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Trial record 36 of 162 for:    MacKay Memorial Hospital, Taiwan

Adding Sitagliptin or Pioglitazone to Type 2 Diabetes Mellitus Insufficiently Controlled With Metformin and Sulfonylurea (JAS)

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ClinicalTrials.gov Identifier: NCT01195090
Recruitment Status : Completed
First Posted : September 3, 2010
Results First Posted : October 10, 2012
Last Update Posted : October 10, 2012
Sponsor:
Collaborator:
Mackay Memorial Hospital
Information provided by (Responsible Party):
Sung-Chen Liu, Mackay Memorial Hospital

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Type 2 Diabetes
Interventions: Drug: Sitagliptin
Drug: pioglitazone

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was started from 01 OCT 2009 to 27 SEP 2011

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

we screened 135 patients and 120 patients were randomized in a 1: 1 ratio to one of the treatment groups.

reson for excluded: 4 patients: ALT or AST >2.5x ULN 8 patiens : withdraw informed consent 3 patiens: baseline A1C>11%


Reporting Groups
  Description
Sitagliptin add sitagliptin100mg/d to pre-study OADs
Pioglitazone add pioglitazone 30mg/d to pre-study OADs

Participant Flow:   Overall Study
    Sitagliptin   Pioglitazone
STARTED   60   60 
COMPLETED   54   52 
NOT COMPLETED   6   8 
Adverse Event                1                2 
Lost to Follow-up                2                2 
Protocol Violation                3                4 



  Baseline Characteristics

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 add sitagliptin100mg/d to pre-study OADs
Pioglitazone add pioglitazone 30mg/d to pre-study OADs
Total Total of all reporting groups

Baseline Measures
   Sitagliptin   Pioglitazone   Total 
Overall Participants Analyzed 
[Units: Participants]
 60   60   120 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   42   49   91 
>=65 years   18   11   29 
Age 
[Units: Years]
Mean (Standard Deviation)
 60.1  (8.9)   58.1  (8.3)   59.1  (8.6) 
Gender 
[Units: Participants]
     
Female   38   37   75 
Male   22   23   45 
Region of Enrollment 
[Units: Participants]
     
Taiwan   60   60   120 


  Outcome Measures

1.  Primary:   Mean Change in Glycosylated Hemoglobin (A1C)   [ Time Frame: 24 weeks ]

2.  Primary:   Baseline A1C   [ Time Frame: Baseline ]

3.  Primary:   The Percentages of Patient Achieving an A1C <7%   [ Time Frame: 24 weeks ]

4.  Secondary:   Changes in Fasting Plasma Glucose   [ Time Frame: 24 weeks ]

5.  Secondary:   Changes in High Sensitive C-reactive Protein   [ Time Frame: 24 weeks ]

6.  Secondary:   Changes in Homoeostasis Model Assessment of Insulin Resistance (HOMA-IR)   [ Time Frame: 24 weeks ]

7.  Secondary:   Body Weight Change   [ Time Frame: 24 weeks ]

8.  Secondary:   Percentages of Patients With Total Adverse Events (AE)   [ Time Frame: 24 weeks ]

9.  Secondary:   Change in Fasting Total-cholesterol   [ Time Frame: 24 weeks ]

10.  Secondary:   Change in Fasting Low-density Lipoprotein Cholesterol (LDL-C)   [ Time Frame: 24 weeks ]

11.  Secondary:   Change in Fasting Triglycerides(TG)   [ Time Frame: 24 weeks ]

12.  Secondary:   Change in Fasting High-density Lipoprotein Cholesterol(HDL-C)   [ Time Frame: 24 weeks ]

13.  Secondary:   Change in Fasting Plasma Alanine-aminotransferase (ALT)   [ Time Frame: 24 weeks ]

14.  Secondary:   Percentages of Patients With Mild to Moderate Hypoglycemia   [ Time Frame: 24 weeks ]

15.  Secondary:   Percentages of Patients With Edema   [ Time Frame: 24 weeks ]

16.  Secondary:   Percentages of Patients With Gastrointestinal Adverse Events   [ Time Frame: 24 weeks ]

17.  Secondary:   Percentages of Patients With Nasopharyngitis   [ Time Frame: 24 weeks ]

18.  Secondary:   Percentages of Patients With Severe Hypoglycemia   [ Time Frame: 24 weeks ]

19.  Secondary:   Baseline Fasting Plasma Glucose   [ Time Frame: baseline ]

20.  Secondary:   Baseline High Sensitive C-reactive Protein   [ Time Frame: baseline ]

21.  Secondary:   Baseline Homoeostasis Model Assessment of Insulin Resistance (HOMA-IR)   [ Time Frame: Baseline HOMA-IR ]

22.  Secondary:   Baseline Alanine-aminotransferase (ALT)   [ Time Frame: Baseline ]

23.  Secondary:   Baseline Body Weight   [ Time Frame: Baseline ]

24.  Secondary:   Baseline Total Cholesterol   [ Time Frame: Baseline ]

25.  Secondary:   Baseline Triglyceride (TG)   [ Time Frame: Baseline ]

26.  Secondary:   Baseline Low-density Lipoprotein Cholesterol (LDL-C)   [ Time Frame: Baseline ]

27.  Secondary:   Baseline High-density Lipoprotein Cholesterol (HDL-C)   [ Time Frame: Baseline ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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

The reasons for withdrawal:

lost to follow-up:2 in pioglitazone and 2 in sitagliptin protocol violation:4 in pioglitazone and 3 in sitagliptin edema:1 in pioglitazone, ALT >3 times ULN:1 in pioglitazone gastrointestinal events:1 in sitagliptin



  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Sung-Chen Liu
Organization: Department of Internal Medicine, Mackay Memorial Hospital
phone: 886-2-2543-3535 ext 2174
e-mail: pine3.tw@yahoo.com.tw



Responsible Party: Sung-Chen Liu, Mackay Memorial Hospital
ClinicalTrials.gov Identifier: NCT01195090     History of Changes
Other Study ID Numbers: 09MMHIS047
First Submitted: September 2, 2010
First Posted: September 3, 2010
Results First Submitted: April 18, 2012
Results First Posted: October 10, 2012
Last Update Posted: October 10, 2012