Foxiga Korea Local Phase 4 Study

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-05

Study Completion Date

2018-01-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dapagliflozin

Dapagliflozin 10mg + Metformin 1000mg

Group Type EXPERIMENTAL

Dapagliflozin

Intervention Type DRUG

Subject who will be randomized to the 'Dapagliflozin arm' will be treated with dapagliflozin 10mg + Metformin 1000 mg as Diabetes Treatment

Glimepiride

Glimepiriide 1-2mg + Metformin 1000mg

Group Type ACTIVE_COMPARATOR

Glimepiride

Intervention Type DRUG

Subject who will be randomized to the 'Glimepiride arm' will be treated with glimepiride 1-2mg + Metformin 1000 mg as Diabetes Treatment

Interventions

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Dapagliflozin

Subject who will be randomized to the 'Dapagliflozin arm' will be treated with dapagliflozin 10mg + Metformin 1000 mg as Diabetes Treatment

Intervention Type DRUG

Glimepiride

Subject who will be randomized to the 'Glimepiride arm' will be treated with glimepiride 1-2mg + Metformin 1000 mg as Diabetes Treatment

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

19 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No