Phase 2
Completed N=246
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
Source: ClinicalTrials.gov NCT01068860 ↗Enrolled (actual)
246
Serious AEs
0.0%
Results posted
Sep 2011
Primary outcomePrimary: Mean Change in Meal Stimulated Insulin Secretion Rate (ISR) Relative to Glucose 0-2 Hours, From Baseline to 4 Weeks. — -0.06; -0.23; 0.04; 0.45 pmol/min/m^2/mmol/L
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in Meal Stimulated Insulin Secretion Rate (ISR) Relative to Glucose 0-2 Hours, From Baseline to 4 Weeks. |
-0.06; -0.23; 0.04; 0.45; -0.79; 1.16 | — |
| SECONDARY Mean Change in Meal Stimulated Insulin Secretion Rate (ISR) Relative to Glucose 2-4 Hours, From Baseline to 4 Weeks |
0.21; -2.15; -2.98; 2.02; 0.15; 1.19 | — |
| SECONDARY Mean Change in Meal Stimulated Insulin Secretion Rate (ISR) Relative to Glucose 0-4 Hours, From Baseline to 4 Weeks. |
0.44; -0.99; -0.32; 1.22; -0.63; 1.24 | — |
| SECONDARY Mean Change in Fasting Plasma Glucose, From Baseline to 4 Weeks |
-0.32; 0.33; -0.20; -0.23; -0.33; -0.36 | — |
| SECONDARY Mean Change in Fructosamine, From Baseline to 4 Weeks |
-5.30; -0.75; -3.45; -7.50; -1.81; -3.07 | — |
| SECONDARY Mean Change in Fasting Plasma Insulin, From Baseline to 4 Weeks |
-3.58; 10.73; -16.07; -9.40; -0.77; 2.31 | — |
| SECONDARY Mean Change in Quantitative Insulin Sensitivity Check Index (QUICKI) Score, From Baseline to 4 Weeks |
0.004; -0.000; 0.002; 0.009; 0.018; -0.001 | — |
| SECONDARY Mean Change in Fasting Glucose Disposition Index(GDI)1 and Index 2, From Baseline to 4 Weeks |
0.06; -0.29; 0.06; 0.37; 0.24; 0.33 | — |
| SECONDARY Mean Change in Absolute Glucose Level at 2 Hours, From Baseline to 4 Weeks |
-0.53; 0.13; -0.60; 0.18; -1.08; -0.56 | — |
| SECONDARY Mean Change in Insulin Area Under the Curve (AUC) 0-4 Hours, From Baseline to 4 Weeks |
-9.37; 1.21; -73.25; -38.32; -36.96; 8.46 | — |
| SECONDARY Mean Change in C-peptide Area Under the Curve (AUC), 0-4 Hours, From Baseline to 4 Weeks |
-0.18; -0.18; -0.21; 0.12; -0.61; 0.02 | — |
| SECONDARY Mean Change in Post-prandial Glucose Area Under the Curve (AUC)0-4 Hours, From Baseline to 4 Weeks |
-0.59; 0.46; -1.37; -1.24; -3.58; -2.88 | — |
| SECONDARY Mean Change in Peak Plasma Glucose, From Baseline to 4 Weeks |
-0.41; 0.21; -0.43; -0.03; -0.82; -0.77 | — |
| SECONDARY Mean Change in Peak Plasma Insulin, From Baseline to 4 Weeks |
8.09; 44.56; -55.07; 11.33; 5.13; -5.15 | — |
| SECONDARY Mean Change in Peak Plasma C-peptide Level, From Baseline to 4 Weeks |
-0.04; -0.04; -0.10; 0.16; -0.21; 0.05 | — |
| SECONDARY Number of Participants Reporting Death, Serious Adverse Events (SAEs) and Adverse Events (AEs) Above 5% Frequency, From Baseline to 4 Weeks |
0; 0; 0; 0; 0; 0 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01068860). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.