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

Peking University

Status and phase: Unknown; Phase 4

Conditions: Diabetes Mellitus, Type 2; Severe Insulin Deficient Diabetes

Treatments: Drug: Glimepiride; Drug: Sitagliptin

Study type: Interventional

Funder types: Other

Identifiers

NCT05386186

zhouxiantong

Details and patient eligibility

About

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.

Full 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.

Enrollment: 192 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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• If other drugs are used during the course of the disease, these drugs should be withdrawn for more than 8 weeks;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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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192 participants in 2 patient groups

Glimepiride

Experimental group

Description:

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.

Treatment:

Drug: Glimepiride

Sitagliptin

Active Comparator group

Description:

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.

Treatment:

Drug: Sitagliptin