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Type 2 Diabetes MellitusNCT05160974

QTERN (SAXAGLIPTIN/DAPAGLIFLOZIN FDC) Regulatory Post-Marketing Surveillance

An observational study of Type 2 Diabetes Mellitus, run by AstraZeneca at 34 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 post-marketing surveillance study. Adult patients with type 2 diabetes mellitus who are initiating Qtern as indicated by the MFDS will be included. 600 patients are followed up 12 weeks and at least 60 patients of the 600 patients are followed up 24 weeks. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Type 2 Diabetes Mellitus
How many people
679 participants
Where
34 sitesSouth Korea
Study dates
30 Dec 2021to 1 Apr 2024
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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult patients who are diagnosed with T2DM eligible for the treatment with Qtern (5 mg saxagliptin/10 mg dapagliflozin) according to prescription information approved by MFDS and as decided by the investigator.

Who may be able to join

  • Patients aged 19 years and older
  • Patients with T2DM eligible for treatment with Qtern 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

  • Patients treated with Qtern outside of the locally approved Prescription Information in Korea
  • Patients with contraindications for the use of Qtern (as described in the Korean Prescription Information)

Trial locations and contacts

34 sites in 1 country.

34 sites in 1 country

South Korea34 sites

  • Research Site

    Busan, 47261

  • Research Site

    Busan, 48092

  • Research Site

    Busan, 49326

  • Research Site

    Changwon, 51495

  • Research Site

    Changwon-si, South Korea, 51139

  • Research Site

    Cheongju-si, 28325

  • Research Site

    Daejeon, 34944

  • Research Site

    Gimcheon, South Korea, 39550

  • Research Site

    Goyang-si, 10588

  • Research Site

    Goyang-si, 13620

  • Research Site

    Gwangju, 12759

  • Research Site

    Gwangmyeong, 14220

  • Research Site

    Gyeonggi-do, 16825

  • Research Site

    Incheon, 21550

  • Research Site

    Incheon, 22372

  • Research Site

    Jeju-do, South Korea, 63241

  • Research Site

    Jeonju, South Korea, 54999

  • Research Site

    Jeonju, 54807

  • Research Site

    Jinju, 52683

  • Research Site

    Pyeongtaek-si, South Korea, 17909

  • Research Site

    Seongnam, 13338

  • Research Site

    Seosan City, South Korea, 31931

  • Research Site

    Seoul, 02841

  • Research Site

    Seoul, 04763

  • Research Site

    Seoul, 05055

  • Research Site

    Seoul, 05372

  • Research Site

    Seoul, 07385

  • Research Site

    Seoul, 07441

  • Research Site

    Seoul, 07694

  • Research Site

    Seoul, 08832

  • Research Site

    Suwon, 16441

  • Research Site

    Ulsan, 44686

  • Research Site

    Yeongcheon-si, South Korea, 38885

  • Research Site

    Yongin-si, 17049

Other trials in South Korea

About this study

This is a local, prospective, non-interventional, regulatory post-marketing surveillance study. Adult patients with type 2 diabetes mellitus who are initiating Qtern as indicated by the MFDS will be included. 600 patients are followed up 12 weeks and at least 60 patients of the 600 patients are followed up 24 weeks. Patients will be treated as part of routine practice at Korean healthcare centers by accredited physicians. In this study, patients will receive Qtern as indicated in the locally approved prescribing information.

Read the detailed description

As part of a post approval commitment, the MFDS has requested a post-marketing surveillance program to characterize safety in patients who are treated with Qtern for T2DM by physicians in the normal clinical practice setting. This study is designed to confirm assess the known safety profile or identify previously unsuspected adverse reactions and to evaluate the effectiveness of Qtern under conditions of routine daily medical practice in Korea.

The primary objective of this study is :

Descriptive analysis of the proportion of adverse events (AEs) and serious adverse events (SAEs) in patients who are treated with Qtern for type 2 diabetes mellitus by physicians in the normal clinical practice setting over a period of 12 and 24 weeks.

The secondary objectives of this study are:

To follow the changes of the 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 Qtern 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)

Medical subject headings
Diabetes Mellitus, Type 2

What is being measured

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

  1. • Incidence (%) of AEs in patients who are treated with Qtern

    Measured: 12 or 24 weeks

  2. • Nature of AE in patients who are treated with Qtern

    Measured: 12 or 24 weeks

  3. • Nature of unexpected adverse drug reactions in patients who are treated with Qtern

    Measured: 12 or 24 weeks

  4. • Severity of AE in patients who are treated with Qtern

    Measured: 12 or 24 weeks

  5. • Incidence of unexpected adverse drug reactions in patients who are treated with Qtern

    Measured: 12 or 24 weeks

  6. • Severity of unexpected adverse drug reactions in patients who are treated with Qtern

    Measured: 12 or 24 weeks

  7. • Incidence (%) of SAEs in patients who are treated with Qtern

    Measured: 12 or 24 weeks

Secondary outcomes (10)

  1. • Change in HbA1c during the observation period

    Measured: 12 or 24 weeks

  2. • Change in FPG during the observation period

    Measured: 12 or 24 weeks

  3. • Change of PPG-2hr during the observation period

    Measured: 12 or 24 weeks

  4. • Change in blood pressure during the observation period

    Measured: 12 or 24 weeks

  5. • Change in abdominal circumference during the observation period

    Measured: 12 or 24 weeks

  6. • Change in body weight during the observation period

    Measured: 12 or 24 weeks

  7. • Overall assessment on the outcome of the treatment by investigators

    The overall investigator's assessment on the outcome will be based on the investigator's clinical judgment and classified as below criteria issued by the Korean Ministry of Food and Drug Safety (MFDS):

    • Improved: Signs and symptoms are significantly improved or maintenance effect
    • Unchanged: Improvement in signs and symptoms is not significant or there is no change in signs and symptoms
    • Worsened: Signs and symptoms are worsened
    • Assessment impossible: Assessment is impossible because the surveillance drug was discontinued before 12 weeks

    Measured: 12 or 24 weeks

  8. • Clinically significant results from blood chemistry test

    Clinically significance will be determined as per the investigators clinical judgement based on routine clinical practice.

    Measured: 12 or 24 weeks

  9. • Clinically significant results from complete blood count test

    Clinically significance will be determined as per the investigators clinical judgement based on routine clinical practice.

    Measured: 12 or 24 weeks

  10. • Clinically significant results from urinalysis

    Clinically significance will be determined as per the investigators clinical judgement based on routine clinical practice.

    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 posted16 Dec 2021
  2. Study start30 Dec 2021
  3. Primary completion1 Apr 2024
  4. Study completion1 Apr 2024

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
679 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05160974
Sponsor's protocol ID
D1683R00008
Status last verified
Mar 2025
First submitted
4 Nov 2021
Last updated
6 Mar 2025
Results posted
No
FDA-regulated drug
No
Individual data sharing
Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Questions about this trial

What is this clinical trial studying?

An observational study of Type 2 Diabetes Mellitus, run by AstraZeneca at 34 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 3 inclusion and 2 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 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 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?

• Incidence (%) of AEs in patients who are treated with Qtern (time frame: 12 or 24 weeks). The study lists 7 primary outcomes in all. 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 NCT05160974.

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 6 Mar 2025.

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