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

Primary Purpose

Diabetes Mellitus, Type 2, Severe Insulin Deficient Diabetes

Status

Recruiting

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Glimepiride

Sitagliptin

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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If other drugs are used during the course of the disease, these drugs should be withdrawn for more than 8 weeks;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.

Sites / Locations

Peking University People's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Glimepiride

Sitagliptin

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Hemoglobin A1c on-target rate

the percentage of A1c<7.0% or A1c<6.5%

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

The mean of 4-point SMBG for every four weeks

The incidence rate of hypoglycemia

Any measurement of blood glucose<3.9mmol/L or symptoms related to hypoglycemia

The level of weight gain

The difference between body weights at the beginning and end of the trial

Full Information

NCT ID

NCT05386186

First Posted

May 12, 2022

Last Updated

May 18, 2022

Sponsor

Peking University People's Hospital

Collaborators

Peking University First Hospital, Jiangsu Province Geriatric Institute

1. Study Identification

Unique Protocol Identification Number

NCT05386186

Brief Title

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

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Recruiting

Study Start Date

January 1, 2022 (Actual)

Primary Completion Date

October 31, 2023 (Anticipated)

Study Completion Date

March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Peking University People's Hospital

Collaborators

Peking University First Hospital, Jiangsu Province Geriatric Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 2, Severe Insulin Deficient Diabetes

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

192 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Glimepiride

Arm Type

Experimental

Arm 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.

Arm Title

Sitagliptin

Arm Type

Active Comparator

Arm 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.

Intervention Type

Drug

Intervention Name(s)

Glimepiride

Other Intervention Name(s)

SU group (sulphonylurea group)

Intervention Description

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

Intervention Name(s)

Sitagliptin

Other Intervention Name(s)

DPPIVi Group (dipeptidyl peptidase IV inhibitor group)

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

26 weeks

Secondary Outcome Measure Information:

Title

Hemoglobin A1c on-target rate

Description

the percentage of A1c<7.0% or A1c<6.5%

Time Frame

26 weeks

Title

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

Description

The mean of 4-point SMBG for every four weeks

Time Frame

for 26 weeks

Title

The incidence rate of hypoglycemia

Description

Any measurement of blood glucose<3.9mmol/L or symptoms related to hypoglycemia

Time Frame

for 26 weeks

Title

The level of weight gain

Description

The difference between body weights at the beginning and end of the trial

Time Frame

for 26 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xiantong Zou, MD.Ph.D.

Phone

13370172042

eva2172@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xiantong Zou, M.D. Ph.D.

Organizational Affiliation

Peking University People's Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Peking University People's Hospital

City

Beijing

State/Province

Please Select

ZIP/Postal Code

100044

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xiantong Zou

Phone

88324371

eva2172@163.com

12. IPD Sharing Statement

Learn more about this trial

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

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