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Contribution of Pancreatic αcells Function to Blood Glucose Regulation in Chinese Type 2 Diabetics― the Effect of Sitagliptin on Glucagon Secretion, Insulin Secretion and Insulin Resistance in Chinese Type 2 Diabetics

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ClinicalTrials.gov Identifier: NCT01610154
Recruitment Status : Completed
First Posted : June 1, 2012
Results First Posted : April 4, 2017
Last Update Posted : May 11, 2017
Sponsor:
Information provided by (Responsible Party):
Guangwei Li, Chinese Academy of Medical Sciences, Fuwai Hospital

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Insulin Secretion
Insulin Resistance
Intervention Drug: Sitagliptin
Enrollment 85
Recruitment Details Sitagliptin 100 mg QD for 12 weeks and followed-up every 4 weeks
Pre-assignment Details  
Arm/Group Title Sitagliptin Treatment
Hide Arm/Group Description Sitagliptin 100 mg QD for 12 weeks
Period Title: Overall Study
Started 85
Completed 84
Not Completed 1
Arm/Group Title Sitagliptin Treatment
Hide Arm/Group Description Sitagliptin 100 mg QD for 12 weeks
Overall Number of Baseline Participants 84
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 84 participants
<=18 years 0
Between 18 and 65 years 84
>=65 years 0
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 84 participants
48.8  (12.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 84 participants
Female 37
Male 47
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
China Number Analyzed 84 participants
84
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m2
Number Analyzed 84 participants
25.8  (3.41)
1.Primary Outcome
Title Change From Baseline in Hemoglobin A1c (HbA1c)
Hide Description [Not Specified]
Time Frame Baseline to 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sitagliptin
Hide Arm/Group Description:
Sitagliptin 100 mg QD
Overall Number of Participants Analyzed 84
Mean (Standard Deviation)
Unit of Measure: percentage
-1.08  (0.13)
2.Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose (FPG)
Hide Description [Not Specified]
Time Frame Baseline to 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sitagliptin
Hide Arm/Group Description:
Sitagliptin 100 mg QD
Overall Number of Participants Analyzed 84
Mean (Standard Deviation)
Unit of Measure: mmol/L
-1.99  (0.18)
3.Secondary Outcome
Title Change From Baseline in Postprandial Plasma Glucose (PPG)
Hide Description [Not Specified]
Time Frame Baseline to 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sitagliptin
Hide Arm/Group Description:
Sitagliptin 100 mg QD
Overall Number of Participants Analyzed 84
Mean (Standard Deviation)
Unit of Measure: mmol/L
-4.69  (0.41)
4.Secondary Outcome
Title Change From Baseline in Insulin Sensitivity
Hide Description The insulin sensitivity was detected by evaluating the glucose infusion rate (GIR) with euglycemic hyperinsulinemic clamp test.
Time Frame Baseline to 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sitagliptin
Hide Arm/Group Description:
Sitagliptin 100 mg QD
Overall Number of Participants Analyzed 84
Median (Inter-Quartile Range)
Unit of Measure: mg/kg/min
0.64
(0.27 to 1.58)
5.Secondary Outcome
Title Change From Baseline in Insulin Sensitivity in Patients With Different BMI
Hide Description The insulin sensitivity was detected by evaluating the glucose infusion rate (GIR) with euglycemic hyperinsulinemic clamp test.
Time Frame Baseline to 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Non-obese Group Obese Group
Hide Arm/Group Description:
BMI<25 kg/m2
BMI≥25 kg/m2
Overall Number of Participants Analyzed 34 50
Median (Inter-Quartile Range)
Unit of Measure: mg/kg/min
0.42
(0.14 to 1.25)
0.72
(0.32 to 1.93)
6.Secondary Outcome
Title Change From Baseline in Pancreatic β Cell Function
Hide Description The early phase insulin response (△I30/△G30) was adopted to determine β cell function.
Time Frame Baseline to 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sitagliptin
Hide Arm/Group Description:
Sitagliptin 100 mg QD
Overall Number of Participants Analyzed 84
Median (Inter-Quartile Range)
Unit of Measure: μu/ml/mmol
2.53
(0.78 to 5.64)
7.Secondary Outcome
Title Change From Baseline in Pancreatic β Cell Function in Patients With Different BMI
Hide Description The early phase insulin response (△I30/△G30) was adopted to determine β cell function.
Time Frame Baseline to 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Non-obese Group Obese Group
Hide Arm/Group Description:
BMI<25 kg/m2
BMI≥25 kg/m2
Overall Number of Participants Analyzed 34 50
Median (Inter-Quartile Range)
Unit of Measure: μu/ml/mmol
2.30
(0.96 to 4.65)
2.85
(0.81 to 6.47)
8.Secondary Outcome
Title Change From Baseline in Pancreatic α Cell Function
Hide Description The glucagon-AUC was adopted to show pancreatic α cell function.
Time Frame Baseline to 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sitagliptin
Hide Arm/Group Description:
Sitagliptin 100 mg QD
Overall Number of Participants Analyzed 84
Mean (Standard Deviation)
Unit of Measure: min∙pg/ml
-27.8  (32.3)
9.Secondary Outcome
Title Change From Baseline in Pancreatic α Cell Function in Patients With Different BMI
Hide Description The glucagon-AUC was adopted to show pancreatic α cell function.
Time Frame Baseline to 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Non-obese Group Obese Group
Hide Arm/Group Description:
BMI<25 kg/m2
BMI≥25 kg/m2
Overall Number of Participants Analyzed 34 50
Mean (Standard Deviation)
Unit of Measure: min∙pg/ml
13.6  (87.4) -54.0  (307.4)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sitagliptin Treatment
Hide Arm/Group Description Sitagliptin 100 mg QD
All-Cause Mortality
Sitagliptin Treatment
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Sitagliptin Treatment
Affected / at Risk (%) # Events
Total   0/84 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Sitagliptin Treatment
Affected / at Risk (%) # Events
Total   8/84 (9.52%)    
Infections and infestations   
Upper respiratory infection  1/84 (1.19%)  1
Nasopharyngitis  2/84 (2.38%)  2
Metabolism and nutrition disorders   
Hypoglycemia ( symptom only)  5/84 (5.95%)  5
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Hui Wang
Organization: Fuwai Hospital
Phone: 86-010-88396587
Responsible Party: Guangwei Li, Chinese Academy of Medical Sciences, Fuwai Hospital
ClinicalTrials.gov Identifier: NCT01610154     History of Changes
Other Study ID Numbers: CIFuwaiHospital-MISP39889
First Submitted: May 30, 2012
First Posted: June 1, 2012
Results First Submitted: November 27, 2016
Results First Posted: April 4, 2017
Last Update Posted: May 11, 2017