CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 457 enrolled
Drug / intervention
insulin detemir +1 moredrug
Likely dose
insulin detemir 1500 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/NCT00909480
NCT00909480Phase 4Completed
CompareCT.gov

A 26 Week Randomised, Multinational, Open Labelled, 2 Armed, Parallel Group, Treat-to-target Once Daily Treatment Trial With Insulin Detemir Versus Insulin Glargine, Both in Combination With Metformin in Subjects With Type 2 Diabetes

Novo Nordisk A/S·interventional·Posted May 28, 2009·Updated Mar 10, 2017

In Brief

A Phase 4 clinical trial evaluating insulin detemir and insulin glargine for Diabetes and Diabetes Mellitus, Type 2. Completed, enrolled 457 participants across 88 sites in 6 countries.

Detailed Summary

This trial is conducted in Asia, South America and the United States of America (USA). The aim of this clinical trial is to determine whether two insulin treatments given once daily are equally effective with respect to the blood glucose lowering effect in subjects with type 2 diabetes inadequately controlled on metformin treatment with or without an additional anti-diabetic drug (OAD).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes, Diabetes Mellitus, Type 2
CountriesArgentina, India, Puerto Rico, South Korea, Thailand, United States
Collaborators--

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 28, 2009
Enrollment StartMay 1, 2009
Primary CompletionJun 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 17.1 years ago

Interventions

insulin detemirdrug

Treat-to-target (individually adjusted dose) titration according to titration algorithm. S.c. (under the skin) injection once daily as an add-on to subjects' stable pre-trial metformin dose (at least 1500 mg/day). Any other use of OAD will be discontinued

insulin glarginedrug

Treat-to-target (individually adjusted dose) titration according to titration algorithm. S.c. (under the skin) injection once daily as an add-on to subjects' stable pre-trial metformin dose (at least 1500 mg/day). Any other use of OAD will be discontinued