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

P

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  • If other drugs are used during the course of the disease, these drugs should be withdrawn for more than 8 weeks;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

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

Trial contacts and locations

1

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Central trial contact

Xiantong Zou, MD.Ph.D.

Data sourced from clinicaltrials.gov

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