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Foxiga Korea Local Phase 4 Study (BEYOND)

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Dapagliflozin
Glimepiride
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring DM

Eligibility Criteria

19 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Research Site
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  • Research Site
  • Research Site
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dapagliflozin

Glimepiride

Arm Description

Dapagliflozin 10mg + Metformin 1000mg

Glimepiriide 1-2mg + Metformin 1000mg

Outcomes

Primary Outcome Measures

Adjusted Mean Changes From Baseline in Total Body Fat Mass by DXA Scan
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
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

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

Full Information

First Posted
September 23, 2015
Last Updated
August 19, 2019
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT02564926
Brief Title
Foxiga Korea Local Phase 4 Study
Acronym
BEYOND
Official Title
Effects of Dapagliflozin Compared With Glimepiride on Body Composition in Patients With Type 2 Diabetes Inadequately Controlled With Metformin
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
January 5, 2016 (Actual)
Primary Completion Date
January 15, 2018 (Actual)
Study Completion Date
January 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
DM

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
125 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dapagliflozin
Arm Type
Experimental
Arm Description
Dapagliflozin 10mg + Metformin 1000mg
Arm Title
Glimepiride
Arm Type
Active Comparator
Arm Description
Glimepiriide 1-2mg + Metformin 1000mg
Intervention Type
Drug
Intervention Name(s)
Dapagliflozin
Intervention Description
Subject who will be randomized to the 'Dapagliflozin arm' will be treated with dapagliflozin 10mg + Metformin 1000 mg as Diabetes Treatment
Intervention Type
Drug
Intervention Name(s)
Glimepiride
Intervention Description
Subject who will be randomized to the 'Glimepiride arm' will be treated with glimepiride 1-2mg + Metformin 1000 mg as Diabetes Treatment
Primary Outcome Measure Information:
Title
Adjusted Mean Changes From Baseline in Total Body Fat Mass by DXA Scan
Description
Adjusted mean changes in total body fat mass from baseline using DXA scan in 52 weeks after the start of the treatment
Time Frame
From baseline to Week 52
Title
Adjusted Mean Changes From Baseline in Percentage of Total Body Fat Assessed by DXA Scan
Description
Adjusted mean percent changes in total body fat mass from baseline using DXA scan in 52 weeks after the start of the treatment
Time Frame
From baseline to Week 52
Secondary Outcome Measure Information:
Title
Adjusted Mean Change in HbA1c at Week 52
Description
Adjusted Mean Change in HbA1c at Week 52
Time Frame
From baseline to Week 52
Title
HbA1c <7.0% at Week 52
Description
HbA1c <7.0% at Week 52
Time Frame
52 weeks
Title
Adjusted Mean Change in Fasting Blood Sugar (FBS) at Week 52
Description
Adjusted Mean Change in Fasting Blood Sugar (FBS) at Week 52
Time Frame
From baseline to Week 52
Title
Adjusted Mean Change in Total Body Weight at Week 52
Description
Adjusted Mean Change in Total Body Weight at Week 52
Time Frame
From baseline to Week 52
Title
Adjusted Mean Change in Waist Circumference at Week 52
Description
Adjusted Mean Change in Waist Circumference at Week 52
Time Frame
From baseline to Week 52
Title
Adjusted Mean Change in Body Mass Index (BMI) at Week 52
Description
Adjusted Mean Change in Body Mass Index (BMI) at Week 52
Time Frame
From baseline to Week 52
Title
Adjusted Mean Change in Systolic Blood Pressure (SBP) at Week 52
Description
Adjusted Mean Change in Systolic Blood Pressure (SBP) at Week 52
Time Frame
From baseline to Week 52
Title
Adjusted Mean Change in Diastolic Blood Pressure (DBP) at Week 52
Description
Adjusted Mean Change in Diastolic Blood Pressure (DBP) at Week 52
Time Frame
From baseline to Week 52
Title
Adjusted Mean Change in Visceral Adipose Tissue (VAT) Area at Week 52
Description
Adjusted Mean Change in Visceral Adipose Tissue (VAT) area at Week 52
Time Frame
From baseline to Week 52
Title
Adjusted Mean Change in Subcutaneous Adipose Tissue (SAT) Area at Week 52
Description
Adjusted Mean Change in Subcutaneous Adipose Tissue (SAT) area at Week 52
Time Frame
From baseline to Week 52
Title
Adjusted Mean Change in Visceral to Subcutaneous Adipose Tissue Ratio at Week 52
Description
Adjusted Mean Change in Visceral to Subcutaneous Adipose Tissue Ratio at Week 52
Time Frame
From baseline to Week 52
Title
Adjusted Mean Change in Lean Body Mass at Week 52
Description
Adjusted Mean Change in Lean Body Mass at Week 52
Time Frame
From baseline to Week 52
Title
Adjusted Mean Change in Adinopectin at Week 52
Description
Adjusted Mean Change in Adinopectin at Week 52
Time Frame
From baseline to Week 52
Title
Adjusted Mean Change in High Sensitivity C-Reactive Protein (hsCRP) at Week 52
Description
Adjusted Mean Change in High Sensitivity C-Reactive Protein (hsCRP) at Week 52
Time Frame
From baseline to Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Research Site
City
Ansan-si
ZIP/Postal Code
15355
Country
Korea, Republic of
Facility Name
Research Site
City
Changwon-si
ZIP/Postal Code
51353
Country
Korea, Republic of
Facility Name
Research Site
City
Daegu
ZIP/Postal Code
41931
Country
Korea, Republic of
Facility Name
Research Site
City
Daejeon-si
ZIP/Postal Code
35233
Country
Korea, Republic of
Facility Name
Research Site
City
Goyang-si
ZIP/Postal Code
10326
Country
Korea, Republic of
Facility Name
Research Site
City
Incheon
ZIP/Postal Code
21565
Country
Korea, Republic of
Facility Name
Research Site
City
Seongnam-si
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
01830
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
04401
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
05278
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
06273
Country
Korea, Republic of
Facility Name
Research Site
City
Suwon-si
ZIP/Postal Code
16499
Country
Korea, Republic of
Facility Name
Research Site
City
Uijeongbu-si
ZIP/Postal Code
11765
Country
Korea, Republic of
Facility Name
Research Site
City
Wonju-si
ZIP/Postal Code
220-701
Country
Korea, Republic of

12. IPD Sharing Statement

Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=3942&filename=D1690l00067_CSP_Redacted.pdf
Description
D1690l00067_CSP_Redacted
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=3942&filename=D1690l00067_SAP_Redacted.pdf
Description
D1690l00067_SAP_Redacted

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Foxiga Korea Local Phase 4 Study

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