| Trial ID: | L2485 |
| Source ID: | NCT01068860
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| Associated Drug: |
Canakinumab 150 Mg
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| 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
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| Acronym: |
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| Status: |
COMPLETED
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| Study Results: |
YES
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| Results: |
https://ClinicalTrials.gov/show/NCT01068860/results
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| Conditions: |
Type 2 Diabetes Mellitus|Impaired Glucose Tolerance
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| Interventions: |
DRUG: Canakinumab 150 mg|DRUG: Placebo to Canakinumab
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| Outcome Measures: |
Primary: Mean Change in Meal Stimulated Insulin Secretion Rate (ISR) Relative to Glucose 0-2 Hours, From Baseline to 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, Baseline, 4 weeks | Secondary: Mean Change in Meal Stimulated Insulin Secretion Rate (ISR) Relative to Glucose 2-4 Hours, From Baseline to 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, Baseline, 4 weeks|Mean Change in Meal Stimulated Insulin Secretion Rate (ISR) Relative to Glucose 0-4 Hours, From Baseline to 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., Baseline, 4 weeks|Mean Change in Fasting Plasma Glucose, From Baseline to 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, Baseline, 4 weeks|Mean Change in Fructosamine, From Baseline to 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, Baseline, 4 weeks|Mean Change in Fasting Plasma Insulin, From Baseline to 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, Baseline, 4 weeks|Mean Change in Quantitative Insulin Sensitivity Check Index (QUICKI) Score, From Baseline to 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., Baseline, 4 weeks|Mean Change in Fasting Glucose Disposition Index(GDI)1 and Index 2, From Baseline to 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., Baseline, 4 weeks|Mean Change in Absolute Glucose Level at 2 Hours, From Baseline to 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., Baseline, 4 weeks|Mean Change in Insulin Area Under the Curve (AUC) 0-4 Hours, From Baseline to 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., Baseline, 4 weeks|Mean Change in C-peptide Area Under the Curve (AUC), 0-4 Hours, From Baseline to 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., Baseline, 4 weeks|Mean Change in Post-prandial Glucose Area Under the Curve (AUC)0-4 Hours, From Baseline to 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., Baseline, 4 weeks|Mean Change in Peak Plasma Glucose, From Baseline to 4 Weeks, Change in peak plasma glucose level as measured from Baseline to 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., Baseline, 4 weeks|Mean Change in Peak Plasma Insulin, From Baseline to 4 Weeks, Change in mean peak plasma Insulin level as measured from Baseline to 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., Baseline, 4 weeks|Mean Change in Peak Plasma C-peptide Level, From Baseline to 4 Weeks, Change in mean peak plasma C-peptide level measured from Baseline to 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., Baseline, 4 weeks|Number of Participants Reporting Death, Serious Adverse Events (SAEs) and Adverse Events (AEs) Above 5% Frequency, From Baseline to 4 Weeks, An adverse event is any unwanted event, whether related to study drug or not occuring during the study period. A Serious Adverse Event (SAE) is an event resulting in death, requiring or prolonging hospitalization, a congenital anomaly or other important medical event. AEs and SAEs were recorded at each visit., Baseline, 4 weeks
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| Sponsor/Collaborators: |
Sponsor: Novartis
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
PHASE2
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| Enrollment: |
246
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| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
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| Start Date: |
2010-02
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| Completion Date: |
2010-08
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| Results First Posted: |
2011-09-05
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| Last Update Posted: |
2011-09-05
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| Locations: |
National Research Institute, Los Angeles, California, United States|Crest Clinical Trials, Santa Ana, California, United States|Encompass Clinical Research, Spring Valley, California, United States|Commonwealth Biomedical Research LLC, Madisonville, Kentucky, United States|University of Nebraska Medical Center, Omaha, Nebraska, United States|VA Medical Center, Omaha, Nebraska, United States|Lillestol Research LLC, Fargo, North Dakota, United States|Preferred Primary Care Physicians, Pittsburgh, Pennsylvania, United States|Dallas Diabetes and Endocrine Center, Dallas, Texas, United States|Texas Center for Drug Development P.A., Houston, Texas, United States|Utah Clinical Trials, Salt Lake City, Utah, United States|Barwon Health - Geelong Hospital, Geelong, Victoria, Australia|Austin Health - Heidelberg Repatriation Hospital, Heidelberg Heights, Victoria, Australia|Melbourne Health - Royal Melbourne Hospital, Melbourne, Victoria, Australia|Lifestyle Metabolism Centre (Etobicoke), Etobicoke, Ontario, Canada|LMC Endocrinology Centres (Markham) Ltd, Markham, Ontario, Canada|LMC Endocrinology Centres (Thornhill) Ltd, Thornhill, Ontario, Canada|Centre de recherche clinique de Laval, Laval, Quebec, Canada|Hôpital Maisonneuve-Rosemont, Montreal, Quebec, Canada|Lihavuustutkimusyksikkö, Helsinki, Finland|Lääkärikeskus Mehiläinen Töölö, Helsinki, Finland|ODL Terveys Oy, Oulu, Finland|Clintrial Berlin Praxis fuer medizinische Studien, Berlin, Germany|Klinische Forschung Berlin-Buch Dr. Andrei Khariouzov, Berlin, Germany|"Sana Krankenhaus Gerresheim, Duesseldorf, Germany|Gemeinschaftspraxis Dr. Ingo Zeissig, Duisburg, Germany|Praxis Dr. Thorsten Rau, Essen, Germany|Praxis Dr. med. Joerg Luedemann, Falkensee, Germany|Dr. Helmut Anderten Gemeinschaftspraxis Dres. Anderten und Krok, Hildesheim, Germany|Praxis Dr. Julia Chevts, Karlsruhe, Germany|Pro Scientia Med, Luebeck, Germany|Praxis Dr. Winfried Keuthage, Muenster, Germany|Praxis Dr. Uwe Boeckmann, Neumuenster, Germany|Dr. Klaus Funke IkFE Studiencenter Potsdam GMBH I.G., Potsdam, Germany|Praxis Dr. Gerhard Steinmaier, Viernheim, Germany|Praxis Dr. Reinhold U. Schneider, Wetzlar-Naunheim, Germany|Visakha Diabetes & Endocrine Centre, Visakhapatnam, AP, India|Jnana Sanjeevini Medical Center, Bangalore, Kar, India|Bangalore Diabetes Hospital,, Banglore, KAR, India|Health & Research Centre, Trivandrum, Ker, India|Indrayani Speciality Hospital,, Nagpur, Maharastra, India|Sahyadri Hospital Bibewewadi Centre of Excellence for Diabetics, Pune, Mah, India|Diabetes Thyroid Hormone Research Institute Pvt .Ltd., Indore, MP, India|Madras Diabetes Research Foundation, Chennai, TN, India|Azienda Ospedaliera-Ospedali Riuniti di BergamoU, Bergamo, BG, Italy|Az. Ospedaliera Universit. S.Martino-Universita degli Studi, Genova, GE, Italy|Azienda Ospedaliera S. Paolo-Polo Universitario, Milano, MI, Italy|Fondazione Centro San Raffaele del Monte Tabor-IRCCSUnità, Milano, Mi, Italy|Az. Ospedaliera Della Prov.di Pavia, Casorate Primo, PV, Italy|A.O.Universitaria Senese, Universita degli Studi di Siena, Siena, SI, Italy|S.C.D.U. Endocrinologia e Malattie del Metabolismo, Torino, To, Italy|Policlinico A.Gemelli - Univ.Cattolica del Sacro Cuore, Roma, Italy
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| URL: |
https://clinicaltrials.gov/show/NCT01068860
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