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Diabetes drug showdown: which Add-On works best?

NCT ID NCT03499704

Disease control Sponsor: Celltrion Pharm, Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 adding pioglitazone or dapagliflozin to standard diabetes pills (alogliptin and metformin) helps control blood sugar better in adults with type 2 diabetes. A total of 133 participants took one of the two extra drugs for 26 weeks. The main goal was to see which combination lowered HbA1c (a measure of blood sugar control) more effectively.

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

133 people

The number who actually took part.

Started

Feb 2020

Finished

Jan 2024

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

19 to 75 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: 1. The subject is a regular outpatient with an has a historical diagnosis of type 2 diabetes. 2. The subject has metabolic syndrome as jointly defined by the International Diabetes Federation (IDF); National Heart, Lung, and Blood Institute (NHLBI) / American Heart Association (AHA); and International Association for the Study of Obesity (IASO). If any 3 of the following 5 risk factors are present, metabolic syndrome can be considered: * High waist circumference: male ≥ 90 cm, female ≥ 85 cm. * High TGs (drug treatment for high TGs is an alternate indicator): ≥ 150 mg/dL (1.7 mmol/L). * Low HDL-C (drug treatment for low HDL-C is an alternate indicator): \< 40 mg/dL(1.0 mmol/L) in males, \< 50 mg/dL (1.3 mmol/L) in females. * High blood pressure (antihypertensive drug treatment in a subject with a history of hypertension is an alternate indicator): Systolic ≥ 130 mmHg and/or diastolic ≥ 85 mmHg. * High fasting glucose (drug treatment of high glucose is an alternate indicator): ≥ 100 mg/dL. 3. The subject has been receiving a stable dose of DPP-4 inhibitor + metformin therapy with diet and exercise for ≥ 3 months prior to Randomization. 4. The subject has a HbA1c value between 7.0 and 11% inclusively within 28 days of Randomization via central laboratory test or after run-in period for 4 weeks via central laboratory test. Exclusion Criteria: 1. The subject has type 1 diabetes, diabetic ketoacidosis, diabetic coma or diabetic precoma. 2. The subject has an active bladder cancer or a history of bladder cancer. 3. The use of any medications ie, oral or systemically injected glucocorticoids (including intra-articular injection), weight-loss drugs, insulin or other anti-diabetic drugs except DPP-4 inhibitor and metformin, within 3 months prior to randomization. Strong Cytochrome P450 2C8 (CYP2C8) inhibitors (eg, gemfibrozil, montelukast, quercetin, phenelzine) and CYP2C8 inducers (eg, rifampin) that in the opinion of the Investigator or Sponsor require treatment contraindicated during the study. The diuretics, angiotensin receptor blockers (ARBs), angiotensin-converting enzyme (ACE) -inhibitors and nonsteroidal anti-inflammatory drugs (NSAIDs) are to be used per product label with close monitoring under Investigator's supervision. 4. Has genetic problems such as galactose intolerance, Lapp lactose dehydrogenase deficiency or glucose-galactose uptake disorder, etc. 5. Has a history of alcohol abuse within 2 years prior to randomization.

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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.

Diabetes mellitus type 2

Contacts and locations

Locations

  • Ajou University Hospital

    Suwon, Gyeonggi-do, 16499, South Korea

  • Chosun University Hospital

    Gwangju, 61453, South Korea

  • Daejeon Eulji Medical Center, Eulji University

    Daejeon, 35233, South Korea

  • Inje University Haeundae Paik Hospital

    Busan, 48108, South Korea

  • Kangbuk Samsung Hospital

    Seoul, 03181, South Korea

  • Korea University Anam Hospital

    Seoul, 02841, South Korea

  • Kyung Hee University Hospital at Gangdong

    Seoul, 05278, South Korea

  • Pusan National University Hospital

    Busan, 49241, South Korea

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620, South Korea

  • The Catholic University of Korea, Bucheon, St. Marys Hospital

    Bucheon-si, Gyeonggi-do, 14647, South Korea

  • The Catholic University of Korea, ST. Vincents Hospital

    Suwon, Gyeonggi-do, 16247, South Korea

  • Ulsan University Hospital

    Ulsan, 44033, South Korea

  • YeungNam University Hospital

    Daegu, 42415, South Korea

  • Yonsei University Health System Severance Hospital

    Seoul, 03722, South Korea

More trials for these conditions

Other studies related to the condition(s) this trial covers.