Foxiga Korea Local Phase 4 Study (BEYOND)

AstraZeneca

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Glimepiride; Drug: Dapagliflozin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02564926

D1690L00067

Details and patient eligibility

About

To evaluate the effect of dapagliflozin on body composition in Korean T2DM subjects.12-month, randomised, open-label, parallel-group, multi-centre phase IV study.

Full description

This is a 52 weeks, randomized, open-label, parallel-group, multi-centres phase IV study.

Participants will be randomized 1:1 to receive dapagliflozin 10 mg qd or glimepiride 1~2 mgqd in an open-label manner for 12 months as add-on to metformin 1000 mg.

Parallel group study design was chosen. In order maintain the practicality of the phase IV study, open label design of study drug delivery was chosen. The reading of the DXA scans will be conducted by one expert in blinded manner. Glimepiride is the most frequently used SUs in Korea and therefore this was chosen as comparator.Dapagliflozin treatment will be associated with reduction of total body FM, BW, abdominal VAT and SAT volume compared with glimepiride.

Enrollment: 125 patients

Sex: All

Ages: 19 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adults with T2DM (Male or female, ≥ 19 and ≤ 75 yrs)

2. Patients in insufficient glycemic control (HbA1c > 7.5% and < 9.5% in recent 4 weeks)

3. Patients with an unchanged dose of metformin (≥ 1,000 mg/day) for > 8 weeks prior to randomization

4. Written informed consent

5. WOCBP must take precautions to avoid pregnancy throughout the study and for 4 weeks after intake of the last dose.

   • WOCBP must have a negative urine pregnancy test at screening visit WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal.
   • WOCBP must be willing to use a medically accepted method of contraception that is considered reliable in the judgment of the Investigator.

Exclusion criteria

1. Type 1 diabetes or history of diabetic ketoacidosis
2. Pregnant or breast-feeding patients
3. eGFR < 60 mL/min/1.73 m2 (MDRD) on visit 1.
4. Indication of active liver disease (AST/ALT/total bilirubin > 3 X upper limits of normal) on visit 1.
5. Acute coronary syndrome, stroke or TIA within 3 months prior to randomization
6. Bariatric surgery within 2 years; treatment of anti-obesity drugs 3 months prior to randomization; any treatment leading to unstable body weight. (Unstable body weight is considered reliable in the judgment of the Investigator.)
7. History of bladder cancer or history of radiation therapy to the lower abdomen or pelvis at any time
8. History of any other malignancy within 5 years (with the exception of successfully treated non-melanoma skin cancers)
9. History of alcohol or drug abuse judged by physician within 3 months prior to randomization
10. Concomitant participation in any other clinical study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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125 participants in 2 patient groups

Dapagliflozin

Experimental group

Description:

Dapagliflozin 10mg + Metformin 1000mg

Treatment:

Drug: Dapagliflozin

Glimepiride

Active Comparator group

Description:

Glimepiriide 1-2mg + Metformin 1000mg

Treatment:

Drug: Glimepiride