Incretin Effect and Use After Clinical Islet Transplantation

This study has been completed.
Sponsor:
Collaborator:
Juvenile Diabetes Research Foundation
Information provided by (Responsible Party):
University of Alberta
ClinicalTrials.gov Identifier:
NCT00768651
First received: October 7, 2008
Last updated: May 29, 2015
Last verified: May 2015
Results First Received: May 10, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Type 1 Diabetes
Interventions: Drug: Pantoprazole
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
Recruitment period took place between March 2010 thru October 2010. Consent took place in the Clinical Islet Transplant Program at the University of Alberta.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients signed Informed Consent after a consultation with the PI. Then they proceeded through the evaluation phase of the study. During this phase, some patients were excluded based on the protocol's inclusion and exclusion criteria (i.e. lab reports or procedure that did not meet protocol standards).

Reporting Groups
  Description
Sitagliptin + Pantoprazole

Intervention Details:

Pantoprazole: Starting on Day 1, Pantoprazole 80 mg daily (40 mg every morning and 40 mg every evening) administered orally at the same time each day for a period of 6 months, followed by a three-month washout.

Sitagliptin: Starting on Day 1, Sitagliptin 100mg once daily administered orally at the same time each day for a period of 6 months, followed by a three-month washout.


Participant Flow:   Overall Study
    Sitagliptin + Pantoprazole  
STARTED     8  
COMPLETED     7  
NOT COMPLETED     1  
Withdrawal by Subject                 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.
Patients with evidence of early graft insufficiency following a period of insulin independence after one or more islet infusions for c-peptide negative type 1 diabetes participated in the study.

Reporting Groups
  Description
One Arm: Sitagliptin + Pantoprazole

Intervention Details:

Sitagliptin 100 mg daily and Pantoprazole 40 mg bid for 6 months, followed by a three-month washout:

Pantoprazole: Starting on Day 1, Pantoprazole 80 mg daily (40 mg every morning and 40 mg every evening) administered orally at the same time each day for a period of 6 months.

Sitagliptin: Starting on Day 1, Sitagliptin 100mg once daily administered orally at the same time each day for a period of 6 months.


Baseline Measures
    One Arm: Sitagliptin + Pantoprazole  
Number of Participants  
[units: participants]
  8  
Age  
[units: years]
Median (Full Range)
  54   (40 to 64)  
Gender  
[units: participants]
 
Female     1  
Male     7  
Region of Enrollment  
[units: participants]
 
Canada     8  
Weight  
[units: kg]
Mean (Standard Deviation)
  69  (15)  
BMI  
[units: kg/m^2]
Mean (Standard Deviation)
  22.6  (3.4)  
Diabetes Duration Prior to 1st Transplant  
[units: years]
Mean (Full Range)
  36.1   (24.7 to 50.2)  
Number of islet infusions  
[units: number of islet infusions]
Median (Full Range)
  2   (1 to 4)  
Islet equivalents infused  
[units: equivalents total]
Mean (Standard Deviation)
  814,061  (231,463)  
Islet equivalents infused  
[units: equivalents per kg]
Mean (Standard Deviation)
  12,046  (4,030)  
Time since first transplant  
[units: months]
Median (Full Range)
  67   (25 to 137)  
Interval since last transplant  
[units: months]
Median (Full Range)
  53   (17 to 136)  
Time insulin free  
[units: months]
Median (Full Range)
  47.8   (15.4 to 135.3)  
Tacrolimus daily dose  
[units: mg]
Mean (Standard Deviation)
  4.5  (1.2)  
Mycophenolate daily dose  
[units: mg]
Mean (Standard Deviation)
  1406  (461)  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   The Primary Endpoint Will be Insulin Independence After 6 Months of Therapy.   [ Time Frame: 6 months ]

2.  Secondary:   Insulin Independence After the 3 Month Washout Period   [ Time Frame: After the 3 month washout period ]

3.  Primary:   Number of Participants Not Using Insulin for at Least One Week After 6 Months of Therapy   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Primary:   Number of Participants With HbA1c < 6.0 % After 6 Months of Therapy   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Primary:   Number of Participants With Fasting Plasma Glucose (FPG) < 7 mmol/l After 6 Months of Therapy   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Primary:   Mean Daily Insulin Use (U/Day) After 6 Months of Therapy   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

7.  Primary:   Change From Baseline of GLP-1 Level After One Month of Therapy   [ Time Frame: Baseline and One month ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

8.  Primary:   Change From Baseline on Gastrin Level After One Month of Therapy   [ Time Frame: Baseline and One month ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

9.  Primary:   HbA1c Plasma Laboratory Value for Participants After 6 Months of Therapy   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

10.  Primary:   Acute Insulin Responses to Arginine After 6 Months of Therapy   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

11.  Primary:   C-peptide Laboratory Value at 90 Minutes After a Mixed Meal Tolerance Test (MMTT) After 6 Months of Therapy   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

12.  Primary:   C-peptide Laboratory Value Before a Mixed Meal Tolerance Test (MMTT) After 6 Months of Therapy   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

13.  Primary:   Glucose Laboratory Value at 90 Minutes After Mixed Meal Tolerance Test (MMTT) After 6 Months of Therapy.   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

14.  Primary:   Blood Glucose Laboratory Value Before Mixed Meal Tolerance Test (MMTT) After 6 Months of Therapy   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

15.  Primary:   Weight Change From Baseline After 6 Months of Therapy   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

16.  Secondary:   Insulin Dose (U/Day)   [ Time Frame: After the 3 month washout period ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

17.  Secondary:   Acute Insulin Response to Arginine After the 3 Month Washout Period   [ Time Frame: 3 months - washout period ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

18.  Secondary:   HbA1c Plasma Laboratory Value for Participants After the 3 Month Washout Period   [ Time Frame: After the 3 month washout period ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

19.  Secondary:   C-peptide Plasma Laboratory Value at 90 Minutes After a Mixed Meal Tolerance Test (MMTT) at the End of the 3 Month Washout Period.   [ Time Frame: After the 3 month washout period ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

20.  Secondary:   C-peptide Laboratory Value Before a Mixed Meal Tolerance Test (MMTT) After the 3 Month Washout Period.   [ Time Frame: 3 months - washout period ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

21.  Secondary:   Glucose Laboratory Value at 90 Minutes After Mixed Meal Tolerance Test (MMTT) After the 3 Month Washout Period.   [ Time Frame: 3 months - washout period ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

22.  Secondary:   Blood Glucose Laboratory Value Before Mixed Meal Tolerance Test (MMTT) After the 3 Month Washout Period   [ Time Frame: After the 3 month washout period ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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
The major weaknesses of the study are the small sample size and the lack of a control group.


  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: Peter Senior, MD, PhD - Professor of Medicine, Medical Director-Clinical Islet Transplant Program,
Organization: Faculty of Medicine and Dentistry, University of Alberta
phone: 780-407-1480
e-mail: peters@islet.ca


No publications provided


Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT00768651     History of Changes
Other Study ID Numbers: 7331
Study First Received: October 7, 2008
Results First Received: May 10, 2015
Last Updated: May 29, 2015
Health Authority: Canada: Health Canada