Effect of Metformin, Dapagliflozin, Combination of Metformin and Pioglitazone in Patients With Type 2 Diabetes

• Status: Not yet recruiting
• Trial end date: 2023-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Although, a number of drugs are promising treatment strategies for insulin resistance, a critical question arises to which drug benefits patients with type 2 diabetes more from reduced insulin resistance and consequent glycemic control. In this study, we aim to evaluate the effect of metformin, dapagliflozin and the fixed-dose combination of metformin and pioglitazone (500mg metformin plus 15mg pioglitazone) on insulin sensitivity and glycemic control in overweight patients with newly diagnosed type 2 diabetes.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nanjing First Hospital, Nanjing Medical University
• Treatments: Dapagliflozin; Metformin; Pioglitazone

Criteria

Inclusion Criteria:

• Willing to participate in this present study;

• Regular diet and exercise;

• Age 18 to 60 years;

• Screening glycated hemoglobin (HbA1c) > 9.0%;

• Body mass index (BMI) ≥ 24.0 kg/m2

Exclusion Criteria:

• Other forms of diabetes;

• Insulin allergy or intolerance of metformin, pioglitazone and dapagliflozin;

• Renal dysfunction (estimated glomerular filtration rate < 45 mL/min);

• Severe liver disease or elevated transaminases (2.5-fold the upper limit);

• History of alcohol dependence or drug abuse in the past 5 years;

• Systemic steroids therapy or other medication influencing cholesterol metabolism in the past 3 months;

• Acute infection or stress state 1 month prior to this study;

• Pregnancy or lactation;

• History of diabetic ketoacidosis (DKA) within the previous year;

• Psychiatric disease;

• Other comorbid serious condition including severe heart and pulmonary disease, heart failure of New York Heart Association class IV, and tumors.