None listed
Conditions
Interventions
Group 1 Type of group
In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥
In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥
1000 mg daily (or lower dose if required by local regulations).
Sponsors
NOVARTIS BIOSCIENSES PERU S.A.,
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: • Patients must provide written informed consent before performing any study procedure. • Patients should have a documented diagnosis of type 2 diabetes confirmed by WHO criteria, either a GRA s 7.0 mmol / l (126 mg / dl) or a GR (post-prandial blood glucose) at 2 hours in the RTOG (carbohydrate tolerance test)> 11.1 mmol / l (200 mg / dl). • Not having received antidiabetic drug treatment (except for short-term courses of treatment with Insulin in connection with hospitalization, etc.) • Have an HbA1c between 7.5% and 11% (inclusive) in the selection visit analyzed by the Central Laboratory • Be eligible for metformin monotherapy • Being under treatment with metformin as stable monotherapy for at least three months in the National Team • Have an HbA1c between 7.0% and 9% (inclusive) in the selection visit analyzed by the Central Laboratory • Receive metformin as your first and only treatment with antidiabetic drugs (except for short-term courses of insulin treatment in connection with hospitalization, etc.) • Patients should have a fasting plasma glucose result 1000 mg (or less if local regulation does not allow 1000 mg / day). • Age 18-74 years, inclusive, and of any sex.
Exclusion criteria
Exclusion criteria: • Positive antibody-serum GAD analyzed by the Central Laboratory • Clinically significant TSH outside the normal range in the selection visit analyzed by the Central Laboratory • Renal function that indicates high risk for metformin use, including serum creatinine concentrations (> 1.5 mg / dl for men,> 1.4 mg / dl for women) or other evidence of abnormal creatinine clearance. • Alanine aminotransferase (ALT) and / or aspartate aminotransferase (ASI)> 2 X normal upper limit (LSN) in the Selection, confirmed with repeated measurement within one week. • History of positive result of the skin test for PPD, with positive chest x-ray and no end of treatment • A positive PPD skin test plus a positive chest x-ray during the selection period. • Requirement of antibiotic administration against latent tuberculosis (eg Isoniazide). Antibiotic treatment courses initiated before entering the study should not be terminated prematurely to allow inclusion in the study. • Known or suspected presence of bacterial, fungal or viral infection, active or recurrent, at the time of enrollment, including patients with evidence of Human Immunodeficiency Virus (HIV) infection, Hepatitis B and Hepatitis C infections (based on history and / or findings of the Central Lab). • Any surgical or hepatic, hematologic, pulmonary, infectious, autoimmune or gastrointestinal underlying condition that, at the discretion of the investigator,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name: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. Measure:Number of Participants With Adverse Events (AEs), Serious Adverse Events, Death and Clinical Significant AEs During 4 Months (Period II) Timepoints:4 months (Period II) ; Outcome name: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. Measure:Change From Baseline in Hemoglobin A1c (HbA1c) at Month 4 During Dose-finding Period of the Study (Period II) Timepoints:Baseline, Month 4 ; Outcome name:This was planned as interim analysis and was not conducted because the study was terminated in period III. Measure:Change From Baseline in Dynamic Phase Secreted Insulin Per Unit of Glucose Concentration (Φd) Over 4 Months (Period III) Timepoints:baseline, Over Month 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name: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. Measure:Change From Baseline in C-peptide Area Under Curve (AUC 0-4 Hours ) Following Meal Test (Period II) Timepoints:Baseline, Month 4 ; Outcome name: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. Measure:Change From Baseline in Prandial Plasma Glucose Area Under Curve (AUC0-4 Hours ) Following Meal Test (Period II) Timepoints:Baseline, Month 4 ; Outcome name: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 | — |
Countries
Argentina, Belgium, China, Germany, Hungary, India, Japan, Korea South, Peru, Romania, South Africa, Turkey, United Kindgdom, United States
Contacts
Public ContactGustabo Humberto Toribio Roca
NOVARTIS BIOSCIENCES PERU S.A.
Outcome results
None listed