CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 687 enrolled
Drug / intervention
insulin degludec +2 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/NCT01006291
NCT01006291Phase 3Completed
CompareCT.gov

A 26 Week Randomised, Controlled, Open Label, Multicentre, Multinational, Three-arm, Treat to Target Trial Comparing Efficacy and Safety of Three Different Dosing Regimens of Either Soluble Insulin Basal Analogue (SIBA) or Insulin Glargine With or Without Combination With OAD Treatment, in Subjects With Type 2 Diabetes Mellitus (BEGIN™ : FLEX)

Novo Nordisk A/S·interventional·Posted Nov 2, 2009·Updated Feb 9, 2017

In Brief

A Phase 3 clinical trial evaluating insulin degludec and insulin glargine for Diabetes and Diabetes Mellitus, Type 2. Completed, enrolled 687 participants across 72 sites in 14 countries.

Detailed Summary

This trial is conducted in Africa, Asia, Europe and South America. The aim of this clinical trial is to compare NN1250 (insulin degludec (IDeg) with insulin glargine (IGlar) in patients with type 2 diabetes. Subjects treated with oral antidiabetic drug(s) (OAD(s)) should continue their current OAD treatment at the stable, prerandomisation dose level and dosing frequency.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes, Diabetes Mellitus, Type 2
CountriesArgentina, Finland, Hungary, India, Israel, Malaysia, Mexico, North Macedonia, Norway, Russia, Serbia, South Africa, Taiwan, United Kingdom
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 2, 2009
Enrollment StartNov 1, 2009
Primary CompletionSep 1, 2010
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 16.7 years ago

Interventions

insulin degludecdrug

Injected s.c. (under the skin) once daily (alternative regimen). Dose was individually adjusted.

insulin degludecdrug

Injected s.c. (under the skin) once daily. Dose was individually adjusted.

insulin glarginedrug

Insulin glargine injected s.c. (under the skin) once daily. Dose was individually adjusted.