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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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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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