CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 460 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/NCT01068665
NCT01068665Phase 3Completed

A Trial Comparing Efficacy and Safety of NN1250 and Insulin Glargine in Subjects With Type 2 Diabetes (BEGIN™: LOW VOLUME)

Novo Nordisk A/S·interventional·Posted Feb 15, 2010·Updated Mar 6, 2017

In Brief

A Phase 3 clinical trial evaluating insulin degludec and insulin glargine for Diabetes and Diabetes Mellitus, Type 2. Completed, enrolled 460 participants across 116 sites in 8 countries.

Detailed Summary

This trial is conducted in South Africa, Europe and North America. The aim of this trial is to compare efficacy and safety of NN1250 (insulin degludec (IDeg)) with insulin glargine (IGlar), as add-on to subject's ongoing treatment with metformin and/or dipeptyl peptidase 4 (DPP-4) inhibitors, in patients with type 2 diabetes being treated with oral anti-diabetic drugs (OADs) qualifying for intensified treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, France, Ireland, Russia, South Africa, Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 15, 2010
Enrollment StartMar 1, 2010
Primary CompletionNov 1, 2010
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 16.4 years ago

Interventions

insulin degludecdrug

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

insulin glarginedrug

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