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Completed

NCT Number: 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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Hyperinsulinism Impaired Glucose Tolerance Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutritional and Metabolic Diseases

Age range

18 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Barwon Health - Geelong Hospital, Geelong, Victoria, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Canakinumab 150 mg

Drug

Single subcutaneous injection of Canakinumab 150 mg.

Other 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

Placebo to Canakinumab

Drug

Single subcutaneous injection of Placebo to Canakinumab.

Other 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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

    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

  2. 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

    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.

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

    Time frame: Baseline, 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

  4. Mean Change in Fructosamine, From Baseline to 4 Weeks

    Time frame: Baseline, 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

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

    Time frame: Baseline, 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

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

    Time frame: Baseline, 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.

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

    Time frame: Baseline, 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.

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

    Time frame: Baseline, 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.

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

    Time frame: Baseline, 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.

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

    Time frame: Baseline, 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.

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

    Time frame: Baseline, 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.

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

    Time frame: Baseline, 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.

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

    Time frame: Baseline, 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.

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

    Time frame: Baseline, 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.

  15. 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

    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.

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Feb 15, 2010
Registry last updated
Sep 5, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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