Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

COMPLETED 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

NCT01068860 · View on ClinicalTrials.gov ↗

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

60 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01068860

The ClinicalTrials.gov registry entry for NCT01068860 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 246 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis, which has 60 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01068860 reports 20 study locations spanning 11 distinct geographic areas — top geographies include California, Victoria, Ontario. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01068860?

The interventions under investigation include: Canakinumab 150 mg (DRUG), Placebo to Canakinumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01068860?

This trial is sponsored by Novartis, which has 60 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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