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Adult Patients With Type 2 Diabetes MellitusXigduoPMSNCT03038789

XIGDUO Extended Release (XR) Post Marketing Surveillance

An observational study of Adult Patients With Type 2 Diabetes Mellitus, run by AstraZeneca at 8 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
How many people
623 participants
Where
8 sitesSouth Korea
Study dates
20 Apr 2017to 30 Aug 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Who may be able to join

  • -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.
  • Patients aged 18 years and older
  • Patients with T2DM eligible for treatment with Xigduo XR at first according to the indication as indicated in the locally approved prescribing information
  • 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.

Who cannot join

  • Hypersensitivity to the active substances or to any of the excipients
  • 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.
  • Patients with type 1 diabetes mellitus, lactic acidosis, or acute or chronic metabolic acidosis including diabetic ketoacidosis with or without a coma
  • Diabetic precoma
  • Congestive heart failure that medicinal treatment is required
  • 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)
Show all 12Show fewer
  • Patients with severe infection or severe traumatism
  • In terms of Surgical procedures (except minor procedures not associated with restricted intake of food and fluids)
  • Patients with nutrition poor condition, starvation condition, pituitary insufficiency, capsular insufficiency
  • 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.)
  • Pregnant women, women with potential of pregnancy, lactating women
  • Patients with hereditary problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

South Korea8 sites

  • Research Site

    Busan

  • Research Site

    ChungCheong

  • Research Site

    Daegu

  • Research Site

    Daejeon

  • Research Site

    Gyeonggi-do

  • Research Site

    Seoul

  • Research Site

    Suncheon

  • Research Site

    Wŏnju

Other trials in South Korea

About this study

Official title: 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.

Read the 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)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 12 or 24 weeks

Secondary outcomes (8)

  1. Hemoglobin A1c (HbA1c)

    Change in HbA1c in % during the observation period to evaluate effectivenss

    Measured: 12 or 24 weeks

  2. Fasting plasma glucose (FPG)

    Change in FPG in mg/dL during the observation period to evaluate effectivenss

    Measured: 12 or 24 weeks

  3. 2-hr post-prandial glucose (PPG-2hr)

    Change of PPG-2hr in mg/dL during the observation period to evaluate effectivenss

    Measured: 12 or 24 weeks

  4. Blood pressure

    Change in blood pressure in mmHg during the observation period to evaluate effectivenss

    Measured: 12 or 24 weeks

  5. Abdominal circumference

    Change in abdominal circumference in cm during the observation period to evaluate effectiveness

    Measured: 12 or 24 weeks

  6. Body weight

    Change in body weight in Kg during the observation period to evaluate effectiveness

    Measured: 12 or 24 weeks

  7. 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"

    Measured: 12 or 24 weeks

  8. 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

    Measured: 12 or 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Feb 2017 (estimated)
  2. Study start20 Apr 2017
  3. Primary completion30 Aug 2019
  4. Study completion30 Aug 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
623 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03038789
Sponsor's protocol ID
D1691R00001
Acronym
XigduoPMS
Status last verified
Jul 2020
First submitted
27 Dec 2016
Last updated
14 Jul 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Adult Patients With Type 2 Diabetes Mellitus, run by AstraZeneca at 8 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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) (time frame: 12 or 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03038789.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2020.

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