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 A/S
ClinicalTrials.gov Identifier:
NCT01272193
First received: January 6, 2011
Last updated: November 21, 2013
Last verified: November 2013

January 6, 2011
November 21, 2013
January 2011
September 2011   (final data collection date for primary outcome measure)
Change in Glycosylated Haemoglobin (HbA1c) [ Time Frame: Week 0, Week 26 ] [ Designated as safety issue: No ]
Change from baseline in HbA1c (glycosylated haemoglobin A1c) [ Time Frame: Week 0, week 26 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01272193 on ClinicalTrials.gov Archive Site
  • Mean Increment of 9-point Self Measured Plasma Glucose Profile (SMPG) at the Main Evening Meal [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
  • Rate of Treatment Emergent Adverse Events (AEs) [ Time Frame: Week 0 to Week 26 + 7 days follow up ] [ Designated as safety issue: No ]
  • Rate of Confirmed Hypoglycaemic Episodes [ Time Frame: Week 0 to Week 26 + 7 days follow up ] [ Designated as safety issue: No ]
  • Rate of Nocturnal Confirmed Hypoglycaemic Episodes [ Time Frame: Week 0 to Week 26 + 7 days follow up ] [ Designated as safety issue: No ]
  • Change in Body Weight [ Time Frame: Week 0, Week 26 ] [ Designated as safety issue: No ]
  • 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 ]
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 Insulin Degludec/Insulin Aspart With Insulin Glargine in Insulin Naive Subjects With Type 2 Diabetes (BOOST™: JAPAN)

This trial is conducted in Japan. The aim of this trial is to investigate the efficacy and safety of NN5401 (insulin degludec/insulin aspart) with insulin glargine in subjects with type 2 diabetes in Japan. Depending on pre-trial oral anti-diabetic drugs (OADs), subjects continued 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
  • Diabetes Mellitus, Type 2
  • Drug: insulin degludec/insulin aspart
    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
    Administered according to approved labelling either as monotherapy or combined with no more than 2 OADs.
  • Experimental: IDegAsp OD
    Intervention: Drug: insulin degludec/insulin aspart
  • Active Comparator: IGlar OD
    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) by central laboratory analysis
  • Body Mass Index (BMI) below or equal to 35.0 kg/m^2
  • Insulin naive subject and ongoing treatment with 1 or more oral antidiabetic drugs (OADs) for at least 12 weeks prior to randomisation with at least recommended maintenance dose according to local, approved labelling Allowed are: a. Previous short term insulin treatment up to 14 days; b. Treatment during hospitalization or during gestational diabetes is allowed for periods longer than 14 days)

Exclusion Criteria:

  • Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers, mono amino oxidase (MAO) inhibitors
  • Use of glucagon-like peptide-1 (GLP-1) receptor agonists, buformine and/or rosiglitazone within the last 12 weeks prior to randomisation
  • Cardiovascular disease, within the last 6 months prior to Visit 1, defined as: stroke; decompensated heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01272193
NN5401-3896, U1111-1118-0124, JapicCTI-111385
No
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Camilla Møntegaard Novo Nordisk A/S
Novo Nordisk A/S
November 2013

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