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

Last updated: October 20, 2022
Sponsor: Nanjing First Hospital, Nanjing Medical University
Overall Status: Active - Not Recruiting

Phase

3

Condition

Hormone Deficiencies

Stress

Diabetes Prevention

Treatment

N/A

Clinical Study ID

NCT05591235
KY20220314-01
  • Ages 18-60
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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 inthe 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, heartfailure of New York Heart Association class IV, and tumors.

Study Design

Total Participants: 60
Study Start date:
November 01, 2022
Estimated Completion Date:
February 28, 2023