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

May 18, 2022 updated by: Xiantong Zou, MD. Ph.D., Peking University People's Hospital
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.

Study Overview

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.

Study Type

Interventional

Enrollment (Anticipated)

192

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Xiantong Zou, MD.Ph.D.
  • Phone Number: 13370172042
  • Email: eva2172@163.com

Study Locations

    • Please Select
      • Beijing, Please Select, China, 100044
        • Recruiting
        • Peking University People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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  • If other drugs are used during the course of the disease, these drugs should be withdrawn for more than 8 weeks;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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Other Names:
  • SU group (sulphonylurea group)
Active Comparator: 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.
Add sitagliptin 100mg once daily in all patients randomized to this arm.
Other Names:
  • DPPIVi Group (dipeptidyl peptidase IV inhibitor group)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction of hemoglobin A1c from baseline at the end of the trial.
Time Frame: 26 weeks
The Least squre mean of the decline of hemoglobin A1c from baseline to the end of the trial
26 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin A1c on-target rate
Time Frame: 26 weeks
the percentage of A1c<7.0% or A1c<6.5%
26 weeks
The difference of self measure blood glucose (SMBG) at every month
Time Frame: for 26 weeks
The mean of 4-point SMBG for every four weeks
for 26 weeks
The incidence rate of hypoglycemia
Time Frame: for 26 weeks
Any measurement of blood glucose<3.9mmol/L or symptoms related to hypoglycemia
for 26 weeks
The level of weight gain
Time Frame: for 26 weeks
The difference between body weights at the beginning and end of the trial
for 26 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Xiantong Zou, M.D. Ph.D., Peking University People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Anticipated)

October 31, 2023

Study Completion (Anticipated)

March 31, 2024

Study Registration Dates

First Submitted

May 12, 2022

First Submitted That Met QC Criteria

May 18, 2022

First Posted (Actual)

May 23, 2022

Study Record Updates

Last Update Posted (Actual)

May 23, 2022

Last Update Submitted That Met QC Criteria

May 18, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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