Trial intelligence / Profile preview

Exenatide Plus Dapagliflozin on Glucose Variability in T2DM

NCT03970044Phase 4

Key facts

Status: Completed
Start: Jul 2019
Primary completion: Jun 2021
Countries: 1
Sponsor: Consano Clinical Research
Modality: Peptides, Small Molecules

Drugs: exenatidedapagliflozin
Conditions: type 2 diabetes mellitus (T2DM)

Overview

Phase 4, randomised, open-label trial in type 2 diabetes mellitus (T2DM) comparing Exenatide + Dapagliflozin, Exenatide and Dapagliflozin (3 arms). Primary endpoint: Mean Amplitude of Glycemic Excursions at 14 weeks. Started Jul 2019; status: completed.

Design

3 arms

Study design: RandomizedOpen-label

Exenatide + Dapagliflozin
Exenatide 2 mg weekly + Dapagliflozin 10 mg daily
Exenatide
Exenatide 2 mg weekly
Dapagliflozin
Dapagliflozin 10 mg daily

Endpoints

Primary

Mean Amplitude of Glycemic Excursions14 weeks

Secondary

Fasting Plasma Glucose14 weeks
Hemoglobin A1c14 weeks
Body Weight14 weeks
Blood Pressure14 weeks
Blood Glucose Variability14 weeks
24 Hour Mean Blood Glucose17 weeks
Blood Glucose Time In Range14 weeks

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