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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Drug: 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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Nanjing, China
    • Gu Gao

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycemic variations	CV	Endpoint at the third month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycemic variations	TIR	Endpoint at the third month

Collaborators and Investigators

• Sponsor: Nanjing First Hospital, Nanjing Medical University
• Investigators: Study Chair: Jianhua Ma, MD, Nanjing First Hospital, Nanjing, Jiangsu, China, 210012

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2020
• Primary Completion (Actual): April 30, 2021
• Study Completion (Actual): May 5, 2021

Study Registration Dates

• First Submitted: April 14, 2021
• First Submitted That Met QC Criteria: August 30, 2021
• First Posted (Actual): September 5, 2021

Study Record Updates

• Last Update Posted (Actual): September 5, 2021
• Last Update Submitted That Met QC Criteria: August 30, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protease Inhibitors; Incretins; Dipeptidyl-Peptidase IV Inhibitors; Glycoside Hydrolase Inhibitors; Sitagliptin Phosphate; Acarbose
• Other Study ID Numbers: KY20190926-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No