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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: Completed Phase 2 study of Type 2 Diabetes Mellitus and Impaired Glucose Tolerance, sponsored by Novartis.
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 2,958-participant average among 130 other Type 2 Diabetes Mellitus trials with a reported enrollment target (92% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Change in Insulin Secretion Rate stimulated by Liquid mixed-meal challenge. Blood samples were taken prior to and after meal for glucose and insulin at sample times: -20, -10, -1 and 10, 20, 30, 60, 90, 120, 180, and 240 minutes relative to the start of the meal.A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixe
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 246 participants |
| Start Date | 2010-02 |
| Est. Completion | 2010-08 |
| Phase | Phase 2 |
What the finished NCT01068860 record still lists
NCT01068860 is an interventional study that assigns participants to a tested intervention. The registered 246 participants enrollment target is mid-sized for trials with a published cap, below the 2,958-participant average among 130 other Type 2 Diabetes Mellitus trials with a reported enrollment target (92% lower).
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 names 20 study sites across 11 states, led by 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.
Learn More About Clinical Trials
Similar trials for Type 2 Diabetes Mellitus
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01068860's enrollment target sits among peer trials
246 32nd of 130 higher than 99 of 130 other Type 2 Diabetes Mellitus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 2 Diabetes Mellitus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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