CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 161 enrolled
Drug / intervention
biphasic insulin aspart 50 +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/NCT01892020
NCT01892020Phase 4Completed
CompareCT.gov

A Multi-centre, Randomised, Open-labelled, 2-sequence, 2-period Crossover Trial to Investigate the Efficacy and Safety of Biphasic Insulin Aspart 50 (BIAsp 50) Twice Daily Versus Biphasic Human Insulin 50 (BHI 50) Twice Daily Both in Combination With Metformin in Chinese Subjects With Type 2 Diabetes Mellitus

Novo Nordisk A/S·interventional·Posted Jul 3, 2013·Updated Jul 9, 2015

In Brief

A Phase 4 clinical trial evaluating biphasic insulin aspart 50 and biphasic human insulin 50 for Diabetes and Diabetes Mellitus, Type 2. Completed, enrolled 161 participants across 1 site.

Detailed Summary

This trial is conducted in Asia. The aim of the trial is to investigate the efficacy and safety of biphasic insulin aspart 50 (BIAsp 50) twice daily versus biphasic human insulin 50 (BHI 50) twice daily, both in combination with metformin, in Chinese subjects with type 2 diabetes mellitus.

Study Details

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

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJul 3, 2013
Enrollment StartJun 1, 2013
Primary CompletionMay 1, 2014
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 13.0 years ago

Interventions

biphasic insulin aspart 50drug

Administered subcutaneously (s.c., under the skin) twice daily (BID). Dose individually adjusted. All subjects will receive metformin in combination with trial insulin.

biphasic human insulin 50drug

Administered subcutaneously (s.c., under the skin) twice daily (BID). Dose individually adjusted. All subjects will receive metformin in combination with trial insulin.