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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01610154
First Posted: June 1, 2012
Last Update Posted: May 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Guangwei Li, Chinese Academy of Medical Sciences, Fuwai Hospital
Results First Submitted: November 27, 2016  
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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Sitagliptin 100 mg QD for 12 weeks and followed-up every 4 weeks

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Sitagliptin Treatment Sitagliptin 100 mg QD for 12 weeks

Participant Flow:   Overall Study
    Sitagliptin Treatment
STARTED   85 
COMPLETED   84 
NOT COMPLETED   1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Sitagliptin Treatment Sitagliptin 100 mg QD for 12 weeks

Baseline Measures
   Sitagliptin Treatment 
Overall Participants Analyzed 
[Units: Participants]
 84 
Age 
[Units: Participants]
Count of Participants
 
<=18 years   0 
Between 18 and 65 years   84 
>=65 years   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 48.8  (12.2) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female   37 
Male   47 
Region of Enrollment 
[Units: Participants]
 
China   84 
Body Mass Index (BMI) 
[Units: Kg/m2]
Mean (Standard Deviation)
 25.8  (3.41) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Hemoglobin A1c (HbA1c)   [ Time Frame: Baseline to 12 weeks ]

2.  Secondary:   Change From Baseline in Fasting Plasma Glucose (FPG)   [ Time Frame: Baseline to 12 weeks ]

3.  Secondary:   Change From Baseline in Postprandial Plasma Glucose (PPG)   [ Time Frame: Baseline to 12 weeks ]

4.  Secondary:   Change From Baseline in Insulin Sensitivity   [ Time Frame: Baseline to 12 weeks ]

5.  Secondary:   Change From Baseline in Insulin Sensitivity in Patients With Different BMI   [ Time Frame: Baseline to 12 weeks ]

6.  Secondary:   Change From Baseline in Pancreatic β Cell Function   [ Time Frame: Baseline to 12 weeks ]

7.  Secondary:   Change From Baseline in Pancreatic β Cell Function in Patients With Different BMI   [ Time Frame: Baseline to 12 weeks ]

8.  Secondary:   Change From Baseline in Pancreatic α Cell Function   [ Time Frame: Baseline to 12 weeks ]

9.  Secondary:   Change From Baseline in Pancreatic α Cell Function in Patients With Different BMI   [ Time Frame: Baseline to 12 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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
e-mail: wh_endo@163.com



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