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

Phase 3

Not yet recruiting

• Conditions: Insulin Resistance; Type2diabetes
• Interventions: Drug: Dapagliflozin; Drug: Metformin; Drug: Fixed-dose combination of metformin and pioglitazone (500mg metformin plus 15mg pioglitazone)

• Registration Number: NCT05591235
• Lead Sponsor: Nanjing First Hospital, Nanjing Medical University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-09
• Study First Submitted: 2022-10-16
• Study First Submitted QC: 2022-10-20
• Last Update Submitted: 2022-10-20
• Study First Posted: 2022-10-24
• Last Update Posted: 2022-10-24
• Study Start: 2022-11
• Primary Completion: 2022-12
• Study Completion: 2023-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dapagliflozin	Fixed-dose combination of metformin and pioglitazone (500mg metformin plus 15mg pioglitazone)	-
Metformin	Fixed-dose combination of metformin and pioglitazone (500mg metformin plus 15mg pioglitazone)	-
Metformin	Dapagliflozin	-
Fixed-dose combination of metformin and pioglitazone (500mg metformin plus 15mg pioglitazone)	Dapagliflozin	-
Fixed-dose combination of metformin and pioglitazone (500mg metformin plus 15mg pioglitazone)	Metformin	-
Dapagliflozin	Metformin	-

Primary Outcome Measures

Name	Time	Method
Insulin resistance	week 5	change from baseline insulin resistance at the fifth week