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NCT01068860 · ClinicalTrials.gov registry record · Phase 2

To Compare the Effect of a Subcutaneous Canakinumab Administration to Placebo in Patients With Impaired Glucose Tolerance or Patients With Type 2 Diabetes With Differing Baseline Diabetes Therapies

A Phase 2 study of Type 2 Diabetes Mellitus and Impaired Glucose Tolerance, sponsored by Novartis.

Completed
Registry status
Phase 2
Development phase
246
Enrollment target
20
Study locations

NCT01068860 is a Phase 2 study of Type 2 Diabetes Mellitus and Impaired Glucose Tolerance that has completed, run by Novartis. The registered enrollment target is 246 participants, below the 2,746-participant average among 122 other Type 2 Diabetes Mellitus trials with a reported enrollment target (91% lower). The trial reports 20 study locations across 11 states.

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The verdict

NCT01068860, a Phase 2 study of Type 2 Diabetes Mellitus and Impaired Glucose Tolerance, has completed, sponsored by Novartis.

COMPLETED
Registry status
Phase 2
Development phase
246 participants
Enrollment target
20
Study locations

Study 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.

Interventions

  • DRUG Canakinumab 150 mg
  • DRUG Placebo to Canakinumab

Study Locations (20)

California

  • National Research Institute - Los Angeles
  • Crest Clinical Trials - Santa Ana
  • Encompass Clinical Research - Spring Valley

Victoria

  • Barwon Health - Geelong Hospital - Geelong
  • Austin Health - Heidelberg Repatriation Hospital - Heidelberg Heights
  • Melbourne Health - Royal Melbourne Hospital - Melbourne

Ontario

  • Lifestyle Metabolism Centre (Etobicoke) - Etobicoke
  • LMC Endocrinology Centres (Markham) Ltd - Markham
  • LMC Endocrinology Centres (Thornhill) Ltd - Thornhill

Nebraska

  • University of Nebraska Medical Center - Omaha
  • VA Medical Center - Omaha

Texas

  • Dallas Diabetes and Endocrine Center - Dallas
  • Texas Center for Drug Development P.A. - Houston

Quebec

  • Centre de recherche clinique de Laval - Laval
  • Hôpital Maisonneuve-Rosemont - Montreal

Kentucky

  • Commonwealth Biomedical Research LLC - Madisonville

North Dakota

  • Lillestol Research LLC - Fargo

Trial Details

FieldValue
Enrollment Target 246 participants
Start Date 2010-02
Est. Completion 2010-08
Phase Phase 2

Sponsor

Novartis

265 total trials

What the Registry Record Tells You About NCT01068860

The ClinicalTrials.gov registry entry for NCT01068860 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 246 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,746-participant average among 122 other Type 2 Diabetes Mellitus trials with a reported enrollment target (91% lower). The listed sponsor is Novartis, which has 265 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Type 2 Diabetes Mellitus appearing as the primary indexed condition, and to 2 interventions - of which Canakinumab 150 mg is the first listed.

NCT01068860 reports 20 study locations spanning 11 distinct geographic areas - top geographies include California, Victoria, Ontario.

Frequently Asked Questions

What is clinical trial NCT01068860 about?

NCT01068860 is a clinical study titled "To Compare the Effect of a Subcutaneous Canakinumab Administration to Placebo in Patients With Impaired Glucose Tolerance or Patients With Type 2 Diabetes With Differing Baseline Diabetes Therapies". 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.

What is the current status of trial NCT01068860?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 246 participants. The study started on 2010-02. Estimated completion is 2010-08.

What conditions does trial NCT01068860 study?

This clinical trial studies the following conditions: Type 2 Diabetes Mellitus, Impaired Glucose Tolerance.

What interventions are being tested in trial NCT01068860?

The interventions under investigation include: Canakinumab 150 mg (DRUG), Placebo to Canakinumab (DRUG).

Who is sponsoring clinical trial NCT01068860?

This trial is sponsored by Novartis, which has 265 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01068860 being conducted?

This trial has 20 study locations across California, Kentucky, Nebraska, North Dakota, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.