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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

Primary Purpose

Type 2 Diabetes Mellitus, Impaired Glucose Tolerance

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Canakinumab 150 mg

Placebo to Canakinumab

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

18 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

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

Arm Description

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 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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.

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

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

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

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.

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.

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.

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.

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

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.

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.

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.

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.

Full Information

NCT ID

NCT01068860

First Posted

February 12, 2010

Last Updated

August 3, 2011

Sponsor

Novartis

1. Study Identification

Unique Protocol Identification Number

NCT01068860

Brief 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

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 Type

Interventional

2. Study Status

Record Verification Date

August 2011

Overall Recruitment Status

Completed

Study Start Date

February 2010 (undefined)

Primary Completion Date

August 2010 (Actual)

Study Completion Date

August 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Novartis

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes Mellitus, Impaired Glucose Tolerance

Keywords

Type 2 Diabetes Mellitus, canakinumab, Pre diabetic, glucose intolerant, oral anti diabetic medication, insulin treatment, metabolic syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

246 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Canakinumab 150 mg + Metformin

Arm Type

Experimental

Arm Description

Arm Title

Placebo + Metformin

Arm Type

Placebo Comparator

Arm Description

Arm Title

Canakinumab 150 mg + Metforimin + Sulfonylurea

Arm Type

Experimental

Arm Description

Arm Title

Placebo + Metforimin + Sulfonylurea

Arm Type

Placebo Comparator

Arm Description

Arm Title

Canakinumab 150 mg + Met + Sulfonyl + Thiazolidinedione

Arm Type

Experimental

Arm Description

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.

Arm Title

Placebo + Met + Sulfonyl + Thiazolidinedione

Arm Type

Placebo Comparator

Arm Description

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.

Arm Title

Canakinumab 150 mg + Insulin

Arm Type

Experimental

Arm Description

Arm Title

Placebo + Insulin

Arm Type

Placebo Comparator

Arm Description

Arm Title

Canakinumab 150 mg in patients with IGT

Arm Type

Experimental

Arm Description

Arm Title

Placebo in patients with IGT

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Canakinumab 150 mg

Other Intervention Name(s)

ACZ885, Glucophage, Chlorpropramide, Diabinese, Acetohexamide, Dymelor, Tolazamise, Tolinase, Tolbutamise, Orinase, Glipizide, Glucotrol, Glimepiride, Amaryl, Glyburide, DiaBeta, Micronase, Glynase PresTab, Troglitazone, Rezulin, Insulin, Iletin, Novolin, Velosulin, Humalog, Humulin, Lente, Ultralente, NPH Iletin

Intervention Description

Single subcutaneous injection of Canakinumab 150 mg.

Intervention Type

Drug

Intervention Name(s)

Placebo to Canakinumab

Other Intervention Name(s)

Intervention Description

Single subcutaneous injection of Placebo to Canakinumab.

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Baseline, 4 weeks

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

Baseline, 4 weeks

Title

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

Description

Time Frame

Baseline, 4 weeks

Title

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

Description

Time Frame

Baseline, 4 weeks

Title

Mean Change in Fructosamine, From Baseline to 4 Weeks

Description

Time Frame

Baseline, 4 weeks

Title

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

Description

Time Frame

Baseline, 4 weeks

Title

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

Description

Time Frame

Baseline, 4 weeks

Title

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

Description

Time Frame

Baseline, 4 weeks

Title

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

Description

Time Frame

Baseline, 4 weeks

Title

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

Description

Time Frame

Baseline, 4 weeks

Title

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

Description

Time Frame

Baseline, 4 weeks

Title

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

Description

Time Frame

Baseline, 4 weeks

Title

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

Description

Time Frame

Baseline, 4 weeks

Title

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

Description

Time Frame

Baseline, 4 weeks

Title

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

Description

Time Frame

Baseline, 4 weeks

Title

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

Description

Time Frame

Baseline, 4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

74 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals Corporation

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

National Research Institute

City

Los Angeles

State/Province

California

Country

United States

Facility Name

Crest Clinical Trials

City

Santa Ana

State/Province

California

Country

United States

Facility Name

Encompass Clinical Research

City

Spring Valley

State/Province

California

Country

United States

Facility Name

Commonwealth Biomedical Research LLC

City

Madisonville

State/Province

Kentucky

Country

United States

Facility Name

University of Nebraska Medical Center

City

Omaha

State/Province

Nebraska

Country

United States

Facility Name

VA Medical Center

City

Omaha

State/Province

Nebraska

Country

United States

Facility Name

Lillestol Research LLC

City

Fargo

State/Province

North Dakota

Country

United States

Facility Name

Preferred Primary Care Physicians

City

Pittsburgh

State/Province

Pennsylvania

Country

United States

Facility Name

Dallas Diabetes and Endocrine Center

City

Dallas

State/Province

Texas

Country

United States

Facility Name

Texas Center for Drug Development P.A.

City

Houston

State/Province

Texas

Country

United States

Facility Name

Utah Clinical Trials

City

Salt Lake City

State/Province

Utah

Country

United States

Facility Name

Barwon Health - Geelong Hospital

City

Geelong

State/Province

Victoria

Country

Australia

Facility Name

Austin Health - Heidelberg Repatriation Hospital

City

Heidelberg Heights

State/Province

Victoria

Country

Australia

Facility Name

Melbourne Health - Royal Melbourne Hospital

City

Melbourne

State/Province

Victoria

Country

Australia

Facility Name

Lifestyle Metabolism Centre (Etobicoke)

City

Etobicoke

State/Province

Ontario

Country

Canada

Facility Name

LMC Endocrinology Centres (Markham) Ltd

City

Markham

State/Province

Ontario

Country

Canada

Facility Name

LMC Endocrinology Centres (Thornhill) Ltd

City

Thornhill

State/Province

Ontario

Country

Canada

Facility Name

Centre de recherche clinique de Laval

City

Laval

State/Province

Quebec

Country

Canada

Facility Name

Hôpital Maisonneuve-Rosemont

City

Montreal

State/Province

Quebec

Country

Canada

Facility Name

Lihavuustutkimusyksikkö

City

Helsinki

Country

Finland

Facility Name

Lääkärikeskus Mehiläinen Töölö

City

Helsinki

Country

Finland

Facility Name

ODL Terveys Oy

City

Oulu

Country

Finland

Facility Name

Clintrial Berlin Praxis fuer medizinische Studien

City

Berlin

Country

Germany

Facility Name

Klinische Forschung Berlin-Buch Dr. Andrei Khariouzov

City

Berlin

Country

Germany

Facility Name

"Sana Krankenhaus Gerresheim

City

Duesseldorf

Country

Germany

Facility Name

Gemeinschaftspraxis Dr. Ingo Zeissig

City

Duisburg

Country

Germany

Facility Name

Praxis Dr. Thorsten Rau

City

Essen

Country

Germany

Facility Name

Praxis Dr. med. Joerg Luedemann

City

Falkensee

Country

Germany

Facility Name

Dr. Helmut Anderten Gemeinschaftspraxis Dres. Anderten und Krok

City

Hildesheim

Country

Germany

Facility Name

Praxis Dr. Julia Chevts

City

Karlsruhe

Country

Germany

Facility Name

Pro Scientia Med

City

Luebeck

Country

Germany

Facility Name

Praxis Dr. Winfried Keuthage

City

Muenster

Country

Germany

Facility Name

Praxis Dr. Uwe Boeckmann

City

Neumuenster

Country

Germany

Facility Name

Dr. Klaus Funke IkFE Studiencenter Potsdam GMBH I.G.

City

Potsdam

Country

Germany

Facility Name

Praxis Dr. Gerhard Steinmaier

City

Viernheim

Country

Germany

Facility Name

Praxis Dr. Reinhold U. Schneider

City

Wetzlar-Naunheim

Country

Germany

Facility Name

Visakha Diabetes & Endocrine Centre

City

Visakhapatnam

State/Province

Country

India

Facility Name

Jnana Sanjeevini Medical Center

City

Bangalore

State/Province

Kar

Country

India

Facility Name

Bangalore Diabetes Hospital,

City

Banglore

State/Province

KAR

Country

India

Facility Name

Health & Research Centre

City

Trivandrum

State/Province

Ker

Country

India

Facility Name

Indrayani Speciality Hospital,

City

Nagpur

State/Province

Maharastra

Country

India

Facility Name

Sahyadri Hospital Bibewewadi Centre of Excellence for Diabetics

City

Pune

State/Province

Mah

Country

India

Facility Name

Diabetes Thyroid Hormone Research Institute Pvt .Ltd.

City

Indore

State/Province

Country

India

Facility Name

Madras Diabetes Research Foundation

City

Chennai

State/Province

Country

India

Facility Name

Azienda Ospedaliera-Ospedali Riuniti di BergamoU

City

Bergamo

State/Province

Country

Italy

Facility Name

Az. Ospedaliera Universit. S.Martino-Universita degli Studi

City

Genova

State/Province

Country

Italy

Facility Name

Azienda Ospedaliera S. Paolo-Polo Universitario

City

Milano

State/Province

Country

Italy

Facility Name

Fondazione Centro San Raffaele del Monte Tabor-IRCCSUnità

City

Milano

State/Province

Country

Italy

Facility Name

Az. Ospedaliera Della Prov.di Pavia

City

Casorate Primo

State/Province

Country

Italy

Facility Name

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

City

Siena

State/Province

Country

Italy

Facility Name

S.C.D.U. Endocrinologia e Malattie del Metabolismo

City

Torino

State/Province

Country

Italy

Facility Name

Policlinico A.Gemelli - Univ.Cattolica del Sacro Cuore

City

Roma

Country

Italy

12. IPD Sharing Statement

Learn more about this trial

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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