Completed

Dapagliflozin and Saxagliptin Combination for Improved Glucose Metabolism in Type 2 Diabetes

Study Aim

This study aims to evaluate the effect of combining Dapagliflozin and Saxagliptin on glucose metabolism in individuals with Type 2 Diabetes, comparing it to the effects of using each drug individually.

What is being tested

Dapagliflozin 10mg

+ Saxagliptin 5mg

+ Saxagliptin 5mg + Dapagliflozin 10 mg

Drug

Who is being recruted

From 35 to 70 Years

+22 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2

Interventional

Study Start: July 2018

See protocol details

Summary

Principal SponsorUniversity of Pisa

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: July 24, 2018

Actual date on which the first participant was enrolled.

This study focuses on improving treatment for type 2 diabetes, specifically for patients whose condition is not well-managed with metformin. The study involves two medications: Dapagliflozin (Forxiga) and Saxagliptin. Dapagliflozin works by promoting glucose excretion in the urine, lowering blood sugar levels. Saxagliptin, on the other hand, is a DPP4 inhibitor that helps increase insulin production and decrease glucagon concentrations, leading to lower blood sugar levels. The goal of this research is to explore how these two drugs, when used together with metformin, can improve glucose metabolism in type 2 diabetes patients. During the study, participants will be randomly assigned to receive either a combination of Dapagliflozin and Saxagliptin, or one of these drugs alone, in addition to their current metformin treatment. The primary outcome measured is the effect of these treatments on pancreatic hormone secretion and endogenous glucose production. This will be evaluated by comparing the results of the combined therapy with those of the individual drugs. The study aims to understand if the combination of Dapagliflozin and Saxagliptin can offer improved blood sugar control for type 2 diabetes patients who are not adequately managed with metformin alone.

Official TitleA Randomized Study of the Effects of Dapagliflozin+Saxagliptin in Addition to Metformin Versus Single Addition Saxagliptin or Dapagliflozin on Glucose Metabolism in Patients With DM2 Poorly Controlled With Metformin

NCT03714594

Principal SponsorUniversity of Pisa

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

48 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 35 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

6 inclusion criteria required to participate

Males and females

Age = 35-70 years

BMI ≤ 40 Kg/m 2 and stable weight (± 3 lbs) over the preceding three months

Type 2 diabetes (HbA1c > 7 % and < 10 %)

Show More Criteria

16 exclusion criteria prevent from participating

Drugs known to affect glucose metabolism (other than metformin) for more than14 days during the 12 weeks before screening

Known Dapagliflozin and Saxagliptin Excipient Hypersensitivity

Type 1 Diabetes or History of Ketoacidosis

history of cancer of any type;

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Active Comparator

Dapagliflozin inhibits SGLT2 promoting the excretion of glucose in the urine,and lowers the plasma glucose concentration. This class of drugs has been shown to effectively reduce the HbA1c at all stages of T2DM and can be used in combination of all other anti-diabetic agents including insulin.

Group II

Active Comparator

Saxagliptin is a DPP4 inhibitor.In patients with type 2 diabetes,administration of saxagliptin led to inhibition of DPP4 enzyme activity.After an oral glucose load,this DPP4 inhibition resulted in a increase in circulating levels of active incretin hormones include GLP-1 and GIP, decreased glucagon concentrations and increased glucose-dependent beta-cell responsiveness,which resulted in higher insulin and C-peptide concentrations.The rise in insulin from pancreatic beta-cells and the decrease in glucagon from pancreatic alpha-cells were associated with lower fasting glucose concentrations and reduced glucose excursion following an oral glucose load or a meal.Saxagliptin improves glycaemic control by reducing fasting and postprandial glucose concentrations in patients with type 2 diabetes.

Group III

Active Comparator

Please see Arm 1 and 2

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Department of Endocrinology and Metabolism, University of Pisa

Pisa, ItalyOpen Department of Endocrinology and Metabolism, University of Pisa in Google Maps

CompletedOne Study Center