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Comparison of NN5401 With Insulin Glargine in Insulin Naive Subjets With Type 2 Diabetes (BOOST™)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01272193
First received: January 6, 2011
Last updated: January 17, 2012
Last verified: January 2012
History of Changes

January 6, 2011
January 17, 2012
January 2011
September 2011   (final data collection date for primary outcome measure)
Change from baseline in HbA1c (glycosylated haemoglobin A1c) [ Time Frame: Week 0, week 26 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01272193 on ClinicalTrials.gov Archive Site
  • Prandial plasma glucose (PG) increment at dinner of the day (90 min. after start of dinner as measured by self-monitored plasma glucose (SMPG) [ Time Frame: Week 0, week 26 ] [ Designated as safety issue: No ]
  • Change from baseline in body weight [ Time Frame: Week 0, week 26 ] [ Designated as safety issue: No ]
  • Number of hypoglycaemic episodes [ Time Frame: Weeks 0-26 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Comparison of NN5401 With Insulin Glargine in Insulin Naive Subjets With Type 2 Diabetes
A Trial Comparing Efficacy and Safety of NN5401 With Insulin Glargine in Insulin Naive Subjects With Type 2 Diabetes (BOOST™: JAPAN)

This trial is conducted in Japan. The aim of the trial is to investigate the efficacy and safety of NN5401 with insulin glargine in subjects with type 2 diabetes in Japan. Depending on pre-trial OADs, subjects will continue at the same dose and dosing frequency.
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: NN5401
    Individually adjusted NN5401 injected subcutaneously (under the skin) once daily prior to the largest meal of the day as monotherapy or combined with no more than 2 oral anti-diabetic drugs (OADs).
  • Drug: insulin glargine
    Individually adjusted insulin glargine administered according to approved labelling either as monotherapy or combined with no more than 2 OADs.
  • Experimental: A
    Intervention: Drug: NN5401
  • 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
296
September 2011
September 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months
  • HbA1c 7.0-10.0% (both inclusive)
  • BMI below or equal to 35.0 kg/m^2
  • Insulin naive subject and ongoing treatment with 1 or more OADs for at least 12 weeks prior to randomisation (visit 2/week 0) with at least recommended maintenance dose according to local, approved labelling.

Exclusion Criteria:

  • Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers, MAO (Mono Amino Oxidase) inhibitors
  • Use of glucagon-like peptide-1 (GLP-1) receptor agonists, buformine and/or rosiglitazone within the last 12 weeks prior to randomisation (visit 2/week 0)
  • Cardiovascular disease within the last 6 months prior to screening (visit 1)
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01272193
NN5401-3896, U1111-1118-0124, 111385
No
Novo Nordisk
Novo Nordisk
Not Provided
Study Director: Camilla Møntegaard Novo Nordisk
Novo Nordisk
January 2012

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