Overview

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

Status:
Recruiting
Trial end date:
2024-03-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Peking University People's Hospital
Collaborators:
Jiangsu Province Geriatric Institute
Peking University First Hospital
Treatments:
Dipeptidyl-Peptidase IV Inhibitors
Glimepiride
Sitagliptin Phosphate
Criteria
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withdrawn for more than 8 weeks;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.