Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Peking University First Hospital | OTHER |
| Jiangsu Province Geriatric Institute | UNKNOWN |
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glimepiride | Experimental | 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. |
|
| Sitagliptin | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glimepiride | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiantong Zou, MD.Ph.D. | Contact | 13370172042 | eva2172@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiantong Zou, M.D. Ph.D. | Peking University People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Recruiting | Beijing | Please Select | 100044 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Sitagliptin | Drug | Add sitagliptin 100mg once daily in all patients randomized to this arm. |
|
|
| 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 |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C057619 | glimepiride |
| D000068900 | Sitagliptin Phosphate |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011719 | Pyrazines |
Not provided
Not provided