Foxiga Korea Local Phase 4 Study

Diabetes Mellitus, Type 2 Clinical Trial

— BEYOND  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02564926
• Other study ID #: D1690L00067
• Status: Completed
• Phase: Phase 4
• Start date: January 5, 2016
• Est. completion date: January 15, 2018

Study information

• Verified date: August 2019
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: January 15, 2018
• Est. primary completion date: January 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Drug:
• Dapagliflozin
Subject who will be randomized to the 'Dapagliflozin arm' will be treated with dapagliflozin 10mg + Metformin 1000 mg as Diabetes Treatment
• Glimepiride
Subject who will be randomized to the 'Glimepiride arm' will be treated with glimepiride 1-2mg + Metformin 1000 mg as Diabetes Treatment

Locations

Country	Name	City	State
Korea, Republic of	Research Site	Ansan-si
Korea, Republic of	Research Site	Changwon-si
Korea, Republic of	Research Site	Daegu
Korea, Republic of	Research Site	Daejeon-si
Korea, Republic of	Research Site	Goyang-si
Korea, Republic of	Research Site	Incheon
Korea, Republic of	Research Site	Seongnam-si
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Suwon-si
Korea, Republic of	Research Site	Uijeongbu-si
Korea, Republic of	Research Site	Wonju-si

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	From baseline to Week 52
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	From baseline to Week 52
Secondary	Adjusted Mean Change in HbA1c at Week 52	Adjusted Mean Change in HbA1c at Week 52	From baseline to Week 52
Secondary	HbA1c <7.0% at Week 52	HbA1c <7.0% at Week 52	52 weeks
Secondary	Adjusted Mean Change in Fasting Blood Sugar (FBS) at Week 52	Adjusted Mean Change in Fasting Blood Sugar (FBS) at Week 52	From baseline to Week 52
Secondary	Adjusted Mean Change in Total Body Weight at Week 52	Adjusted Mean Change in Total Body Weight at Week 52	From baseline to Week 52
Secondary	Adjusted Mean Change in Waist Circumference at Week 52	Adjusted Mean Change in Waist Circumference at Week 52	From baseline to Week 52
Secondary	Adjusted Mean Change in Body Mass Index (BMI) at Week 52	Adjusted Mean Change in Body Mass Index (BMI) at Week 52	From baseline to Week 52
Secondary	Adjusted Mean Change in Systolic Blood Pressure (SBP) at Week 52	Adjusted Mean Change in Systolic Blood Pressure (SBP) at Week 52	From baseline to Week 52
Secondary	Adjusted Mean Change in Diastolic Blood Pressure (DBP) at Week 52	Adjusted Mean Change in Diastolic Blood Pressure (DBP) at Week 52	From baseline to Week 52
Secondary	Adjusted Mean Change in Visceral Adipose Tissue (VAT) Area at Week 52	Adjusted Mean Change in Visceral Adipose Tissue (VAT) area at Week 52	From baseline to Week 52
Secondary	Adjusted Mean Change in Subcutaneous Adipose Tissue (SAT) Area at Week 52	Adjusted Mean Change in Subcutaneous Adipose Tissue (SAT) area at Week 52	From baseline to Week 52
Secondary	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	From baseline to Week 52
Secondary	Adjusted Mean Change in Lean Body Mass at Week 52	Adjusted Mean Change in Lean Body Mass at Week 52	From baseline to Week 52
Secondary	Adjusted Mean Change in Adinopectin at Week 52	Adjusted Mean Change in Adinopectin at Week 52	From baseline to Week 52
Secondary	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	From baseline to Week 52

External Links

•   D1690l00067_CSP_Redacted
•   D1690l00067_SAP_Redacted