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A Comparison of Adding Exenatide With Switching to Exenatide in Patients With Type 2 Diabetes Experiencing Inadequate Glycemic Control With Sitagliptin Plus Metformin

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Amylin Pharmaceuticals, LLC.
ClinicalTrials.gov Identifier:
NCT00870194
First received: March 25, 2009
Last updated: February 27, 2013
Last verified: February 2013
History of Changes
Results First Received: April 11, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Type 2 Diabetes Mellitus
Interventions: Drug: exenatide and sitagliptin
Drug: exenatide and placebo

  Participant Flow
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  Baseline Characteristics
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Reporting Groups
  Description
Exenatide + Placebo Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
Exenatide + Sitagliptin Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
Total Total of all reporting groups

Baseline Measures
    Exenatide + Placebo     Exenatide + Sitagliptin     Total  
Number of Participants  
[units: participants]
 		  97     111     208  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     81     97     178  
>=65 years     16     14     30  
Age  
[units: years]
Mean ± Standard Deviation 		  54.8  ± 10.97     54.6  ± 9.66     54.7  ± 10.27  
Gender  
[units: participants]
 		     
Female     46     58     104  
Male     51     53     104  



  Outcome Measures
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1.  Primary:   Change in HbA1c (Percent)   [ Time Frame: Baseline to 20 Weeks ]
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2.  Secondary:   Percentage of Patients Achieving HbA1c <=7.0%   [ Time Frame: Baseline to 20 Weeks ]
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3.  Secondary:   Percentage of Patients Achieving HbA1c <7.0%   [ Time Frame: Baseline to 20 Weeks ]
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4.  Secondary:   Percentage of Patients Achieving HbA1c <=6.5%   [ Time Frame: Baseline to 20 Weeks ]
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5.  Secondary:   Change in FSG (mmol/L)   [ Time Frame: Baseline to 20 Weeks ]
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6.  Secondary:   Change in Body Weight (kg)   [ Time Frame: Baseline to 20 Weeks ]
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7.  Secondary:   Change in Waist Circumference (cm)   [ Time Frame: Baseline to 20 Weeks ]
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8.  Secondary:   Waist-to-Hip Ratio   [ Time Frame: Baseline to 20 Weeks ]
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9.  Secondary:   SMBG (mmol/L)   [ Time Frame: Baseline to 20 Weeks ]
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10.  Secondary:   Change in Triglycerides (mmol/L)   [ Time Frame: Baseline to 20 Weeks ]
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11.  Secondary:   Change in HDL (mmol/L)   [ Time Frame: Baseline to 20 Weeks ]
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12.  Secondary:   Change in LDL (mmol/L)   [ Time Frame: Baseline to 20 Weeks ]
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13.  Secondary:   Change in Total Cholesterol (mmol/L)   [ Time Frame: Baseline to 20 Weeks ]
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14.  Secondary:   Incidence of Hypoglycemia (Overall)   [ Time Frame: Baseline to 20 Weeks ]
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15.  Secondary:   Incidence of Severe Hypoglycemia(Overall)   [ Time Frame: Baseline to 20 Weeks ]
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16.  Secondary:   Incidence of Nocturnal Hypoglycemia (Overall)   [ Time Frame: Baseline to 20 Weeks ]
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17.  Secondary:   Incidence of Confirmed Hypoglycemia(Overall)   [ Time Frame: Baseline to 20 Weeks ]
  Show Outcome Measure 17


  Serious Adverse Events
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  Other Adverse Events
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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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


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
No text entered.  


Results Point of Contact:  
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 1-800-LILLYRX
e-mail: clinicaltrials@amylin.com


No publications provided by Amylin Pharmaceuticals, LLC.

Publications automatically indexed to this study:


Responsible Party: Amylin Pharmaceuticals, LLC.
ClinicalTrials.gov Identifier: NCT00870194     History of Changes
Other Study ID Numbers: H8O-CR-GWDK
Study First Received: March 25, 2009
Results First Received: April 11, 2011
Last Updated: February 27, 2013
Health Authority: Argentina: Ministry of Health
Australia: National Health and Medical Research Council
Germany: Federal Institute for Drugs and Medical Devices
Greece: Ministry of Health and Welfare
India: Drugs Controller General of India
South Korea: Korea Food and Drug Administration (KFDA)
Mexico: Ministry of Health