Foxiga Korea Local Phase 4 Study

NCT02564926 | Completed Phase 4 Results

• 1 other identifier: D1690L00067
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 14

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

DM

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (14)

• Adjusted Mean Change in HbA1c at Week 52

  From baseline to Week 52

• HbA1c <7.0% at Week 52

  52 weeks

• Adjusted Mean Change in Fasting Blood Sugar (FBS) at Week 52

  From baseline to Week 52

• Adjusted Mean Change in Total Body Weight at Week 52

  From baseline to Week 52

• Adjusted Mean Change in Waist Circumference at Week 52

  From baseline to Week 52

Study Arms (2)

Dapagliflozin

EXPERIMENTAL

Dapagliflozin 10mg + Metformin 1000mg

Drug: Dapagliflozin

Glimepiride

ACTIVE COMPARATOR

Glimepiriide 1-2mg + Metformin 1000mg

Drug: Glimepiride

Interventions

Dapagliflozin DRUG

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

Dapagliflozin

Glimepiride DRUG

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

Glimepiride

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (14)

Research Site

Ansan-si, 15355, South Korea

Location

Research Site

Changwon-si, 51353, South Korea

Location

Research Site

Daegu, 41931, South Korea

Location

Research Site

Daejeon, 35233, South Korea

Location

Research Site

Goyang-si, 10326, South Korea

Location

Research Site

Incheon, 21565, South Korea

Location

Research Site

Seongnam-si, 13620, South Korea

Location

Research Site

Seoul, 01830, South Korea

Location

Research Site

Seoul, 04401, South Korea

Location

Research Site

Seoul, 05278, South Korea

Location

Research Site

Seoul, 06273, South Korea

Location

Research Site

Suwon, 16499, South Korea

Location

Research Site

Uijeongbu-si, 11765, South Korea

Location

Research Site

Wŏnju, 220-701, South Korea

Location

Related Links

• D1690l00067\_CSP\_Redacted
• D1690l00067\_SAP\_Redacted

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

dapagliflozin; glimepiride

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: EunYoung Kim / Local Study Specialist
• Organization: Astrazeneca, Korea

EunYoung.Kim@astrazeneca.com

82 2 2188 0946

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2015
• First Posted: October 1, 2015
• Study Start: January 5, 2016
• Primary Completion: January 15, 2018
• Study Completion: January 15, 2018
• Last Updated: August 20, 2019
• Results First Posted: August 20, 2019

Record last verified: 2019-08

Locations

KR (14)