CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 611 enrolled
Drug / intervention
Insulin detemir +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/NCT01232491
NCT01232491Phase 4Completed
CompareCT.gov

A 26-week Randomised, Controlled, Open Label, Multicentre, Multinational, Treat to Target Trial Investigating the Impact of Dietary Intervention on Weight Change and the Relationship Between Weight Change and Baseline Body Mass Index (BMI) in Subjects With Type 2 Diabetes Inadequately Controlled on Oral Antidiabetic Drugs (OADs) Initiating Insulin Therapy With Insulin Detemir in Combination With Metformin (Levemir DIET)

Novo Nordisk A/S·interventional·Posted Nov 2, 2010·Updated May 1, 2017

In Brief

A Phase 4 clinical trial evaluating Insulin detemir and Dietary regimen for Diabetes and Diabetes Mellitus, Type 2. Completed, enrolled 611 participants across 112 sites in 11 countries.

Detailed Summary

This trial is conducted in Europe, and North and South America. The aim of this trial is to investigate if a dietary intervention has an effect on weight when initiating insulin treatment in subjects with type 2 diabetes currently treated with oral antidiabetic drugs (OADs).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes, Diabetes Mellitus, Type 2
CountriesArgentina, Germany, Poland, Puerto Rico, Russia, Serbia, Slovakia, Slovenia, Spain, Turkey (Türkiye), United States
Collaborators--

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedNov 2, 2010
Enrollment StartOct 29, 2010
Primary CompletionNov 1, 2011
Study CompletionNov 14, 2011
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 15.7 years ago

Interventions

Insulin detemirdrug

Individually adjusted insulin detemir subcutaneously (under the skin) once daily. Subjects continue their pre-trial metformin treatment.

Dietary regimendietary

Subjects receive dietary consultation by a dietician at six occasions during the trial.