Slot name | Gold standard | Extractive prediction | Generative prediction |
---|---|---|---|
Template Publication | |||
describes | Â | Â | Â |
Author | Shankar RR | Bao Y | Han P | Hu J | Ma J | Peng Y | Wu F | Xu L | Engel SS | Jia W | Shankar RR | Bao Y | Han P | Hu J | Ma J | Peng Y | Wu F | Xu L | Engel SS | Jia W | Shankar RR | Bao Y | Han P | Hu J | Ma J | Peng Y | Wu F | Xu L | Engel SS | Jia W |
Journal | J Diabetes Investig. | J Diabetes Investig. | J Diabetes Investig. |
PMID | 27740719 | 27740719 | 27740719 |
PublicationYear | 2017 | 2017 | 2017 |
Title | Sitagliptin added to stable insulin therapy with or without metformin in Chinese patients with type 2 diabetes. | Sitagliptin added to stable insulin therapy with or without metformin in Chinese patients with type 2 diabetes. | Sitagliptin added to stable insulin therapy with or without metformin in Chinese patients with type 2 diabetes. |
Template Intervention | |||
Frequency | once daily | once daily | once daily |
Medication | Â | Â | Â |
Template Population | |||
Country | USA | Australia | USA | USA |
Ethnicity | Chinese | Â | Â |
Precondition | Chinese patients with type 2 diabetes mellitus receiving stable insulin therapy alone or in combination with metformin | patients with inadequate glycemic control on insulin ( glycated hemoglobin [ HbA1c ] < 7. 5 % and < 11 % ) | patients with inadequate glycemic control on insulin | patients with inadequate glycemic control on insulin ( glycated hemoglobin [ HbA1c ] < |
Template Arm | |||
AdverseEffect | Â | Â | Â |
Intervention | Â | Â | Â |
Outcome | Â | Â | Â |
Template Endpoint | |||
BaselineUnit | % | % | Â |
EndoPointDescription | HbA1c | HbA1c of <7. 0 % | adverse events |
BaselineUnit | Â | mg / dL | mg / dL | Â |
EndoPointDescription | HbA1c of < 7. 0 % | fasting plasma glucose | 2 - h post - meal glucose | adverse events of hypoglycemia | hypoglycemia |
BaselineUnit | mg / dL | Â | % |
EndoPointDescription | 2 - h post - meal glucose | Â | HbA1c |
BaselineUnit | mg / dL | Â | Â |
EndoPointDescription | fasting plasma glucose | Â | HbA1c of < |
BaselineUnit | Â | Â | mg / dL |
EndoPointDescription | hypoglycemia ( symptomatic or asymptomatic ) | Â | 2 - h post - meal glucose |
BaselineUnit | Â | Â | Â |
EndoPointDescription | bodyweight | Â | fasting plasma glucose |
BaselineUnit | Â | Â | Â |
EndoPointDescription | Â | Â | adverse events |
BaselineUnit | Â | Â | Â |
EndoPointDescription | Â | Â | hypoglycemia |
BaselineUnit | Â | Â | % |
EndoPointDescription | Â | Â | HbA1c |
BaselineUnit | Â | Â | Â |
EndoPointDescription | Â | Â | HbA1c of < |
BaselineUnit | Â | Â | mg / dL |
EndoPointDescription | Â | Â | 2 - h post - meal glucose |
BaselineUnit | Â | Â | Â |
EndoPointDescription | Â | Â | fasting plasma glucose |
Template ClinicalTrial | |||
analysesHealthCondition | type 2 diabetes mellitus | type 2 diabetes | type 2 diabetes mellitus |
AllocationRatio | 1 : 1 | 1 : 1 | Â |
Arm | Â | Â | Â |
CTDesign | randomized | randomized | randomized |
CTduration | 24 weeks | 24 weeks | 24 weeks |
ConclusionComment | After 24 weeks, sitagliptin added to stable insulin therapy ( < metformin ) was generally well tolerated and improved glycemic control in Chinese patients with type 2 diabetes mellitus. | After 24 weeks, sitagliptin added to stable insulin therapy ( <metformin ) was generally well tolerated and improved glycemic control in Chinese patients with type 2 diabetes mellitus. | After 24 weeks, sitagliptin added to stable insulin therapy ( < | ) was generally well tolerated and improved glycemic control in Chinese patients with type 2 diabetes mellitus. |
DiffBetweenGroups | Â | Â | Â |
NumberPatientsCT | 467 | 467 | 467 |
ObjectiveDescription | We evaluated the tolerability and efficacy of the addition of sitagliptin in Chinese patients with type 2 diabetes mellitus receiving stable insulin therapy alone or in combination with metformin. | We evaluated the tolerability and efficacy of the addition of sitagliptin in Chinese patients with type 2 diabetes mellitus receiving stable insulin therapy alone or in combination with metformin. | We evaluated the tolerability and efficacy of the addition of sitagliptin in Chinese patients with type 2 diabetes mellitus receiving stable insulin therapy alone or in combination with metformin. |
Population | Â | Â | Â |
Template Medication | |||
DoseUnit | mg | Â | mg |
DoseValue | 100 | 100 | 100 |
Drug | sitagliptin | sitagliptin | sitagliptin |
DoseUnit | Â | mg | Â |
DoseValue | Â | Â | Â |
Drug | placebo | placebo | placebo |
Template Outcome | |||
ChangeValue | 0. 7 | 0. 7 | Â |
Endpoint | Â | Â | Â |
NumberAffected | Â | Â | 64 |
ObservedResult | Â | Â | Â |
PercentageAffected | Â | Â | 27. 4 |
TimePoint | Â | week 24 | Â |
ChangeValue | 0. 3 | 26. 5 | 0. 3 | 14. 4 | Â |
Endpoint | Â | Â | Â |
NumberAffected | Â | Â | 51 |
ObservedResult | Â | Â | Â |
PercentageAffected | Â | 16 | 21. 9 | 64 | 8 | 27. 4 | 51 | 21. 9 |
TimePoint | Â | week 24 | Â |
ChangeValue | Â | Â | 0. 7 |
Endpoint | Â | Â | Â |
NumberAffected | Â | Â | Â |
ObservedResult | Â | Â | Â |
PercentageAffected | 16 | Â | Â |
TimePoint | week 24 | Â | week 24 |
ChangeValue | Â | Â | Â |
Endpoint | Â | Â | Â |
NumberAffected | Â | Â | Â |
ObservedResult | Â | Â | Â |
PercentageAffected | 8 | Â | 16 |
TimePoint | week 24 | Â | week 24 |
ChangeValue | 26. 5 | Â | Â |
Endpoint | Â | Â | Â |
NumberAffected | Â | Â | Â |
ObservedResult | Â | Â | Â |
PercentageAffected | Â | Â | Â |
TimePoint | Â | Â | Â |
ChangeValue | 14. 4 | Â | Â |
Endpoint | Â | Â | Â |
NumberAffected | Â | Â | 51 |
ObservedResult | Â | Â | Â |
PercentageAffected | Â | Â | 21. 9 |
TimePoint | Â | Â | Â |
ChangeValue | 10. 7 | Â | Â |
Endpoint | Â | Â | Â |
NumberAffected | Â | Â | 51 |
ObservedResult | Â | Â | Â |
PercentageAffected | Â | Â | 21. 9 |
TimePoint | Â | Â | Â |
ChangeValue | Â | Â | 0. 3 |
Endpoint | Â | Â | Â |
NumberAffected | 64 | Â | Â |
ObservedResult | Â | Â | Â |
PercentageAffected | 27. 4 | Â | Â |
TimePoint | Â | Â | week 24 |
ChangeValue | Â | Â | Â |
Endpoint | Â | Â | Â |
NumberAffected | 51 | Â | Â |
ObservedResult | Â | Â | Â |
PercentageAffected | 21. 9 | Â | 8 |
TimePoint | Â | Â | week 24 |
ChangeValue | Â | Â | Â |
Endpoint | Â | Â | Â |
NumberAffected | Â | Â | Â |
ObservedResult | Neither group had a significant change from baseline in bodyweight. | Â | Â |
PercentageAffected | Â | Â | Â |
TimePoint | Â | Â | Â |
Template DiffBetweenGroups | |||
Outcome1 | Â | Â | Â |
Outcome2 | Â | Â | Â |
PvalueDiff | P < 0. 001 | P <0. 001 | P = 0. 013 |
Outcome1 | Â | Â | Â |
Outcome2 | Â | Â | Â |
PvalueDiff | P = 0. 013 | P = 0. 013 | P = 0. 013 |
Outcome1 | Â | Â | Â |
Outcome2 | Â | Â | Â |
PvalueDiff | P < 0. 001 | P <0. 001 | Â |