Foxiga Korea Local Phase 4 Study

Phase 4

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: Dapagliflozin
Drug: Glimepiride

Registration Number: NCT02564926

Lead Sponsor: AstraZeneca

Brief Summary: 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.

Detailed 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 125

Inclusion Criteria

Adults with T2DM (Male or female, ≥ 19 and ≤ 75 yrs)
Patients in insufficient glycemic control (HbA1c > 7.5% and < 9.5% in recent 4 weeks)
Patients with an unchanged dose of metformin (≥ 1,000 mg/day) for > 8 weeks prior to randomization
Written informed consent
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

Type 1 diabetes or history of diabetic ketoacidosis
Pregnant or breast-feeding patients
eGFR < 60 mL/min/1.73 m2 (MDRD) on visit 1.
Indication of active liver disease (AST/ALT/total bilirubin > 3 X upper limits of normal) on visit 1.
Acute coronary syndrome, stroke or TIA within 3 months prior to randomization
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.)
History of bladder cancer or history of radiation therapy to the lower abdomen or pelvis at any time
History of any other malignancy within 5 years (with the exception of successfully treated non-melanoma skin cancers)
History of alcohol or drug abuse judged by physician within 3 months prior to randomization
Concomitant participation in any other clinical study.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dapagliflozin	Dapagliflozin	Dapagliflozin 10mg + Metformin 1000mg
Glimepiride	Glimepiride	Glimepiriide 1-2mg + Metformin 1000mg

Primary Outcome Measures

Name	Time	Method
Adjusted Mean Changes From Baseline in Total Body Fat Mass by DXA Scan	From baseline to Week 52	Adjusted mean changes in total body fat mass from baseline using DXA scan in 52 weeks after the start of the treatment
Adjusted Mean Changes From Baseline in Percentage of Total Body Fat Assessed by DXA Scan	From baseline to Week 52	Adjusted mean percent changes in total body fat mass from baseline using DXA scan in 52 weeks after the start of the treatment

Secondary Outcome Measures

Name	Time	Method
Adjusted Mean Change in Waist Circumference at Week 52	From baseline to Week 52	Adjusted Mean Change in Waist Circumference at Week 52
HbA1c <7.0% at Week 52	52 weeks	HbA1c \<7.0% at Week 52
Adjusted Mean Change in Fasting Blood Sugar (FBS) at Week 52	From baseline to Week 52	Adjusted Mean Change in Fasting Blood Sugar (FBS) at Week 52
Adjusted Mean Change in Diastolic Blood Pressure (DBP) at Week 52	From baseline to Week 52	Adjusted Mean Change in Diastolic Blood Pressure (DBP) at Week 52
Adjusted Mean Change in Visceral Adipose Tissue (VAT) Area at Week 52	From baseline to Week 52	Adjusted Mean Change in Visceral Adipose Tissue (VAT) area at Week 52
Adjusted Mean Change in Subcutaneous Adipose Tissue (SAT) Area at Week 52	From baseline to Week 52	Adjusted Mean Change in Subcutaneous Adipose Tissue (SAT) area at Week 52
Adjusted Mean Change in HbA1c at Week 52	From baseline to Week 52	Adjusted Mean Change in HbA1c at Week 52
Adjusted Mean Change in Total Body Weight at Week 52	From baseline to Week 52	Adjusted Mean Change in Total Body Weight at Week 52
Adjusted Mean Change in Body Mass Index (BMI) at Week 52	From baseline to Week 52	Adjusted Mean Change in Body Mass Index (BMI) at Week 52
Adjusted Mean Change in Systolic Blood Pressure (SBP) at Week 52	From baseline to Week 52	Adjusted Mean Change in Systolic Blood Pressure (SBP) at Week 52
Adjusted Mean Change in Adinopectin at Week 52	From baseline to Week 52	Adjusted Mean Change in Adinopectin at Week 52
Adjusted Mean Change in Visceral to Subcutaneous Adipose Tissue Ratio at Week 52	From baseline to Week 52	Adjusted Mean Change in Visceral to Subcutaneous Adipose Tissue Ratio at Week 52
Adjusted Mean Change in Lean Body Mass at Week 52	From baseline to Week 52	Adjusted Mean Change in Lean Body Mass at Week 52
Adjusted Mean Change in High Sensitivity C-Reactive Protein (hsCRP) at Week 52	From baseline to Week 52	Adjusted Mean Change in High Sensitivity C-Reactive Protein (hsCRP) at Week 52