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

NCT ID: NCT05035849

Last Updated: 2021-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-30
• Study Completion Date: 2021-05-05

Brief 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.

Detailed 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.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A

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.

Group Type: ACTIVE_COMPARATOR

sitagliptin and acarbose

Intervention Type: DRUG

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

Group B

Patients in group B were given acarbose and metformin for the first two weeks, and then were treated with sitagliptin and metformin for the second two weeks.FGM was used to monitor glycemic variations during the whole four weeks.

Group Type: ACTIVE_COMPARATOR

sitagliptin and acarbose

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanjing First Hospital, Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jianhua Ma, MD

Role: STUDY_CHAIR

Nanjing First Hospital, Nanjing, Jiangsu, China, 210012

Locations

Gu Gao

Nanjing, , China

Countries

China

Other Identifiers

KY20190926-02

Identifier Type: -

Identifier Source: org_study_id