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
Type 2 Diabetes Mellitus, Impaired Glucose Tolerance
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Type 2 Diabetes Mellitus, canakinumab, Pre diabetic, glucose intolerant, oral anti diabetic medication, insulin treatment, metabolic syndrome
Eligibility Criteria
Inclusion Criteria:
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
- HbA1c between 6.5% and 8%, inclusive, at Screening; this criterion does not apply to the IGT group
- Age from 18-74 years, inclusive, and of either sex
Exclusion Criteria:
- Type 1 diabetes or diabetes that is a result of pancreatic injury or other secondary forms of diabetes
- History or current findings of active pulmonary disease (e.g. tuberculosis, fungal diseases) as defined in the protocol:
- Known presence or suspicion of active or recurrent bacterial, fungal or viral infection at the time of enrollment proven.
Sites / Locations
- National Research Institute
- Crest Clinical Trials
- Encompass Clinical Research
- Commonwealth Biomedical Research LLC
- University of Nebraska Medical Center
- VA Medical Center
- Lillestol Research LLC
- Preferred Primary Care Physicians
- Dallas Diabetes and Endocrine Center
- Texas Center for Drug Development P.A.
- Utah Clinical Trials
- Barwon Health - Geelong Hospital
- Austin Health - Heidelberg Repatriation Hospital
- Melbourne Health - Royal Melbourne Hospital
- Lifestyle Metabolism Centre (Etobicoke)
- LMC Endocrinology Centres (Markham) Ltd
- LMC Endocrinology Centres (Thornhill) Ltd
- Centre de recherche clinique de Laval
- Hôpital Maisonneuve-Rosemont
- Lihavuustutkimusyksikkö
- Lääkärikeskus Mehiläinen Töölö
- ODL Terveys Oy
- Clintrial Berlin Praxis fuer medizinische Studien
- Klinische Forschung Berlin-Buch Dr. Andrei Khariouzov
- "Sana Krankenhaus Gerresheim
- Gemeinschaftspraxis Dr. Ingo Zeissig
- Praxis Dr. Thorsten Rau
- Praxis Dr. med. Joerg Luedemann
- Dr. Helmut Anderten Gemeinschaftspraxis Dres. Anderten und Krok
- Praxis Dr. Julia Chevts
- Pro Scientia Med
- Praxis Dr. Winfried Keuthage
- Praxis Dr. Uwe Boeckmann
- Dr. Klaus Funke IkFE Studiencenter Potsdam GMBH I.G.
- Praxis Dr. Gerhard Steinmaier
- Praxis Dr. Reinhold U. Schneider
- Visakha Diabetes & Endocrine Centre
- Jnana Sanjeevini Medical Center
- Bangalore Diabetes Hospital,
- Health & Research Centre
- Indrayani Speciality Hospital,
- Sahyadri Hospital Bibewewadi Centre of Excellence for Diabetics
- Diabetes Thyroid Hormone Research Institute Pvt .Ltd.
- Madras Diabetes Research Foundation
- Azienda Ospedaliera-Ospedali Riuniti di BergamoU
- Az. Ospedaliera Universit. S.Martino-Universita degli Studi
- Azienda Ospedaliera S. Paolo-Polo Universitario
- Fondazione Centro San Raffaele del Monte Tabor-IRCCSUnità
- Az. Ospedaliera Della Prov.di Pavia
- A.O.Universitaria Senese, Universita degli Studi di Siena
- S.C.D.U. Endocrinologia e Malattie del Metabolismo
- Policlinico A.Gemelli - Univ.Cattolica del Sacro Cuore
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Canakinumab 150 mg + Metformin
Placebo + Metformin
Canakinumab 150 mg + Metforimin + Sulfonylurea
Placebo + Metforimin + Sulfonylurea
Canakinumab 150 mg + Met + Sulfonyl + Thiazolidinedione
Placebo + Met + Sulfonyl + Thiazolidinedione
Canakinumab 150 mg + Insulin
Placebo + Insulin
Canakinumab 150 mg in patients with IGT
Placebo in patients with IGT
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
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
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.
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.
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.
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.
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
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
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.
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.