Clinical trial NCT03038789: XIGDUO Extended Release (XR) Post Marketing Surveillance
Official title: XIGDUO Extended Release (XR) (DAPAGLIFLOZIN/METFORMIN XR FDC) Regulatory Postmarketing Surveillance To Observe Safety and Effectiveness Of XigduoXR (Registered) In Korean Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adult Patients With Type 2 Diabetes Mellitus
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2017-02-01
Enrollment: 623
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

Brief summary: 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.

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)

Eligibility 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.

Primary outcomes:
measure: 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)
timeFrame: 12 or 24 weeks
Secondary outcomes:
measure: Hemoglobin A1c (HbA1c)
timeFrame: 12 or 24 weeks
measure: Fasting plasma glucose (FPG)
timeFrame: 12 or 24 weeks
measure: 2-hr post-prandial glucose (PPG-2hr)
timeFrame: 12 or 24 weeks
measure: Blood pressure
timeFrame: 12 or 24 weeks
measure: Abdominal circumference
timeFrame: 12 or 24 weeks
measure: Body weight
timeFrame: 12 or 24 weeks
measure: Overall investigator's assessment on the outcome of the treatment
timeFrame: 12 or 24 weeks
measure: Number of Participants With Abnormal Laboratory Values
timeFrame: 12 or 24 weeks
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Research Site
city: ChungCheong
country: Korea, Republic of
facility: Research Site
city: DaeGu
country: Korea, Republic of
facility: Research Site
city: DaeJeon
country: Korea, Republic of
facility: Research Site
city: GyeongGi
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: SunCheon
country: Korea, Republic of
facility: Research Site
city: WonJu
country: Korea, Republic of
facility: Research Site
Study officials:
affiliation: YoungNam University Hospital
name: JiSeong Yoon, PhD
role: PRINCIPAL_INVESTIGATOR
References: