CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 274 enrolled
Drug / intervention
insulin degludec/insulin aspart +2 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/NCT01713530
NCT01713530Phase 3Completed
CompareCT.gov

A 26-week Trial Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart BID and Insulin Degludec OD Plus Insulin Aspart in Subjects With Type 2 Diabetes Mellitus Treated With Basal Insulin in Need of Treatment Intensification With Mealtime Insulin

Novo Nordisk A/S·interventional·Posted Oct 24, 2012·Updated Apr 2, 2018

In Brief

A Phase 3 clinical trial evaluating insulin degludec/insulin aspart, insulin degludec, and 1 other intervention for Diabetes and Diabetes Mellitus, Type 2. Completed, enrolled 274 participants across 51 sites in 5 countries.

Detailed Summary

This trial is conducted in Africa, Europe and the United States of America (USA). The aim of the trial is to compare the difference in change in glycosylated haemoglobin (HbA1c) between insulin degludec/insulin aspart (IDegAsp) and/or oral anti-diabetic drugs (OADs) and insulin degludec (IDeg) plus insulin aspart (IAsp)and/or OADs.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes, Diabetes Mellitus, Type 2
CountriesAlgeria, Austria, France, Norway, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 24, 2012
Enrollment StartFeb 21, 2013
Primary CompletionJan 9, 2014
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 13.7 years ago

Interventions

insulin degludec/insulin aspartdrug

Dose individually adjusted. For subcutaneous (s.c, under the skin) administration twice a day.

insulin degludecdrug

Dose individually adjusted. For subcutaneous (s.c, under the skin) administration once daily.

insulin aspartdrug

Dose individually adjusted. For subcutaneous (s.c, under the skin) administration with the main meals 2-4 times daily in accordance with local labelling.