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Background <p>To assess the efficacy and safety of a fixed-dose combination (FDC) of dapagliflozin and pioglitazone versus a loose combination (LC) in Patients with Type 2 Diabetes Mellitus inadequately controlled on earlier metformin containing mono therapy.</p> Materials and methods <p>This 12-week PRO-1 study was a randomized, open-label, multicenter phase 3 trial that enrolled 180 Indian adults with T2DM, Glycated Hemoglobin (HbA1c) &gt; 7.5% to 10% inadequately controlled with metformin. The participants received once-daily FDC (dapagliflozin 10&#xa0;mg/pioglitazone 15&#xa0;mg) or equivalent LC therapy (1:1 randomization). The primary endpoint was the HbA1c change (non-inferiority margin, 0.3). The secondary endpoints included fasting plasma glucose (FPG), postprandial glucose (PPG), and HbA1c &lt; 7.5%.</p> Results <p>At week 12, the least-squares mean HbA1c reduction was − 1.20% (FDC) versus − 1.02% (LC). A between-group difference of − 0.18% (95% CI: −0.56 to 0.20) demonstrated non-inferiority. FPG decreased by − 8.6&#xa0;mg/dL (FDC) and − 12.0&#xa0;mg/dL (LC); PPG decreased by − 28.2&#xa0;mg/dL and − 29.5&#xa0;mg/dL, respectively. Target HbA1c &lt; 7.5% was achieved in 52.9% (FDC) versus 54.8% (LC) of patients. (mITT population; <i>p</i> = 0.877). Both regimens were generally well tolerated; adverse events were more frequent with the fixed-dose combination than with the loose combination (8.9% versus 1.1%, <i>p</i> = 0.034), but were mild and self-limiting, with no serious events, hypoglycemia, or treatment discontinuation in either group.</p> Conclusions <p>The fixed-dose combination of dapagliflozin and pioglitazone was non inferior to separate administration with respect to glycemic efficacy in Indian adults with inadequately controlled type 2 diabetes mellitus receiving metformin, with a favorable and comparable safety profile.</p> Trial registration <p>CTRI/2024/09/073221.</p>

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Efficacy and safety of fixed-dose dapagliflozin–pioglitazone in Indian adults with type 2 diabetes: a phase 3 PRO-1 trial

  • 期刊论文

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  • 发表日期：

    2026年1月11日

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  • Awadhesh Kumar Singh,
  • Krishna G Seshadri,
  • A G Unnikrishnan,
  • Jothydev Kesavadev,
  • Sanjay Kalra,
  • Shashank R Joshi,
  • Kaushik Pandit,
  • Rakesh K Sahay,
  • Vijay K Panikar,
  • Ambrish Mithal,
  • Smriti Gadia,
  • Thamburaj Anthuvan

摘要

Background

To assess the efficacy and safety of a fixed-dose combination (FDC) of dapagliflozin and pioglitazone versus a loose combination (LC) in Patients with Type 2 Diabetes Mellitus inadequately controlled on earlier metformin containing mono therapy.

Materials and methods

This 12-week PRO-1 study was a randomized, open-label, multicenter phase 3 trial that enrolled 180 Indian adults with T2DM, Glycated Hemoglobin (HbA1c) > 7.5% to 10% inadequately controlled with metformin. The participants received once-daily FDC (dapagliflozin 10 mg/pioglitazone 15 mg) or equivalent LC therapy (1:1 randomization). The primary endpoint was the HbA1c change (non-inferiority margin, 0.3). The secondary endpoints included fasting plasma glucose (FPG), postprandial glucose (PPG), and HbA1c < 7.5%.

Results

At week 12, the least-squares mean HbA1c reduction was − 1.20% (FDC) versus − 1.02% (LC). A between-group difference of − 0.18% (95% CI: −0.56 to 0.20) demonstrated non-inferiority. FPG decreased by − 8.6 mg/dL (FDC) and − 12.0 mg/dL (LC); PPG decreased by − 28.2 mg/dL and − 29.5 mg/dL, respectively. Target HbA1c < 7.5% was achieved in 52.9% (FDC) versus 54.8% (LC) of patients. (mITT population; p = 0.877). Both regimens were generally well tolerated; adverse events were more frequent with the fixed-dose combination than with the loose combination (8.9% versus 1.1%, p = 0.034), but were mild and self-limiting, with no serious events, hypoglycemia, or treatment discontinuation in either group.

Conclusions

The fixed-dose combination of dapagliflozin and pioglitazone was non inferior to separate administration with respect to glycemic efficacy in Indian adults with inadequately controlled type 2 diabetes mellitus receiving metformin, with a favorable and comparable safety profile.

Trial registration

CTRI/2024/09/073221.