Phase III Trial of SGLT2 Inhibitor and Thiazolidinedione Fixed-Dose Combination vs. Monotherapy in Type 2 Diabetes Patients on Metformin
NCT ID: NCT07057479
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
INTERVENTIONAL
2026-09-30
2028-02-29
Brief Summary
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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.
Detailed Description
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The SGLT2 inhibitor component lowers blood glucose by increasing urinary glucose excretion, while the TZD component improves insulin sensitivity. Previous studies have shown that these drug classes may offer complementary benefits for metabolic control and cardiovascular risk reduction. However, the TZD component has been associated with side effects including fluid retention and weight gain in some patients. This trial will assess whether the combination can maintain the therapeutic benefits of both drugs while potentially reducing TZD-related adverse effects.
The randomized, double-blind, double-dummy design compares three treatment arms: the FDC, SGLT2 inhibitor monotherapy, and TZD monotherapy. The primary endpoint is the change in HbA1c from baseline after 24 weeks of treatment. Secondary endpoints include measures of safety, tolerability, and additional metabolic parameters.
Participants will undergo regular monitoring including blood tests, physical examinations, and safety assessments throughout the study period. The trial includes specific protocols for detecting and managing potential side effects, particularly those related to fluid retention.
This study addresses an important clinical question regarding optimal treatment strategies for type 2 diabetes, particularly the potential advantages of fixed-dose combinations in simplifying treatment regimens while maintaining efficacy and safety. The results may provide evidence for a new therapeutic option that combines the established benefits of these two drug classes while potentially mitigating some limitations of monotherapy approaches.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Fixed-Dose Combination of SGLT2i /TZD + Metformin
Participants receive a fixed-dose combination tablet containing two antidiabetic agents (an SGLT2 inhibitor and a thiazolidinedione) once daily, plus matching placebos for both comparator drugs to maintain blinding. All participants continue background metformin therapy (≥1000mg/day). Sample size: 136.
Fixed-dose combination of SGLT2 inhibitor and thiazolidinedione
Oral fixed-dose combination tablet containing an SGLT2 inhibitor and a thiazolidinedione, administered once daily. Participants also receive matching placebos for both comparator drugs to maintain blinding. All participants continue background metformin therapy (≥1000mg/day).
Background Therapy (All Groups) - Metformin
Extended-release metformin tablets (≥1000mg daily) continued as background therapy for all participants throughout the study duration.
Control Group 1 - SGLT2 Inhibitor + Metformin
Participants receive monotherapy with an SGLT2 inhibitor once daily, plus matching placebos for both the FDC and the thiazolidinedione comparator to maintain blinding. All participants continue background metformin therapy (≥1000mg/day). Sample size: 136.
Control Group 1 Intervention - SGLT2 inhibitor monotherapy
Oral tablet containing an SGLT2 inhibitor, administered once daily. Participants also receive matching placebos for both the fixed-dose combination and the thiazolidinedione comparator to maintain blinding. All participants continue background metformin therapy (≥1000mg/day). This represents standard monotherapy for comparison against the combination approach.
Background Therapy (All Groups) - Metformin
Extended-release metformin tablets (≥1000mg daily) continued as background therapy for all participants throughout the study duration.
Control Group 2 - Thiazolidinedione + Metformin
Participants receive monotherapy with a thiazolidinedione once daily, plus matching placebos for both the FDC and the SGLT2 inhibitor comparator to maintain blinding. All participants continue background metformin therapy (≥1000mg/day). Sample size: 136.
Control Group 2 Intervention - Thiazolidinedione monotherapy
Oral tablet containing a thiazolidinedione, administered once daily. Participants also receive matching placebos for both the fixed-dose combination and the SGLT2 inhibitor comparator to maintain blinding. All participants continue background metformin therapy (≥1000mg/day). This represents standard monotherapy for comparison against the combination approach.
Background Therapy (All Groups) - Metformin
Extended-release metformin tablets (≥1000mg daily) continued as background therapy for all participants throughout the study duration.
Interventions
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Fixed-dose combination of SGLT2 inhibitor and thiazolidinedione
Oral fixed-dose combination tablet containing an SGLT2 inhibitor and a thiazolidinedione, administered once daily. Participants also receive matching placebos for both comparator drugs to maintain blinding. All participants continue background metformin therapy (≥1000mg/day).
Control Group 1 Intervention - SGLT2 inhibitor monotherapy
Oral tablet containing an SGLT2 inhibitor, administered once daily. Participants also receive matching placebos for both the fixed-dose combination and the thiazolidinedione comparator to maintain blinding. All participants continue background metformin therapy (≥1000mg/day). This represents standard monotherapy for comparison against the combination approach.
Control Group 2 Intervention - Thiazolidinedione monotherapy
Oral tablet containing a thiazolidinedione, administered once daily. Participants also receive matching placebos for both the fixed-dose combination and the SGLT2 inhibitor comparator to maintain blinding. All participants continue background metformin therapy (≥1000mg/day). This represents standard monotherapy for comparison against the combination approach.
Background Therapy (All Groups) - Metformin
Extended-release metformin tablets (≥1000mg daily) continued as background therapy for all participants throughout the study duration.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Severe hyperglycemia (≥270 mg/dL) or diabetic ketoacidosis in past 12 weeks
* Hypersensitivity to study drugs or excipients
* Pregnancy, lactation, or planning pregnancy
* Severe diabetic complications (proliferative retinopathy, severe neuropathy)
* 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)
* Moderate/severe renal impairment (eGFR \<45 mL/min/1.73m²)
* Liver disease (cirrhosis, active hepatitis)
* History of malignancy (except treated skin cancers) in past 5 years
* Use of non-metformin antidiabetics or weight-loss drugs in past 12 weeks
18 Years
ALL
No
Sponsors
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Eurofarma Laboratorios S.A.
INDUSTRY
Responsible Party
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Locations
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Eurofarma Laboratórios S.A
Itapevi, São Paulo, Brazil
Countries
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Other Identifiers
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EF191
Identifier Type: -
Identifier Source: org_study_id