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
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
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.

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 ]

2.  Secondary:   Change in HbA1c From Baseline to Week 364   [ Time Frame: Day -3, Week 364 ]

3.  Secondary:   Percentage of Subjects Achieving HbA1c Target of <7%   [ Time Frame: Week 30 ]

4.  Secondary:   Percentage of Subjects Achieving HbA1c Target of <7%   [ Time Frame: Week 364 ]

5.  Secondary:   Percentage of Subjects Achieving HbA1c Target of <=6.5%   [ Time Frame: Week 30 ]

6.  Secondary:   Percentage of Subjects Achieving HbA1c Target of <=6.5%   [ Time Frame: Week 364 ]

7.  Secondary:   Percentage of Subjects Achieving HbA1c Target of <=6.0%   [ Time Frame: Week 30 ]

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

9.  Secondary:   Change in 2 Hours (2h) Postprandial Glucose From Baseline to Week 14   [ Time Frame: Day -3, Week 14 ]

10.  Secondary:   Change in Body Weight From Baseline to Week 30   [ Time Frame: Day -3, Week 30 ]

11.  Secondary:   Change in Body Weight From Baseline to Week 364   [ Time Frame: Day -3, Week 364 ]

12.  Secondary:   Change in Fasting Plasma Glucose From Baseline to Week 30   [ Time Frame: Day -3, Week 30 ]

13.  Secondary:   Change in Fasting Plasma Glucose From Baseline to Week 364   [ Time Frame: Day -3, Week 364 ]

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

15.  Secondary:   Change in Blood Pressure From Baseline to Week 364   [ Time Frame: Day -3, Week 364 ]

16.  Secondary:   Change in Total Cholesterol From Baseline to Week 30   [ Time Frame: Day -3, Week 30 ]

17.  Secondary:   Change in Total Cholesterol From Baseline to Week 364   [ Time Frame: Day -3, Week 364 ]

18.  Secondary:   Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 30   [ Time Frame: Day -3, Week 30 ]

19.  Secondary:   Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 364   [ Time Frame: Day -3, Week 364 ]

20.  Secondary:   Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 364   [ Time Frame: Day -3, Week 364 ]

21.  Secondary:   Ratio of Triglycerides at Week 30 to Baseline   [ Time Frame: Day -3, Week 30 ]

22.  Secondary:   Ratio of Triglycerides at Week 364 to Baseline   [ Time Frame: Day -3, Week 364 ]

23.  Secondary:   Assessment on Event Rate of Treatment-emergent Hypoglycemic Events With SU Use at Screening   [ Time Frame: Day 1 to Week 364 ]

24.  Secondary:   Assessment on Event Rate of Treatment-emergent Hypoglycemic Events With Non-SU Use at Screening   [ Time Frame: Day 1 to Week 364 ]

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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  Limitations and Caveats


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