Trial · NCT01068860
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, Phase 2, Completed, Novartis; results first posted 2011-09-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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. Trials, record NCT01068860. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01068860
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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
- NCT number
- NCT01068860
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 246 participants, actual
- Lead sponsor
- Novartis
- Conditions
- Type 2 Diabetes Mellitus, Impaired Glucose Tolerance
- Interventions
- Canakinumab 150 mg, Placebo to Canakinumab
- First posted
- 2010-02-15
- Last updated
- 2011-09-05
- Results first posted
- 2011-09-05
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change in Meal Stimulated Insulin Secretion Rate (ISR) Relative to Glucose 0-2 Hours, From Baseline to 4 Weeks. | Baseline, 4 weeks | 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 mixed model did not include patients from the IGT population |
| Secondary | Mean Change in Meal Stimulated Insulin Secretion Rate (ISR) Relative to Glucose 2-4 Hours, From Baseline to 4 Weeks | Baseline, 4 weeks | 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 mixed model did not include participants from the IGT population |
| Secondary | Mean Change in Meal Stimulated Insulin Secretion Rate (ISR) Relative to Glucose 0-4 Hours, From Baseline to 4 Weeks. | Baseline, 4 weeks | Change in Insulin Secretion Rate stimulated by Liquid mixed-meal challenge. Blood samples were taken prior to and after meal for glucose, insulin and C-peptide 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 mixed model did not include participants from the IGT population. |
| Secondary | Mean Change in Fasting Plasma Glucose, From Baseline to 4 Weeks | Baseline, 4 weeks | Change in Fasting Glucose Level measured from plasma taken at Baseline and after 4 weeks of treatment. 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 mixed model did not include participants from the IGT population |
| Secondary | Mean Change in Fructosamine, From Baseline to 4 Weeks | Baseline, 4 weeks | Change in Fructosamine Level taken from plasma, measured at Baseline and after 4 weeks of treatment. 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 mixed model did not include participants from the IGT population |
| Secondary | Mean Change in Fasting Plasma Insulin, From Baseline to 4 Weeks | Baseline, 4 weeks | Change in Fasting Insulin level taken from plasma, measured at Baseline and after 4 weeks of treatment. 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 mixed model did not include participants from the IGT population |
| Secondary | Mean Change in Quantitative Insulin Sensitivity Check Index (QUICKI) Score, From Baseline to 4 Weeks | Baseline, 4 weeks | The Quantitative Insulin Sensitivity Check Index (QUICKI) score, measures insulin sensitivity which is the inverse of insulin resistance. The score is calculated by the equation: 1 /(log(fasting insulin µU/mL) + log(fasting glucose mg/dL)). In normal subjects the mean score ± SE is 0.366 ± 0.029. 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 mixed model did not include participants from the IGT population. |
| Secondary | Mean Change in Fasting Glucose Disposition Index(GDI)1 and Index 2, From Baseline to 4 Weeks | Baseline, 4 weeks | GDI 1 is the product of insulin sensitivity index (Si)during the 1st phase of insulin secretion and β-cell function as measured by the acute insulin response (AIR).GDI 2 is the product of (Si)during the 2nd phase of insulin secretion and β-cell function as measured by the acute insulin response (AIR). 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 mixed model did not include participants from the IGT group. |
| Secondary | Mean Change in Absolute Glucose Level at 2 Hours, From Baseline to 4 Weeks | Baseline, 4 weeks | Change in glucose level measured after 2 hours of fasting. Blood sample was drawn at 0 minutes and at 240 minutes. 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 mixed model did not include participants from the IGT population. |
| Secondary | Mean Change in Insulin Area Under the Curve (AUC) 0-4 Hours, From Baseline to 4 Weeks | Baseline, 4 weeks | Blood samples were drawn after a test meal at 0, 15, 30, 45, 60, 90, 120, 180 and 240 min. Insulin levels over 4 hrs were shown as Area Under the Curve,(AUC). AUC was calculated as: x=1 AUC ΣAx n Where Ax = AUC for the 240 min.interval, and X = 1 for the 1st interval. 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 vs placebo within each T2DM group. The mixed model didn't include the IGT group. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change in Meal Stimulated Insulin Secretion Rate (ISR) Relative to Glucose 0-2 Hours, From Baseline to 4 Weeks. | Baseline, 4 weeks | Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours. | pmol/min/m^2/mmol/L | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change in Meal Stimulated Insulin Secretion Rate (ISR) Relative to Glucose 2-4 Hours, From Baseline to 4 Weeks | Baseline, 4 weeks | Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours. | pmol/min/m^2/mmol/L | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change in Meal Stimulated Insulin Secretion Rate (ISR) Relative to Glucose 0-4 Hours, From Baseline to 4 Weeks. | Baseline, 4 weeks | Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours. | pmol/min/m^2/mmol/L | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change in Fasting Plasma Glucose, From Baseline to 4 Weeks | Baseline, 4 weeks | Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours. | mmol/L | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change in Fructosamine, From Baseline to 4 Weeks | Baseline, 4 weeks | Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours. | mmol/L | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change in Fasting Plasma Insulin, From Baseline to 4 Weeks | Baseline, 4 weeks | Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours. | pmol/L | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change in Quantitative Insulin Sensitivity Check Index (QUICKI) Score, From Baseline to 4 Weeks | Baseline, 4 weeks | Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours. | number | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change in Fasting Glucose Disposition Index(GDI)1 and Index 2, From Baseline to 4 Weeks | Baseline, 4 weeks | Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours. | number | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change in Absolute Glucose Level at 2 Hours, From Baseline to 4 Weeks | Baseline, 4 weeks | Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours. | mmol/L | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change in Insulin Area Under the Curve (AUC) 0-4 Hours, From Baseline to 4 Weeks | Baseline, 4 weeks | Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours. | pmol*hour/L | LEAST_SQUARES_MEAN |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group180
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change in Meal Stimulated Insulin Secretion Rate (ISR) Relative to Glucose 0-2 Hours, From Baseline to 4 Weeks. | Canakinumab 150 mg + Metformin | -0.06 | Standard Error 0.943 | pmol/min/m^2/mmol/L | |
| Mean Change in Meal Stimulated Insulin Secretion Rate (ISR) Relative to Glucose 0-2 Hours, From Baseline to 4 Weeks. | Placebo + Metformin | -0.23 | Standard Error 1.334 | pmol/min/m^2/mmol/L | |
| Mean Change in Meal Stimulated Insulin Secretion Rate (ISR) Relative to Glucose 0-2 Hours, From Baseline to 4 Weeks. | Canakinumab 150 mg + Metformin + Sulfonylurea | 0.04 | Standard Error 0.958 | pmol/min/m^2/mmol/L | |
| Mean Change in Meal Stimulated Insulin Secretion Rate (ISR) Relative to Glucose 0-2 Hours, From Baseline to 4 Weeks. | Placebo + Metformin + Sulfonylurea | 0.45 | Standard Error 1.378 | pmol/min/m^2/mmol/L | |
| Mean Change in Meal Stimulated Insulin Secretion Rate (ISR) Relative to Glucose 0-2 Hours, From Baseline to 4 Weeks. | Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia | -0.79 | Standard Error 0.958 | pmol/min/m^2/mmol/L | |
| Mean Change in Meal Stimulated Insulin Secretion Rate (ISR) Relative to Glucose 0-2 Hours, From Baseline to 4 Weeks. | Placebo + Met + Sulfonyl + Thiaz | 1.16 | Standard Error 1.426 | pmol/min/m^2/mmol/L | |
| Mean Change in Meal Stimulated Insulin Secretion Rate (ISR) Relative to Glucose 0-2 Hours, From Baseline to 4 Weeks. | Canakinumab 150 mg + Insulin | 1.23 | Standard Error 1.046 | pmol/min/m^2/mmol/L | |
| Mean Change in Meal Stimulated Insulin Secretion Rate (ISR) Relative to Glucose 0-2 Hours, From Baseline to 4 Weeks. | Placebo + Insulin | -0.49 | Standard Error 1.378 | pmol/min/m^2/mmol/L | |
| Mean Change in Meal Stimulated Insulin Secretion Rate (ISR) Relative to Glucose 0-2 Hours, From Baseline to 4 Weeks. | Canakinumab 150 mg in Participants With IGT | -1.50 | Standard Error 1.975 | pmol/min/m^2/mmol/L | |
| Mean Change in Meal Stimulated Insulin Secretion Rate (ISR) Relative to Glucose 0-2 Hours, From Baseline to 4 Weeks. | Placebo in Participants With IGT | -1.93 | Standard Error 1.737 | pmol/min/m^2/mmol/L |
1 to 10 of 180Source ClinicalTrials.gov
See all 180 results by groupParticipant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Canakinumab 150 mg + Metformin | 33 | |
| Overall Study | STARTED | Placebo + Metformin | 17 | |
| Overall Study | STARTED | Canakinumab 150 mg + Metformin + Sulfonylurea | 33 | |
| Overall Study | STARTED | Placebo + Metformin + Sulfonylurea | 17 | |
| Overall Study | STARTED | Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia | 32 | |
| Overall Study | STARTED | Placebo + Met + Sulfonyl + Thiaz | 16 | |
| Overall Study | STARTED | Canakinumab 150 mg + Insulin | 28 | |
| Overall Study | STARTED | Placebo + Insulin | 15 | |
| Overall Study | STARTED | Canakinumab 150 mg in Participants With IGT | 28 | |
| Overall Study | STARTED | Placebo in Participants With IGT | 27 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events180
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Vertigo | Ear and labyrinth disorders | Canakinumab 150 mg + Metformin | 0 | 33 | |
| other | Vertigo | Ear and labyrinth disorders | Placebo + Metformin | 1 | 17 | |
| other | Vertigo | Ear and labyrinth disorders | Canakinumab 150 mg + Metforimin + Sulfonylurea | 0 | 32 | |
| other | Vertigo | Ear and labyrinth disorders | Placebo + Metforimin + Sulfonylurea | 0 | 17 | |
| other | Vertigo | Ear and labyrinth disorders | Canakinumab 150 mg + Met + Sulfonyl + Thiazolidinedione | 0 | 32 | |
| other | Vertigo | Ear and labyrinth disorders | Placebo + Met + Sulfonyl + Thiazolidinedione | 0 | 16 | |
| other | Vertigo | Ear and labyrinth disorders | Canakinumab 150 mg + Insulin | 0 | 28 | |
| other | Vertigo | Ear and labyrinth disorders | Placebo + Insulin | 0 | 15 | |
| other | Vertigo | Ear and labyrinth disorders | Canakinumab 150 mg in Patients With IGT | 0 | 28 | |
| other | Vertigo | Ear and labyrinth disorders | Placebo in Patients With IGT | 0 | 26 |
1 to 10 of 180Source ClinicalTrials.gov
See all 180 adverse eventsAdverse event totals30
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Canakinumab 150 mg + Metformin | ||
| Total, all-cause mortality | Placebo + Metformin | ||
| Total, all-cause mortality | Canakinumab 150 mg + Metforimin + Sulfonylurea | ||
| Total, all-cause mortality | Placebo + Metforimin + Sulfonylurea | ||
| Total, all-cause mortality | Canakinumab 150 mg + Met + Sulfonyl + Thiazolidinedione | ||
| Total, all-cause mortality | Placebo + Met + Sulfonyl + Thiazolidinedione | ||
| Total, all-cause mortality | Canakinumab 150 mg + Insulin | ||
| Total, all-cause mortality | Placebo + Insulin | ||
| Total, all-cause mortality | Canakinumab 150 mg in Patients With IGT | ||
| Total, all-cause mortality | Placebo in Patients With IGT |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01068860
GET https://conductscience.org/api/trials/v1/NCT01068860/results?page=2