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Effect of Exenatide, Sitagliptin or Glimepiride on Functional ß -Cell Mass

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00775684
First Posted: October 20, 2008
Last Update Posted: December 6, 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.
Collaborator:
Pennsylvania Department of Health
Information provided by (Responsible Party):
University of Pennsylvania
Results First Submitted: September 22, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Pre-diabetes
Type 2 Diabetes
Interventions: Drug: Exenatide
Drug: Sitagliptin
Drug: Glimepiride

  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 is now closed for this study. All subject follow-up was completed in the spring of 2012.

The purpose of the study was to evaluate three medications for the treatment of high blood sugar.


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
Exenatide

Exenatide (Byetta®)—5 µg injected subcutaneously twice daily and increased after 1 month to 10 µg twice daily as tolerated by gastrointestinal effects

Exenatide: Exenatide (Byetta®)—5 µg injected subcutaneously twice daily and increased after 1 month to 10 µg twice daily as tolerated by gastrointestinal effects

Sitagliptin

Sitagliptin (Januvia®)—100 mg by mouth every morning

Sitagliptin: Sitagliptin (Januvia®)100 mg by mouth every morning

Glimepiride

Glimepiride (Amaryl®)—0.5 mg by mouth every morning and then increased by 0.5 - 1.0 mg at each monthly visit to achieve an average fasting glucose < 110mg/dl

Glimepiride: Glimepiride (Amaryl®)—0.5 mg by mouth every morning and then increased by 0.5 - 1.0 mg at each monthly visit to achieve an average fasting glucose < 110mg/dl


Participant Flow:   Overall Study
    Exenatide   Sitagliptin   Glimepiride
STARTED   17   13   17 
COMPLETED   14   12   14 
NOT COMPLETED   3   1   3 



  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
Exenatide

Exenatide (Byetta®)—5 µg injected subcutaneously twice daily and increased after 1 month to 10 µg twice daily as tolerated by gastrointestinal effects

Exenatide: Exenatide (Byetta®)—5 µg injected subcutaneously twice daily and increased after 1 month to 10 µg twice daily as tolerated by gastrointestinal effects

Sitagliptin

Sitagliptin (Januvia®)—100 mg by mouth every morning

Sitagliptin: Sitagliptin (Januvia®)100 mg by mouth every morning

Glimepiride

Glimepiride (Amaryl®)—0.5 mg by mouth every morning and then increased by 0.5 - 1.0 mg at each monthly visit to achieve an average fasting glucose < 110mg/dl

Glimepiride: Glimepiride (Amaryl®)—0.5 mg by mouth every morning and then increased by 0.5 - 1.0 mg at each monthly visit to achieve an average fasting glucose < 110mg/dl

Total Total of all reporting groups

Baseline Measures
   Exenatide   Sitagliptin   Glimepiride   Total 
Overall Participants Analyzed 
[Units: Participants]
 17   13   17   47 
Age 
[Units: Participants]
Count of Participants
       
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      17 100.0%      13 100.0%      17 100.0%      47 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 57  (2)   57  (3)   52  (3)   55.3  (2.6) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      6  35.3%      4  30.8%      7  41.2%      17  36.2% 
Male      11  64.7%      9  69.2%      10  58.8%      30  63.8% 
Region of Enrollment 
[Units: Participants]
       
United States   17   13   17   47 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Effect on Functional Beta-cell Mass as Determined by Change in ß-cell Secretory Capacity at 6 Months (μU/ml)   [ Time Frame: Baseline and 6 months ]

2.  Primary:   Effect on Functional Beta-cell Mass as Determined by Change in ß-cell Secretory Capacity at 6 Months (pg/mL)   [ Time Frame: Baseline and 6 months ]

3.  Secondary:   Change in Acute Insulin Response to Arginine. (AIRarg)   [ Time Frame: Baseline and 6 months ]

4.  Secondary:   Insulin Sensitivity at Baseline and 6 Months   [ Time Frame: Baseline and 6 months ]

5.  Secondary:   PG 50 (the Plasma Glucose Level at Which Half-maximal Insulin Secretion is Achieved During the Glucose-potentiated Arginine Test) at Baseline and 6 Months   [ Time Frame: Baseline and 6 months ]


  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:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Associate Professor of Medicine. Director, Translational Research Center
Organization: University of Pennsylvania
phone: 215 746-0025
e-mail: rickels@mail.med.upenn.edu


Publications:

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00775684     History of Changes
Other Study ID Numbers: 808425
First Submitted: October 17, 2008
First Posted: October 20, 2008
Results First Submitted: September 22, 2016
Results First Posted: December 6, 2017
Last Update Posted: December 6, 2017