XIGDUO extended release (XR) Post Marketing Surveillance - XigduoPMS

Study identifier:D1691R00001

ClinicalTrials.gov identifier:NCT03038789

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

XIGDUO extended release (XR) (DAPAGLIFLOZIN/METFORMIN XR FDC) Regulatory Postmarketing Surveillance To Observe Safety and effectiveness Of XigduoXR (Registered) In Korean Patients

Medical condition

Adult patients with type 2 diabetes mellitus

Phase

N/A

Healthy volunteers

Study drug

Sex

All

Actual Enrollment

623

Study type

Observational

Age

N/A

Date

Study Start Date: 20 Apr 2017

Primary Completion Date: 30 Aug 2019

Study Completion Date: 30 Aug 2019

Study design

Allocation: -
Endpoint Classification: -
Intervention Model: -
Masking: -
Primary Purpose: -

Verification:

Verified 01 Jul 2020 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

Inclusion Criteria

-Patients will be enrolled by a continuous registration method. Investigators should enroll adult patients who are diagnosed with T2DM and who initiate treatment with Xigduo XR for the first time. Patients (or a legally acceptable representative) who has been informed of all pertinent aspects of the study will sign the Informed Consent Form for use of data. Discontinuation of treatment will be determined by a patient’s willingness to continue treatment and the investigator’s discretion. The reason for discontinued treatment will be documented.
1. Patients aged 18 years and older
2. Patients with T2DM eligible for treatment with Xigduo XR at first according to the indication as indicated in the locally approved prescribing information
3. Patients with evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

Exclusion Criteria

1. Hypersensitivity to the active substances or to any of the excipients
2. Patients with renal impairment (e.g., serum creatinine levels ≥ 1.5 mg/dL for men, ≥ 1.4 mg/dL for women, or creatinine clearance < 60 milliliter(mL)/min or estimated glomerular filtration rate (eGFR)< 60mL/min/1.73 m2) which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction, and septicemia.
3. Patients with type 1 diabetes mellitus, lactic acidosis, or acute or chronic metabolic acidosis including diabetic ketoacidosis with or without a coma
4. Diabetic precoma
5. Congestive heart failure that medicinal treatment is required
6. Patients with radiologic studies involving the use of intravascular iodinated contrast materials (for example, intravenous urogram, intravenous cholangiography, angiography, and computed tomography (CT) scans with intravascular contrast materials)
7. Patients with severe infection or severe traumatism
8. In terms of Surgical procedures (except minor procedures not associated with restricted intake of food and fluids)
9. Patients with nutrition poor condition, starvation condition, pituitary insufficiency, capsular insufficiency
10. Patients with impaired hepatic function (Since impaired hepatic function has been associated with some cases of lactic acidosis, this drug should generally be avoided in patients with clinical or laboratory evidence of hepatic disease.), respiratory failure, acute myocardial infarction, acute or chronic disease causing histotoxic hypoxia like shock, an alcoholic, gastroenteric trouble (anhydremia, diarrhea, vomiting and etc.)
11. Pregnant women, women with potential of pregnancy, lactating women
12. Patients with hereditary problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.

No locations available

Arms	Assigned Interventions

Documents available

D1691R00001 CSR synopsis
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]

Investigators

Principal Investigator

JiSeong Yoon

YoungNam University Hospital