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

NCT01068860 | Completed Phase 2 Results

• 1 other identifier: CACZ885I2207
• Study Type: interventional
• Target: 246
• Locations: 7 countries
• Sites: 52

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

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

  Baseline, 4 weeks

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

  Baseline, 4 weeks

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

  Baseline, 4 weeks

• Mean Change in Fructosamine, From Baseline to 4 Weeks

  Baseline, 4 weeks

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

  Baseline, 4 weeks

Study Arms (10)

Canakinumab 150 mg + Metformin

EXPERIMENTAL

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

Placebo + Metformin

PLACEBO COMPARATOR

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

Canakinumab 150 mg + Metforimin + Sulfonylurea

EXPERIMENTAL

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

Placebo + Metforimin + Sulfonylurea

PLACEBO COMPARATOR

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

Canakinumab 150 mg + Met + Sulfonyl + Thiazolidinedione

EXPERIMENTAL

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

Placebo + Met + Sulfonyl + Thiazolidinedione

PLACEBO COMPARATOR

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

Canakinumab 150 mg + Insulin

EXPERIMENTAL

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

Placebo + Insulin

PLACEBO COMPARATOR

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

Canakinumab 150 mg in patients with IGT

EXPERIMENTAL

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

Placebo in patients with IGT

PLACEBO COMPARATOR

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

Interventions

Canakinumab 150 mg DRUG

Single subcutaneous injection of Canakinumab 150 mg.

Also known as: 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

Canakinumab 150 mg + Insulin; Canakinumab 150 mg + Met + Sulfonyl + Thiazolidinedione; Canakinumab 150 mg + Metforimin + Sulfonylurea; Canakinumab 150 mg + Metformin; Canakinumab 150 mg in patients with IGT

Placebo to Canakinumab DRUG

Single subcutaneous injection of Placebo to Canakinumab.

Also known as: 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

Placebo + Insulin; Placebo + Met + Sulfonyl + Thiazolidinedione; Placebo + Metforimin + Sulfonylurea; Placebo + Metformin; Placebo in patients with IGT

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis: lead

Study Sites (52)

National Research Institute

Los Angeles, California, United States

Location

Crest Clinical Trials

Santa Ana, California, United States

Location

Encompass Clinical Research

Spring Valley, California, United States

Location

Commonwealth Biomedical Research LLC

Madisonville, Kentucky, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, United States

Location

VA Medical Center

Omaha, Nebraska, United States

Location

Lillestol Research LLC

Fargo, North Dakota, United States

Location

Preferred Primary Care Physicians

Pittsburgh, Pennsylvania, United States

Location

Dallas Diabetes and Endocrine Center

Dallas, Texas, United States

Location

Texas Center for Drug Development P.A.

Houston, Texas, United States

Location

Utah Clinical Trials

Salt Lake City, Utah, United States

Location

Barwon Health - Geelong Hospital

Geelong, Victoria, Australia

Location

Austin Health - Heidelberg Repatriation Hospital

Heidelberg Heights, Victoria, Australia

Location

Melbourne Health - Royal Melbourne Hospital

Melbourne, Victoria, Australia

Location

Lifestyle Metabolism Centre (Etobicoke)

Etobicoke, Ontario, Canada

Location

LMC Endocrinology Centres (Markham) Ltd

Markham, Ontario, Canada

Location

LMC Endocrinology Centres (Thornhill) Ltd

Thornhill, Ontario, Canada

Location

Centre de recherche clinique de Laval

Laval, Quebec, Canada

Location

Hôpital Maisonneuve-Rosemont

Montreal, Quebec, Canada

Location

Lihavuustutkimusyksikkö

Helsinki, Finland

Location

Lääkärikeskus Mehiläinen Töölö

Helsinki, Finland

Location

ODL Terveys Oy

Oulu, Finland

Location

Clintrial Berlin Praxis fuer medizinische Studien

Berlin, Germany

Location

Klinische Forschung Berlin-Buch Dr. Andrei Khariouzov

Berlin, Germany

Location

Gemeinschaftspraxis Dr. Ingo Zeissig

Duisburg, Germany

Location

"Sana Krankenhaus Gerresheim

Düsseldorf, Germany

Location

Praxis Dr. Thorsten Rau

Essen, Germany

Location

Praxis Dr. med. Joerg Luedemann

Falkensee, Germany

Location

Dr. Helmut Anderten Gemeinschaftspraxis Dres. Anderten und Krok

Hildesheim, Germany

Location

Praxis Dr. Julia Chevts

Karlsruhe, Germany

Location

Pro Scientia Med

Lübeck, Germany

Location

Praxis Dr. Winfried Keuthage

Münster, Germany

Location

Praxis Dr. Uwe Boeckmann

Neumünster, Germany

Location

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

Potsdam, Germany

Location

Praxis Dr. Gerhard Steinmaier

Viernheim, Germany

Location

Praxis Dr. Reinhold U. Schneider

Wetzlar-Naunheim, Germany

Location

Visakha Diabetes & Endocrine Centre

Visakhapatnam, Andhra Pradesh, India

Location

Jnana Sanjeevini Medical Center

Bangalore, Kar, India

Location

Bangalore Diabetes Hospital,

Banglore, KAR, India

Location

Health & Research Centre

Trivandrum, Ker, India

Location

Diabetes Thyroid Hormone Research Institute Pvt .Ltd.

Indore, Madhya Pradesh, India

Location

Indrayani Speciality Hospital,

Nagpur, Maharashtra, India

Location

Sahyadri Hospital Bibewewadi Centre of Excellence for Diabetics

Pune, Mah, India

Location

Madras Diabetes Research Foundation

Chennai, Tamil Nadu, India

Location

Azienda Ospedaliera-Ospedali Riuniti di BergamoU

Bergamo, BG, Italy

Location

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

Genova, GE, Italy

Location

Azienda Ospedaliera S. Paolo-Polo Universitario

Milan, MI, Italy

Location

Fondazione Centro San Raffaele del Monte Tabor-IRCCSUnità

Milan, Mi, Italy

Location

Az. Ospedaliera Della Prov.di Pavia

Casorate Primo, PV, Italy

Location

Policlinico A.Gemelli - Univ.Cattolica del Sacro Cuore

Roma, Roma, Italy

Location

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

Siena, SI, Italy

Location

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

Torino, To, Italy

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Glucose Intolerance; Metabolic Syndrome

Interventions

canakinumab; Metformin; Chlorpropamide; Acetohexamide; Tolazamide; Tolbutamide; Glipizide; glimepiride; Glyburide; Troglitazone; Insulin; Insulin, Regular, Pork; Insulin Lispro; Insulin, Regular, Human

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperglycemia; Insulin Resistance; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Benzenesulfonamides; Sulfonamides; Amides; Sulfonylurea Compounds; Urea; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Thiazolidinediones; Thiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chromans; Benzopyrans; Pyrans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Insulin, Short-Acting

Results Point of Contact

• Title: Dr. Tom Thuren/Global Brand Medical Director
• Organization: Novartis Pharmaceuticals

tom.thuren@novartis.com

862-778-1828

Study Officials

• Novartis Pharmaceuticals Corporation

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 12, 2010
• First Posted: February 15, 2010
• Study Start: February 1, 2010
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: September 5, 2011
• Results First Posted: September 5, 2011

Record last verified: 2011-08

Locations

CA (5); DE (14); IN (8); US (11); IT (8); FI (3); AU (3)