The Effect of Glimepiride Compared With Sitagliptin as an add-on Therapy to Metformin in Severe Insulin Deficiency Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

The Effect of Glimepiride Compared With Sitagliptin as an add-on Therapy to Metformin in Severe Insulin Deficiency Diabetes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05386186
• Other study ID #: zhouxiantong
• Status: Recruiting
• Phase: Phase 4
• Start date: January 1, 2022
• Est. completion date: March 31, 2024

Study information

• Verified date: May 2022
• Source: Peking University People's Hospital
• Contact: Xiantong Zou, MD.Ph.D.
• Phone: 13370172042
• Email: eva2172[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the trial is to verify the effectiveness and safety of glimepiride compared with sitagliptin as an add-on therapy to metformin in severe insulin deficiency diabetes.

Description:

This clinical trial is a multi-centre, prospective, intervention, randomized-controlled clinical trial, and uses a superiority test to determine whether the experimental group is superior to the control group in terms of main efficacy endpoints.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 192
• Est. completion date: March 31, 2024
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• According to the World Health Organization (the WHO) 1999 criteria for the diagnosis of type 2 diabetes; the subtype was allocated to severe insulin deficiency diabetes (SIDD) at diagnosis using data-driven diabetes clusters APP.

• Men and women aged = 18 years and = 75 years;

• Diagnosed as severe insulin deficiency diabetes by the cluster classifier of Peking University People's Hospital at the initial stage of the disease course;

• Metformin monotherapy with dosage =1500 mg/day for at least 8 weeks;

• Diabetes duration less than 5 years;

• The HbA1c value of the central laboratory before randomization: 7.0% = HbA1c <10.5%

• estimated estimated glomerular filtration rate (eGFR)>=60 ml/min1.73m2, alanine aminotransferase(ALT)<120U/L ;

• If other drugs are used during the course of the disease, these drugs should be withdrawn for more than 8 weeks;

• Without acute diabetic complications at present.

Exclusion Criteria:

• Type 1 diabetes or other special types of diabetes mellitus; glutamic acid decarboxylase antibody (GADA) positive, the subtype was allocated to other subtypes at diagnosis using data-driven diabetes clusters APP.

• Pregnancy or have a pregnancy plan within a year;

• Lactation or have a lactation plan within a year;

• Renal insufficiency, eGFR<60; transaminase elevated, ALT>= 120U/L; unstable coronary heart disease.

• Recurrent spontaneous diabetic ketosis or uncorrected acute diabetic complications;

• Participated in other clinical trials within 8 weeks before randomization; Unable to complete the study follow-up for 6 months; Have situations such as operation and need to change to insulin therapy in 6 months.

• Use concomitant medication such as glucocorticoids which can affect blood sugar.

• The investigator judged that it is not suitable to participate in this clinical trial.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Glimepiride
Initiate glimepiride 1-4mg once daily as an add-on therapy to metformin and adjust the glimepiride dosage to 1-6 mg once daily in the first 12 weeks according to the diabetes management guideline recommended by the Chinese Diabetes Society.
• Sitagliptin
Add sitagliptin 100mg once daily in all patients randomized to this arm.

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing	Please Select

Sponsors (3)

Lead Sponsor	Collaborator
Peking University People's Hospital	Jiangsu Province Geriatric Institute, Peking University First Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of hemoglobin A1c from baseline at the end of the trial.	The Least squre mean of the decline of hemoglobin A1c from baseline to the end of the trial	26 weeks
Secondary	Hemoglobin A1c on-target rate	the percentage of A1c<7.0% or A1c<6.5%	26 weeks
Secondary	The difference of self measure blood glucose (SMBG) at every month	The mean of 4-point SMBG for every four weeks	for 26 weeks
Secondary	The incidence rate of hypoglycemia	Any measurement of blood glucose<3.9mmol/L or symptoms related to hypoglycemia	for 26 weeks
Secondary	The level of weight gain	The difference between body weights at the beginning and end of the trial	for 26 weeks