Last updated on November 2019

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


Brief description of study

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.

Detailed Study Description

  1. Study design This is a 24-week, multicenter, randomized, open-label, parallel-group, active controlled Phase IV study The open-label study design rather than double-blind is considered due to the difficulty of placebo supply. The primary efficacy endpoint will be blinded to both patients and investigators, so the measurements as well as the management of the patients will not be impacted by the design of open-label.

The study is powered to show non-inferiority of dapagliflozin versus acarbose regarding with HbA1c reduction.

A non-inferiority margin of 0.25% for the difference of the reduction in HbA1c is considered in the study.

  1. Primary and secondary outcome variables In the clinical guidelines for type 2 diabetes, HbA1c is recommended as gold standard for determination of glycemic control and is therefore chosen as the primary outcome variable. Certain secondary outcome variables have been selected for additional assessment because of their clinical relevance and importance.
  2. Dosing and study duration Dapagliflozin will be started from 5 mg once a day, taken orally in the morning, before or after food. In patients tolerating dapagliflozin 5 mg once a day, the dose will be increased to 10 mg once a day from the second week.

Acarbose will be 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 from the fourth week onwards.

The dosing in study is in line with the local labels for dapagliflozin and acarbose.

Treatment duration of 24 weeks is considered to be adequate to establish glycemic efficacy of dapagliflozin monotherapy compared with acarbose monotherapy in lowering blood glucose indicated by HbA1c change in patients with T2DM inadequately controlled with diet and exercise.

2. Benefit/risk and ethical assessment According to the available data so far, glucose lowering effect of dapagliflozin is associated with a favourable safety and tolerability profile, and accompanied with a slightly increased risk of genital infection and urinary tract infection [9, 10].

Acarbose is the most widely used oral anti-diabetic drug in china. The common side effects of acarbose treatment are flatulence, borborygmus and diarrhoea, according to the prescribing information and clinical experience from physicians.

The treatment regimens in the study are in line the prescribing information for dapagliflozin and acarbose. Patients with potential contraindications or not considered to get benefit from dapagliflozin or acarbose treatment will be excluded from the study by the inclusion/exclusion criteria set in the study. And the patient safety will be closely monitored in the study by Adverse events/Serious Adverse events collecting and assessment, laboratory testing, ECG, glucometer, vital sign and physical examination.

Overall, the study drugs investigated and the study design is considered to have a favorable benefit-risk profile in the treatment of patients with T2DM.

Methods for assigning treatment groups A block stratified randomization method will be used to assign patients to the treatment groups in this study. Patients will be randomized 1:1 to treatment groups via a central randomization system (interactive voice / web response system [Interactive Voice Response System/Interactive Web Response System])(IVRS/IWRS), and drug will be dispensed accordingly.

The study population will be stratified based on the level of HbA1c at baseline (HbA1c < 8.0% 8.0% ~ < 9.0% and 9.0%)

Clinical Study Identifier: NCT03344341

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