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

Nanjing Medical University

Status and phase: Not yet enrolling; Phase 3

Conditions: Type2diabetes; Insulin Resistance

Treatments: Drug: Dapagliflozin; Drug: Fixed-dose combination of metformin and pioglitazone (500mg metformin plus 15mg pioglitazone); Drug: Metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT05591235

KY20220314-01

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

60 participants in 3 patient groups

Metformin

Active Comparator group

Treatment:

Drug: Fixed-dose combination of metformin and pioglitazone (500mg metformin plus 15mg pioglitazone)

Drug: Dapagliflozin

Fixed-dose combination of metformin and pioglitazone (500mg metformin plus 15mg pioglitazone)

Active Comparator group

Treatment:

Drug: Dapagliflozin

Drug: Metformin

Dapagliflozin

Active Comparator group

Treatment:

Drug: Fixed-dose combination of metformin and pioglitazone (500mg metformin plus 15mg pioglitazone)

Drug: Metformin