CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 182 enrolled
Drug / intervention
insulin degludec/insulin aspart +3 moredrug
Likely dose
metformin 2000 mgfrom 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/NCT00613951
NCT00613951Phase 2Completed
CompareCT.gov

A 16 Week Randomised, Open Labelled, 3-armed, Parallel Group, Treat-to-target Trial Comparing Twice Daily (BID) Injections of SIAC 30 (B), SIAC 45 (B) and NovoMix®30, All in Combination With Metformin in Subjects With Type 2 Diabetes Failing on OAD Treatment

Novo Nordisk A/S·interventional·Posted Feb 13, 2008·Updated Mar 20, 2017

In Brief

A Phase 2 clinical trial evaluating insulin degludec/insulin aspart, biphasic insulin aspart, and 1 other intervention for Diabetes and Diabetes Mellitus, Type 2. Completed, enrolled 182 participants across 31 sites in 5 countries.

Detailed Summary

This trial is conducted in Europe. The aim of this trial is to compare two NN5401 (Soluble Insulin Analogue Combination \[SIAC\], insulin degludec/insulin aspart) formulations with each other and with biphasic insulin aspart 30, all in combination with metformin in insulin naive subjects with type 2 diabetes.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes, Diabetes Mellitus, Type 2
CountriesFinland, France, Germany, Poland, Spain
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 13, 2008
Enrollment StartJan 1, 2008
Primary CompletionAug 1, 2008
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 18.4 years ago

Interventions

insulin degludec/insulin aspartdrug

Formulation B: Treat-to-target dose titration scheme, injection s.c., twice daily

insulin degludec/insulin aspartdrug

Formulation B: Treat-to-target dose titration scheme, injection s.c., twice daily

biphasic insulin aspartdrug

Treat-to-target dose titration scheme, injection s.c., twice daily

metformindrug

Tablets, 1500-2000 mg/daily