CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 530 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/NCT01045707
NCT01045707Phase 3Completed
CompareCT.gov

NN5401-3590: A Trial Comparing Efficacy and Safety of NN5401 With Insulin Glargine in Insulin Naive Subjects With Type 2 Diabetes (BOOST™ : START 1) / NN5401-3726: An Extension Trial Comparing Safety and Efficacy of NN5401 With Insulin Glargine in Subjects With Type 2 Diabetes (BOOST™: START 1)

Novo Nordisk A/S·interventional·Posted Jan 11, 2010·Updated Dec 8, 2016

In Brief

A Phase 3 clinical trial evaluating insulin degludec/insulin aspart and insulin glargine for Diabetes and Diabetes Mellitus, Type 2. Completed, enrolled 530 participants across 92 sites in 9 countries.

Detailed Summary

This trial is conducted in Asia, Europe and the United States of America (USA). The aim of this trial is to compare the efficacy and safety of NN5401 (insulin degludec/insulin aspart (IDegAsp)) with insulin glargine (IGlar), both as add-on to subject's ongoing treatment with metformin + at least one OAD (oral anti-diabetic drug). The main period is registered internally at Novo Nordisk as NN5401-3590 while the extension period is registered as NN5401-3726.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes, Diabetes Mellitus, Type 2
CountriesAustria, India, Poland, Puerto Rico, Russia, South Korea, Spain, Turkey (Türkiye), United States
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 11, 2010
Enrollment StartJan 1, 2010
Primary CompletionOct 1, 2010
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 16.5 years ago

Interventions

insulin degludec/insulin aspartdrug

Injected s.c. (under the skin) once daily with the breakfast meal. Dose was individually adjusted.

insulin glarginedrug

Injected s.c. (under the skin) once daily. Dose was individually adjusted.