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Trelagliptin Succinate Monotherapy for Type 2 Diabetes
NCT03940183Phase 3
Key facts
- Status
- Completed
- Start
- Jul 2019
- Primary completion
- Dec 2020
- Countries
- 1
- Modality
- Small Molecules
- Drugs
- trelagliptin
- Conditions
- type 2 diabetes mellitus (T2DM)
01
Overview
Phase 3, randomised, double-blind trial in type 2 diabetes mellitus (T2DM) comparing Trelagliptin with Placebo (2 arms). Primary endpoint: Hemoglobin A1c at 24 weeks. Started Jul 2019; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Trelagliptin
Trelagliptin succinate 100 mg tablets, once a week
Placebo
Placebo tablets, once a week
03
Who it enrols
Adult patients aged 18-75 with Type 2 Diabetes Mellitus (diagnosed recently or within 2 years), HbA1c 7.0-10.0%, and BMI 19-35 kg/m^2. Patients must be drug-naïve or not taking regular medication for at least 8 weeks. Excludes severe complications, renal/liver insufficiency, and active heart disease.
04
Endpoints
Primary
Hemoglobin A1c
Secondary
Hemoglobin A1c
Fasting Blood Glucose
2-hour Postprandial Blood Glucose
Fasting Insulin
Fasting Glucagon
Active Glucagon-like peptide-1
Percentage of patients with HbA1c <6.5% and <7%
Body Weight
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