XIGDUO Extended Release (XR) Post Marketing Surveillance (XigduoPMS)

XIGDUO Extended Release (XR) (DAPAGLIFLOZIN/METFORMIN XR FDC) Regulatory Postmarketing Surveillance To Observe Safety and Effectiveness Of XigduoXR (Registered) In Korean Patients

This is a local, prospective, non-interventional, regulatory postmarketing surveillance study. Adult patients with type 2 diabetes mellitus who are initiating Xigduo XR as indicated by the Ministry of Food and Drug Safety (MFDS) will be included.

Study Overview

• Status: Completed
• Conditions: Adult Patients With Type 2 Diabetes Mellitus

Detailed Description

• Primary objective: Descriptive analysis of the proportion (%) of adverse events (AEs), serious adverse events (SAEs), unexpected adverse events∙adverse drug reactions and AEs of special interest (AESI) in patients who are treated with Xigduo XR for type 2 diabetes mellitus by physicians in the normal clinical practice setting over a period of 12 or 24 weeks.
• Secondary objective: To follow the changes of values of hemoglobin A1c (HbA1c), fasting plasma glucose (FPG), 2-hr post-prandial glucose (PPG-2hr), blood pressure, abdominal circumference and body weight and self-reported data in this cohort of patients from baseline to completion of the study.

To evaluate the safety and tolerability of Xigduo XR in patients with type 2 diabetes mellitus based on conducted laboratory test (Laboratory tests are not mandatory because of the non-interventional nature of this study)

• Study Type: Observational
• Enrollment (Actual): 623

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of
    • Research Site
  • ChungCheong, Korea, Republic of
    • Research Site
  • DaeGu, Korea, Republic of
    • Research Site
  • DaeJeon, Korea, Republic of
    • Research Site
  • GyeongGi, Korea, Republic of
    • Research Site
  • Seoul, Korea, Republic of
    • Research Site
  • SunCheon, Korea, Republic of
    • Research Site
  • WonJu, Korea, Republic of
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients who are diagnosed with type 2 diabetes mellitus (T2DM) eligible for the treatment with Xigduo XR according to prescription information approved by MFDS and as decided by the investigator

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Descriptive analysis of the percentage (%) of adverse events (AEs), serious adverse events (SAEs), unexpected adverse events∙adverse drug reactions and AEs of special interest (AESI)	Percentage (%) of AEs, SAEs and AESI in patients who are treated with Xigduo XR; Nature, incidence and severity of AE in patients who are treated with Xigduo XR; Nature, incidence and severity of unexpected adverse drug reactions in patients who are treated with Xigduo XR	12 or 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemoglobin A1c (HbA1c)	Change in HbA1c in % during the observation period to evaluate effectivenss	12 or 24 weeks
Fasting plasma glucose (FPG)	Change in FPG in mg/dL during the observation period to evaluate effectivenss	12 or 24 weeks
2-hr post-prandial glucose (PPG-2hr)	Change of PPG-2hr in mg/dL during the observation period to evaluate effectivenss	12 or 24 weeks
Blood pressure	Change in blood pressure in mmHg during the observation period to evaluate effectivenss	12 or 24 weeks
Abdominal circumference	Change in abdominal circumference in cm during the observation period to evaluate effectiveness	12 or 24 weeks
Body weight	Change in body weight in Kg during the observation period to evaluate effectiveness	12 or 24 weeks
Overall investigator's assessment on the outcome of the treatment	Overall investigator's assessment on the outcome of the treatment: "Improved", "Unchanged", "Worsened", "Assessment impossible"	12 or 24 weeks
Number of Participants With Abnormal Laboratory Values	Laboratory measures (chemistry/hematology/ urinalysis) during the observation period to evaluate the safety and tolerability of Xigduo XR based on conducted laboratory test (Laboratory tests are not mandatory because of the non-interventional nature of this study).; Chemistry: AST, ALT, BUN, Cr, Na+, K+, Total cholesterol, TG; Hematology: Hb, Hct; Urinalylsis: Proteinurea	12 or 24 weeks

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: JiSeong Yoon, PhD, Youngnam University Hospital

Publications and helpful links

Helpful Links

• D1691R00001 CSR synopsis

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 20, 2017
• Primary Completion (ACTUAL): August 30, 2019
• Study Completion (ACTUAL): August 30, 2019

Study Registration Dates

• First Submitted: December 27, 2016
• First Submitted That Met QC Criteria: January 30, 2017
• First Posted (ESTIMATE): February 1, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 14, 2020
• Last Update Submitted That Met QC Criteria: July 10, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: D1691R00001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No