New triple therapy aims to tame type 2 diabetes
NCT ID NCT07026968
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 3 trial tests whether adding two new drugs—prusogliptin and dapagliflozin—to standard metformin can improve blood sugar control in adults with type 2 diabetes. About 815 participants who are not well-controlled on metformin alone will receive either the triple combination or a placebo plus metformin. The main goal is to see if the combo lowers HbA1c (a key blood sugar measure) more effectively after 24 weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- prusogliptin, dapagliflozin, and metformin
- What this could lead to
- If successful, this triple-drug combination could offer a new, more effective option for managing blood sugar in people with type 2 diabetes who don't get enough help from metformin alone.
- What could go wrong
- This is a phase 3 trial, but results are not yet available. The combination may not prove significantly better than existing treatments, and side effects from multiple drugs could be a concern.
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 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
About 815 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2025
- Expected to finish
-
Nov 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Subjects with type 2 diabetes was confirmed at least 10 weeks prior to the screening; * Male or female, 18 years ≤ age ≤ 75 years; * Body Mass Index (BMI) ≥ 18.5 kg/m\^2, and ≤40 kg/m\^2; * Stable metformin therapy for at least 10 weeks prior to screening at a dose ≥ 1500 mg per day; * The glycated hemoglobin must meet the following standards:During screening: 7.5% ≤ HbA1c ≤ 11.0% (local laboratory);Before random sampling: 7.0% ≤ HbA1c ≤ 10.5% (central laboratory); * Be able to understand and follow the test procedures, voluntarily participate in the test and sign the ICF. Exclusion Criteria: * Type 1 diabetes or other special types of diabetes; * ≥2 episodes of Grade 3 hypoglycemia within 6 months prior to screening, or any Grade 3 hypoglycemia occurring from screening to randomization; * ≥1 episode of acute diabetic complications (e.g., diabetic ketoacidosis, hyperglycemic hyperosmolar state) within 6 months prior to screening or prior to randomization; * Severe chronic diabetic complications (e.g., proliferative diabetic retinopathy, severe diabetic neuropathy, diabetic foot) within 6 months prior to screening; * History of acute or chronic pancreatitis at screening or prior to randomization; * Inflammatory bowel disease, partial intestinal obstruction, or chronic intestinal diseases associated with malabsorption within 6 months prior to screening or prior to randomization; * Previous gastrointestinal surgeries that may cause malabsorption (excluding polypectomy and appendectomy), or chronic use of medications directly affecting gastrointestinal motility at screening or prior to randomization; * Any cardiovascular event within 6 months prior to screening or prior to randomization, including: decompensated heart failure (NYHA Class III or IV); unstable angina, myocardial infarction, coronary artery bypass grafting, or coronary stent implantation; long QT syndrome or prolonged QTcF interval (male \>450 ms, female \>470 ms); clinically significant arrhythmia requiring treatment and deemed unsuitable for trial participation by the investigator; * Hemorrhagic stroke or acute ischemic stroke within 6 months prior to screening or prior to randomization; * Acute gallbladder disease within 6 months prior to screening, or active gallbladder disease requiring treatment at screening/prior to randomization; * History of severe psychiatric disorders (e.g., depression, anxiety disorders), severe osteoporosis, or other medical conditions that may endanger participant safety as judged by the investigator; * Malignancy (except clinically cured basal cell carcinoma or carcinoma in situ) diagnosed or treated within 5 years prior to screening or prior to randomization; * Severe infection or trauma within 4 weeks prior to screening/prior to randomization; recurrent urinary tract infections or genital infections within 6 months prior to screening; or symptomatic urinary/genital infections at screening/prior to randomization; * Clinically significant hematologic diseases (e.g., aplastic anemia, myelodysplastic syndrome) or conditions causing hemolysis or erythrocyte instability (e.g., malaria) at screening/prior to randomization; * Pregnant or lactating women; * Other conditions deemed unsuitable for trial participation by the investigator.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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No. 896, Zhongshan East Road, High-tech Industrial Development Zone
Shijiazhuang, Hebei, 050035, China
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