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Bydureon for Carotid Atherosclerosis in T2DM
NCT02162550Phase 4
Key facts
- Status
- Unknown
- Start
- Jun 2014
- Primary completion
- Apr 2019
- Countries
- 1
- Sponsor
- Phoenix VA Health Care System
- Modality
- Peptides
- Drugs
- exenatide
- Conditions
- type 2 diabetes mellitus (T2DM)atherosclerosis
01
Overview
Phase 4, randomised, double-blind trial in type 2 diabetes mellitus (T2DM) and atherosclerosis comparing Bydureon with Placebo (2 arms). Primary endpoint: Change in carotid plaque volume at 18 months. Status: unknown.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Bydureon
Bydureon 2 mg/week subcutaneous injection
Placebo
Matching placebo subcutaneous injection
03
Who it enrols
Patients with T2DM, HbA1c 6.5-10.0% on stable oral agents, with carotid plaque thickness >= 0.75 mm. Excludes recent CVD, severe renal disease, pancreatitis, and history of medullary thyroid carcinoma.
04
Endpoints
Primary
Change in carotid plaque volume
Secondary
Change in reactive hyperemic index
Change in carotid plaque composition
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