CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 145 enrolled
Drug / intervention
biphasic insulin aspart 30 +2 moredrug
Likely dose
biphasic human insulin 30 0.3 IUfrom 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/NCT00807092
NCT00807092Phase 4Completed
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Comparison of the Efficacy on Glycaemic Control and Safety Profile of Biphasic Insulin Aspart 30 and Biphasic Human Insulin 30 Both in Combination With Metformin in Insulin-naïve Subjects With Type 2 Diabetes Mellitus Inadequately Controlled on Oral Antidiabetic Drugs (OADs) Therapy

Novo Nordisk A/S·interventional·Posted Dec 11, 2008·Updated Mar 4, 2015

In Brief

A Phase 4 clinical trial evaluating biphasic insulin aspart 30, biphasic human insulin 30, and 1 other intervention for Diabetes and Diabetes Mellitus, Type 2. Completed, enrolled 145 participants across 1 site.

Detailed Summary

This trial is conducted in Asia. The aim of this clinical trial is to investigate the blood sugar lowering effect and the safety profile of biphasic insulin aspart 30 compared to biphasic human insulin 30, both in combination with metformin in Chinese insulin-naive subjects with type 2 diabetes when failing on oral antidiabetic drug (OAD) therapy.

Study Details

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

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 11, 2008
Enrollment StartDec 1, 2008
Primary CompletionOct 1, 2009
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 17.6 years ago

Interventions

biphasic insulin aspart 30drug

The initial doses for BIAsp 30 twice-daily regimen will be recommended to start at a total daily dose of 0.3 U/kg body weight and to be equally divided (1/2:1/2) between pre-breakfast and pre-dinner

biphasic human insulin 30drug

The initial doses for BHI 30 twice-daily regimen will be recommended to start at a total daily dose of 0.3 IU/kg body weight and to be divided in the ratio of 2/3:1/3 between pre-breakfast and pre-dinner

metformindrug

Metformin dose must remain the same as that used prior to the trial.