Type 2 Diabetes MellitusPhase 2NCT01068860
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
A Phase 2 study testing Canakinumab 150 mg in people with Type 2 Diabetes Mellitus and Impaired Glucose Tolerance, run by Novartis at 52 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, Impaired Glucose Tolerance
- What is being tested?
- Canakinumab 150 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 246 participants
- Where
- 52 sitesin 7 countries
- Study dates
- Feb 2010to Aug 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
52 sites in 7 countries.
52 sites in 7 countries
Germany14 sites
Clintrial Berlin Praxis fuer medizinische Studien
Berlin
Klinische Forschung Berlin-Buch Dr. Andrei Khariouzov
Berlin
Gemeinschaftspraxis Dr. Ingo Zeissig
Duisburg
"Sana Krankenhaus Gerresheim
Düsseldorf
Praxis Dr. Thorsten Rau
Essen
Praxis Dr. med. Joerg Luedemann
Falkensee
Dr. Helmut Anderten Gemeinschaftspraxis Dres. Anderten und Krok
Hildesheim
Praxis Dr. Julia Chevts
Karlsruhe
Pro Scientia Med
Lübeck
Praxis Dr. Winfried Keuthage
Münster
Praxis Dr. Uwe Boeckmann
Neumünster
Dr. Klaus Funke IkFE Studiencenter Potsdam GMBH I.G.
Potsdam
Praxis Dr. Gerhard Steinmaier
Viernheim
Praxis Dr. Reinhold U. Schneider
Wetzlar-Naunheim
United States11 sites
Dallas Diabetes and Endocrine Center
Dallas, Texas
Lillestol Research LLC
Fargo, North Dakota
Texas Center for Drug Development P.A.
Houston, Texas
National Research Institute
Los Angeles, California
Commonwealth Biomedical Research LLC
Madisonville, Kentucky
University of Nebraska Medical Center
Omaha, Nebraska
VA Medical Center
Omaha, Nebraska
Preferred Primary Care Physicians
Pittsburgh, Pennsylvania
Utah Clinical Trials
Salt Lake City, Utah
Crest Clinical Trials
Santa Ana, California
Encompass Clinical Research
Spring Valley, California
India8 sites
Jnana Sanjeevini Medical Center
Bangalore, Kar
Bangalore Diabetes Hospital,
Banglore, KAR
Madras Diabetes Research Foundation
Chennai, Tamil Nadu
Diabetes Thyroid Hormone Research Institute Pvt .Ltd.
Indore, Madhya Pradesh
Indrayani Speciality Hospital,
Nagpur, Maharashtra
Sahyadri Hospital Bibewewadi Centre of Excellence for Diabetics
Pune, Mah
Health & Research Centre
Trivandrum, Ker
Visakha Diabetes & Endocrine Centre
Visakhapatnam, Andhra Pradesh
Italy8 sites
Azienda Ospedaliera-Ospedali Riuniti di BergamoU
Bergamo, BG
Az. Ospedaliera Della Prov.di Pavia
Casorate Primo, PV
Az. Ospedaliera Universit. S.Martino-Universita degli Studi
Genova, GE
Azienda Ospedaliera S. Paolo-Polo Universitario
Milan, MI
Fondazione Centro San Raffaele del Monte Tabor-IRCCSUnità
Milan, Mi
Policlinico A.Gemelli - Univ.Cattolica del Sacro Cuore
Roma, Roma
A.O.Universitaria Senese, Universita degli Studi di Siena
Siena, SI
S.C.D.U. Endocrinologia e Malattie del Metabolismo
Torino, To
Canada5 sites
Lifestyle Metabolism Centre (Etobicoke)
Etobicoke, Ontario
Centre de recherche clinique de Laval
Laval, Quebec
LMC Endocrinology Centres (Markham) Ltd
Markham, Ontario
Hôpital Maisonneuve-Rosemont
Montreal, Quebec
LMC Endocrinology Centres (Thornhill) Ltd
Thornhill, Ontario
Australia3 sites
Barwon Health - Geelong Hospital
Geelong, Victoria
Austin Health - Heidelberg Repatriation Hospital
Heidelberg Heights, Victoria
Melbourne Health - Royal Melbourne Hospital
Melbourne, Victoria
Finland3 sites
Lihavuustutkimusyksikkö
Helsinki
Lääkärikeskus Mehiläinen Töölö
Helsinki
ODL Terveys Oy
Oulu
About this study
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
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.
- Being tested
- Canakinumab 150 mg, Placebo to Canakinumab
- Keywords
- Type 2 Diabetes Mellitus, canakinumab, Pre diabetic, glucose intolerant, oral anti diabetic medication, insulin treatment, metabolic syndrome
- Medical subject headings
- Diabetes Mellitus, Type 2, Glucose Intolerance, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Canakinumab 150 mgDrug
Also called ACZ885, Glucophage, Chlorpropramide, Diabinese
Single subcutaneous injection of Canakinumab 150 mg.
Placebo to CanakinumabDrug
Also called ACZ885, Glucophage, Chlorpropramide, Diabinese
Single subcutaneous injection of Placebo to Canakinumab.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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 Receives: 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 Receives: 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. Receives: 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. Receives: Drug: Placebo to Canakinumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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
Measured: Baseline, 4 weeks
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.
Measured: Baseline, 4 weeks
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
Measured: Baseline, 4 weeks
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
Measured: Baseline, 4 weeks
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
Measured: Baseline, 4 weeks
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.
Measured: Baseline, 4 weeks
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.
Measured: Baseline, 4 weeks
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.
Measured: Baseline, 4 weeks
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.
Measured: Baseline, 4 weeks
Mean Change in C-peptide 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.
Measured: Baseline, 4 weeks
Mean Change in Post-prandial Glucose 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.
Measured: Baseline, 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.
Measured: Baseline, 4 weeks
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.
Measured: Baseline, 4 weeks
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.
Measured: Baseline, 4 weeks
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.
Measured: Baseline, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 246 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis Pharmaceuticals Corporation, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01068860
- Sponsor's protocol ID
- CACZ885I2207
- Status last verified
- Aug 2011
- First submitted
- 12 Feb 2010
- Last updated
- 5 Sep 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01068860
- Acronym / sponsor ID
- CACZ885I2207
- Keywords
- Type 2 Diabetes Mellitus, canakinumab, Pre diabetic, glucose intolerant, oral anti diabetic medication, insulin treatment, metabolic syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 246 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 15 Feb 2010 (estimated)
- Results
- Posted 5 Sep 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Canakinumab 150 mg + Metformin | Experimental | Drug: Canakinumab 150 mgEligible 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 |
| Placebo + Metformin | Placebo comparator | Drug: Placebo to CanakinumabEligible 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 |
| Canakinumab 150 mg + Metforimin + Sulfonylurea | Experimental | Drug: Canakinumab 150 mgEligible 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. |
| Placebo + Metforimin + Sulfonylurea | Placebo comparator | Drug: Placebo to CanakinumabEligible 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. |
| Canakinumab 150 mg + Met + Sulfonyl + Thiazolidinedione | Experimental | Drug: Canakinumab 150 mgEligible 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. |
| Placebo + Met + Sulfonyl + Thiazolidinedione | Placebo comparator | Drug: Placebo to CanakinumabEligible 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. |
| Canakinumab 150 mg + Insulin | Experimental | Drug: Canakinumab 150 mgEligible 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 |
| Placebo + Insulin | Placebo comparator | Drug: Placebo to CanakinumabEligible 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 |
| Canakinumab 150 mg in patients with IGT | Experimental | Drug: Canakinumab 150 mgEligible 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. |
| Placebo in patients with IGT | Placebo comparator | Drug: Placebo to CanakinumabEligible 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. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient must fulfill all criteria in one of the following groups:
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Canakinumab 150 mgAlso: ACZ885, Glucophage, Chlorpropramide, DiabineseSingle subcutaneous injection of Canakinumab 150 mg. | Drug | 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 CanakinumabAlso: ACZ885, Glucophage, Chlorpropramide, DiabineseSingle subcutaneous injection of Placebo to Canakinumab. | Drug | Placebo + Insulin, Placebo + Met + Sulfonyl + Thiazolidinedione, Placebo + Metforimin + Sulfonylurea, Placebo + Metformin, Placebo in patients with IGT |
Primary outcome
Mean Change in Meal Stimulated Insulin Secretion Rate (ISR) Relative to Glucose 0-2 Hours, From Baseline to 4 Weeks.
Time frame: Baseline, 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
15 secondary outcomes
Mean Change in Meal Stimulated Insulin Secretion Rate (ISR) Relative to Glucose 2-4 Hours, From Baseline to 4 Weeks
Time frame: Baseline, 4 weeks
Mean Change in Meal Stimulated Insulin Secretion Rate (ISR) Relative to Glucose 0-4 Hours, From Baseline to 4 Weeks.
Time frame: Baseline, 4 weeks
Mean Change in Fasting Plasma Glucose, From Baseline to 4 Weeks
Time frame: Baseline, 4 weeks
Mean Change in Fructosamine, From Baseline to 4 Weeks
Time frame: Baseline, 4 weeks
Mean Change in Fasting Plasma Insulin, From Baseline to 4 Weeks
Time frame: Baseline, 4 weeks
Mean Change in Quantitative Insulin Sensitivity Check Index (QUICKI) Score, From Baseline to 4 Weeks
Time frame: Baseline, 4 weeks
Mean Change in Fasting Glucose Disposition Index(GDI)1 and Index 2, From Baseline to 4 Weeks
Time frame: Baseline, 4 weeks
Mean Change in Absolute Glucose Level at 2 Hours, From Baseline to 4 Weeks
Time frame: Baseline, 4 weeks
Mean Change in Insulin Area Under the Curve (AUC) 0-4 Hours, From Baseline to 4 Weeks
Time frame: Baseline, 4 weeks
Mean Change in C-peptide Area Under the Curve (AUC), 0-4 Hours, From Baseline to 4 Weeks
Time frame: Baseline, 4 weeks
Mean Change in Post-prandial Glucose Area Under the Curve (AUC)0-4 Hours, From Baseline to 4 Weeks
Time frame: Baseline, 4 weeks
Mean Change in Peak Plasma Glucose, From Baseline to 4 Weeks
Time frame: Baseline, 4 weeks
Mean Change in Peak Plasma Insulin, From Baseline to 4 Weeks
Time frame: Baseline, 4 weeks
Mean Change in Peak Plasma C-peptide Level, From Baseline to 4 Weeks
Time frame: Baseline, 4 weeks
Number of Participants Reporting Death, Serious Adverse Events (SAEs) and Adverse Events (AEs) Above 5% Frequency, From Baseline to 4 Weeks
Time frame: Baseline, 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals Corporation study director
Novartis Pharmaceuticals
52 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Canakinumab 150 mg in people with Type 2 Diabetes Mellitus and Impaired Glucose Tolerance, run by Novartis at 52 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 52 sites in Germany, United States, India, Italy, Canada and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Sep 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change in Meal Stimulated Insulin Secretion Rate (ISR) Relative to Glucose 0-2 Hours, From Baseline to 4 Weeks. (time frame: Baseline, 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2011.