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

N

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

Trial contacts and locations

0

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Central trial contact

Jianhua Ma, professor

Data sourced from clinicaltrials.gov

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