Type 2 Diabetes Mellitus (T2DM)Phase 3CONTROLNCT07057479
Phase III Trial of SGLT2 Inhibitor and Thiazolidinedione Fixed-Dose Combination vs. Monotherapy in Type 2 Diabetes Patients on Metformin
A Phase 3 study testing Fixed-dose combination of SGLT2 inhibitor and thiazolidinedione and Background Therapy (All Groups) - Metformin in people with Type 2 Diabetes Mellitus (T2DM), run by Eurofarma Laboratorios S.A. at 1 site in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM)
- What is being tested?
- Fixed-dose combination of SGLT2 inhibitor and thiazolidinedione and Background Therapy (All Groups) - Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2026to Feb 2028
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Type 1 diabetes or other specific diabetes types (e.g., monogenic, pancreatic, or drug-induced)
- 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)
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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:
Read more
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.
Read the detailed description
This phase III clinical trial investigates a fixed-dose combination (FDC) of two established antidiabetic medications with complementary mechanisms of action: an SGLT2 inhibitor and a thiazolidinedione (TZD). The study aims to evaluate whether combining these medications in a single tablet provides superior glycemic control compared to either medication alone in patients with type 2 diabetes who are already on metformin therapy.
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
- Type 2 Diabetes Mellitus (T2DM)
- Being tested
- Fixed-dose combination of SGLT2 inhibitor and thiazolidinedione, Control Group 1 Intervention - SGLT2 inhibitor monotherapy, Control Group 2 Intervention - Thiazolidinedione monotherapy, Background Therapy (All Groups) - Metformin
- Keywords
- Type 2 Diabetes Mellitus, T2DM, Fixed-dose combination, SGLT2 inhibitor, Thiazolidinedione, Dual therapy, Glycemic control, Insulin resistance, Randomized clinical trial, Phase III trial, Diabetes treatment, Oral antidiabetic drugs, Metformin adjunct therapy, HbA1c reduction, Cardiovascular risk factors, Renal protection, Diabetes complications, Monotherapy comparison, Drug combination efficacy, Diabetes management
- Medical subject headings
- Diabetes Mellitus, Type 2, Insulin Resistance, Diabetes Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fixed-dose combination of SGLT2 inhibitor and thiazolidinedioneDrug
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 monotherapyDrug
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 monotherapyDrug
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) - MetforminDrug
Extended-release metformin tablets (≥1000mg daily) continued as background therapy for all participants throughout the study duration.
| Study group | Role | What they receive |
|---|---|---|
| Fixed-Dose Combination of SGLT2i /TZD + Metformin | Experimental | 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. Receives: Drug: Fixed-dose combination of SGLT2 inhibitor and thiazolidinedione; Drug: Background Therapy (All Groups) - Metformin |
| Control Group 1 - SGLT2 Inhibitor + Metformin | Active comparator | 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. Receives: Drug: Control Group 1 Intervention - SGLT2 inhibitor monotherapy; Drug: Background Therapy (All Groups) - Metformin |
| Control Group 2 - Thiazolidinedione + Metformin | Active comparator | 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. Receives: Drug: Control Group 2 Intervention - Thiazolidinedione monotherapy; Drug: Background Therapy (All Groups) - Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in glycated hemoglobin (HbA1c) from baseline to week 24
Measured: From baseline to week 24
Secondary outcomes (5)
Proportion of participants achieving HbA1c <7.0% at week 24
Measured: At week 24
Change in fasting plasma glucose from baseline to week 24
Measured: Baseline to week 24
Incidence of adverse events (AEs) over 24 weeks
Measured: Baseline to week 24
Incidence of peripheral edema over 24 weeks
Measured: Baseline to week 24
Incidence of moderate/severe hypoglycemia (Level 2/3) over 24 weeks
Measured: Baseline to week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2025
- Study startSep 2026 (estimated)
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Why it stopped: Strategic change in development priorities
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eurofarma Laboratorios S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07057479
- Sponsor's protocol ID
- EF191
- Acronym
- CONTROL
- Status last verified
- Jun 2025
- First submitted
- 30 Jun 2025
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07057479
- Acronym / sponsor ID
- CONTROL / EF191
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Keywords
- Type 2 Diabetes Mellitus, T2DM, Fixed-dose combination, SGLT2 inhibitor, Thiazolidinedione, Dual therapy, Glycemic control, Insulin resistance
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Strategic change in development priorities
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Eurofarma Laboratorios S.A.Industry (pharma, biotech, devices)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 9 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This phase III clinical trial investigates a fixed-dose combination (FDC) of two established antidiabetic medications with complementary mechanisms of action: an SGLT2 inhibitor and a thiazolidinedione (TZD). The study aims to evaluate whether combining these medications in a single tablet provides superior glycemic control compared to either medication alone in patients with type 2 diabetes who are already on metformin therapy.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fixed-Dose Combination of SGLT2i /TZD + Metformin | Experimental | Drug: Fixed-dose combination of SGLT2 inhibitor and thiazolidinedione, Drug: Background Therapy (All Groups) - MetforminParticipants 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. |
| Control Group 1 - SGLT2 Inhibitor + Metformin | Active comparator | Drug: Control Group 1 Intervention - SGLT2 inhibitor monotherapy, Drug: Background Therapy (All Groups) - MetforminParticipants 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 2 - Thiazolidinedione + Metformin | Active comparator | Drug: Control Group 2 Intervention - Thiazolidinedione monotherapy, Drug: Background Therapy (All Groups) - MetforminParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- Type 1 diabetes or other specific diabetes types (e.g., monogenic, pancreatic, or drug-induced)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fixed-dose combination of SGLT2 inhibitor and thiazolidinedioneOral 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). | Drug | Fixed-Dose Combination of SGLT2i /TZD + Metformin |
| Control Group 1 Intervention - SGLT2 inhibitor monotherapyOral 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. | Drug | Control Group 1 - SGLT2 Inhibitor + Metformin |
| Control Group 2 Intervention - Thiazolidinedione monotherapyOral 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. | Drug | Control Group 2 - Thiazolidinedione + Metformin |
| Background Therapy (All Groups) - MetforminExtended-release metformin tablets (≥1000mg daily) continued as background therapy for all participants throughout the study duration. | Drug | Control Group 1 - SGLT2 Inhibitor + Metformin, Control Group 2 - Thiazolidinedione + Metformin, Fixed-Dose Combination of SGLT2i /TZD + Metformin |
Primary outcome
Change in glycated hemoglobin (HbA1c) from baseline to week 24
Time frame: From baseline to week 24
5 secondary outcomes
Proportion of participants achieving HbA1c <7.0% at week 24
Time frame: At week 24
Change in fasting plasma glucose from baseline to week 24
Time frame: Baseline to week 24
Incidence of adverse events (AEs) over 24 weeks
Time frame: Baseline to week 24
Incidence of peripheral edema over 24 weeks
Time frame: Baseline to week 24
Incidence of moderate/severe hypoglycemia (Level 2/3) over 24 weeks
Time frame: Baseline to week 24
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
Related trials for Type 2 Diabetes Mellitus (T2DM)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 2
A Phase 2 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of SAL0150 Tablets in Subjects With Type 2 Diabetes Mellitus
Type 2 Diabetes Mellitus (T2DM), Type 2 Diabetes
RecruitingPhase 3
A Study to Evaluate the Effects of Enicepatide in Participants With Obesity or Overweight, With or Without Type 2 Diabetes
Obesity, Overweight
RecruitingObservational study
Chiglitazar Added to SGLT-2 Inhibitors for Type 2 Diabetes
T2DM (Type 2 Diabetes Mellitus)
Active, not recruitingObservational study
An Observational Study to Learn More About How Safe Finerenone is and How Well it Works in Indian People With Chronic Kidney Disease and Type 2 Diabetes in Routine Medical Practice
Chronic Kidney Disease, Type 2 Diabetes Mellitus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fixed-dose combination of SGLT2 inhibitor and thiazolidinedione and Background Therapy (All Groups) - Metformin in people with Type 2 Diabetes Mellitus (T2DM), run by Eurofarma Laboratorios S.A. at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in glycated hemoglobin (HbA1c) from baseline to week 24 (time frame: From baseline to week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.