Last updated July 18, 2026
Key finding
Adverse events were more frequent with the fixed-dose combination than with the loose combination (8.9% vs. 1.1%, p = 0.034).
This study evaluated the efficacy and safety of a fixed-dose combination of dapagliflozin and pioglitazone in patients with type 2 diabetes inadequately controlled on metformin. The findings suggested that while both treatments reduced HbA1c, the fixed-dose combination had a higher rate of adverse events.
Quick read
The essential study design details in one scan.
EvidenceScore™
Moderate
Study type
RCTs
Follow-up
Medium-Term (3–12 mo)
Risk of bias
High Risk
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Plain-language summary
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Study focus
This study evaluated the efficacy and safety of a fixed-dose combination of dapagliflozin and pioglitazone in patients with type 2 diabetes inadequately controlled on metformin. The findings suggested that while both treatments reduced HbA1c, the fixed-dose combination had a higher rate of adverse events.
This study is significant as it highlights the balance between efficacy and safety in diabetes management. While the fixed-dose combination may offer better glycemic control, the increased risk of adverse events must be considered when making treatment decisions for patients with type 2 diabetes.
The study did not assess long-term outcomes beyond the trial duration. The sample size may limit the generalizability of the findings. Potential confounding factors were not fully explored.
Published in
Publication details and source links for this paper.
Awadhesh KS, Krishna GS, A GU, et al. Efficacy and safety of a fixed-dose combination of dapagliflozin and pioglitazone in patients with type 2 diabetes mellitus inadequately controlled on metformin: a randomized controlled trial. Diabetology & Metabolic Syndrome. 2026;18:125. doi:10.1186/s13098-026-02086-3
The fixed-dose combination reduced HbA1c by -1.20%, while loose combination therapy reduced it by -1.02%.
Fasting plasma glucose decreased by -8.6 mg/dL in the fixed-dose group compared to -12.0 mg/dL in the loose combination group.
Adverse events occurred in 8.9% of the fixed-dose group versus 1.1% in the loose combination group.
Evidence network
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This study contributes evidence to Dapagliflozin and Adverse events incidence, Fasting Plasma Glucose (FPG), Glucose iAUC (OGTT), and 1 more.
This study contributes evidence to
Primary intervention
Dapagliflozin
Primary outcomes
Primary intervention
Intervention and outcome relationships this study adds to the evidence network.
Editorial context
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Evidence network role
This section describes how the study fits into the current evidence network. It does not determine whether an intervention works on its own.
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Contributes evidence
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Primary evidence
Evidence relationship
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Evidence relationship
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Evidence relationship
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Core evidence
The primary outcomes reported in this study.
Dapagliflozin → Adverse events incidence
Dapagliflozin → Adverse events incidence
Dapagliflozin → Fasting Plasma Glucose (FPG)
Dapagliflozin → Fasting Plasma Glucose (FPG)
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Relationships organized using the Dediabetes Evidence Intelligence™ framework.
This study contributes to evidence on SGLT2 Inhibitors and HbA1c, SGLT2 Inhibitors and Fasting Glucose.
This study contributes to the evidence on the following intervention-outcome relationships.
Medications
Medications
Curated evidence collections and hubs this study is part of.
All studies measuring HbA1c
Measures HbA1c as a key outcome.
All studies on SGLT2 Inhibitors
Contributes to SGLT2 Inhibitors evidence base.
All studies measuring Fasting Glucose
Measures Fasting Glucose as a key outcome.
Latest published studies
Published within the last 2 years.
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6 results
3 results
6 results
6 results
3 results
Generated from the study's connected evidence using Evidence Intelligence™.
SGLT2 Inhibitors may improve HbA1c.
ConsistencyScore™: Results are consistent across studies.
Ranked evidence signals
HbA1c
EvidenceScore™ Strong | EvidenceScore™ 78.9 | strong positive | ConsistencyScore™ Consistent | 1 study
Why this answer: This answer is based on 15 supporting studies with consistent results and a positive effect signal.
Limitations
SGLT2 Inhibitors may improve Fasting Glucose.
ConsistencyScore™: Results are consistent across studies.
Ranked evidence signals
Fasting Plasma Glucose (FPG)
EvidenceScore™ Strong | EvidenceScore™ 77.9 | moderate positive | ConsistencyScore™ Consistent | 1 study
Why this answer: This answer is based on 11 supporting studies with consistent results and a positive effect signal.
Limitations
SGLT2 Inhibitors may improve Postprandial and OGTT Glucose.
ConsistencyScore™: Results are consistent across studies.
Ranked evidence signals
Glucose iAUC (OGTT)
EvidenceScore™ Moderate | EvidenceScore™ 69.0 | moderate positive | ConsistencyScore™ Consistent | 1 study
Why this answer: This answer is based on 3 supporting studies with consistent results and a positive effect signal.
Limitations
Current evidence does not show a clear benefit of Dapagliflozin for Adverse events incidence.
ConsistencyScore™: Consistency cannot yet be determined from the available evidence.
Ranked evidence signals
Adverse events incidence
EvidenceScore™ Emerging | EvidenceScore™ 59.0 | neutral | ConsistencyScore™ Unclear | 1 study
Why this answer: This answer is based on a single supporting study.
Limitations
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