CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 480 enrolled
Drug / intervention
biphasic insulin aspart +3 moredrug
Likely dose
metformin 2550 mcgfrom 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/NCT00469092
NCT00469092Phase 4Completed
CompareCT.gov

A Multi-national, Open-labelled, Randomised, Parallel Group, 4 Week run-in and 26 Weeks Treat-to-target Comparison of Biphasic Insulin Aspart 30 Once Daily Versus Insulin Glargine Once Daily Both in Combination With Metformin and Glimepiride in Insulin naïve Subjects With Type 2 Diabetes

Novo Nordisk A/S·interventional·Posted May 4, 2007·Updated Feb 23, 2017

In Brief

A Phase 4 clinical trial evaluating biphasic insulin aspart, insulin glargine, and 2 other interventions for Diabetes and Diabetes Mellitus, Type 2. Completed, enrolled 480 participants across 69 sites in 15 countries.

Detailed Summary

This trial is conducted in Africa, Asia, Europe, Oceania and South America. This trial aims for a comparison of biphasic insulin aspart 30 once daily versus insulin glargine once daily all in combination with metformin and glimepiride in insulin naive subjects with type 2 diabetes.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes, Diabetes Mellitus, Type 2
CountriesArgentina, Austria, Czechia, France, India, Malaysia, Mexico, Netherlands, Philippines, Poland, Romania, Serbia and Montenegro, South Africa, Spain, Sweden
Collaborators--

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 4, 2007
Enrollment StartMay 1, 2007
Primary CompletionApr 1, 2008
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 19.2 years ago

Interventions

biphasic insulin aspartdrug

Treat-to-target dose titration scheme. The titration scheme is based on the previous 3 days fasting plasma glucose (FPG) measurements.

insulin glarginedrug

Treat-to-target dose titration scheme. The titration scheme is based on the previous 3 days fasting plasma glucose (FPG) measurements.

metformindrug

Tablets, 2550 mcg. Administered once daily.

glimepiridedrug

Tablets 2 mg. 4, 6 or 8 mg administered once daily.