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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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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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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 + 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.

Participant Flow:   Overall Study
    Exenatide + Placebo     Exenatide + Sitagliptin  
STARTED     127     128  
Per Protocol Set     97     111  
COMPLETED     101     114  
NOT COMPLETED     26     14  
Adverse Event                 10                 5  
Lack of Efficacy                 0                 1  
Lost to Follow-up                 2                 0  
Physician Decision                 3                 1  
Protocol Violation                 3                 3  
Entry Criteria Not Met                 1                 2  
Subject Decision                 7                 2  



  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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Measure Type Secondary
Measure Title Percentage of Patients Achieving HbA1c <=7.0%
Measure Description Percentage of patients whose baseline HbA1c was > 7.0% achieving HbA1c <=7.0% at endpoint (Week 20)
Time Frame Baseline to 20 Weeks  
Safety Issue No  

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 in the Per Protocol Set whose baseline HbA1c was > 7.0%; Last Observation Carried Forward.Per Protocol Set: the set of data generated by the subset of patients who sufficiently complied with the protocol to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model.

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.

Measured Values
    Exenatide + Placebo     Exenatide + Sitagliptin  
Number of Participants Analyzed  
[units: participants]
 		  88     106  
Percentage of Patients Achieving HbA1c <=7.0%  
[units: Percentage]
 		  29.5     44.3  


Statistical Analysis 1 for Percentage of Patients Achieving HbA1c <=7.0%
Groups [1] All groups
Method [2] Fisher`s Exact Test
P Value [3] .038
[1] Additional details about the analysis, such as null hypothesis and power calculation:
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[2] Other relevant information, such as adjustments or degrees of freedom:
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[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
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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 ]
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  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
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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