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

Primary Purpose

Type2diabetes, Insulin Resistance

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Metformin
Dapagliflozin
Fixed-dose combination of metformin and pioglitazone (500mg metformin plus 15mg pioglitazone)
Sponsored by
Nanjing First Hospital, Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type2diabetes

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Metformin

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

    Dapagliflozin

    Arm Description

    Outcomes

    Primary Outcome Measures

    Insulin resistance
    change from baseline insulin resistance at the fifth week

    Secondary Outcome Measures

    Full Information

    First Posted
    October 16, 2022
    Last Updated
    October 20, 2022
    Sponsor
    Nanjing First Hospital, Nanjing Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05591235
    Brief Title
    Effect of Metformin, Dapagliflozin, Combination of Metformin and Pioglitazone in Patients With Type 2 Diabetes
    Official Title
    Effect of Metformin, Dapagliflozin, Fixed Combination of Metformin and Pioglitazone in Overweighted Patients With Newly Diagnosed Type 2 Diabetes
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 2022 (Anticipated)
    Primary Completion Date
    December 2022 (Anticipated)
    Study Completion Date
    February 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Nanjing First Hospital, Nanjing Medical University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Type2diabetes, Insulin Resistance

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Metformin
    Arm Type
    Active Comparator
    Arm Title
    Fixed-dose combination of metformin and pioglitazone (500mg metformin plus 15mg pioglitazone)
    Arm Type
    Active Comparator
    Arm Title
    Dapagliflozin
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Metformin
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Dapagliflozin
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Fixed-dose combination of metformin and pioglitazone (500mg metformin plus 15mg pioglitazone)
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Insulin resistance
    Description
    change from baseline insulin resistance at the fifth week
    Time Frame
    week 5

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jianhua Ma, professor
    Phone
    18951670116
    Email
    majianhua196503@126.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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