CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 447 enrolled
Drug / intervention
insulin degludec/insulin aspart +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01009580
NCT01009580Phase 3Completed
CompareCT.gov

A 26-week, Randomised, Open-labelled, Two-arm, Parallel-group, Treat-to-target Trial Comparing Efficacy and Safety of Soluble Insulin Analogue Combination (SIAC) Twice Daily (BID) With Biphasic Insulin Aspart (BIAsp) 30 BID, With or Without Metformin, With or Without DPP-4 Inhibitor, With or Without Pioglitazone in Subjects With Type 2 Diabetes in Inadequate Glycaemic Control on Once or Twice Daily Premixed or Self-mixed Insulin Regimen With or Without OADs (BOOST™: Intensify Premix 1)

Novo Nordisk A/S·interventional·Posted Nov 6, 2009·Updated Dec 19, 2018

In Brief

A Phase 3 clinical trial evaluating insulin degludec/insulin aspart and biphasic insulin aspart 30 for Diabetes and Diabetes Mellitus, Type 2. Completed, enrolled 447 participants across 53 sites in 10 countries.

Detailed Summary

This trial is conducted in Asia, Europe and Oceania. The aim of this clinical trial is to compare NN5401 (insulin degludec/insulin aspart) with biphasic insulin aspart 30 in subjects with type 2 diabetes.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes, Diabetes Mellitus, Type 2
CountriesAustralia, Denmark, Finland, India, Malaysia, Poland, Sweden, Taiwan, Thailand, Turkey (Türkiye)
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 6, 2009
Enrollment StartNov 5, 2009
Primary CompletionAug 23, 2010
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 16.7 years ago

Interventions

insulin degludec/insulin aspartdrug

Injected s.c. (under the skin) with the breakfast meal and main evening meal. The dose were individually adjusted. Subjects continued their pre-trial OADs (oral antidiabetic drug(s)) treatment of Metformin, the specific DPP-4 Inhibitor and Pioglitazone.

biphasic insulin aspart 30drug

Injected s.c. (under the skin) with the breakfast meal and main evening meal. The dose were individually adjusted. Subjects continued their pre-trial OADs (oral antidiabetic drug(s)) treatment of Metformin, the specific DPP-4 Inhibitor and Pioglitazone.