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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05035849
• Other study ID #: KY20190926-02
• Status: Completed
• Phase: N/A
• Start date: January 30, 2020
• Est. completion date: May 5, 2021

Study information

• Verified date: August 2021
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 5, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Participate voluntarily and sign the subject informed consent before the test.

2. Patients with type 2 diabetes, aged 18-75 years, meeting the diagnostic criteria of WHO1999, have not been treated with any hypoglycemic drugs.

3. No acute complications such as diabetic ketoacidosis and diabetic hyperosmolar syndrome.

4. Subjects are able and willing to undergo FGM examination, diet and exercise regularly.

Exclusion Criteria:

1. Patients allergic to insulin.

2. 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.

3. A history of drug abuse and alcohol dependence within the past 5 years.

4. Systemic hormone therapy was used in recent 3 months.

5. Patients with poor compliance and irregular diet and exercise.

6. Patients with infection and stress within four weeks.

7. Patients who cannot tolerate flash glucose mornitoring(FGM).

8. Patients who are pregnant, nursing or preparing to become pregnant.

9. 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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

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

Locations

Country	Name	City	State
China	Gu Gao	Nanjing

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycemic variations	CV	Endpoint at the third month
Secondary	Glycemic variations	TIR	Endpoint at the third month