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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00308139
First received: March 27, 2006
Last updated: May 21, 2014
Last verified: May 2014
Results First Received: February 14, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Bio-availability Study;   Intervention Model: Crossover 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 Subcutaneous injection of 2 mg exenatide, once a week
Exenatide Twice Daily 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)

Participant Flow:   Overall Study
    Exenatide Once Weekly     Exenatide Twice Daily  
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  
COMPLETED     128     130  
NOT COMPLETED     24     21  
Adverse Event                 9                 8  
Lost to Follow-up                 6                 4  
Protocol Violation                 2                 2  
Withdrawal of Consent                 6                 4  
Investigator Decision                 1                 3  
[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.



  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.
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Reporting Groups
  Description
Exenatide Once Weekly Subcutaneous injection of 2 mg exenatide, once a week
Exenatide Twice Daily 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)
Total Total of all reporting groups

Baseline Measures
    Exenatide Once Weekly     Exenatide Twice Daily     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     23     44  
Metformin (MET)     56     50     106  
Sulfonylurea (SU)     6     10     16  
Thiazolidinediones (TZD)     2     7     9  
MET+SU     43     39     82  
MET+TZD     14     13     27  
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:   Percentage of Subjects Achieving HbA1c Target of <7%   [ Time Frame: Week 30 ]

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

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

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

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

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

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

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

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

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

12.  Secondary:   Assessment on Event Rate of Treatment-emergent Major Hypoglycemic Events   [ Time Frame: Day 1 to Week 30 ]

13.  Secondary:   Assessment on Event Rate of Treatment-emergent Minor Hypoglycemic Events   [ Time Frame: Day 1 to Week 30 ]

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

15.  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 posted.   Anticipated Posting Date:   02/2015   Safety Issue:   No

16.  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 posted.   Anticipated Posting Date:   02/2015   Safety Issue:   Yes


  Serious Adverse Events
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Additional Description No text entered.

Reporting Groups
  Description
Exenatide Once Weekly Subcutaneous injection of 2 mg exenatide, once a week
Exenatide Twice Daily 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)

Serious Adverse Events
    Exenatide Once Weekly     Exenatide Twice Daily  
Total, serious adverse events      
# participants affected / at risk     8/148 (5.41%)     5/145 (3.45%)  
Cardiac disorders      
Myocardial infarction * 1    
# participants affected / at risk     1/148 (0.68%)     0/145 (0.00%)  
Arteriosclerosis coronary artery * 1    
# participants affected / at risk     0/148 (0.00%)     1/145 (0.69%)  
Cardiac arrest * 1    
# participants affected / at risk     0/148 (0.00%)     1/145 (0.69%)  
Gastrointestinal disorders      
Tooth impacted * 1    
# participants affected / at risk     1/148 (0.68%)     0/145 (0.00%)  
Hepatobiliary disorders      
Cholecystitis acute * 1    
# participants affected / at risk     1/148 (0.68%)     0/145 (0.00%)  
Infections and infestations      
Bacteraemia * 1    
# participants affected / at risk     1/148 (0.68%)     0/145 (0.00%)  
Diverticulitis * 1    
# participants affected / at risk     1/148 (0.68%)     0/145 (0.00%)  
Injury, poisoning and procedural complications      
Dislocation of joint prosthesis * 1    
# participants affected / at risk     0/148 (0.00%)     1/145 (0.69%)  
Multiple fractures * 1    
# participants affected / at risk     0/148 (0.00%)     1/145 (0.69%)  
Subdural haemorrhage * 1    
# participants affected / at risk     0/148 (0.00%)     1/145 (0.69%)  
Musculoskeletal and connective tissue disorders      
Intervertebral disc protrusion * 1    
# participants affected / at risk     0/148 (0.00%)     1/145 (0.69%)  
Osteoarthritis * 1    
# participants affected / at risk     0/148 (0.00%)     1/145 (0.69%)  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)      
Bladder cancer * 1    
# participants affected / at risk     1/148 (0.68%)     0/145 (0.00%)  
Prostate cancer * 1    
# participants affected / at risk     1/148 (0.68%)     0/145 (0.00%)  
Nervous system disorders      
Cerebral artery occlusion * 1    
# participants affected / at risk     1/148 (0.68%)     0/145 (0.00%)  
Convulsion * 1    
# participants affected / at risk     0/148 (0.00%)     1/145 (0.69%)  
Renal and urinary disorders      
Nephrolithiasis * 1    
# participants affected / at risk     0/148 (0.00%)     1/145 (0.69%)  
Renal failure acute * 1    
# participants affected / at risk     0/148 (0.00%)     1/145 (0.69%)  
Respiratory, thoracic and mediastinal disorders      
Dyspnoea * 1    
# participants affected / at risk     1/148 (0.68%)     0/145 (0.00%)  
* Events were collected by non-systematic assessment
1 Term from vocabulary, MedDRA 10.1




  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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