Clinical trial NCT01068860: 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
Overall status: COMPLETED
Phase: PHASE2
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
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-02-15
Enrollment: 246
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Mean Change in Meal Stimulated Insulin Secretion Rate (ISR) Relative to Glucose 0-2 Hours, From Baseline to 4 Weeks.
timeFrame: Baseline, 4 weeks
Secondary outcomes:
measure: Mean Change in Meal Stimulated Insulin Secretion Rate (ISR) Relative to Glucose 2-4 Hours, From Baseline to 4 Weeks
timeFrame: Baseline, 4 weeks
measure: Mean Change in Meal Stimulated Insulin Secretion Rate (ISR) Relative to Glucose 0-4 Hours, From Baseline to 4 Weeks.
timeFrame: Baseline, 4 weeks
measure: Mean Change in Fasting Plasma Glucose, From Baseline to 4 Weeks
timeFrame: Baseline, 4 weeks
measure: Mean Change in Fructosamine, From Baseline to 4 Weeks
timeFrame: Baseline, 4 weeks
measure: Mean Change in Fasting Plasma Insulin, From Baseline to 4 Weeks
timeFrame: Baseline, 4 weeks
measure: Mean Change in Quantitative Insulin Sensitivity Check Index (QUICKI) Score, From Baseline to 4 Weeks
timeFrame: Baseline, 4 weeks
measure: Mean Change in Fasting Glucose Disposition Index(GDI)1 and Index 2, From Baseline to 4 Weeks
timeFrame: Baseline, 4 weeks
measure: Mean Change in Absolute Glucose Level at 2 Hours, From Baseline to 4 Weeks
timeFrame: Baseline, 4 weeks
measure: Mean Change in Insulin Area Under the Curve (AUC) 0-4 Hours, From Baseline to 4 Weeks
timeFrame: Baseline, 4 weeks
measure: Mean Change in C-peptide Area Under the Curve (AUC), 0-4 Hours, From Baseline to 4 Weeks
timeFrame: Baseline, 4 weeks
measure: Mean Change in Post-prandial Glucose Area Under the Curve (AUC)0-4 Hours, From Baseline to 4 Weeks
timeFrame: Baseline, 4 weeks
measure: Mean Change in Peak Plasma Glucose, From Baseline to 4 Weeks
timeFrame: Baseline, 4 weeks
measure: Mean Change in Peak Plasma Insulin, From Baseline to 4 Weeks
timeFrame: Baseline, 4 weeks
measure: Mean Change in Peak Plasma C-peptide Level, From Baseline to 4 Weeks
timeFrame: Baseline, 4 weeks
measure: Number of Participants Reporting Death, Serious Adverse Events (SAEs) and Adverse Events (AEs) Above 5% Frequency, From Baseline to 4 Weeks
timeFrame: Baseline, 4 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: National Research Institute
state: California
city: Santa Ana
country: United States
facility: Crest Clinical Trials
state: California
city: Spring Valley
country: United States
facility: Encompass Clinical Research
state: California
city: Madisonville
country: United States
facility: Commonwealth Biomedical Research LLC
state: Kentucky
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Omaha
country: United States
facility: VA Medical Center
state: Nebraska
city: Fargo
country: United States
facility: Lillestol Research LLC
state: North Dakota
city: Pittsburgh
country: United States
facility: Preferred Primary Care Physicians
state: Pennsylvania
city: Dallas
country: United States
facility: Dallas Diabetes and Endocrine Center
state: Texas
city: Houston
country: United States
facility: Texas Center for Drug Development P.A.
state: Texas
city: Salt Lake City
country: United States
facility: Utah Clinical Trials
state: Utah
city: Geelong
country: Australia
facility: Barwon Health - Geelong Hospital
state: Victoria
city: Heidelberg Heights
country: Australia
facility: Austin Health - Heidelberg Repatriation Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Melbourne Health - Royal Melbourne Hospital
state: Victoria
city: Etobicoke
country: Canada
facility: Lifestyle Metabolism Centre (Etobicoke)
state: Ontario
city: Markham
country: Canada
facility: LMC Endocrinology Centres (Markham) Ltd
state: Ontario
city: Thornhill
country: Canada
facility: LMC Endocrinology Centres (Thornhill) Ltd
state: Ontario
city: Laval
country: Canada
facility: Centre de recherche clinique de Laval
state: Quebec
city: Montreal
country: Canada
facility: Hôpital Maisonneuve-Rosemont
state: Quebec
city: Helsinki
country: Finland
facility: Lihavuustutkimusyksikkö
city: Helsinki
country: Finland
facility: Lääkärikeskus Mehiläinen Töölö
city: Oulu
country: Finland
facility: ODL Terveys Oy
city: Berlin
country: Germany
facility: Clintrial Berlin Praxis fuer medizinische Studien
city: Berlin
country: Germany
facility: Klinische Forschung Berlin-Buch Dr. Andrei Khariouzov
city: Duesseldorf
country: Germany
facility: "Sana Krankenhaus Gerresheim
city: Duisburg
country: Germany
facility: Gemeinschaftspraxis Dr. Ingo Zeissig
city: Essen
country: Germany
facility: Praxis Dr. Thorsten Rau
city: Falkensee
country: Germany
facility: Praxis Dr. med. Joerg Luedemann
city: Hildesheim
country: Germany
facility: Dr. Helmut Anderten Gemeinschaftspraxis Dres. Anderten und Krok
city: Karlsruhe
country: Germany
facility: Praxis Dr. Julia Chevts
city: Luebeck
country: Germany
facility: Pro Scientia Med
city: Muenster
country: Germany
facility: Praxis Dr. Winfried Keuthage
city: Neumuenster
country: Germany
facility: Praxis Dr. Uwe Boeckmann
city: Potsdam
country: Germany
facility: Dr. Klaus Funke IkFE Studiencenter Potsdam GMBH I.G.
city: Viernheim
country: Germany
facility: Praxis Dr. Gerhard Steinmaier
city: Wetzlar-Naunheim
country: Germany
facility: Praxis Dr. Reinhold U. Schneider
city: Visakhapatnam
country: India
facility: Visakha Diabetes & Endocrine Centre
state: AP
city: Bangalore
country: India
facility: Jnana Sanjeevini Medical Center
state: Kar
city: Banglore
country: India
facility: Bangalore Diabetes Hospital,
state: KAR
city: Trivandrum
country: India
facility: Health & Research Centre
state: Ker
city: Nagpur
country: India
facility: Indrayani Speciality Hospital,
state: Maharastra
city: Pune
country: India
facility: Sahyadri Hospital Bibewewadi Centre of Excellence for Diabetics
state: Mah
city: Indore
country: India
facility: Diabetes Thyroid Hormone Research Institute Pvt .Ltd.
state: MP
city: Chennai
country: India
facility: Madras Diabetes Research Foundation
state: TN
city: Bergamo
country: Italy
facility: Azienda Ospedaliera-Ospedali Riuniti di BergamoU
state: BG
city: Genova
country: Italy
facility: Az. Ospedaliera Universit. S.Martino-Universita degli Studi
state: GE
city: Milano
country: Italy
facility: Azienda Ospedaliera S. Paolo-Polo Universitario
state: MI
city: Milano
country: Italy
facility: Fondazione Centro San Raffaele del Monte Tabor-IRCCSUnità
state: Mi
city: Casorate Primo
country: Italy
facility: Az. Ospedaliera Della Prov.di Pavia
state: PV
city: Siena
country: Italy
facility: A.O.Universitaria Senese, Universita degli Studi di Siena
state: SI
city: Torino
country: Italy
facility: S.C.D.U. Endocrinologia e Malattie del Metabolismo
state: To
city: Roma
country: Italy
facility: Policlinico A.Gemelli - Univ.Cattolica del Sacro Cuore
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals Corporation
role: STUDY_DIRECTOR
References: