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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):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00870194
First received: March 25, 2009
Last updated: March 20, 2015
Last verified: March 2015
Results First Received: April 11, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, 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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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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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 + 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 
Overall Participants Analyzed 
[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
  Show All Outcome Measures

1.  Primary:   Change in HbA1c (Percent)   [ Time Frame: Baseline to 20 Weeks ]

2.  Secondary:   Percentage of Patients Achieving HbA1c <=7.0%   [ Time Frame: Baseline to 20 Weeks ]

3.  Secondary:   Percentage of Patients Achieving HbA1c <7.0%   [ Time Frame: Baseline to 20 Weeks ]

4.  Secondary:   Percentage of Patients Achieving HbA1c <=6.5%   [ Time Frame: Baseline to 20 Weeks ]

5.  Secondary:   Change in FSG (mmol/L)   [ Time Frame: Baseline to 20 Weeks ]

6.  Secondary:   Change in Body Weight (kg)   [ Time Frame: Baseline to 20 Weeks ]

7.  Secondary:   Change in Waist Circumference (cm)   [ Time Frame: Baseline to 20 Weeks ]

8.  Secondary:   Waist-to-Hip Ratio   [ Time Frame: Baseline to 20 Weeks ]

9.  Secondary:   SMBG (mmol/L)   [ Time Frame: Baseline to 20 Weeks ]

10.  Secondary:   Change in Triglycerides (mmol/L)   [ Time Frame: Baseline to 20 Weeks ]

11.  Secondary:   Change in HDL (mmol/L)   [ Time Frame: Baseline to 20 Weeks ]

12.  Secondary:   Change in LDL (mmol/L)   [ Time Frame: Baseline to 20 Weeks ]

13.  Secondary:   Change in Total Cholesterol (mmol/L)   [ Time Frame: Baseline to 20 Weeks ]

14.  Secondary:   Incidence of Hypoglycemia (Overall)   [ Time Frame: Baseline to 20 Weeks ]

15.  Secondary:   Incidence of Severe Hypoglycemia(Overall)   [ Time Frame: Baseline to 20 Weeks ]

16.  Secondary:   Incidence of Nocturnal Hypoglycemia (Overall)   [ Time Frame: Baseline to 20 Weeks ]

17.  Secondary:   Incidence of Confirmed Hypoglycemia(Overall)   [ Time Frame: Baseline to 20 Weeks ]


  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 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.


Results Point of Contact:  
Name/Title: Peter Ohman, Medical Science Director
Organization: AstraZeneca
e-mail: ClinicalTrialTransparency@astrazeneca.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: AstraZeneca
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: March 20, 2015