Spain,   Turkey

Administrative Information

NCT ID  ICMJENCT01045707
Responsible PartyPublic Access to Clinical Trials, Novo Nordisk A/S
Study ID Numbers  ICMJENN5401-3590, UTN: U1111-1111-7178, EudraCT No: 2009-011271-78
Study Sponsor  ICMJENovo Nordisk
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Lotte Askevig, M.Sc.PharmNovo Nordisk
Information Provided ByNovo Nordisk