Trial · NCT00900146
Dose Finding, Safety and Efficacy of Monthly Subcutaneous Canakinumab Administration in Metformin Monotherapy Treated Type 2 Diabetic Patients
NCT00900146, Phase 2, Phase 3, Terminated, Novartis; results first posted 2012-02-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Dose Finding, Safety and Efficacy of Monthly Subcutaneous Canakinumab Administration in Metformin Monotherapy Treated Type 2 Diabetic Patients. Trials, record NCT00900146. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00900146
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dose Finding, Safety and Efficacy of Monthly Subcutaneous Canakinumab Administration in Metformin Monotherapy Treated Type 2 Diabetic Patients
- NCT number
- NCT00900146
- Status
- Terminated
- Phases
- Phase 2, Phase 3
- Enrollment
- 556 participants, actual
- Lead sponsor
- Novartis
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Canakinumab, Metformin, Placebo
- First posted
- 2009-05-12
- Last updated
- 2012-02-20
- Results first posted
- 2012-02-20
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events (AEs), Serious Adverse Events, Death and Clinical Significant AEs During 4 Months (Period II) | 4 months (Period II) | Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards. |
| Primary | Change From Baseline in Hemoglobin A1c (HbA1c) at Month 4 During Dose-finding Period of the Study (Period II) | Baseline, Month 4 | HbA1c was measured by National glycohemoglobin standardization program (NGSP) certified methodology. HbA1c is an integrated measure of average glucose concentration in plasma in the last 2-3 months. The analysis of covariance (ANCOVA) included treatment and metformin dose group as main effects and baseline HbA1c as a covariate. |
| Primary | Change From Baseline in Dynamic Phase Secreted Insulin Per Unit of Glucose Concentration (Φd) Over 4 Months (Period III) | Baseline, Over Month 4 | This was planned as interim analysis and was not conducted because the study was terminated in period III. |
| Secondary | Change From Baseline in C-peptide Area Under Curve (AUC 0-4 Hours ) Following Meal Test (Period II) | Baseline, Month 4 | A standard liquid mixed-meal challenge was done at baseline and Month 4. Patients completed each standard meal challenge with measurement of C-peptide prior to and after a liquid mixed meal. Sampling times were -20, -10, and -1, 10, 20, 30, 60, 90, 120, 150, 180 and 240 minutes relative to start of meal. C-peptide 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. The analysis of covariance included baseline C-peptide AUC 0-4 hours as a covariate. |
| Secondary | Change From Baseline in Prandial Plasma Glucose Area Under Curve (AUC0-4 Hours ) Following Meal Test (Period II) | Baseline, Month 4 | A standard liquid mixed-meal challenge was done at baseline and Month 4. Patients completed each standard meal challenge with measurement of glucose prior to and after a liquid mixed meal. Sampling times were -20, -10, and -1, 10, 20, 30, 60, 90, 120, 150, 180 and 240 minutes relative to the start of meal. Glucose 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. The model of analysis of covariance included baseline plasma glucose AUC 0-4 hours as a covariate. |
| Secondary | Change From Baseline in Insulin Area Under Curve (AUC 0-4 Hours ) Following Meal Test (Period II) | Baseline, Month 4 | A standard liquid mixed-meal challenge was done at baseline and Month 4. Patients completed each standard meal challenge with measurement of insulin prior to and after a liquid mixed meal. Sampling times were -20, -10, and -1, 10, 20, 30, 60, 90, 120, 150, 180 and 240 minutes relative to the start of meal. 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. Model of analysis of covariance included baseline insulin AUC 0-4 hours as covariate. |
| Secondary | Change From Baseline in 2-hour Glucose Level Following Meal Test (Period II) | Baseline, Month 4 | A standard liquid mixed-meal challenge was done at baseline and Month 4. Patients fasted overnight after 10 pm on day prior to scheduled visit. Study visits should occur before 10 am. Patients completed each standard meal challenge with measurement of glucose prior to and after a liquid mixed meal. The sampling times were -20, -10, and -1, 10, 20, 30, 60, 90, 120, 150, 180 and 240 minutes relative to the start of meal. The analysis of covariance included treatment and metformin dose group as main effects and baseline 2-hour glucose level as covariate. |
| Secondary | Change From Baseline in Peak Glucose Level Following Meal Test (Period II) | Baseline, Month 4 | A standard liquid mixed-meal challenge was done at baseline and Month 4. Patients fasted overnight after 10 pm on day prior to scheduled visit. Study visits should occur before 10 am. Patients completed each standard meal challenge with measurement of glucose prior to and after a liquid mixed meal. The sampling times were -20, -10, and -1, 10, 20, 30, 60, 90, 120, 150, 180 and 240 minutes relative to the start of meal. The analysis of covariance included treatment and metformin dose group as main effects and baseline peak glucose level as covariate. |
| Secondary | Change From Baseline in Peak C-peptide Following Meal Test (Period II) | Baseline, Month 4 | A standard liquid mixed-meal challenge was done at baseline and Month 4. Patients fasted overnight after 10 pm on the day prior to scheduled visit. Study visits should occur before 10 am. Patients completed each standard meal challenge with measurement of C-peptide prior to and after a liquid mixed meal. Sampling times were -20, -10, and -1, 10, 20, 30, 60, 90, 120, 150, 180 and 240 minutes relative to the start of meal. The analysis of covariance included treatment and metformin dose group as main effects and baseline peak C-peptide level as a covariate. |
| Secondary | Change From Baseline in Peak Insulin Level Following Meal Test (Period II) | Baseline, Month 4 | A standard liquid mixed-meal challenge was done at baseline and Month 4. Patients fasted overnight after 10 pm on day prior to scheduled visit. Study visits should occur before 10 am. Patients completed each standard meal challenge with measurement of insulin prior to and after a liquid mixed meal. The sampling times were -20, -10, and -1, 10, 20, 30, 60, 90, 120, 150, 180 and 240 minutes relative to the start of meal. The analysis of covariance included treatment and metformin dose group as main effects and baseline 2-hour insulin level as covariate. |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes21
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Events (AEs), Serious Adverse Events, Death and Clinical Significant AEs During 4 Months (Period II) | 4 months (Period II) | The safety set (SAF) included all patients who received at least one dose of study medication during Period II. | Participants | NUMBER |
| PRIMARY | Change From Baseline in Hemoglobin A1c (HbA1c) at Month 4 During Dose-finding Period of the Study (Period II) | Baseline, Month 4 | The full analysis set (included all randomized patients except for mis-randomized patients who randomized in error but did not receive study drug. Last observation carried forward (LOCF) method was used for patients without Month 4 HbA1c data for any reason and who used rescue medication or any other glucose lowering agents other than metformin. | percentage of hemoglobin A1c | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in C-peptide Area Under Curve (AUC 0-4 Hours ) Following Meal Test (Period II) | Baseline, Month 4 | The full analysis set included all randomized patients except for mis-randomized patients who inadvertently randomized into study and did not receive study drug. Last observation carried forward method was used for patients without Month 4 data for any reason and who used rescue medication or any other glucose lowering agents other than metformin. | nmol*hour/L | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Prandial Plasma Glucose Area Under Curve (AUC0-4 Hours ) Following Meal Test (Period II) | Baseline, Month 4 | The full analysis set included all randomized patients except for mis-randomized patients who inadvertently randomized into study and did not receive study drug. Last observation carried forward method was used for patients without Month 4 data for any reason and who used rescue medication or any other glucose lowering agents other than metformin. | mmol*hour/L | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Insulin Area Under Curve (AUC 0-4 Hours ) Following Meal Test (Period II) | Baseline, Month 4 | The full analysis set included all randomized patients except for mis-randomized patients who inadvertently randomized into study and did not receive study drug. Last observation carried forward method was used for patients without Month 4 data for any reason and who used rescue medication or any other glucose lowering agents other than metformin. | pmol*hour/L | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in 2-hour Glucose Level Following Meal Test (Period II) | Baseline, Month 4 | The full analysis set included all randomized patients except for mis-randomized patients who inadvertently randomized into study and did not receive study drug. Last observation carried forward method was used for patients without Month 4 data for any reason and who used rescue medication or any other glucose lowering agents other than metformin. | mmol/L | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Peak Glucose Level Following Meal Test (Period II) | Baseline, Month 4 | The full analysis set included all randomized patients except for mis-randomized patients who inadvertently randomized into study and did not receive study drug. Last observation carried forward method was used for patients without Month 4 data for any reason and who used rescue medication or any other glucose lowering agents other than metformin. | mmol/L | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Peak C-peptide Following Meal Test (Period II) | Baseline, Month 4 | The full analysis set included all randomized patients except for mis-randomized patients who inadvertently randomized into study and did not receive study drug. Last observation carried forward method was used for patients without Month 4 data for any reason and who used rescue medication or any other glucose lowering agents other than metformin. | nmol/L | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Peak Insulin Level Following Meal Test (Period II) | Baseline, Month 4 | The full analysis set included all randomized patients except for mis-randomized patients who inadvertently randomized into study and did not receive study drug. Last observation carried forward method was used for patients without Month 4 data for any reason and who used rescue medication or any other glucose lowering agents other than metformin. | pmol/L | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Insulin Secretion Rates Relative to Glucose AUC (0-2 Hours) at Month 4 Following Meal Test (Period II) | Baseline, Month 4 | The full analysis set included all randomized patients except for mis-randomized patients who inadvertently randomized into study and did not receive study drug. Last observation carried forward method was used for patients without Month 4 data for any reason and who used rescue medication or any other glucose lowering agents other than metformin. | pmol/min/m²/mmol *hour/L | LEAST_SQUARES_MEAN |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 outcomesResults by group135
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events (AEs), Serious Adverse Events, Death and Clinical Significant AEs During 4 Months (Period II) | Canakinumab 5 mg + Metformin | Any Adverse Events | 33 | Participants | |
| Number of Participants With Adverse Events (AEs), Serious Adverse Events, Death and Clinical Significant AEs During 4 Months (Period II) | Canakinumab 15 mg + Metformin | Any Adverse Events | 43 | Participants | |
| Number of Participants With Adverse Events (AEs), Serious Adverse Events, Death and Clinical Significant AEs During 4 Months (Period II) | Canakinumab 50 mg + Metformin | Any Adverse Events | 45 | Participants | |
| Number of Participants With Adverse Events (AEs), Serious Adverse Events, Death and Clinical Significant AEs During 4 Months (Period II) | Canakinumab 150 mg + Metformin | Any Adverse Events | 43 | Participants | |
| Number of Participants With Adverse Events (AEs), Serious Adverse Events, Death and Clinical Significant AEs During 4 Months (Period II) | Placebo + Metformin | Any Adverse Events | 76 | Participants | |
| Number of Participants With Adverse Events (AEs), Serious Adverse Events, Death and Clinical Significant AEs During 4 Months (Period II) | Canakinumab 5 mg + Metformin | Death | 0 | Participants | |
| Number of Participants With Adverse Events (AEs), Serious Adverse Events, Death and Clinical Significant AEs During 4 Months (Period II) | Canakinumab 15 mg + Metformin | Death | 0 | Participants | |
| Number of Participants With Adverse Events (AEs), Serious Adverse Events, Death and Clinical Significant AEs During 4 Months (Period II) | Canakinumab 50 mg + Metformin | Death | 0 | Participants | |
| Number of Participants With Adverse Events (AEs), Serious Adverse Events, Death and Clinical Significant AEs During 4 Months (Period II) | Canakinumab 150 mg + Metformin | Death | 0 | Participants | |
| Number of Participants With Adverse Events (AEs), Serious Adverse Events, Death and Clinical Significant AEs During 4 Months (Period II) | Placebo + Metformin | Death | 0 | Participants |
1 to 10 of 135Source ClinicalTrials.gov
See all 135 results by groupParticipant flow40
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Dose Finding: Period II (4 Months) | STARTED | Canakinumab 5 mg + Metformin | 93 | |
| Dose Finding: Period II (4 Months) | STARTED | Canakinumab 15 mg + Metformin | 95 | |
| Dose Finding: Period II (4 Months) | STARTED | Canakinumab 50 mg + Metformin | 92 | |
| Dose Finding: Period II (4 Months) | STARTED | Canakinumab 150 mg + Metformin | 92 | |
| Dose Finding: Period II (4 Months) | STARTED | Placebo + Metformin | 179 | |
| Dose Finding: Period II (4 Months) | Full Analysis Set (FAS)/Safety | Canakinumab 5 mg + Metformin | 93 | |
| Dose Finding: Period II (4 Months) | Full Analysis Set (FAS)/Safety | Canakinumab 15 mg + Metformin | 95 | |
| Dose Finding: Period II (4 Months) | Full Analysis Set (FAS)/Safety | Canakinumab 50 mg + Metformin | 92 | |
| Dose Finding: Period II (4 Months) | Full Analysis Set (FAS)/Safety | Canakinumab 150 mg + Metformin | 92 | |
| Dose Finding: Period II (4 Months) | Full Analysis Set (FAS)/Safety | Placebo + Metformin | 179 |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 participant flowAdverse events175
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 | Diarrhoea | Gastrointestinal disorders | Canakinumab 5 mg + Metformin | 2 | 93 | |
| other | Diarrhoea | Gastrointestinal disorders | Canakinumab 15 mg + Metformin | 2 | 95 | |
| other | Diarrhoea | Gastrointestinal disorders | Canakinumab 50 mg + Metformin | 5 | 92 | |
| other | Diarrhoea | Gastrointestinal disorders | Canakinumab 150 mg + Metformin | 0 | 92 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo + Metformin | 3 | 179 | |
| other | Nasopharyngitis | Infections and infestations | Canakinumab 5 mg + Metformin | 5 | 93 | |
| other | Nasopharyngitis | Infections and infestations | Canakinumab 15 mg + Metformin | 4 | 95 | |
| other | Nasopharyngitis | Infections and infestations | Canakinumab 50 mg + Metformin | 9 | 92 | |
| other | Nasopharyngitis | Infections and infestations | Canakinumab 150 mg + Metformin | 4 | 92 | |
| other | Nasopharyngitis | Infections and infestations | Placebo + Metformin | 15 | 179 |
1 to 10 of 175Source ClinicalTrials.gov
See all 175 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Canakinumab 5 mg + Metformin | ||
| Total, all-cause mortality | Canakinumab 15 mg + Metformin | ||
| Total, all-cause mortality | Canakinumab 50 mg + Metformin | ||
| Total, all-cause mortality | Canakinumab 150 mg + Metformin | ||
| Total, all-cause mortality | Placebo + Metformin | ||
| Total, other adverse events | Canakinumab 5 mg + Metformin | 9 | 93 |
| Total, other adverse events | Canakinumab 15 mg + Metformin | 9 | 95 |
| Total, other adverse events | Canakinumab 50 mg + Metformin | 15 | 92 |
| Total, other adverse events | Canakinumab 150 mg + Metformin | 8 | 92 |
| Total, other adverse events | Placebo + Metformin | 26 | 179 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers3
The papers the trial lists on ClinicalTrials.gov.
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/NCT00900146
GET https://conductscience.org/api/trials/v1/NCT00900146/registered?page=2