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Clinical Trials/NCT01059812
NCT01059812
Completed
Phase 3

A Pan Asian Trial Comparing Efficacy and Safety of NN5401 and Biphasic Insulin Aspart 30 in Type 2 Diabetes (BOOST™: INTENSIFY ALL)

Novo Nordisk A/S1 site in 1 country424 target enrollmentFebruary 1, 2010
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ConditionsDiabetesDiabetes Mellitus, Type 2
Interventionsinsulin degludec/insulin aspartbiphasic insulin aspart 30
Drugsinsulin degludec/insulin aspartbiphasic insulin aspart 30

Overview

Phase
Phase 3
Intervention
insulin degludec/insulin aspart
Conditions
Diabetes
Sponsor
Novo Nordisk A/S
Enrollment
424
Locations
1
Primary Endpoint
Change in HbA1c (Glycosylated Haemoglobin) After 26 Weeks of Treatment
Status
Completed
Last Updated
7 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

Brief Summary

This trial is conducted in Asia. The aim of this clinical trial is to compare NN5401 (insulin degludec/insulin aspart (IDegAsp)) with biphasic insulin aspart (BIAsp) 30 in patients with type 2 diabetes not optimally controlled on once or twice daily insulin with or without metformin.

Registry
clinicaltrials.gov
Start Date
February 1, 2010
End Date
December 23, 2010
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Male or female at least 18 years of age (at least 20 years for Japan)
  • •Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months
  • •Subject on basal human or analogue insulin, once daily (OD) or twice daily (BID) with or without metformin for at least 3 months or subject on premixed human or analogue insulin or self-mixed insulin regimen, containing 20-40% fast/rapid-acting component, OD or BID, with or without metformin, for at least 3 months
  • •HbA1c 7.0-10.0 % (both inclusive) by central laboratory analysis
  • •Body mass index (BMI) maximum 35.0 kg/m\^2

Exclusion Criteria

  • •Treatment with oral antidiabetic drugs (OADs) (except metformin) within the last 8 weeks prior to Visit 1
  • •Treatment with thiazolidinediones (TZDs) or glucagon like peptide 1 (GLP-1) receptor agonists within 3 months prior to Visit 1
  • •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
  • •Uncontrolled treated/untreated severe hypertension (systolic blood pressure at least 180 millimetre (mm) mercury (Hg) and/or diastolic blood pressure at least 100 mmHg)
  • •Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
  • •Cancer and medical history of cancer (except basal cell skin cancer or squamous cell skin cancer)

Arms & Interventions

IDegAsp BID

Intervention: insulin degludec/insulin aspart

BIAsp 30 BID

Intervention: biphasic insulin aspart 30

Outcomes

Primary Outcomes

Change in HbA1c (Glycosylated Haemoglobin) After 26 Weeks of Treatment

Time Frame: Week 0, Week 26

Change from baseline in HbA1c after 26 weeks of treatment.

Secondary Outcomes

  • Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 26(Week 26)
  • Rate of Confirmed Hypoglycaemic Episodes(Week 0 to Week 26 + 7 days follow up)
  • Change in Body Weight(Week 0, Week 26)
  • Rate of Nocturnal Confirmed Hypoglycaemic Episodes(Week 0 to Week 26 + 7 days follow up)

Study Sites (1)

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