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 Multi-center, Double-blind, Placebo-controlled, Randomized Study to Compare the Effect of a Subcutaneous Canakinumab Administration to Placebo in Patients With Impaired Glucose Tolerance or Patients With Type 2 Diabetes Treated 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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus; Impaired Glucose Tolerance
• Intervention / Treatment: Drug: Canakinumab 150 mg; Drug: Placebo to Canakinumab

• Study Type: Interventional
• Enrollment (Actual): 246
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Geelong, Victoria, Australia
      • Barwon Health - Geelong Hospital
    • Heidelberg Heights, Victoria, Australia
      • Austin Health - Heidelberg Repatriation Hospital
    • Melbourne, Victoria, Australia
      • Melbourne Health - Royal Melbourne Hospital
• Canada
  • Ontario
    • Etobicoke, Ontario, Canada
      • Lifestyle Metabolism Centre (Etobicoke)
    • Markham, Ontario, Canada
      • LMC Endocrinology Centres (Markham) Ltd
    • Thornhill, Ontario, Canada
      • LMC Endocrinology Centres (Thornhill) Ltd
  • Quebec
    • Laval, Quebec, Canada
      • Centre de Recherche Clinique de Laval
    • Montreal, Quebec, Canada
      • Hôpital Maisonneuve-Rosemont
• Finland
  • Helsinki, Finland
    • Lihavuustutkimusyksikkö
  • Helsinki, Finland
    • Lääkärikeskus Mehiläinen Töölö
  • Oulu, Finland
    • ODL Terveys Oy
• Germany
  • Berlin, Germany
    • Clintrial Berlin Praxis fuer medizinische Studien
  • Berlin, Germany
    • Klinische Forschung Berlin-Buch Dr. Andrei Khariouzov
  • Duesseldorf, Germany
    • "Sana Krankenhaus Gerresheim
  • Duisburg, Germany
    • Gemeinschaftspraxis Dr. Ingo Zeissig
  • Essen, Germany
    • Praxis Dr. Thorsten Rau
  • Falkensee, Germany
    • Praxis Dr. med. Joerg Luedemann
  • Hildesheim, Germany
    • Dr. Helmut Anderten Gemeinschaftspraxis Dres. Anderten und Krok
  • Karlsruhe, Germany
    • Praxis Dr. Julia Chevts
  • Luebeck, Germany
    • Pro Scientia med
  • Muenster, Germany
    • Praxis Dr. Winfried Keuthage
  • Neumuenster, Germany
    • Praxis Dr. Uwe Boeckmann
  • Potsdam, Germany
    • Dr. Klaus Funke IkFE Studiencenter Potsdam GMBH I.G.
  • Viernheim, Germany
    • Praxis Dr. Gerhard Steinmaier
  • Wetzlar-Naunheim, Germany
    • Praxis Dr. Reinhold U. Schneider
• India
  • AP
    • Visakhapatnam, AP, India
      • Visakha Diabetes & Endocrine Centre
  • KAR
    • Banglore, KAR, India
      • Bangalore Diabetes Hospital,
  • Kar
    • Bangalore, Kar, India
      • Jnana Sanjeevini Medical Center
  • Ker
    • Trivandrum, Ker, India
      • Health & Research Centre
  • MP
    • Indore, MP, India
      • Diabetes Thyroid Hormone Research Institute Pvt .Ltd.
  • Mah
    • Pune, Mah, India
      • Sahyadri Hospital Bibewewadi Centre of Excellence for Diabetics
  • Maharastra
    • Nagpur, Maharastra, India
      • Indrayani Speciality Hospital,
  • TN
    • Chennai, TN, India
      • Madras Diabetes Research Foundation
• Italy
  • Roma, Italy
    • Policlinico A.Gemelli - Univ.Cattolica del Sacro Cuore
  • BG
    • Bergamo, BG, Italy
      • Azienda Ospedaliera-Ospedali Riuniti di BergamoU
  • GE
    • Genova, GE, Italy
      • Az. Ospedaliera Universit. S.Martino-Universita degli Studi
  • MI
    • Milano, MI, Italy
      • Azienda Ospedaliera S. Paolo-Polo Universitario
  • Mi
    • Milano, Mi, Italy
      • Fondazione Centro San Raffaele del Monte Tabor-IRCCSUnità
  • PV
    • Casorate Primo, PV, Italy
      • Az. Ospedaliera Della Prov.di Pavia
  • SI
    • Siena, SI, Italy
      • A.O.Universitaria Senese, Universita degli Studi di Siena
  • To
    • Torino, To, Italy
      • S.C.D.U. Endocrinologia e Malattie del Metabolismo
• United States
  • California
    • Los Angeles, California, United States
      • National Research Institute
    • Santa Ana, California, United States
      • Crest Clinical Trials
    • Spring Valley, California, United States
      • Encompass Clinical Research
  • Kentucky
    • Madisonville, Kentucky, United States
      • Commonwealth Biomedical Research LLC
  • Nebraska
    • Omaha, Nebraska, United States
      • University of Nebraska Medical Center
    • Omaha, Nebraska, United States
      • VA Medical Center
  • North Dakota
    • Fargo, North Dakota, United States
      • Lillestol Research LLC
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States
      • Preferred Primary Care Physicians
  • Texas
    • Dallas, Texas, United States
      • Dallas Diabetes and Endocrine Center
    • Houston, Texas, United States
      • Texas Center for Drug Development P.A.
  • Utah
    • Salt Lake City, Utah, United States
      • Utah Clinical Trials

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 74 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patient must fulfill all criteria in one of the following groups:

   • Impaired Glucose Tolerance (IGT) as diagnosed per protocol and not on an anti-diabetic medicine during the study
   • Diagnosis of Type 2 diabetes in stable treatment with metformin
   • Diagnosis of Type 2 diabetes in stable treatment with metformin (at least 1000 mg/day) in combination with a sulfonylurea
   • Diagnosis of Type 2 diabetes in stable treatment with metformin (at least 1000 mg/day), sulfonylurea and thiazolidinedione combination therapy
   • Diagnosis of Type 2 diabetes in stable treatment with at least two insulin injections a day with or without metformin
2. HbA1c between 6.5% and 8%, inclusive, at Screening; this criterion does not apply to the IGT group
3. Age from 18-74 years, inclusive, and of either sex

Exclusion Criteria:

1. Type 1 diabetes or diabetes that is a result of pancreatic injury or other secondary forms of diabetes
2. History or current findings of active pulmonary disease (e.g. tuberculosis, fungal diseases) as defined in the protocol:
3. Known presence or suspicion of active or recurrent bacterial, fungal or viral infection at the time of enrollment proven.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

10

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Canakinumab 150 mg + Metformin; Eligible participants received a single subcutaneous injection Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening	Drug: Canakinumab 150 mg; Single subcutaneous injection of Canakinumab 150 mg.; Other Names: Amaryl; Humalog; ACZ885; Glucophage; Glucotrol; Micronase; Insulin; Humulin; Glimepiride; Orinase; Glipizide; Chlorpropramide; Diabinese; Acetohexamide; Dymelor; Tolazamise; Tolinase; Tolbutamise; Glyburide; DiaBeta; Glynase PresTab; Troglitazone; Rezulin; Iletin; Novolin; Velosulin; Lente; Ultralente; NPH Iletin
PLACEBO_COMPARATOR: Placebo + Metformin; Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening	Drug: Placebo to Canakinumab; Single subcutaneous injection of Placebo to Canakinumab.; Other Names: Amaryl; Humalog; ACZ885; Glucophage; Glucotrol; Micronase; Insulin; Humulin; Glimepiride; Orinase; Glipizide; Chlorpropramide; Diabinese; Acetohexamide; Dymelor; Tolazamise; Tolinase; Tolbutamise; Glyburide; DiaBeta; Glynase PresTab; Troglitazone; Rezulin; Iletin; Novolin; Velosulin; Lente; Ultralente; NPH Iletin
EXPERIMENTAL: Canakinumab 150 mg + Metforimin + Sulfonylurea; Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.	Drug: Canakinumab 150 mg; Single subcutaneous injection of Canakinumab 150 mg.; Other Names: Amaryl; Humalog; ACZ885; Glucophage; Glucotrol; Micronase; Insulin; Humulin; Glimepiride; Orinase; Glipizide; Chlorpropramide; Diabinese; Acetohexamide; Dymelor; Tolazamise; Tolinase; Tolbutamise; Glyburide; DiaBeta; Glynase PresTab; Troglitazone; Rezulin; Iletin; Novolin; Velosulin; Lente; Ultralente; NPH Iletin
PLACEBO_COMPARATOR: Placebo + Metforimin + Sulfonylurea; Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.	Drug: Placebo to Canakinumab; Single subcutaneous injection of Placebo to Canakinumab.; Other Names: Amaryl; Humalog; ACZ885; Glucophage; Glucotrol; Micronase; Insulin; Humulin; Glimepiride; Orinase; Glipizide; Chlorpropramide; Diabinese; Acetohexamide; Dymelor; Tolazamise; Tolinase; Tolbutamise; Glyburide; DiaBeta; Glynase PresTab; Troglitazone; Rezulin; Iletin; Novolin; Velosulin; Lente; Ultralente; NPH Iletin
EXPERIMENTAL: Canakinumab 150 mg + Met + Sulfonyl + Thiazolidinedione; Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.	Drug: Canakinumab 150 mg; Single subcutaneous injection of Canakinumab 150 mg.; Other Names: Amaryl; Humalog; ACZ885; Glucophage; Glucotrol; Micronase; Insulin; Humulin; Glimepiride; Orinase; Glipizide; Chlorpropramide; Diabinese; Acetohexamide; Dymelor; Tolazamise; Tolinase; Tolbutamise; Glyburide; DiaBeta; Glynase PresTab; Troglitazone; Rezulin; Iletin; Novolin; Velosulin; Lente; Ultralente; NPH Iletin
PLACEBO_COMPARATOR: Placebo + Met + Sulfonyl + Thiazolidinedione; Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.	Drug: Placebo to Canakinumab; Single subcutaneous injection of Placebo to Canakinumab.; Other Names: Amaryl; Humalog; ACZ885; Glucophage; Glucotrol; Micronase; Insulin; Humulin; Glimepiride; Orinase; Glipizide; Chlorpropramide; Diabinese; Acetohexamide; Dymelor; Tolazamise; Tolinase; Tolbutamise; Glyburide; DiaBeta; Glynase PresTab; Troglitazone; Rezulin; Iletin; Novolin; Velosulin; Lente; Ultralente; NPH Iletin
EXPERIMENTAL: Canakinumab 150 mg + Insulin; Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening	Drug: Canakinumab 150 mg; Single subcutaneous injection of Canakinumab 150 mg.; Other Names: Amaryl; Humalog; ACZ885; Glucophage; Glucotrol; Micronase; Insulin; Humulin; Glimepiride; Orinase; Glipizide; Chlorpropramide; Diabinese; Acetohexamide; Dymelor; Tolazamise; Tolinase; Tolbutamise; Glyburide; DiaBeta; Glynase PresTab; Troglitazone; Rezulin; Iletin; Novolin; Velosulin; Lente; Ultralente; NPH Iletin
PLACEBO_COMPARATOR: Placebo + Insulin; Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening	Drug: Placebo to Canakinumab; Single subcutaneous injection of Placebo to Canakinumab.; Other Names: Amaryl; Humalog; ACZ885; Glucophage; Glucotrol; Micronase; Insulin; Humulin; Glimepiride; Orinase; Glipizide; Chlorpropramide; Diabinese; Acetohexamide; Dymelor; Tolazamise; Tolinase; Tolbutamise; Glyburide; DiaBeta; Glynase PresTab; Troglitazone; Rezulin; Iletin; Novolin; Velosulin; Lente; Ultralente; NPH Iletin
EXPERIMENTAL: Canakinumab 150 mg in patients with IGT; Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.	Drug: Canakinumab 150 mg; Single subcutaneous injection of Canakinumab 150 mg.; Other Names: Amaryl; Humalog; ACZ885; Glucophage; Glucotrol; Micronase; Insulin; Humulin; Glimepiride; Orinase; Glipizide; Chlorpropramide; Diabinese; Acetohexamide; Dymelor; Tolazamise; Tolinase; Tolbutamise; Glyburide; DiaBeta; Glynase PresTab; Troglitazone; Rezulin; Iletin; Novolin; Velosulin; Lente; Ultralente; NPH Iletin
PLACEBO_COMPARATOR: Placebo in patients with IGT; Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.	Drug: Placebo to Canakinumab; Single subcutaneous injection of Placebo to Canakinumab.; Other Names: Amaryl; Humalog; ACZ885; Glucophage; Glucotrol; Micronase; Insulin; Humulin; Glimepiride; Orinase; Glipizide; Chlorpropramide; Diabinese; Acetohexamide; Dymelor; Tolazamise; Tolinase; Tolbutamise; Glyburide; DiaBeta; Glynase PresTab; Troglitazone; Rezulin; Iletin; Novolin; Velosulin; Lente; Ultralente; NPH Iletin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Novartis

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (ACTUAL): August 1, 2010
• Study Completion (ACTUAL): August 1, 2010

Study Registration Dates

• First Submitted: February 12, 2010
• First Submitted That Met QC Criteria: February 12, 2010
• First Posted (ESTIMATE): February 15, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): September 5, 2011
• Last Update Submitted That Met QC Criteria: August 3, 2011
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Keywords: metabolic syndrome; insulin treatment; Type 2 Diabetes Mellitus; canakinumab; Pre diabetic; glucose intolerant; oral anti diabetic medication
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Hyperglycemia; Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Intolerance; Hypoglycemic Agents; Physiological Effects of Drugs; Anti-Arrhythmia Agents; Immunosuppressive Agents; Immunologic Factors; Insulin; Insulin, Globin Zinc; Metformin; Antibodies, Monoclonal; Insulin Lispro; Glimepiride; Glipizide; Glyburide; Insulin, Isophane; Tolbutamide; Insulin, Regular, Pork; Chlorpropamide; Troglitazone; Acetohexamide; Tolazamide
• Other Study ID Numbers: CACZ885I2207