The Effect of Glimepiride Compared With Sitagliptin as an add-on Therapy to Metformin in Severe Insulin Deficiency Diabetes
- Conditions
- Diabetes Mellitus, Type 2Severe Insulin Deficient Diabetes
- Interventions
- Registration Number
- NCT05386186
- Lead Sponsor
- Peking University People's Hospital
- 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 control group in terms of main efficacy endpoints.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 192
- 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- If other drugs are used during the course of the disease, these drugs should be withdrawn for more than 8 weeks;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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Glimepiride Glimepiride All participants have background therapy of metformin 1500mg-2000mg, glimepiride1-4mg were added in the patients randomised to this arm considering the baseline HbA1c of the participants. Sitagliptin Sitagliptin All participants have background therapy of metformin 1500mg-2000mg, Sitagliptin 100mg were added in the patients randomised to this arm regardless of the baseline HbA1c level in this arm.
- Primary Outcome Measures
Name Time Method Reduction of hemoglobin A1c from baseline at the end of the trial. 26 weeks The Least squre mean of the decline of hemoglobin A1c from baseline to the end of the trial
- Secondary Outcome Measures
Name Time Method Hemoglobin A1c on-target rate 26 weeks the percentage of A1c\<7.0% or A1c\<6.5%
The difference of self measure blood glucose (SMBG) at every month for 26 weeks The mean of 4-point SMBG for every four weeks
The incidence rate of hypoglycemia for 26 weeks Any measurement of blood glucose\<3.9mmol/L or symptoms related to hypoglycemia
The level of weight gain for 26 weeks The difference between body weights at the beginning and end of the trial
Trial Locations
- Locations (1)
Peking University People's Hospital
🇨🇳Beijing, Please Select, China