CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 246 enrolled
Drug / intervention
Canakinumab 150 mg +1 moredrug
Likely dose
Canakinumab 150 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/NCT01068860
NCT01068860Phase 2Completed

A Multi-center, Double-blind, Placebo-controlled, Randomized Study to Compare the Effect of a Subcutaneous Canakinumab Administration to Placebo in Patients With Impaired Glucose Tolerance or Patients With Type 2 Diabetes Treated With Differing Baseline Diabetes Therapies

Novartis·interventional·Posted Feb 15, 2010·Updated Sep 5, 2011

In Brief

A Phase 2 clinical trial evaluating Canakinumab 150 mg and Placebo to Canakinumab for Type 2 Diabetes Mellitus and Impaired Glucose Tolerance. Completed, enrolled 246 participants across 52 sites in 7 countries.

Detailed Summary

This was a 10-week, placebo-controlled, randomized study to investigate the effect of injectable IL-1B antagonist, Canakinumab , in participants with impaired glucose tolerance or Type 2 Diabetes Mellitus (T2DM) already treated on different background diabetes therapies.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Canada, Finland, Germany, India, Italy, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 15, 2010
Enrollment StartFeb 1, 2010
Primary CompletionAug 1, 2010
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 16.4 years ago

Interventions

Canakinumab 150 mgdrug

Single subcutaneous injection of Canakinumab 150 mg.

Placebo to Canakinumabdrug

Single subcutaneous injection of Placebo to Canakinumab.