Foxiga Korea Local Phase 4 Study

Effects of Dapagliflozin Compared With Glimepiride on Body Composition in Patients With Type 2 Diabetes Inadequately Controlled With Metformin

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02564926

Acronym

BEYOND

Enrollment

125

Registered

2015-10-01

Start date

2016-01-05

Completion date

2018-01-15

Last updated

2019-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Keywords

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.

Interventions

DRUGDapagliflozin

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

DRUGGlimepiride

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 75 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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 Waist Circumference at Week 52	From baseline to Week 52	Adjusted Mean Change in Waist Circumference 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 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 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 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 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 Adinopectin at Week 52	From baseline to Week 52	Adjusted Mean Change in Adinopectin 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
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 HbA1c at Week 52	From baseline to Week 52	Adjusted Mean Change in HbA1c at Week 52

Countries

South Korea

Participant flow

Recruitment details

First patient enrolled: 05 January 2016 Last patient last visit: 15 January 2018

Pre-assignment details

178 patients provided informed consent. 121 patients received study treatment and were included in the SAF population. 112 patients received study treatment and had at least one post-baseline primary efficacy assessment and were included in the FAS population (56 patients in each treatment group).

Participants by arm

Arm	Count
Dapagliflozin Dapagliflozin 10mg + Metformin 1000mg	60
Glimepiride Glimepiriide 1-2mg + Metformin 1000mg	61
Total	121

Baseline characteristics

Characteristic	Dapagliflozin	Glimepiride	Total
Age, Continuous	54.6 years STANDARD_DEVIATION 9.09	55.7 years STANDARD_DEVIATION 10.24	55.2 years STANDARD_DEVIATION 9.66
Race/Ethnicity, Customized Korean	60 Participants	61 Participants	121 Participants
Sex: Female, Male Female	23 Participants	34 Participants	57 Participants
Sex: Female, Male Male	37 Participants	27 Participants	64 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 60	0 / 61
other Total, other adverse events	11 / 60	10 / 61
serious Total, serious adverse events	6 / 60	6 / 61

Outcome results

Primary

Adjusted Mean Changes From Baseline in Percentage of Total Body Fat Assessed by DXA Scan

Adjusted mean percent changes in total body fat mass from baseline using DXA scan in 52 weeks after the start of the treatment