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Effects of Exenatide Long-Acting Release on Glucose Control and Safety in Subjects With Type 2 Diabetes Mellitus(DURATION - 1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00308139
First received: March 27, 2006
Last updated: July 29, 2015
Last verified: July 2015
History of Changes
Results First Received: February 14, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Type 2 Diabetes Mellitus
Interventions: Drug: exenatide, long acting release
Drug: exenatide

  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 Once Weekly -> Exenatide Once Weekly Subcutaneous injection of 2 mg exenatide, once a week.
Exenatide Twice Daily -> Exenatide Once Weekly Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.

Participant Flow:   Overall Study
    Exenatide Once Weekly -> Exenatide Once Weekly     Exenatide Twice Daily -> Exenatide Once Weekly  
STARTED     152     151  
Intent to Treat (ITT)     148 [1]   147 [1]
ITT in the 30-Week Assessment     148 [2]   145 [2]
Pharmacokinetics Population     129     0  
Evaluable Meal Tolerance Cohort     27     24  
30-Week Completed     128 [3]   130 [3]
COMPLETED     58 [4]   64 [4]
NOT COMPLETED     94     87  
Adverse Event                 20                 14  
Lost to Follow-up                 13                 8  
Protocol Violation                 3                 2  
Withdrawal of Consent                 40                 42  
Investigator Decision                 11                 10  
Loss of Glucose Control                 5                 7  
Administrative                 1                 4  
Other                 1                 0  
[1] Subjects who received at least one injection of lead-in exenatide 5 mcg.
[2] ITT Subjects who received at least one injection of randomized dose.
[3] Subjects who completed 30 weeks of assessment
[4] Subjects who completed 364 weeks of assessment



  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 Once Weekly -> Exenatide Once Weekly Subcutaneous injection of 2 mg exenatide, once a week.
Exenatide Twice Daily -> Exenatide Once Weekly Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
Total Total of all reporting groups

Baseline Measures
    Exenatide Once Weekly -> Exenatide Once Weekly     Exenatide Twice Daily -> Exenatide Once Weekly     Total  
Number of Participants  
[units: participants]
 		  148     147     295  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     122     123     245  
>=65 years     26     24     50  
Age  
[units: years]
Mean (Standard Deviation) 		  55.2  (9.72)     54.9  (9.63)     55.0  (9.66)  
Gender  
[units: participants]
 		     
Female     66     72     138  
Male     82     75     157  
Glycosylated hemoglobin (HbA1c)  
[units: percentage of total hemoglobin]
Mean (Standard Deviation) 		  8.3  (0.99)     8.3  (1.00)     8.3  (0.99)  
Weight  
[units: kg]
Mean (Standard Deviation) 		  101.7  (18.76)     101.9  (21.05)     101.8  (19.90)  
Background Oral Antidiabetic Agent  
[units: participants]
 		     
Diet and Exercise     21     22     43  
Metformin (MET)     56     50     106  
Sulfonylurea (SU)     6     10     16  
Thiazolidinediones (TZD)     2     7     9  
MET+SU     43     39     82  
MET+TZD     14     14     28  
SU+TZD     5     5     10  
SU+MET+TZD     1     0     1  



  Outcome Measures
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1.  Primary:   Change in HbA1c From Baseline to Week 30   [ Time Frame: Day -3, Week 30 ]
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2.  Secondary:   Change in HbA1c From Baseline to Week 364   [ Time Frame: Day -3, Week 364 ]
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3.  Secondary:   Percentage of Subjects Achieving HbA1c Target of <7%   [ Time Frame: Week 30 ]
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4.  Secondary:   Percentage of Subjects Achieving HbA1c Target of <7%   [ Time Frame: Week 364 ]
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5.  Secondary:   Percentage of Subjects Achieving HbA1c Target of <=6.5%   [ Time Frame: Week 30 ]
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6.  Secondary:   Percentage of Subjects Achieving HbA1c Target of <=6.5%   [ Time Frame: Week 364 ]
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7.  Secondary:   Percentage of Subjects Achieving HbA1c Target of <=6.0%   [ Time Frame: Week 30 ]
  Show Outcome Measure 7

8.  Secondary:   Exenatide LAR Steady State Concentration From Week 29 to Week 30   [ Time Frame: Week 29 to Week 30 ]
  Show Outcome Measure 8

9.  Secondary:   Change in 2 Hours (2h) Postprandial Glucose From Baseline to Week 14   [ Time Frame: Day -3, Week 14 ]
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10.  Secondary:   Change in Body Weight From Baseline to Week 30   [ Time Frame: Day -3, Week 30 ]
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11.  Secondary:   Change in Body Weight From Baseline to Week 364   [ Time Frame: Day -3, Week 364 ]
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12.  Secondary:   Change in Fasting Plasma Glucose From Baseline to Week 30   [ Time Frame: Day -3, Week 30 ]
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13.  Secondary:   Change in Fasting Plasma Glucose From Baseline to Week 364   [ Time Frame: Day -3, Week 364 ]
  Hide Outcome Measure 13

Measure Type Secondary
Measure Title Change in Fasting Plasma Glucose From Baseline to Week 364
Measure Description Change in fasting plasma glucose from baseline (Day -3) to Week 364.
Time Frame Day -3, Week 364  
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.
7-Year Completer Population. Missing data up to Week 364 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.

Reporting Groups
  Description
Exenatide Once Weekly -> Exenatide Once Weekly Subcutaneous injection of 2 mg exenatide, once a week.
Exenatide Twice Daily -> Exenatide Once Weekly Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
All Treatment No text entered.

Measured Values
    Exenatide Once Weekly -> Exenatide Once Weekly     Exenatide Twice Daily -> Exenatide Once Weekly     All Treatment  
Number of Participants Analyzed  
[units: participants]
 		  58     64     122  
Change in Fasting Plasma Glucose From Baseline to Week 364  
[units: mg/dL]
Least Squares Mean (95% Confidence Interval) 		  -18.3  
  (-30.8 to -5.7)   		  -27.7  
  (-39.0 to -16.4)   		  -23.6  
  (-33.0 to -14.2)  

No statistical analysis provided for Change in Fasting Plasma Glucose From Baseline to Week 364



14.  Secondary:   Change in Blood Pressure From Baseline to Week 30   [ Time Frame: Day -3, Week 30 ]
  Show Outcome Measure 14

15.  Secondary:   Change in Blood Pressure From Baseline to Week 364   [ Time Frame: Day -3, Week 364 ]
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16.  Secondary:   Change in Total Cholesterol From Baseline to Week 30   [ Time Frame: Day -3, Week 30 ]
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17.  Secondary:   Change in Total Cholesterol From Baseline to Week 364   [ Time Frame: Day -3, Week 364 ]
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18.  Secondary:   Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 30   [ Time Frame: Day -3, Week 30 ]
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19.  Secondary:   Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 364   [ Time Frame: Day -3, Week 364 ]
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20.  Secondary:   Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 364   [ Time Frame: Day -3, Week 364 ]
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21.  Secondary:   Ratio of Triglycerides at Week 30 to Baseline   [ Time Frame: Day -3, Week 30 ]
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22.  Secondary:   Ratio of Triglycerides at Week 364 to Baseline   [ Time Frame: Day -3, Week 364 ]
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23.  Secondary:   Assessment on Event Rate of Treatment-emergent Hypoglycemic Events With SU Use at Screening   [ Time Frame: Day 1 to Week 364 ]
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24.  Secondary:   Assessment on Event Rate of Treatment-emergent Hypoglycemic Events With Non-SU Use at Screening   [ Time Frame: Day 1 to Week 364 ]
  Show Outcome Measure 24

25.  Primary:   Sub-study Relative Bioavailability of Exenatide When Administered Using the Exenatide Once Weekly Dual Chambered Pen and the Exenatide Once Weekly Single Dose Tray (Single Dose Tray-11 Weekly Doses Switch to Dual Chamber Pen-11 Weekly Dose)   [ Time Frame: Week 22 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

26.  Secondary:   Sub-study Safety and Tolerability of Exenatide When Administered Using the Once Weekly Single Dose Tray and the Once Weekly Dual (Single Dose Tray-11 Weekly Doses Switch to Dual Chamber Pen-11 Weekly Dose)   [ Time Frame: Week 22 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events
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  Other Adverse Events
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  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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