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

NCT ID: NCT01068860

Last Updated: 2011-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 246 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2010-08-31

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.

Conditions

Type 2 Diabetes Mellitus; Impaired Glucose Tolerance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

Canakinumab 150 mg

Intervention Type: DRUG

Single subcutaneous injection of Canakinumab 150 mg.

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

Group Type: PLACEBO_COMPARATOR

Placebo to Canakinumab

Intervention Type: DRUG

Single subcutaneous injection of Placebo to Canakinumab.

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.

Group Type: EXPERIMENTAL

Canakinumab 150 mg

Intervention Type: DRUG

Single subcutaneous injection of Canakinumab 150 mg.

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.

Group Type: PLACEBO_COMPARATOR

Placebo to Canakinumab

Intervention Type: DRUG

Single subcutaneous injection of Placebo to Canakinumab.

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.

Group Type: EXPERIMENTAL

Canakinumab 150 mg

Intervention Type: DRUG

Single subcutaneous injection of Canakinumab 150 mg.

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.

Group Type: PLACEBO_COMPARATOR

Placebo to Canakinumab

Intervention Type: DRUG

Single subcutaneous injection of Placebo to Canakinumab.

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

Group Type: EXPERIMENTAL

Canakinumab 150 mg

Intervention Type: DRUG

Single subcutaneous injection of Canakinumab 150 mg.

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

Group Type: PLACEBO_COMPARATOR

Placebo to Canakinumab

Intervention Type: DRUG

Single subcutaneous injection of Placebo to Canakinumab.

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.

Group Type: EXPERIMENTAL

Canakinumab 150 mg

Intervention Type: DRUG

Single subcutaneous injection of Canakinumab 150 mg.

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.

Group Type: PLACEBO_COMPARATOR

Placebo to Canakinumab

Intervention Type: DRUG

Single subcutaneous injection of Placebo to Canakinumab.

Interventions

Canakinumab 150 mg

Single subcutaneous injection of Canakinumab 150 mg.

Intervention Type: DRUG

Placebo to Canakinumab

Single subcutaneous injection of Placebo to Canakinumab.

Intervention Type: DRUG

Other Intervention Names

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; 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

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: lead

Responsible Party

Novartis Pharmaceuticals

Principal Investigators

Novartis Pharmaceuticals Corporation

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

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

Gemeinschaftspraxis Dr. Ingo Zeissig

Duisburg, , Germany

"Sana Krankenhaus Gerresheim

Düsseldorf, , 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

Lübeck, , Germany

Praxis Dr. Winfried Keuthage

Münster, , Germany

Praxis Dr. Uwe Boeckmann

Neumünster, , 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, Andhra Pradesh, India

Jnana Sanjeevini Medical Center

Bangalore, Kar, India

Bangalore Diabetes Hospital,

Banglore, KAR, India

Health & Research Centre

Trivandrum, Ker, India

Diabetes Thyroid Hormone Research Institute Pvt .Ltd.

Indore, Madhya Pradesh, India

Indrayani Speciality Hospital,

Nagpur, Maharashtra, India

Sahyadri Hospital Bibewewadi Centre of Excellence for Diabetics

Pune, Mah, India

Madras Diabetes Research Foundation

Chennai, Tamil Nadu, 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

Milan, MI, Italy

Fondazione Centro San Raffaele del Monte Tabor-IRCCSUnità

Milan, Mi, Italy

Az. Ospedaliera Della Prov.di Pavia

Casorate Primo, PV, Italy

Policlinico A.Gemelli - Univ.Cattolica del Sacro Cuore

Roma, Roma, 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

Countries

United States; Australia; Canada; Finland; Germany; India; Italy

Other Identifiers

CACZ885I2207

Identifier Type: -

Identifier Source: org_study_id