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

NCT05035849 | Completed

• 1 other identifier: KY20190926-02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Glycemic variations

  CV

  Endpoint at the third month

Secondary Outcomes (1)

• Glycemic variations

  Endpoint at the third month

Study Arms (2)

Group A

ACTIVE COMPARATOR

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.

Drug: sitagliptin and acarbose

Group B

ACTIVE COMPARATOR

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.

Drug: sitagliptin and acarbose

Interventions

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.

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (1)

Gu Gao

Nanjing, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sitagliptin Phosphate; Acarbose

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines; Trisaccharides; Oligosaccharides; Polysaccharides; Carbohydrates

Study Officials

• Jianhua Ma, MD

  Nanjing First Hospital, Nanjing, Jiangsu, China, 210012

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2021
• First Posted: September 5, 2021
• Study Start: January 30, 2020
• Primary Completion: April 30, 2021
• Study Completion: May 5, 2021
• Last Updated: September 5, 2021

Record last verified: 2021-08

Locations

CN (1)