Status:
UNKNOWN
The Effect of Glimepiride Compared With Sitagliptin as an add-on Therapy to Metformin in Severe Insulin Deficiency Diabetes
Lead Sponsor:
Peking University People's Hospital
Collaborating Sponsors:
Peking University First Hospital
Jiangsu Province Geriatric Institute
Conditions:
Diabetes Mellitus, Type 2
Severe Insulin Deficient Diabetes
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief 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.
Detailed 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 contr...
Eligibility Criteria
Inclusion
- 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- If other drugs are used during the course of the disease, these drugs should be withdrawn for more than 8 weeks;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
- 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.
Key Trial Info
Start Date :
January 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2024
Estimated Enrollment :
192 Patients enrolled
Trial Details
Trial ID
NCT05386186
Start Date
January 1 2022
End Date
March 31 2024
Last Update
May 23 2022
Active Locations (1)
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1
Peking University People's Hospital
Beijing, Please Select, China, 100044