CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 521 enrolled
Drug / intervention
biphasic insulin aspart 30 +3 moredrug
Likely dose
metformin 500 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/NCT01123980
NCT01123980Phase 4Completed
CompareCT.gov

An Open-labelled, Randomised, Parallel Group, 3 Week run-in and 24 Week Treat-to-target Comparison of Biphasic Insulin Aspart 30 Once Daily Versus Insulin Glargine Once Daily Both in Combination With Metformin and Glimepiride in Chinese and Japanese Insulin Naive Subjects With Type 2 Diabetes

Novo Nordisk A/S·interventional·Posted May 14, 2010·Updated Feb 24, 2017

In Brief

A Phase 4 clinical trial evaluating biphasic insulin aspart 30, metformin, and 2 other interventions for Diabetes and Diabetes Mellitus, Type 2. Completed, enrolled 521 participants across 34 sites in 2 countries.

Detailed Summary

This trial is conducted in Asia. The aim of this clinical trial is to investigate the blood sugar lowering effect of biphasic insulin aspart 30 once daily compared to insulin glargine once daily both in combination with metformin and glimepiride in Chinese and Japanese subjects with type 2 diabetes who have never received insulin before. The trial is conducted as a phase 4 trial in China and phase 3 in Japan.

Study Details

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

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 14, 2010
Enrollment StartMay 1, 2010
Primary CompletionJun 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 16.1 years ago

Interventions

biphasic insulin aspart 30drug

Treat-to-target titration according to titration algorithm. Subcutaneous (under the skin) injection once daily.

metformindrug

China: Tablets, 500 mg. Min. 1500 mg/day. Japan: Tablets, 250 mg. Min 500 mg/day.

glimepiridedrug

China: Tablets, 2 mg. Min. 4 mg/day. Japan: Tablets, 1 mg. Min. 4 mg/day.

insulin glarginedrug

Treat-to-target titration according to titration algorithm. Subcutaneous (under the skin) injection once daily.