CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 335 enrolled
Drug / intervention
biphasic insulin aspart 30 +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/NCT02453685
NCT02453685Phase 4Completed
CompareCT.gov

A 32-week Randomised, Multinational, Treat-to-target, Open Label, Parallel Group Comparison of Stepwise Insulin Intensification of Biphasic Insulin Aspart (BIAsp) 30 and Basal-bolus Therapy With Insulin Glargine and Insulin Aspart in Insulin naïve Type 2 Diabetic Patients Inadequately Controlled on Oral Anti-diabetic Therapy

Novo Nordisk A/S·interventional·Posted May 25, 2015·Updated Feb 8, 2019

In Brief

A Phase 4 clinical trial evaluating biphasic insulin aspart 30, insulin glargine, and 1 other intervention for Diabetes and Diabetes Mellitus, Type 2. Completed, enrolled 335 participants across 41 sites in 9 countries.

Detailed Summary

This trial is conducted globally. The aim of this trial is to compare stepwise insulin intensification of biphasic insulin aspart (BIAsp) 30 and basal-bolus therapy with insulin glargine and insulin aspart in insulin naïve type 2 diabetic patients inadequately controlled on oral anti-diabetic therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes, Diabetes Mellitus, Type 2
CountriesAustralia, Bulgaria, Hungary, India, Serbia, South Korea, Thailand, Turkey (Türkiye), United Arab Emirates
Collaborators--

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 25, 2015
Enrollment StartAug 31, 2015
Primary CompletionSep 20, 2016
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 11.1 years ago

Interventions

biphasic insulin aspart 30drug

Injected s.c./subcutaneously once daily with the largest meal Subjects should continue their pre-trial metformin and sulfonylurea dosages all throughout the trial while other oral antidiabetic drugs will be discontinued.

insulin glarginedrug

Injected s.c./subcutaneously once daily at the same time every day, with the possibility of treatment intensification with insulin aspart (Basal-bolus arm) Subjects should continue their pre-trial metformin and sulfonylurea dosages all throughout the trial while other oral antidiabetic drugs will be discontinued.

insulin aspartdrug

Injected s.c./subcutaneously once daily.