CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 65 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/NCT00841087
NCT00841087Phase 2Completed
CompareCT.gov

A 6-week, Randomised, Multi-centre, Open-labelled, Parallel Group, Exploratory Trial to Investigate the Safety of SIBA Once Daily + NovoRapid® Compared to Insulin Detemir Once Daily + NovoRapid®, All in a Basal-bolus Regimen in Subjects With Type 1 Diabetes Mellitus

Novo Nordisk A/S·interventional·Posted Feb 11, 2009·Updated Mar 3, 2017

In Brief

A Phase 2 clinical trial evaluating insulin degludec, insulin detemir, and 1 other intervention for Diabetes and Diabetes Mellitus, Type 1. Completed, enrolled 65 participants across 8 sites.

Detailed Summary

This trial is conducted in Japan. The aim of this clinical trial is to investigate the safety (with emphasis on hypoglycaemia) after switching from long-acting insulin analogue or intermediate-acting insulin to insulin degludec (NN1250, SIBA) on a basal-bolus regimen in subjects with type 1 diabetes mellitus.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes, Diabetes Mellitus, Type 1
CountriesJapan
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 11, 2009
Enrollment StartJan 1, 2009
Primary CompletionMay 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 17.4 years ago

Interventions

insulin degludecdrug

The insulin NN1250 (insulin degludec) injected subcutaneously at bedtime

insulin detemirdrug

Injection subcutaneously at bedtime

insulin aspartdrug

Injection subcutaneously immediately before each meal.