Understanding Artificial Pancreas Systems: Results from a 24-Month Trial

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HbA1c decreased from 8.76% to 6.97%, a reduction of 1.79% that was statistically significant and clinically meaningful. The improvement was consistent across all participants in the combination group.

Fasting blood sugar dropped by an average of 52.72 mg/dL, showing consistent improvement in morning glucose levels with the combination therapy.

After-meal blood sugar decreased by 74.75 mg/dL on average, demonstrating effective control of glucose spikes following meals with the combination treatment.

Five patients experienced mild low blood sugar events, all of which were successfully treated with full recovery. The low rate suggests the sustained-release gliclazide formulation maintains good safety.

Dapagliflozin 10mg + Gliclazide 60mg SR (Fixed-Dose Combination)

Once daily, combined with background metformin therapy

HbA1c decreased from 8.80% to 7.32%, a reduction of 1.48% that was statistically significant. While effective, the reduction was smaller than with combination therapy.

Fasting blood sugar dropped by 45.15 mg/dL on average with dapagliflozin monotherapy, showing meaningful glucose reduction.

After-meal blood sugar decreased by 65.90 mg/dL with dapagliflozin alone, demonstrating effective postprandial glucose control.

No hypoglycemic events occurred in the dapagliflozin monotherapy group, confirming the favorable safety profile of SGLT2 inhibitors regarding low blood sugar risk.

These results align with the global ADD2DIA study, which found that adding SGLT2 inhibitors to gliclazide-based therapy reduced HbA1c by 1.1% at six months. The current study showed even greater reductions, likely due to similar baseline HbA1c levels and the fixed-dose combination format which may improve adherence. Other studies have shown that SGLT2 inhibitors combined with sulfonylureas produce better results than combining SGLT2 inhibitors with DPP-4 inhibitors.

Moderate confidence. This was a well-designed randomized trial with clear results showing the combination works better than single medication. However, the study was open-label, meaning participants knew which treatment they received, which could introduce bias. The 16-week duration is relatively short, so long-term effects are unknown.

The combination of dapagliflozin plus gliclazide appears to lower HbA1c more than dapagliflozin alone in people taking metformin

Fasting and after-meal blood sugar levels also improved more with the combination

Low blood sugar events were uncommon and not serious

The combination therapy appears to provide meaningful additional blood sugar control compared to single medication

The benefit was consistent across fasting blood sugar, after-meal blood sugar, and HbA1c measurements

Low blood sugar risk remained low despite using a sulfonylurea medication, likely due to the sustained-release formulation

The 16-week study period is relatively short, so longer-term effects are uncertain

Participants received either a fixed-dose combination tablet containing dapagliflozin 10mg and gliclazide 60mg sustained release taken once daily, or dapagliflozin 10mg alone taken once daily. All participants continued their background metformin therapy at doses of at least 1000mg per day. The study lasted 16 weeks with regular monitoring visits.

dapagliflozin, gliclazide sustained release, metformin, SGLT2 inhibitor, sulfonylurea

Erande SG, Raykantiwar A, Shejole V, et al. A Randomized, Multicenter Study Evaluating the Efficacy, Safety and Tolerability of Dapagliflozin + Gliclazide Fixed Dose Combination Over Dapagliflozin Monotherapy in Type 2 Diabetes Mellitus Patients Inadequately Controlled on Metformin Monotherapy. Cureus. 2026;18(2):e103676. doi:10.7759/cureus.103676

The combination of dapagliflozin plus gliclazide reduced HbA1c by 1.79% on average, while dapagliflozin alone reduced it by 1.48%. This 0.31% additional reduction was statistically significant. Fasting blood sugar dropped by 52.72 mg/dL with the combination versus 45.15 mg/dL with single medication. After-meal blood sugar showed similar patterns with greater reductions in the combination group. About 82% of people taking the combination reached an HbA1c below 8%, compared to 76% with single medication, though this difference was not statistically significant.

Combining dapagliflozin with gliclazide improves blood sugar control more than dapagliflozin alone in type 2 diabetes.

The study lasted only 16 weeks, which may not be enough time to understand long-term benefits or risks. The open-label design could introduce bias in how patients reported outcomes. The study excluded people with reduced kidney function, so results may not apply to them. All participants were from India, which may limit how well the findings apply to other populations. While blood sugar levels improved, most participants still did not reach the recommended HbA1c target of less than 7%.

HbA1c → ↓ (moderate improvement, additional 0.3% reduction)

Fasting blood sugar → ↓ (moderate improvement)

After-meal blood sugar → ↓ (moderate improvement)

ADD2Dia: real-world clinical effectiveness of adding a sodium-glucose cotransporter 2 inhibitor to gliclazide-based therapy in type 2 diabetes

Dapagliflozin improves glycemic control and reduces body weight as add-on therapy to metformin plus sulfonylurea

Mayo Clinic: Type 2 Diabetes Treatment Options

This was a phase III clinical trial conducted at 10 centers across India. Researchers randomly assigned 244 adults with type 2 diabetes to one of two groups in equal numbers. One group took a combination tablet with dapagliflozin 10mg plus gliclazide 60mg sustained release. The other group took only dapagliflozin 10mg. All participants continued taking their metformin medication. Patients were followed for 16 weeks with blood sugar measurements at multiple timepoints. The study was open-label, meaning both patients and doctors knew which treatment was given.

Dapagliflozin plus gliclazide combination improves blood sugar control in type 2 diabetes

This 16-week study tested whether combining two diabetes medications works better than one alone. Researchers in India randomly assigned 244 adults with type 2 diabetes to receive either dapagliflozin plus gliclazide together, or dapagliflozin alone. All participants were already taking metformin but their blood sugar remained poorly controlled. The combination reduced HbA1c by 1.79% compared to 1.48% with dapagliflozin alone, a meaningful difference. Fasting and after-meal blood sugar also improved more with the combination. Only 5 patients taking the combination experienced low blood sugar events, and all recovered. The combination appears to help improve blood sugar control in people whose diabetes is not well-managed with metformin alone.

Study participants were from India only, so results may not fully apply to other populations

The 16-week study duration means long-term safety and effectiveness are unknown

People with reduced kidney function were excluded, limiting how broadly these results apply

Even with the combination, most people did not reach the recommended HbA1c goal of less than 7%

A trial of 244 Indian adults with type 2 diabetes testing combination therapy over 16 weeks

Adults aged 18-65 with type 2 diabetes whose blood sugar remains poorly controlled (HbA1c 8-10%) despite taking metformin at adequate doses for at least 3 months. Does not apply to people with reduced kidney function, type 1 diabetes, or very high blood sugar levels.

Adults with type 2 diabetes who are not achieving blood sugar control with metformin alone

Dapagliflozin plus gliclazide combination improves blood sugar control in type 2 diabetes

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