Phase 2
N=189
Safety & Effectiveness on Vascular Structure and Function of ACZ885 in Atherosclerosis and Either T2DM or IGT Patients
Diabetes Mellitus, Type 2 · Atherosclerosis · Prediabetic State
Bottom Line
View on ClinicalTrials.gov: NCT00995930 ↗Enrolled (actual)
189
Serious AEs
20.6%
Results posted
Mar 2015
Primary outcome: Primary: Number of Participants With Adverse Events, Serious Adverse Events and Death — 80; 77; 14; 25 Number of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- ACZ885 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Feb 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events, Serious Adverse Events and Death |
80; 77; 14; 25; 0; 1 | — |
| PRIMARY Change From Baseline in Aortic Distensibility |
-0.0001; 0.0001; -0.0001; -0.0001 | — |
| PRIMARY Change From Baseline in Plaque Burden (Aortic Vessel Wall Area and Carotid Vessel Wall Area) |
14.80; -0.51; 30.58; 8.71; 1.41; -0.29 | — |
| SECONDARY Change From Baseline in Pulse Wave Velocity and Pulse Wave Velocity Error |
-0.39; -0.03; -0.36; -0.26; -0.01; -0.03 | — |
| SECONDARY Change From Baseline in Plaque Composition |
0.002; 0.003; 0.002; 0.003; 0.006; -0.000 | — |
| SECONDARY Change From Baseline in Aortic Strain |
-0.005; 0.002; 0.001; -0.002 | — |
| SECONDARY Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) |
0.93; 0.48; 1.04; 0.51 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose |
0.95; 1.00; 0.95; 0.99 | — |
| SECONDARY Change From Baseline in Hemoglobin A1c (HbA1c) |
1.00; 0.99; 1.00; 0.96 | — |
| SECONDARY Change From Baseline in 2 Hour Glucose Post Oral Glucose Tolerance Test (OGTT) |
0.92; 0.98; 0.93; 0.95 | — |
| SECONDARY Change From Baseline in Beta Cell Function (HOMA-B) |
1.11; 0.99; 1.03; 0.91 | — |
| SECONDARY Change From Baseline Insulin Resistance (HOMA-IR) |
1.00; 1.09; 0.93; 0.97 | — |
| SECONDARY Pharmacokinetics: ACZ885 Serum Concentrations |
0; 480; 10107; 9138; 5936; 8136 | — |
Summary
This study will evaluate the effect of ACZ885 on vascular function in patients with documented atherosclerotic disease and T2DM or IGT.
Eligibility Criteria
Inclusion Criteria
- Patients with known atherosclerotic disease and documented diagnosis of T2DM for ≤ 14 years OR IGT
- HbA1c between 6.0% and 10.0%
- On stable statin therapy or statin intolerant
- Patients who are eligible and able to participate in the study
Exclusion Criteria
- Contraindications to MRI
- NYHA class IV Heart Failure
- NYHA class I - III heart failure with acute exacerbation in 3 months prior to screening
- Patients with type 1 diabetes
- Acute infections
- HsCRP > 30 mg/dL
- Aortic aneurysm ≥5cm
Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT00995930). 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.