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

NCT05591235 | Unknown Phase 3

• 1 other identifier: KY20220314-01
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Type2diabetes; Insulin Resistance

Outcome Measures

Primary Outcomes (1)

• Insulin resistance

  change from baseline insulin resistance at the fifth week

  week 5

Study Arms (3)

Metformin

ACTIVE COMPARATOR

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

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

ACTIVE COMPARATOR

Drug: Metformin; Drug: Dapagliflozin

Dapagliflozin

ACTIVE COMPARATOR

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

Interventions

Metformin DRUG

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

Dapagliflozin DRUG

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); Metformin

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

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.

Dapagliflozin; Metformin

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

MeSH Terms

Conditions

Insulin Resistance

Interventions

Metformin; dapagliflozin; Pioglitazone

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Thiazolidinediones; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Jianhua Ma, professor

CONTACT

18951670116; majianhua196503@126.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2022
• First Posted: October 24, 2022
• Study Start: November 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: February 1, 2023
• Last Updated: October 24, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share