Phase 2 Completed N=231 Randomized Double-blind Treatment

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ACZ885 in Patients With Type 2 Diabetes

Type 2 Diabetes Mellitus

Source: ClinicalTrials.gov NCT00605475 ↗

Enrolled (actual)

231

Serious AEs

1.3%

Results posted

Feb 2012

Primary outcomePrimary: Mean Change From Baseline in Plasma HbA1c (Glycosylated Hemoglobin / Hemoglobin A1c) — -0.38; -0.26; -0.25; -0.30 percent

Summary

The purpose of this study was to evaluate, in patients with Type 2 Diabetes Mellitus, whether Canakinumab can lower Glycosylated hemoglobin / hemoglobin A1c (HbA1c) and/or peak glucose levels in response to an oral glucose tolerance test (OGTT).

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Change From Baseline in Plasma HbA1c (Glycosylated Hemoglobin / Hemoglobin A1c)	-0.38; -0.26; -0.25; -0.30; -0.47; -0.24	—
PRIMARY Mean Change From Baseline in Plasma Glucose Area Under the Curve (AUC) 0 - 4 Hours Following Oral Glucose Tolerance Test (OGTT )	-4.7; -0.9; 1.6; -0.9; -2.8; -2.3	—
SECONDARY Mean Change From Baseline in Plasma C-peptide AUC ( Area Under the Curve) 0-4 Hours, Following Oral Glucose Tolerance Test (OGTT)	-335; -614; -492; -25; 779; 129	—
SECONDARY Mean Change From Baseline in Plasma Insulin AUC ( Area Under the Curve) 0-4 Hours, Following Oral Glucose Tolerance Test ( OGTT )	-1.58; -14.25; -12.61; 6.06; 2.06; -8.26	—
SECONDARY Mean Change From Baseline in Plasma Proinsulin AUC ( Area Under the Curve) 0-4 Hours, Following Oral Glucose Tolerance Test ( OGTT )	-9.9; 11.0; -13.7; -15.0; 26.1; -16.2	—
SECONDARY Mean Change From Baseline in Plasma Glucagon AUC ( Area Under the Curve) 0-4 Hours, Following Oral Glucose Tolerance Test	-3.6; -4.0; -3.1; -3.7; -0.6; -2.7	—
SECONDARY Mean Change From Baseline in Peak Plasma Insulin/Proinsulin Level, Following Oral Glucose Tolerance Test (OGTT)	0.173; -1.035; 0.160; 1.039; 0.293; -0.031	—
SECONDARY Mean Insulin Secretion Rate ( ISR ) Relative to Glucose, 0 - 4 Hours	20.4; 18.0; 14.5; 17.1; 19.1; 18.5	—
SECONDARY Mean Insulin Secretion Rate ( ISR ), 0 - 4 Hours	255; 246; 207; 231; 262; 234	—
SECONDARY Insulin Sensitivity Index ( ISI ) at Day 28, Day 48	2.91; 2.63; 3.13; 2.96; 3.57; 3.77	—
SECONDARY Insulinogenic Index, 0 - 30 Minutes	0.174; 0.140; 0.090; 0.105; 0.139; 0.102	—
SECONDARY Mean Change From Baseline in Peak Plasma Glucose Following Oral Glucose Tolerance Test ( OGTT )	-1.3; 0.0; 0.2; -0.2; -0.8; -1.0	—
SECONDARY Mean Change From Baseline in Peak Plasma Fructosamine Level	4.8; -0.7; -9.2; -13.9; 1.4; -0.9	—
SECONDARY Insulin Resistance as Measured by the Homeostatic Model Assessment (HOMA-IR)	3.30; 3.74; 4.03; 3.34; 3.31; 3.25	—
SECONDARY β-cell Function as Measured by the Homeostatic Model Assessment (HOMA-β )	40.2; 35.9; 38.1; 38.2; 42.0; 37.9	—
SECONDARY Number of Participants Reporting Death, Serious Adverse Events (SAEs), Adverse Events (AE) Above 5% Frequency	0; 0; 1; 2; 0; 0	—

Eligibility Criteria

Inclusion Criteria

Male or female patients aged 18 to 70 years, with type 2 diabetes mellitus (non-insulin dependent diabetes) for at least 6 months prior to study start
HbA1c between 7.0 and 9.5%
On stable dose metformin monotherapy
Stable body weight

Exclusion Criteria

Poorly controlled type 2 diabetes (very low or very high blood sugar levels, or other indicators of poor control)
Acute infections prior to dosing
Patients with type 1 diabetes (insulin-dependent diabetes)
Taking diabetes medication (other than metformin)

Other protocol-defined inclusion/exclusion criteria may apply

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00605475). 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.