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

NCT05386186 | Unknown Phase 4

• 1 other identifier: zhouxiantong
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2; Severe Insulin Deficient Diabetes

Outcome Measures

Primary Outcomes (1)

• Reduction of hemoglobin A1c from baseline at the end of the trial.

  The Least squre mean of the decline of hemoglobin A1c from baseline to the end of the trial

  26 weeks

Secondary Outcomes (4)

• Hemoglobin A1c on-target rate

  26 weeks

• The difference of self measure blood glucose (SMBG) at every month

  for 26 weeks

• The incidence rate of hypoglycemia

  for 26 weeks

• The level of weight gain

  for 26 weeks

Study Arms (2)

Glimepiride

EXPERIMENTAL

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.

Drug: Glimepiride

Sitagliptin

ACTIVE COMPARATOR

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.

Drug: Sitagliptin

Interventions

Glimepiride 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.

Also known as: SU group (sulphonylurea group)

Glimepiride

Sitagliptin DRUG

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

Also known as: DPPIVi Group (dipeptidyl peptidase IV inhibitor group)

Sitagliptin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University People's Hospital: lead
• Peking University First Hospital: collaborator
• Jiangsu Province Geriatric Institute: collaborator

Study Sites (1)

Peking University People's Hospital

Beijing, Please Select, 100044, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

glimepiride; Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines

Study Officials

• Xiantong Zou, M.D. Ph.D.

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiantong Zou, MD.Ph.D.

CONTACT

13370172042; eva2172@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician of the Department of Endocrinology and Metabolism

Study Record Dates

• First Submitted: May 12, 2022
• First Posted: May 23, 2022
• Study Start: January 1, 2022
• Primary Completion: October 31, 2023
• Study Completion: March 31, 2024
• Last Updated: May 23, 2022

Record last verified: 2022-05

Locations

CN (1)