Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sitagliptin treatment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sitagliptin | Drug | Sitagliptin 100 mg QD for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Hemoglobin A1c (HbA1c) | Baseline to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Fasting Plasma Glucose (FPG) | Baseline to 12 weeks | |
| Change From Baseline in Postprandial Plasma Glucose (PPG) | Baseline to 12 weeks | |
| Change From Baseline in Insulin Sensitivity |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai Hospital | Beijing | China |
Not provided
Sitagliptin 100 mg QD for 12 weeks and followed-up every 4 weeks
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Sitagliptin Treatment | Sitagliptin 100 mg QD for 12 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The insulin sensitivity was detected by evaluating the glucose infusion rate (GIR) with euglycemic hyperinsulinemic clamp test. |
| Baseline to 12 weeks |
| Change From Baseline in Insulin Sensitivity in Patients With Different BMI | The insulin sensitivity was detected by evaluating the glucose infusion rate (GIR) with euglycemic hyperinsulinemic clamp test. | Baseline to 12 weeks |
| Change From Baseline in Pancreatic β Cell Function | The early phase insulin response (△I30/△G30) was adopted to determine β cell function. | Baseline to 12 weeks |
| Change From Baseline in Pancreatic β Cell Function in Patients With Different BMI | The early phase insulin response (△I30/△G30) was adopted to determine β cell function. | Baseline to 12 weeks |
| Change From Baseline in Pancreatic α Cell Function | The glucagon-AUC was adopted to show pancreatic α cell function. | Baseline to 12 weeks |
| Change From Baseline in Pancreatic α Cell Function in Patients With Different BMI | The glucagon-AUC was adopted to show pancreatic α cell function. | Baseline to 12 weeks |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Sitagliptin Treatment | Sitagliptin 100 mg QD for 12 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants | No |
| |||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||||
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m2 |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Hemoglobin A1c (HbA1c) | Posted | Mean | Standard Deviation | percentage | Baseline to 12 weeks |
|
|
| |||||||||||||||||||||||||||
| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) | Posted | Mean | Standard Deviation | mmol/L | Baseline to 12 weeks |
|
|
| |||||||||||||||||||||||||||
| Secondary | Change From Baseline in Postprandial Plasma Glucose (PPG) | Posted | Mean | Standard Deviation | mmol/L | Baseline to 12 weeks |
|
|
| |||||||||||||||||||||||||||
| Secondary | Change From Baseline in Insulin Sensitivity | The insulin sensitivity was detected by evaluating the glucose infusion rate (GIR) with euglycemic hyperinsulinemic clamp test. | Posted | Median | Inter-Quartile Range | mg/kg/min | Baseline to 12 weeks |
|
|
| ||||||||||||||||||||||||||
| Secondary | Change From Baseline in Insulin Sensitivity in Patients With Different BMI | The insulin sensitivity was detected by evaluating the glucose infusion rate (GIR) with euglycemic hyperinsulinemic clamp test. | Posted | Median | Inter-Quartile Range | mg/kg/min | Baseline to 12 weeks |
|
| |||||||||||||||||||||||||||
| Secondary | Change From Baseline in Pancreatic β Cell Function | The early phase insulin response (△I30/△G30) was adopted to determine β cell function. | Posted | Median | Inter-Quartile Range | μu/ml/mmol | Baseline to 12 weeks |
|
|
| ||||||||||||||||||||||||||
| Secondary | Change From Baseline in Pancreatic β Cell Function in Patients With Different BMI | The early phase insulin response (△I30/△G30) was adopted to determine β cell function. | Posted | Median | Inter-Quartile Range | μu/ml/mmol | Baseline to 12 weeks |
|
| |||||||||||||||||||||||||||
| Secondary | Change From Baseline in Pancreatic α Cell Function | The glucagon-AUC was adopted to show pancreatic α cell function. | Posted | Mean | Standard Deviation | min∙pg/ml | Baseline to 12 weeks |
|
|
| ||||||||||||||||||||||||||
| Secondary | Change From Baseline in Pancreatic α Cell Function in Patients With Different BMI | The glucagon-AUC was adopted to show pancreatic α cell function. | Posted | Mean | Standard Deviation | min∙pg/ml | Baseline to 12 weeks |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sitagliptin Treatment | Sitagliptin 100 mg QD | 0 | 84 | 8 | 84 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoglycemia ( symptom only) | Metabolism and nutrition disorders |
| |||
| Upper respiratory infection | Infections and infestations |
| |||
| Nasopharyngitis | Infections and infestations |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Hui Wang | Fuwai Hospital | 86-010-88396587 | wh_endo@163.com |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068900 | Sitagliptin Phosphate |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011719 | Pyrazines |
Not provided
Not provided
| Title | Measurements |
|---|---|
|
|
|
|
|
|
|
|