CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 245 enrolled
Drug / intervention
insulin glargine +4 moredrug
Likely dose
metformin 2000 mgfrom 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/NCT00611884
NCT00611884Phase 2Completed
CompareCT.gov

A 16 Week Randomised, Open-labelled, Four-armed, Treat-to-target, Parallel-group Trial Comparing SIBA D Once Daily, SIBA E Once Daily, SIBA D Monday, Wednesday and Friday and Insulin Glargine Once Daily, All in Combination With Metformin in Subjects With Type 2 Diabetes Failing on OAD Treatment

Novo Nordisk A/S·interventional·Posted Feb 11, 2008·Updated Mar 3, 2017

In Brief

A Phase 2 clinical trial evaluating insulin glargine, insulin degludec, and 1 other intervention for Diabetes and Diabetes Mellitus, Type 2. Completed, enrolled 245 participants across 29 sites in 4 countries.

Detailed Summary

This trial is conducted in Africa, Asia and North America. The aim of this trial is to compare two insulin degludec (NN1250, SIBA) formulations with each other and with insulin glargine, all in combination with metformin in insulin naive subjects with type 2 diabetes.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes, Diabetes Mellitus, Type 2
CountriesCanada, India, South Africa, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 11, 2008
Enrollment StartJan 1, 2008
Primary CompletionAug 1, 2008
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 18.4 years ago

Interventions

insulin glarginedrug

Treat-to-target dose titration scheme, s.c. injection.

insulin degludecdrug

Formulation D: Treat-to-target dose titration scheme, s.c. injection, once daily

insulin degludecdrug

Formulation E: Treat-to-target dose titration scheme, s.c. injection, once daily

insulin degludecdrug

Formulation D: Treat-to-target dose titration scheme, s.c. injection, 3 times weekly

metformindrug

Tablets, 1500-2000 mg/day