NCT07057479WithdrawnPhase 3
Phase III Trial of SGLT2 Inhibitor and Thiazolidinedione Fixed-Dose Combination vs. Monotherapy in Type 2 Diabetes Patients on Metformin
Phase III, Adaptive, Multicenter, Randomized, Superiority, Double-Dummy, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of a Fixed-Dose Combination of a Sodium-Glucose Cotransporter-2 (SGLT2) Inhibitor and a Thiazolidinedione in the Treatment of Type 2 Diabetes Mellitus, Compared to Monotherapy, in Patients Treated With Metformin
Source: ClinicalTrials.gov · Last updated 18 Dec 2025
Reason given: Strategic change in development priorities
Brief summary (registry, in English)
This clinical trial is studying whether combining two commonly used diabetes medications into a single pill works better than taking them separately for people with type 2 diabetes who are already on metformin. Both medications work in different ways to lower blood sugar - one helps remove excess sugar through urine while the other helps the body use insulin better. The study has two main goals: To see if the combined pill controls blood sugar more effectively than either medication alone To check if combining them reduces common side effects like weight gain and swelling that can occur with one of the medications Participants will be randomly assigned to one of three groups: The new combination pill One of the standard diabetes medications alone The other standard diabetes medication alone All participants will take their assigned treatment daily and attend regular clinic visits for monitoring. Doctors will track blood sugar control, weight changes, and any side effects throughout the study period. This research could lead to a simpler treatment option that combines the benefits of both medications while potentially minimizing side effects. For people with diabetes who often need multiple medications, a combined pill might make treatment easier to manage while providing better blood sugar control.
- Status (registry)
- Withdrawn
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 0 (actual)
- First submitted
- 30 Jun 2025
- Start date
- Sept 2026
- Primary completion date
- Feb 2028
- Lead sponsor
- Eurofarma Laboratorios S.A.
- Diseases
- Type 2 diabetes
- NCT number
- NCT07057479
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of non-metformin antidiabetics or weight-loss drugs in past 12 weeks
Other illness
- Type 1 diabetes or other specific diabetes types (e.g., monogenic, pancreatic, or drug-induced)
- Hypersensitivity to study drugs or excipients
- Major cardiovascular events in past 12 weeks (e.g., myocardial infarction, heart failure NYHA III/IV)
- Uncontrolled hypertension (SBP >180 mmHg or DBP >110 mmHg)
- Liver disease (cirrhosis, active hepatitis)
- History of malignancy (except treated skin cancers) in past 5 years
Lab values
- Severe hyperglycemia (≥270 mg/dL) or diabetic ketoacidosis in past 12 weeks
- Moderate/severe renal impairment (eGFR <45 mL/min/1.73m²)
Other
- Pregnancy, lactation, or planning pregnancy
- Severe diabetic complications (proliferative retinopathy, severe neuropathy)
Who the study is looking for
- Signed informed consent form
- Age ≥18 years
- Diagnosis of type 2 diabetes (T2DM)
- HbA1c 7.5-10% while on stable metformin monotherapy (≥1000 mg/day) for ≥12 weeks
- ≥80% adherence to run-in medication
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Eurofarma Laboratórios S.A | Itapevi | Brazil | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.