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One pill to rule them all? combo diabetes drug tested in china

NCT ID NCT06327815

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a single pill containing two diabetes drugs (dapagliflozin and metformin) works as well as taking them separately in Chinese adults with type 2 diabetes. Over 24 weeks, 633 participants were randomly assigned to either the combo pill or the separate pills. The main goal was to see if the combo pill is non-inferior in lowering blood sugar (HbA1c) and to check patient satisfaction and adherence.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

633 people

The number who actually took part.

Started

Mar 2024

Finished

Jun 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Age and Informed Consent 1. Patient must be 18 to 80 (years of age inclusive), at the time of signing the ICF(s). Type of Patient and Disease Characteristics 2. Newly diagnosed T2DM (WHO diagnostic criteria 1999) ≤ 1 year with medicine treatment naïve. 3. HbA1c 7.5%-10% at screening by local lab and HbA1c 7.5-10% at pre-randomization visit (by central laboratory). 4. BMI ≥19 and ≤40 kg/m2 at screening. Other Inclusion Criteria 5. Capable of giving signed informed consent as described in Appendix A which includes compliance with the requirements and restrictions listed in the ICF and in this protocol. Exclusion Criteria: Medical Conditions 1. Congestive heart failure NYHA classes III or IV or major cardiovascular events within 6 months before screening. (Significant cardiovascular history within the past 6 months prior to screening defined as: myocardial infarction, coronary angioplasty or bypass graft(s), valvular disease or repair, unstable angina pectoris, transient ischemic attack, or cerebrovascular accident.) 2. Patients with clinically apparent hepatobiliary disease, including but not limited to chronic active hepatitis and/or severe hepatic insufficiency. ALT or AST \> 3x ULN, or serum TB \>34.2 μmol/L (\>2 mg/dL). 3. Patients with eGFR\< 45 mL/min per 1.73 m². 4. Diagnosis or history of acute metabolic diabetic complications such as ketoacidosis or hyperglycemic hyperosmolar state, or diabetes insipidus within the past 6 months. 5. For women only - currently pregnant (confirmed with positive pregnancy test) or breastfeeding. 6. Participation in any other study that included drug treatment during the past 3 months before enrolment. Diagnostic Assessments 7. Patients with a known hypersensitivity to Dapa/Met or any of the excipients of the product. 8. Diagnosis or history of: 1. Chronic pancreatitis within past 6 months or idiopathic acute pancreatitis within past 4 weeks. 2. Gastrointestinal disease including gastroenterostomy, enterectomy, roemheld syndrome, severe hernia, intestinal obstruction, intestinal ulcer within past 6 months. 3. Genetic galactose intolerance, lapp lactase deficiency and glucose-galactose malabsorption. 4. Medullary thyroid carcinoma within past 5 years. 5. Organ transplant or AIDS within the past 6 months. 6. Alcohol abuse or illegal drug abuse within the past 12 months. 7. Laser treatment for proliferative retinopathy within 6 months. 8. Stress condition, such as surgery, serious trauma, etc., within past 6 months, or plan to undergo a surgery during study period. 9. Chronic oxygen deficiency diseases, such as pulmonary emphysema, pulmonary heart disease within past 6 months. 10. T1DM, diabetes resulting from pancreatic injury or secondary forms of diabetes, eg, acromegaly or Cushing's syndrome. Other Exclusions 9. Subject is, in the judgment of the Investigator, unlikely to comply with the protocol or has any severe concurrent medical or psychological condition that may affect the interpretation of study results. 10. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).

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Conditions

The condition(s) this trial relates to.

type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Type 2 diabetes mellitus (T2DM)

Contacts and locations

Locations

  • Research Site

    Beijing, 100020, China

  • Research Site

    Beijing, 100050, China

  • Research Site

    Beijing, 100076, China

  • Research Site

    Beijing, 102218, China

  • Research Site

    Changsha, 410005, China

  • Research Site

    Chengdu, 610072, China

  • Research Site

    Chongqing, 402260, China

  • Research Site

    Chuxiong, 675000, China

  • Research Site

    Dalian, 116001, China

  • Research Site

    Dingzhou, 562100, China

  • Research Site

    Fuyang, 236400, China

  • Research Site

    Guangzhou, 510180, China

  • Research Site

    Guangzhou, 510515, China

  • Research Site

    Guiyang, 550044, China

  • Research Site

    Hefei, 230012, China

  • Research Site

    Jiangyin, 214400, China

  • Research Site

    Jiyuan, 459003, China

  • Research Site

    Kunming, 650032, China

  • Research Site

    Nanchang, 330006, China

  • Research Site

    Nanning, China

  • Research Site

    Nantong, 226001, China

  • Research Site

    Panjin, 124000, China

  • Research Site

    Qingdao, 266200, China

  • Research Site

    Quanzhou, 362000, China

  • Research Site

    Rui’an, 325200, China

  • Research Site

    Shenzhen, 518101, China

  • Research Site

    Suzhou, 215500, China

  • Research Site

    Taiyuan, 030001, China

  • Research Site

    Tianjin, 300134, China

  • Research Site

    Weifang, 261035, China

  • Research Site

    Wenzhou, 325000, China

  • Research Site

    Wuhan, 430010, China

  • Research Site

    Yibin, 610500, China

  • Research Site

    Zhengzhou, 450052, China

  • Research Site

    Zhuji, 311899, China

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