At a glance

ClinicalIndex Comparison Record

Phase 4Completed· 179 enrolled

Drug / intervention

biphasic insulin aspart 30 +2 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/NCT01278160

NCT01278160Phase 4Completed

Compare CT.gov

An Extension Trial of BIAsp-3756, Explorative Comparison of Biphasic Insulin Aspart 30 Twice Daily With Two Different Initial Dosage Split Regimens on the Effect of Glycaemic Control in Chinese Type 2 Diabetes Patients

Novo Nordisk A/S·interventional·Posted Jan 17, 2011·Updated Oct 27, 2014

In Brief

A Phase 4 clinical trial evaluating biphasic insulin aspart 30 and metformin for Diabetes and Diabetes Mellitus, Type 2. Completed, enrolled 179 participants across 1 site.

Detailed Summary

This trial is conducted in Asia. The aim of the trial is to compare the effect on glycaemic control of biphasic insulin aspart 30 twice daily with two different dosage split regimens for Chinese subjects with type 2 diabetes who did not achieve the treatment target of a glycosylated haemoglobin A1c (HbA1c) below 7% in trial BIASP-3756 (NCT01123980).

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsDiabetes, Diabetes Mellitus, Type 2

CountriesChina

Collaborators--

Timeline

Phase 4CompletedFinished

2011201220132014201520162017201820192020202120222023202420252026

Enrollment StartJan 2011

First PostedJan 2011

Primary CompletionSep 2011

TodayJul 2026

First PostedJan 17, 2011

Enrollment StartJan 1, 2011

Primary CompletionSep 1, 2011

TodayJul 2, 2026

Enrollment to primary: 8 monthsPosted 15.5 years ago

Interventions

biphasic insulin aspart 30drug

Administered subcutaneously (under the skin), twice daily with a dosage of 2/3 and 1/3 total daily dose before breakfast and before dinner, in combination with metformin.

biphasic insulin aspart 30drug

Administered subcutaneously (under the skin), twice daily with a split dosage of 1/2 and 1/2 total daily dose before breakfast and before dinner, in combination with metformin.

metformindrug

Tablets 500 mg administered orally with meals. Pre-trial dose and regimen unchanged