NCT05386186

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 192 (estimated)
• Sponsor: Peking University People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	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.
DRUG	Sitagliptin	Add sitagliptin 100mg once daily in all patients randomized to this arm.

Timeline

• Start date: 2022-01-01
• Primary completion: 2023-10-31
• Completion: 2024-03-31
• First posted: 2022-05-23
• Last updated: 2022-05-23

Locations

1 site across 1 country: China