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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

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Type 2 Diabetes Mellitus; Impaired Glucose Tolerance

Intervention: Canakinumab 150 mg (Drug); Placebo to Canakinumab (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals Corporation, Study Director, Affiliation: Novartis Pharmaceuticals

Summary

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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Mean Change in Meal Stimulated Insulin Secretion Rate (ISR) Relative to Glucose 0-2 Hours, From Baseline to 4 Weeks.

Secondary outcome:

Mean Change in Meal Stimulated Insulin Secretion Rate (ISR) Relative to Glucose 2-4 Hours, From Baseline to 4 Weeks

Mean Change in Meal Stimulated Insulin Secretion Rate (ISR) Relative to Glucose 0-4 Hours, From Baseline to 4 Weeks.

Mean Change in Fasting Plasma Glucose, From Baseline to 4 Weeks

Mean Change in Fructosamine, From Baseline to 4 Weeks

Mean Change in Fasting Plasma Insulin, From Baseline to 4 Weeks

Mean Change in Quantitative Insulin Sensitivity Check Index (QUICKI) Score, From Baseline to 4 Weeks

Mean Change in Fasting Glucose Disposition Index(GDI)1 and Index 2, From Baseline to 4 Weeks

Mean Change in Absolute Glucose Level at 2 Hours, From Baseline to 4 Weeks

Mean Change in Insulin Area Under the Curve (AUC) 0-4 Hours, From Baseline to 4 Weeks

Mean Change in C-peptide Area Under the Curve (AUC), 0-4 Hours, From Baseline to 4 Weeks

Mean Change in Post-prandial Glucose Area Under the Curve (AUC)0-4 Hours, From Baseline to 4 Weeks

Mean Change in Peak Plasma Glucose, From Baseline to 4 Weeks

Mean Change in Peak Plasma Insulin, From Baseline to 4 Weeks

Mean Change in Peak Plasma C-peptide Level, From Baseline to 4 Weeks

Number of Participants Reporting Death, Serious Adverse Events (SAEs) and Adverse Events (AEs) Above 5% Frequency, From Baseline to 4 Weeks

Eligibility

Minimum age: 18 Years. Maximum age: 74 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

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

Policlinico A.Gemelli - Univ.Cattolica del Sacro Cuore, Roma, Italy

Visakha Diabetes & Endocrine Centre, Visakhapatnam, AP, India

Azienda Ospedaliera-Ospedali Riuniti di BergamoU, Bergamo, BG, Italy

National Research Institute, Los Angeles, California, United States

Crest Clinical Trials, Santa Ana, California, United States

Encompass Clinical Research, Spring Valley, California, United States

Az. Ospedaliera Universit. S.Martino-Universita degli Studi, Genova, GE, Italy

Bangalore Diabetes Hospital,, Banglore, KAR, India

Jnana Sanjeevini Medical Center, Bangalore, Kar, India

Commonwealth Biomedical Research LLC, Madisonville, Kentucky, United States

Health & Research Centre, Trivandrum, Ker, India

Azienda Ospedaliera S. Paolo-Polo Universitario, Milano, MI, Italy

Diabetes Thyroid Hormone Research Institute Pvt .Ltd., Indore, MP, India

Sahyadri Hospital Bibewewadi Centre of Excellence for Diabetics, Pune, Mah, India

Indrayani Speciality Hospital,, Nagpur, Maharastra, India

Fondazione Centro San Raffaele del Monte Tabor-IRCCSUnità, Milano, Mi, Italy

University of Nebraska Medical Center, Omaha, Nebraska, United States

VA Medical Center, Omaha, Nebraska, United States

Lillestol Research LLC, Fargo, North Dakota, United States

Lifestyle Metabolism Centre (Etobicoke), Etobicoke, Ontario, Canada

LMC Endocrinology Centres (Markham) Ltd, Markham, Ontario, Canada

LMC Endocrinology Centres (Thornhill) Ltd, Thornhill, Ontario, Canada

Az. Ospedaliera Della Prov.di Pavia, Casorate Primo, PV, Italy

Preferred Primary Care Physicians, Pittsburgh, Pennsylvania, United States

Centre de recherche clinique de Laval, Laval, Quebec, Canada

Hôpital Maisonneuve-Rosemont, Montreal, Quebec, Canada

A.O.Universitaria Senese, Universita degli Studi di Siena, Siena, SI, Italy

Madras Diabetes Research Foundation, Chennai, TN, India

Dallas Diabetes and Endocrine Center, Dallas, Texas, United States

Texas Center for Drug Development P.A., Houston, Texas, United States

S.C.D.U. Endocrinologia e Malattie del Metabolismo, Torino, To, Italy

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

Additional Information

Starting date: February 2010
Last updated: August 3, 2011

Page last updated: August 23, 2015

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