At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 394 enrolled
Drug / intervention
insulin degludec/insulin aspartdrug
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.
A 26-week, Randomised, Open-label, Multinational, Treat-to-target Trial Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart (IDegAsp) Twice Daily (BID) and BIAsp 30 BID Both With Metformin in Insulin naïve Subjects With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin Monotherapy or Metformin in Combination With One Additional Oral Antidiabetic Drug (OAD)
In Brief
A Phase 3 clinical trial evaluating insulin degludec/insulin aspart for Diabetes and Diabetes Mellitus, Type 2. Completed, enrolled 394 participants across 49 sites in 10 countries.
Detailed Summary
This trial is conducted in Africa, Asia and Europe. The aim of the trial is to compare the efficacy and safety of insulin degludec/insulin aspart and BIAsp 30 (biphasic insulin aspart 30) in insulin naïve subjects with type 2 diabetes.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes, Diabetes Mellitus, Type 2
CountriesAlgeria, Bulgaria, Croatia, Czechia, Germany, Poland, Romania, Slovakia, Turkey (Türkiye), Ukraine
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartJan 2012
First PostedJan 2012
Primary CompletionNov 2012
TodayJul 2026
First PostedJan 20, 2012
Enrollment StartJan 16, 2012
Primary CompletionNov 19, 2012
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 14.5 years ago
Interventions
insulin degludec/insulin aspartdrug
Administered s.c. (under the skin) twice daily. Dose individually adjusted. Pre-trial metformin treatment to be continued.