| Trial ID: | L3230 |
| Source ID: | NCT05386186
|
| Associated Drug: |
Glimepiride
|
| Title: |
The Effect of Glimepiride Compared With Sitagliptin as an add-on Therapy to Metformin in Severe Insulin Deficiency Diabetes
|
| Acronym: |
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2|Severe Insulin Deficient Diabetes
|
| Interventions: |
DRUG: Glimepiride|DRUG: Sitagliptin
|
| Outcome Measures: |
Primary: 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: Hemoglobin A1c on-target rate, the percentage of A1c\<7.0% or A1c\<6.5%, 26 weeks|The difference of self measure blood glucose (SMBG) at every month, The mean of 4-point SMBG for every four weeks, for 26 weeks|The incidence rate of hypoglycemia, Any measurement of blood glucose\<3.9mmol/L or symptoms related to hypoglycemia, for 26 weeks|The level of weight gain, The difference between body weights at the beginning and end of the trial, for 26 weeks
|
| Sponsor/Collaborators: |
Sponsor: Peking University People's Hospital | Collaborators: Peking University First Hospital|Jiangsu Province Geriatric Institute
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
192
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2022-01-01
|
| Completion Date: |
2024-03-31
|
| Results First Posted: |
|
| Last Update Posted: |
2022-05-23
|
| Locations: |
Peking University People's Hospital, Beijing, Please Select, 100044, China
|
| URL: |
https://clinicaltrials.gov/show/NCT05386186
|
