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Completed

NCT Number: NCT05035849

Comparison of the FGM Profiles in Patients of Type 2 Diabetes Treated With Sitagliptin and Acarbose

The aim of the study is to compare the FGM glycemic profiles in patients with type 2 diabetes mellitus treated with sitagliptin and acarbose.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gu Gao

Nanjing, China

About this study

In this study, 60 patients with type 2 diabetes were randomly divided into group A or group B after stable glucose control. Flash Glucose Mornitoring(FGM) will be used in patients with two groups. Patients in group A were given sitagliptin and metformin for the first two weeks, and then were treated with acarbose and metformin for the second two weeks. FGM was used to monitor glycemic variations during the whole four weeks. The opposite therapy was true for patients in group B.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participate voluntarily and sign the subject informed consent before the test.
  • Patients with type 2 diabetes, aged 18-75 years, meeting the diagnostic criteria of WHO1999, have not been treated with any hypoglycemic drugs.
  • No acute complications such as diabetic ketoacidosis and diabetic hyperosmolar syndrome.
  • Subjects are able and willing to undergo FGM examination, diet and exercise regularly.

Exclusion criteria

  • Patients allergic to insulin.
  • Impaired liver and renal function, ALT 2.5 times higher than the upper limit of normal value;Serum creatinine was 1.3 times higher than the upper limit of normal.
  • A history of drug abuse and alcohol dependence within the past 5 years.
  • Systemic hormone therapy was used in recent 3 months.
  • Patients with poor compliance and irregular diet and exercise.
  • Patients with infection and stress within four weeks.
  • Patients who cannot tolerate flash glucose mornitoring(FGM).
  • Patients who are pregnant, nursing or preparing to become pregnant.
  • Any other apparent condition or comorption as determined by the investigator, such as severe heart and lung disease, endocrine disease, neurological disease, tumor disease, other pancreatic disease, history of mental illness.

Treatment and study plan

Sitagliptin and acarbose

Drug

One group used first sitagliptin and metformin, then used acarbose and metformin. Another group used first acarbose and metformin, then used sitagliptin andmetformin.

Primary outcomes

  1. Glycemic variations

    Time frame: Endpoint at the third month

    CV

Secondary outcomes

  1. Glycemic variations

    Time frame: Endpoint at the third month

    TIR

Sponsors and collaborators

Lead sponsor

Nanjing First Hospital, Nanjing Medical University

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 5, 2021
Registry last updated
Sep 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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