Comparison Study of the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly Suspension to Sitagliptin and Placebo in Subjects With Type 2 Diabetes Mellitus (DURATION-NEO-2)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01652729
First received: July 26, 2012
Last updated: April 27, 2015
Last verified: April 2015
Results First Received: April 3, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Diabetes Type 2
Interventions: Drug: Exenatide once weekly suspension
Drug: Sitagliptin
Drug: Placebo

  Participant Flow
  Hide Participant Flow

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
Subjects were randomly assigned across 3 treatment groups (exenatide, sitagliptin, and placebo) in a ratio of 3:2:1, with randomization stratified by screening HbA1c stratum (< 9% or 9%).

Reporting Groups
  Description
Experimental: Exenatide Exenatide once weekly suspension 2mg subcutaneous injection
Active Comparator: Sitagliptin Sitagliptin 100mg oral tablet once daily
Placebo Comparator: Placebo Placebo oral tablet once daily

Participant Flow:   Overall Study
    Experimental: Exenatide     Active Comparator: Sitagliptin     Placebo Comparator: Placebo  
STARTED     182 [1]   122     61  
Modified Intent-to-Treat     181 [2]   122     61  
Treated     181 [3]   122     61  
Evaluable     143 [4]   91     43  
Meal Test Subjects     60     41     20  
Meal Test Evaluable     44 [5]   31     15  
COMPLETED     155 [6]   109     47  
NOT COMPLETED     27     13     14  
Withdrawal by Subject                 14                 7                 7  
Adverse Event                 4                 0                 3  
Physician Decision                 1                 0                 1  
Protocol Violation                 1                 0                 0  
Lost to Follow-up                 6                 6                 3  
Administrative                 1                 0                 0  
[1] One subject was enrolled twice at different sites. He was randomized to exenatide at both sites.
[2] All randomized subjects who received at least one dose of study drug.
[3] All subjects who received at least one dose of study medication even if not randomized.
[4] Subjects who completed study procedures to Week 24 or beyond and had adequate study drug exposure
[5] ITT subjects who ate >=75% of meal and did not miss 2-hour postprandial glucose measures at V3 and 8
[6] The double-enrolled subject’s reasons for withdrawal were LTFU and PV. Only PV is shown below.



  Baseline Characteristics
  Hide Baseline Characteristics

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.
Modified Intent-to-Treat: Subjects who were randomized and received at least one dose of study drug.

Reporting Groups
  Description
Experimental: Exenatide Exenatide once weekly suspension 2mg subcutaneous injection
Active Comparator: Sitagliptin Sitagliptin 100mg oral tablet once daily
Placebo Comparator: Placebo Placebo oral tablet once daily
Total Total of all reporting groups

Baseline Measures
    Experimental: Exenatide     Active Comparator: Sitagliptin     Placebo Comparator: Placebo     Total  
Number of Participants  
[units: participants]
  181     122     61     364  
Age  
[units: Years]
Mean (Standard Deviation)
  53.4  (9.82)     54.3  (9.01)     53.4  (9.48)     53.7  (9.49)  
Age, Customized [1]
[units: Participants]
       
<65 years     154     106     54     314  
>=65 years     27     16     7     50  
Gender  
[units: Participants]
       
Female     92     56     24     172  
Male     89     66     37     192  
Race/Ethnicity, Customized  
[units: Participants]
       
White     148     98     50     296  
Black or African American     24     18     7     49  
Asian     9     2     3     14  
American Indian or Alaska Native     0     2     1     3  
Other     0     1     0     1  
Native Hawaiian or Other Pacific Islander     0     1     0     1  
Race/Ethnicity, Customized  
[units: Participants]
       
Hispanic or Latino     111     77     32     220  
Not Hispanic or Latino     70     45     29     144  
Weight  
[units: kg]
Mean (Standard Deviation)
  89.15  (21.413)     88.09  (20.282)     88.95  (20.136)     88.76  (20.778)  
Baseline HbA1c  
[units: percentage of total hemoglobin]
Mean (Standard Deviation)
  8.42  (0.997)     8.50  (1.043)     8.50  (1.043)     8.46  (1.018)  
HbA1c Stratum  
[units: number of subjects]
       
< 9.0%     125     83     42     250  
>= 9.0%     56     39     19     114  
Fasting Plasma Glucose  
[units: mg/dL]
Mean (Standard Deviation)
  178.0  (46.64)     176.9  (42.50)     172.8  (44.31)     176.8  (44.82)  
[1] <65 years



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in HbA1c (Glycosylated Hemoglobin) From Baseline to Week 28   [ Time Frame: Baseline to Week 28 ]

2.  Secondary:   Proportion of Subjects Achieving HbA1c <7% at Week 28   [ Time Frame: Baseline to Week 28 ]

3.  Secondary:   Change in Fasting Plasma Glucose Concentrations From Baseline to Week 28   [ Time Frame: Baseline to Week 28 ]

4.  Secondary:   Change in Body Weight (kg) From Baseline to Week 28   [ Time Frame: Baseline to Week 28 ]

5.  Secondary:   Change in 2-hour Postprandial Glucose Concentrations From Baseline to Week 16 (Visit 8)   [ Time Frame: Baseline to Week 16 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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.


  More Information
  Hide More Information

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 more than 60 days but less than or equal to 180 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: ClinicalTrialTransparency@astrazeneca.com
Organization: AstraZeneca
e-mail: ClinicalTrialTransparency@astrazeneca.com


No publications provided


Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01652729     History of Changes
Other Study ID Numbers: BCB120, MB001-004
Study First Received: July 26, 2012
Results First Received: April 3, 2015
Last Updated: April 27, 2015
Health Authority: United States: Food and Drug Administration