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Semaglutide in Chilean Type 2 Diabetes Patients
NCT05533632Phase 4
Key facts
- Status
- Completed
- Start
- Apr 2022
- Primary completion
- Jan 2024
- Countries
- 1
- Sponsor
- Novo Nordisk
- Modality
- Peptides, Recombinant Proteins and Enzymes
- Drugs
- semaglutide
- Conditions
- type 2 diabetes mellitus (T2DM)
01
Overview
Phase 4, open-label, single-arm trial of semaglutide in type 2 diabetes mellitus (T2DM), sponsored by Novo Nordisk. Primary endpoint: Adverse Events at 24 weeks. Started Apr 2022; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Semaglutide
Single arm receiving semaglutide with dose escalation from 0.25 mg to 0.5 mg, with optional increase to 1.0 mg
03
Who it enrols
Adults with type 2 diabetes for ≥90 days, on stable OAD/insulin for ≥60 days, HbA1c 7.5-10%, eGFR ≥30 mL/min/1.73m², no prior GLP-1 RA use, no history of pancreatitis or medullary thyroid carcinoma
04
Endpoints
Primary
Adverse Events
Secondary
Change in Glycosylated Haemoglobin
Participants Achieving HbA1c Less Than 7.0%
Change in Fasting Plasma Glucose
Change in Body Weight
Change in Waist Circumference
Participants Achieving ≥5% Weight Reduction
Participants Achieving ≥10% Weight Reduction
Change in Total Cholesterol
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