CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 344 enrolled
Drug / intervention
biphasic insulin aspart 30drug
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/NCT01618214
NCT01618214Phase 4Completed
CompareCT.gov

A 20-week, Randomised, Open-label, 2-armed, Parallel Group Comparison of Subject-driven Titration of Biphasic Insulin Aspart (BIAsp) 30 Twice Daily Versus Investigator-driven Titration of BIAsp 30 Twice Daily Both in Combination With Oral Antidiabetic Drugs in Subjects With Type 2 Diabetes Inadequately Controlled With Premixed Human Insulin

Novo Nordisk A/S·interventional·Posted Jun 13, 2012·Updated Feb 24, 2017

In Brief

A Phase 4 clinical trial evaluating biphasic insulin aspart 30 for Diabetes and Diabetes Mellitus, Type 2. Completed, enrolled 344 participants across 22 sites.

Detailed Summary

This trial is conducted in Asia. The aim of this trial is to compare BIAsp 30 twice daily individually adjusted by the subject versus BIAsp 30 twice daily individually adjusted by the investigator both combined with oral antidiabetic drugs (OADs) in subjects with type 2 diabetes inadequately controlled with premixed human insulin. Subjects to continue their OAD background treatment: Metformin plus/minus alpha-glucosidase inhibitor.

Study Details

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

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJun 13, 2012
Enrollment StartJun 1, 2012
Primary CompletionJan 1, 2013
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 14.1 years ago

Interventions

biphasic insulin aspart 30drug

Dose individually adjusted, administered subcutaneously (s.c., under the skin) twice daily.