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

Insulin Resistance Clinical Trial

Official title:

Effect of Metformin, Dapagliflozin, Fixed Combination of Metformin and Pioglitazone in Overweighted Patients With Newly Diagnosed Type 2 Diabetes

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05591235
• Other study ID #: KY20220314-01
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: November 2022
• Est. completion date: February 2023

Study information

• Verified date: September 2022
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: Jianhua Ma, professor
• Phone: 18951670116
• Email: majianhua196503[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: February 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Insulin Resistance

Intervention

Drug:
• Metformin
After the screening period, eligible subjects took the hyperinsulinemic euglycemic clamp test and were then admitted to insulin with metformin for 4 weeks. During this timeframe, all patients were instructed to change the insulin pump infusion site and provide one profile of 7-point self-monitored blood glucose every three days. The insulin doses were titrated every day by physicians to achieve the glycemic goal. Participants who failed to attain the glycemic target in three consecutive times or could not afford the side effects of hypoglycemic medications were excluded from this study. On the last day of week 4, a FreeStyle Libre Pro Sensor (FGM system) was inserted to record the glycemic data for up to 14 days. At the end of week 5, all antidiabetic agents were stopped and the hyperinsulinemic euglycemic clamp test was performed again for remaining subjects.
• Dapagliflozin
After the screening period, eligible subjects took the hyperinsulinemic euglycemic clamp test and were then admitted to insulin with dapagliflozin (100mg one day) for 4 weeks. During this timeframe, all patients were instructed to change the insulin pump infusion site and provide one profile of 7-point self-monitored blood glucose every three days. The insulin doses were titrated every day by physicians to achieve the glycemic goal. Participants who failed to attain the glycemic target in three consecutive times or could not afford the side effects of hypoglycemic medications were excluded from this study. On the last day of week 4, a FreeStyle Libre Pro Sensor (FGM system) was inserted to record the glycemic data for up to 14 days. At the end of week 5, all antidiabetic agents were stopped and the hyperinsulinemic euglycemic clamp test was performed again for remaining subjects.
• Fixed-dose combination of metformin and pioglitazone (500mg metformin plus 15mg pioglitazone)
After the screening period, eligible subjects took the hyperinsulinemic euglycemic clamp test and were then admitted to insulin with fixed-dose combination of metformin and pioglitazone (two tablets of 500mg metformin plus 15mg pioglitazone) for 4 weeks. During this timeframe, all patients were instructed to change the insulin pump infusion site and provide one profile of 7-point self-monitored blood glucose every three days. The insulin doses were titrated every day by physicians to achieve the glycemic goal. Participants who failed to attain the glycemic target in three consecutive times or could not afford the side effects of hypoglycemic medications were excluded from this study. On the last day of week 4, a FreeStyle Libre Pro Sensor (FGM system) was inserted to record the glycemic data for up to 14 days. At the end of week 5, all antidiabetic agents were stopped and the hyperinsulinemic euglycemic clamp test was performed again for remaining subjects.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin resistance	change from baseline insulin resistance at the fifth week	week 5