A Phase IV Study in Drug-Naive Patients With T2DM in China

Sponsor
AstraZeneca
Study ID
NCT03344341
Phase
PHASE4
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin — DRUG
    Starting dose of dapagliflozin is 5 mg once daily, taken orally in the morning, before or after breakfast. From the third week,the dose can be increased to 10 mg once daily, and last to the end of the study.
  • Acarbose — DRUG
    Acarbose was started from 50 mg once a day at dinner during the first week and titrated up to 50 mg twice a day at lunch and dinner in the second week, 50 mg three times a day at three meals in the third week, and 100 mg three times a day till the end of the study.

Study Details

This is a 24-week, multicenter, randomized, open-label, parallel-group, active controlled Phase IV study to assess the efficacy and safety of Dapagliflozin as monotherapy compared with Acarbose in patients with T2DM who were inadequately controlled with diet and exercise. The study is designed to evaluate the efficacy and safety of dapagliflozin monotherapy compared with acarbose monotherapy in patients with T2DM inadequately controlled with diet and exercise.

Key Dates

Start date
Dec 15, 2017
Status verified
Nov 2021
Primary completion
May 24, 2019
Completion
May 24, 2019

Study Design

Enrollment
304 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dapagliflozin
    Dapagliflozin is started from 5 mg once a day, taken orally in the morning, before or after breakfast. From the third week, the dose will be increased to 10 mg once a day and last to the end of the study.
  • Active Comparator: Acarbose
    Acarbose is started from 50 mg once a day at dinner during the first week, titrated up to 50 mg twice a day at lunch and dinner in the second week, 50 mg three times a day at three meals in the third week, and 100 mg three times a day till the end of the study.

Primary Outcome Measure

Absolute change from baseline in HbA1c at Week 24 [ Time Frame: At week 24 ]

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