CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 458 enrolled
Drug / intervention
insulin degludec +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/NCT01046110
NCT01046110Phase 3Completed
CompareCT.gov

A Trial Comparing Efficacy and Safety of NN1250 With Sitagliptin in Insulin Naive Subjects With Type 2 Diabetes (BEGIN™ : EARLY)

Novo Nordisk A/S·interventional·Posted Jan 11, 2010·Updated Mar 3, 2017

In Brief

A Phase 3 clinical trial evaluating insulin degludec and sitagliptin for Diabetes and Diabetes Mellitus, Type 2. Completed, enrolled 458 participants across 93 sites in 7 countries.

Detailed Summary

This trial will be conducted in Africa, Asia, North America and South America. The aim of this clinical trial is to compare NN1250 (insulin degludec) with sitagliptin, as add-on to subject's own current oral antidiabetic (OAD) treatment, in subjects with type 2 diabetes inadequately controlled with 1-2 OADs (metformin, sulphonylurea, glinides or pioglitazone).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes, Diabetes Mellitus, Type 2
CountriesArgentina, Canada, India, Mexico, South Africa, Turkey (Türkiye), United States
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 11, 2010
Enrollment StartJan 1, 2010
Primary CompletionNov 1, 2010
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 16.5 years ago

Interventions

insulin degludecdrug

Injected under the skin once daily for 26 weeks. The doses will be individually adjusted.

sitagliptindrug

Sitagliptin tablets administered orally once a day at the same time every day for 26 weeks