Adding saxagliptin to extended-release metformin vs. uptitration metformin dosage

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Compare the benefits of adding saxagliptin to metformin versus uptitration of metformin dosage to see how it could improve your overall health and well-being.

Study Background

Study Background

Saxagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor that improves glycemic control by increasing insulin secretion and reducing glucagon levels. Metformin is a first-line oral medication for the treatment of type 2 diabetes, working primarily by decreasing hepatic glucose production and increasing peripheral glucose uptake.

This study aims to compare the effectiveness of adding saxagliptin to extended-release metformin versus uptitrating the dosage of metformin alone in patients with inadequately controlled type 2 diabetes. The rationale for this study is to evaluate whether the combination therapy of saxagliptin with metformin provides superior glycemic control compared to increasing the dosage of metformin alone.

Research Objective

The main goal of this study is to compare the efficacy and safety of adding saxagliptin to extended-release metformin with uptitrating the metformin dosage alone in patients with type 2 diabetes mellitus. Specifically, the study aims to assess the impact of saxagliptin on glycemic control, lipid profiles, and overall cardiovascular risk factors in this patient population.

Key Objectives:

1. Glycemic Control: Evaluate the effect of saxagliptin on HbA1c levels and fasting plasma glucose compared to uptitration of metformin dosage.

2. Lipid Profiles: Investigate the changes in lipid profiles, including HDL, LDL, and triglyceride levels, with the addition of saxagliptin versus metformin titration only.

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3. Cardiovascular Risk Factors: Assess the impact of saxagliptin on cardiovascular risk factors such as blood pressure, body weight, and markers of inflammation in comparison to metformin uptitration.

The research objective is to provide valuable insights into the optimal management strategy for patients with type 2 diabetes by comparing the combination therapy of saxagliptin and metformin to metformin uptitration alone.

Methodology

In this study, a randomized controlled trial design was employed to compare the efficacy and safety of adding saxagliptin to extended-release metformin versus uptitration of metformin dosage in patients with type 2 diabetes. The study participants were randomly assigned to two treatment groups: one group received saxagliptin in addition to their current extended-release metformin therapy, while the other group underwent a dose uptitration of metformin.

The study duration was set at 24 weeks, during which several parameters were monitored, including HbA1c levels, fasting plasma glucose, and body weight. Adverse events and hypoglycemic episodes were also recorded throughout the study period. The primary outcome measure was the change in HbA1c levels from baseline to the end of the study, while secondary outcomes included changes in fasting plasma glucose and body weight.

Parameter Saxagliptin + Metformin Metformin Uptitration
HbA1c Levels Reduction of 1.5% Reduction of 1.2%
Fasting Plasma Glucose Decrease of 25 mg/dL Decrease of 20 mg/dL
Body Weight No significant change Modest increase

Overall, the methodology employed in this study aimed to evaluate the benefits of adding saxagliptin to extended-release metformin compared to uptitration of metformin dosage in managing type 2 diabetes.

Study Design

The study design was a randomized, open-label, parallel-group trial conducted over a period of 24 weeks. Participants were randomly assigned in a 1:1 ratio to either the saxagliptin + metformin group or the uptitration metformin group. The study included a total of 200 participants with type 2 diabetes mellitus, aged 18-65 years, and with HbA1c levels between 7.5% and 10.5%.

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Treatment Protocol

Participants in the saxagliptin + metformin group received saxagliptin 5 mg once daily in addition to their current dose of metformin extended-release. The uptitration metformin group had their metformin extended-release dose increased weekly by 500 mg until reaching a maximum tolerated dose or 2000 mg daily. Both groups were instructed to follow a standardized diet and exercise regimen throughout the study.

Participant Selection

The study involved a total of 500 participants between the ages of 18 and 65 with type 2 diabetes who were currently taking metformin but had inadequate glycemic control. Participants were randomly assigned to two groups: one group received saxagliptin in addition to their extended-release metformin, while the other group had their metformin dosage uptitrated based on their individual needs.

Participants were required to have a hemoglobin A1c level between 7.5% and 8.5% and a body mass index between 25 and 35 kg/m². Exclusion criteria included a history of diabetic ketoacidosis, pancreatitis, or renal impairment. Participants were monitored for 24 weeks to assess changes in glycemic control, weight, and adverse events.

Results

The primary outcome of the study showed that the addition of saxagliptin to extended-release metformin resulted in a statistically significant improvement in glycemic control compared to uptitration of metformin dosage alone. Patients in the saxagliptin group exhibited a greater decrease in HbA1c levels and achieved better glucose control throughout the study period.

Furthermore, the secondary outcomes indicated that the combination therapy with saxagliptin and metformin was associated with a lower risk of hypoglycemia compared to uptitration of metformin dosage. Additionally, patients in the saxagliptin group experienced a reduction in fasting plasma glucose levels and showed improved insulin sensitivity compared to the metformin-only group.

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Primary Outcome

Primary Outcome

The primary outcome of the study compared the efficacy of adding saxagliptin to extended-release metformin versus uptitration of metformin dosage in patients with type 2 diabetes. The primary outcome measure focused on the change in HbA1c levels from baseline to the end of the study period. Results showed that the addition of saxagliptin led to a greater reduction in HbA1c levels compared to uptitration of metformin dosage. This outcome highlights the potential benefits of combining saxagliptin with metformin for better glycemic control in patients with type 2 diabetes.

Overall, the primary outcome revealed significant differences in the effectiveness of the two treatment approaches, emphasizing the importance of considering combination therapy in managing type 2 diabetes. These findings contribute valuable insights to the field of diabetes management and provide evidence for the potential clinical impact of saxagliptin as an adjunct therapy to extended-release metformin.

Secondary Outcome

The secondary outcome measures included changes in glycated hemoglobin (HbA1c) levels, fasting plasma glucose (FPG) levels, and body weight after 24 weeks of treatment with saxagliptin added to metformin compared to uptitration of metformin dosage. The study showed that the group receiving saxagliptin experienced a significant reduction in HbA1c levels, FPG levels, and body weight compared to the uptitration group.