CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 66 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/NCT00842361
NCT00842361Phase 2Completed
CompareCT.gov

A 6-week, Randomised, Multi-centre, Open-labelled, Parallel Group, Exploratory Trial to Investigate the Safety of SIAC Compared to Mix30 (NovoRapid®30Mix) on a Twice Daily Regimen in Subjects With Type 2 Diabetes Mellitus

Novo Nordisk A/S·interventional·Posted Feb 12, 2009·Updated Feb 9, 2017

In Brief

A Phase 2 clinical trial evaluating insulin degludec/insulin aspart and biphasic insulin aspart 30 for Diabetes and Diabetes Mellitus, Type 2. Completed, enrolled 66 participants across 8 sites.

Detailed Summary

This trial is conducted in Japan. The aim of this clinical trial is to investigate the safety (with emphasis on hypoglycaemia) after switching from long-acting insulin analogue/intermediate-acting insulin or pre-mixed insulin/pre-mixed insulin analogue on a twice daily regimen to NN5401 (SIAC, insulin degludec/insulin aspart) on a twice daily regimen in subjects with type 2 diabetes mellitus.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes, Diabetes Mellitus, Type 2
CountriesJapan
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 12, 2009
Enrollment StartJan 1, 2009
Primary CompletionJun 1, 2009
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 17.4 years ago

Interventions

insulin degludec/insulin aspartdrug

The insulin NN5401 (insulin degludec/insulin aspart) injected subcutaneously immediately before breakfast and dinner.

biphasic insulin aspart 30drug

The insulin (biphasic insulin aspart 30) injected subcutaneously immediately before breakfast and dinner.