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

NCT ID: NCT05386186

Last Updated: 2022-05-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 192 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2024-03-31

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.

Conditions

Diabetes Mellitus, Type 2; Severe Insulin Deficient Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Glimepiride

Intervention Type: DRUG

Initiate glimepiride 1-4mg once daily as an add-on therapy to metformin and adjust the glimepiride dosage to 1-6 mg once daily in the first 12 weeks according to the diabetes management guideline recommended by the Chinese Diabetes Society.

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.

Group Type: ACTIVE_COMPARATOR

Sitagliptin

Intervention Type: DRUG

Add sitagliptin 100mg once daily in all patients randomized to this arm.

Interventions

Glimepiride

Initiate glimepiride 1-4mg once daily as an add-on therapy to metformin and adjust the glimepiride dosage to 1-6 mg once daily in the first 12 weeks according to the diabetes management guideline recommended by the Chinese Diabetes Society.

Intervention Type: DRUG

Sitagliptin

Add sitagliptin 100mg once daily in all patients randomized to this arm.

Intervention Type: DRUG

Other Intervention Names

SU group (sulphonylurea group); DPPIVi Group (dipeptidyl peptidase IV inhibitor group)

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University First Hospital

OTHER

Sponsor Role: collaborator

Jiangsu Province Geriatric Institute

UNKNOWN

Sponsor Role: collaborator

Peking University People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xiantong Zou, MD. Ph.D.

Attending Physician of the Department of Endocrinology and Metabolism

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiantong Zou, M.D. Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Peking University People's Hospital

Locations

Peking University People's Hospital

Beijing, Please Select, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiantong Zou, MD.Ph.D.

Role: CONTACT

eva2172@163.com

13370172042

Facility Contacts

Xiantong Zou

Role: primary

eva2172@163.com

88324371

Other Identifiers

zhouxiantong

Identifier Type: -

Identifier Source: org_study_id