Clinical trial NCT05386186: The Effect of Glimepiride Compared With Sitagliptin as an add-on Therapy to Metformin in Severe Insulin Deficiency Diabetes
Official title: The Effect of Glimepiride Compared With Sitagliptin as an add-on Therapy to Metformin in Severe Insulin Deficiency Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Severe Insulin Deficient Diabetes
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
Collaborators: name: Peking University First Hospital
name: Jiangsu Province Geriatric Institute
First posted: 2022-05-23
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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* If other drugs are used during the course of the disease, these drugs should be withdrawn for more than 8 weeks;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

Primary outcomes:
measure: Reduction of hemoglobin A1c from baseline at the end of the trial.
timeFrame: 26 weeks
Secondary outcomes:
measure: Hemoglobin A1c on-target rate
timeFrame: 26 weeks
measure: The difference of self measure blood glucose (SMBG) at every month
timeFrame: for 26 weeks
measure: The incidence rate of hypoglycemia
timeFrame: for 26 weeks
measure: The level of weight gain
timeFrame: for 26 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Please Select
Study officials:
affiliation: Peking University People's Hospital
name: Xiantong Zou, M.D. Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: