Full Text View
Tabular View
Study Results
Related Studies
An Evaluation of Exenatide and Rosiglitazone in Subjects With Type 2 Diabetes Mellitus
This study has been completed.
Study NCT00135330   Information provided by Amylin Pharmaceuticals, Inc.
First Received: August 24, 2005   Last Updated: July 21, 2009   History of Changes
Study Type: Interventional
Study Design: Randomized, Open Label, Active Control, Parallel Assignment
Condition: Diabetes Mellitus, Type 2
Interventions: Drug: exenatide
Drug: rosiglitazone

  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
Enrollment occurred between 18 October 2005 and 14 March 2008.

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 Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
Exenatide Plus Rosiglitazone Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
Rosiglitazone Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Participant Flow:   Overall Study
  Exenatide Exenatide Plus Rosiglitazone Rosiglitazone
STARTED   45     47     45  
COMPLETED   33     34     34  
NOT COMPLETED   12     13     11  
      Adverse Event               2                 5                 1  
      Lost to Follow-up               0                 2                 3  
      Physician Decision               1                 1                 0  
      Protocol Violation               4                 3                 3  
      Patient Decision               5                 1                 4  
      Sponsor Decision               0                 1                 0  



  Baseline Characteristics
  Hide Baseline Characteristics

Reporting Groups
  Description
Exenatide Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
Exenatide Plus Rosiglitazone Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
Rosiglitazone Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Baseline Measures
  Exenatide Exenatide Plus Rosiglitazone Rosiglitazone Total
Number of Participants  
[units: participants]
 		45 47 45 137
Age  
[units: participants]
 		       
<=18 years 0 0 0 0
Between 18 and 65 years 36 37 36 109
>=65 years 9 10 9 28
Age  
[units: years]
Mean ± Standard Deviation 		56.99 ± 9.71 54.63 ± 9.91 55.54 ± 10.71 55.70 ± 10.09
Gender  
[units: participants]
 		       
Female 22 25 20 67
Male 23 22 25 70



  Outcome Measures
  Hide All Outcome Measures

1.  Primary:   Change in ASIiAUC During a Hyperglycemic Clamp Test.   [ 20 weeks ]

Measure Type Primary
Measure Title Change in ASIiAUC During a Hyperglycemic Clamp Test.
Measure Description Change in insulin incremental area under the concentration-time curve (ASIiAUC) from baseline to week 20. ASIiAUC is a measure of beta-cell function.
Time Frame 20 weeks  
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.
All patients in full analysis set who participated in clamp test and have both baseline and endpoint measurement.

Reporting Groups
  Description
Exenatide Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
Exenatide Plus Rosiglitazone Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
Rosiglitazone Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Measured Values
  Exenatide Exenatide Plus Rosiglitazone Rosiglitazone
Number of Participants Analyzed
[units: participants] 		17 18 15
Change in ASIiAUC During a Hyperglycemic Clamp Test.
[units: uIU-min/ml]
Least Squares Mean ± Standard Error 		     
Baseline ASIiAUC 643.40 ± 106.71 686.41 ± 103.70 786.12 ± 113.60
Change in ASIiAUC at week 20 747.26 ± 187.40 194.68 ± 181.59 -99.85 ± 200.04


Statistical Analysis 1 for Change in ASIiAUC During a Hyperglycemic Clamp Test.
Groups [1] Exenatide Plus Rosiglitazone vs. Rosiglitazone
Method [2] ANCOVA
P Value [3] 0.282
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



2.  Secondary:   Change in AUC for Glucose During a Meal Challenge Test (MCT).   [ Week 20 ]

Measure Type Secondary
Measure Title Change in AUC for Glucose During a Meal Challenge Test (MCT).
Measure Description Change in AUC(15-180 min) for glucose during a MCT baseline to week 20.
Time Frame Week 20  
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.
All patients in full analysis set who have both baseline and endpoint measurement.

Reporting Groups
  Description
Exenatide Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
Exenatide Plus Rosiglitazone Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
Rosiglitazone Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Measured Values
  Exenatide Exenatide Plus Rosiglitazone Rosiglitazone
Number of Participants Analyzed
[units: participants] 		34 35 34
Change in AUC for Glucose During a Meal Challenge Test (MCT).
[units: mmol-min/L]
Least Squares Mean ± Standard Error 		     
Baseline glucose AUC during MCT 1782.86 ± 60.47 1799.68 ± 59.60 1741.87 ± 60.47
Change in glucose AUC during MCT at week 20 -560.12 ± 50.95 -635.24 ± 50.25 -425.59 ± 51.02


Statistical Analysis 1 for Change in AUC for Glucose During a Meal Challenge Test (MCT).
Groups [1] Exenatide Plus Rosiglitazone vs. Rosiglitazone
Method [2] ANCOVA
P Value [3] 0.004
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



3.  Secondary:   Change in Insulin Sensitivity Index as Measured by M-value.   [ Week 20 ]

Measure Type Secondary
Measure Title Change in Insulin Sensitivity Index as Measured by M-value.
Measure Description Change of M-Value (mg/kg-min) during hyperinsulinemic euglycemic clamp test from baseline to week 20.
Time Frame Week 20  
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.
All patients in full analysis set who participated in clamp test and have both baseline and endpoint measurements.

Reporting Groups
  Description
Exenatide Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
Exenatide Plus Rosiglitazone Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
Rosiglitazone Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Measured Values
  Exenatide Exenatide Plus Rosiglitazone Rosiglitazone
Number of Participants Analyzed
[units: participants] 		16 16 15
Change in Insulin Sensitivity Index as Measured by M-value.
[units: mg/kg-min]
Least Squares Mean ± Standard Error 		     
M-Value at baseline 3.89 ± 0.495 2.49 ± 0.495 4.02 ± 0.511
Change in M-Value from baseline at week 20 0.477 ± 0.425 2.07 ± 0.440 1.42 ± 0.442


Statistical Analysis 1 for Change in Insulin Sensitivity Index as Measured by M-value.
Groups [1] Exenatide Plus Rosiglitazone vs. Rosiglitazone
Method [2] ANCOVA
P Value [3] 0.308
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



4.  Secondary:   Change in Insulin AUC in the First Stage From Baseline to Endpoint.   [ Week 20 ]

Measure Type Secondary
Measure Title Change in Insulin AUC in the First Stage From Baseline to Endpoint.
Measure Description Change in insulin AUC in the first stage(uIU-min/ml) from baseline to week 20. "First stage" represents the first 10 minutes after reaching a steady state during a hyperglycemic clamp test.
Time Frame Week 20  
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.
All patients in full analysis set who participated in clamp tests and have both baseline and endpoint

Reporting Groups
  Description
Exenatide Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
Exenatide Plus Rosiglitazone Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
Rosiglitazone Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Measured Values
  Exenatide Exenatide Plus Rosiglitazone Rosiglitazone
Number of Participants Analyzed
[units: participants] 		17 17 15
Change in Insulin AUC in the First Stage From Baseline to Endpoint.
[units: uIU-min/ml]
Least Squares Mean ± Standard Error 		     
Baseline insulin AUC 200.50 ± 50.40 136.84 ± 50.40 157.49 ± 53.66
Change from baseline insulin AUC at week 20 134.88 ± 31.71 32.12 ± 31.65 -50.81 ± 33.59


Statistical Analysis 1 for Change in Insulin AUC in the First Stage From Baseline to Endpoint.
Groups [1] Exenatide Plus Rosiglitazone vs. Rosiglitazone
Method [2] ANCOVA
P Value [3] 0.079
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



5.  Secondary:   Change in Insulin iAUC From Baseline to Endpoint.   [ Week 20 ]

Measure Type Secondary
Measure Title Change in Insulin iAUC From Baseline to Endpoint.
Measure Description Change in insulin iAUC in the first stage(uIU-min/ml) from baseline to week 20. "First stage" represents the first 10 minutes after reaching a steady state during a hyperglycemic clamp test.
Time Frame Week 20  
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.
All patients in full analysis set who participated in clamp tests and have both baseline and endpoint.

Reporting Groups
  Description
Exenatide Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
Exenatide Plus Rosiglitazone Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
Rosiglitazone Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Measured Values
  Exenatide Exenatide Plus Rosiglitazone Rosiglitazone
Number of Participants Analyzed
[units: participants] 		17 17 15
Change in Insulin iAUC From Baseline to Endpoint.
[units: uIU-min/ml]
Least Squares Mean ± Standard Error 		     
Baseline insulin iAUC 5.98 ± 14.29 -9.92 ± 14.29 23.09 ± 15.21
Change from baseline insulin iAUC at week 20 99.08 ± 24.23 53.71 ± 24.54 11.51 ± 26.15


Statistical Analysis 1 for Change in Insulin iAUC From Baseline to Endpoint.
Groups [1] Exenatide Plus Rosiglitazone vs. Rosiglitazone
Method [2] ANCOVA
P Value [3] 0.252
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



6.  Secondary:   Ratio (Value at Endpoint Divided by Value at Baseline) of AUC for Insulin During a Meal Challenge Test (MCT).   [ Week 20 ]

Measure Type Secondary
Measure Title Ratio (Value at Endpoint Divided by Value at Baseline) of AUC for Insulin During a Meal Challenge Test (MCT).
Measure Description Ratio (value at endpoint divided by value at baseline) of AUC (15-180 min) for insulin (uIU-min/ml) during MCT.
Time Frame Week 20  
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.
All patients in full analysis set who have both baseline and endpoint measurement.

Reporting Groups
  Description
Exenatide Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
Exenatide Plus Rosiglitazone Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
Rosiglitazone Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Measured Values
  Exenatide Exenatide Plus Rosiglitazone Rosiglitazone
Number of Participants Analyzed
[units: participants] 		34 35 33
Ratio (Value at Endpoint Divided by Value at Baseline) of AUC for Insulin During a Meal Challenge Test (MCT).
[units: uIU-min/ml]
Geometric Mean ± Standard Error 		     
Baseline AUC for insulin during MCT 5171.40 ± 522.82 4324.13 ± 430.87 5816.83 ± 596.91
Ratio(endpoint/baseline) of insulin AUC during MCT 0.806 ± 0.063 0.664 ± 0.052 0.722 ± 0.058


Statistical Analysis 1 for Ratio (Value at Endpoint Divided by Value at Baseline) of AUC for Insulin During a Meal Challenge Test (MCT).
Groups [1] Exenatide Plus Rosiglitazone vs. Rosiglitazone
Method [2] ANCOVA
P Value [3] 0.465
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



7.  Secondary:   Change in AUC for C-peptide During a Meal Challenge Test (MCT).   [ Week 20 ]

Measure Type Secondary
Measure Title Change in AUC for C-peptide During a Meal Challenge Test (MCT).
Measure Description Ratio (value at endpoint divided by value at baseline) of AUC(15-180 min) for C-peptide (nmol-min/L) during a MCT from baseline to week 20.
Time Frame Week 20  
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.
All patients in full analysis set who have both baseline and endpoint measurement.

Reporting Groups
  Description
Exenatide Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
Exenatide Plus Rosiglitazone Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
Rosiglitazone Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Measured Values
  Exenatide Exenatide Plus Rosiglitazone Rosiglitazone
Number of Participants Analyzed
[units: participants] 		34 34 32
Change in AUC for C-peptide During a Meal Challenge Test (MCT).
[units: nmol-min/L]
Geometric Mean ± Standard Error 		     
Baseline C-peptide during a MCT 319.77 ± 18.13 310.51 ± 17.61 325.65 ± 19.04
Ratio(endpoint/baseline) of C-peptide during a MCT 0.908 ± 0.040 0.804 ± 0.036 0.854 ± 0.039


Statistical Analysis 1 for Change in AUC for C-peptide During a Meal Challenge Test (MCT).
Groups [1] Exenatide Plus Rosiglitazone vs. Rosiglitazone
Method [2] ANCOVA
P Value [3] 0.348
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



8.  Secondary:   Change in Incremental for Postprandial Glucose During a Meal Challenge Test (MCT).   [ Week 20 ]

Measure Type Secondary
Measure Title Change in Incremental for Postprandial Glucose During a Meal Challenge Test (MCT).
Measure Description Change in incremental for postprandial glucose (mmol/L) during a MCT from baseline to week 20.
Time Frame Week 20  
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.
All patients in full analysis set who have both baseline and endpoint measurement.

Reporting Groups
  Description
Exenatide Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
Exenatide Plus Rosiglitazone Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
Rosiglitazone Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Measured Values
  Exenatide Exenatide Plus Rosiglitazone Rosiglitazone
Number of Participants Analyzed
[units: participants] 		34 34 33
Change in Incremental for Postprandial Glucose During a Meal Challenge Test (MCT).
[units: mmol/L]
Least Squares Mean ± Standard Error 		     
Baseline glucose at 15 min 0.950 ± 0.138 1.12 ± 0.138 0.828 ± 0.142
Change fr baseline glucose at 15 min at wk 20 -0.651 ± 0.151 -0.286 ± 0.152 0.150 ± 0.157
Baseline glucose at 30 min 2.39 ± 0.218 2.54 ± 0.221 2.23 ± 0.221
Change fr baseline glucose at 30 min at wk 20 -1.46 ± 0.248 -1.06 ± 0.252 -0.066 ± 0.252
Baseline glucose at 60 minutes 3.59 ± 0.273 3.88 ± 0.273 3.48 ± 0.273
Change fr baseline glucose at 60 min at wk 20 -2.56 ± 0.329 -2.46 ± 0.330 -0.720 ± 0.329
Baseline glucose at 90 minutes 3.24 ± 0.231 3.36 ± 0.228 3.48 ± 0.239
Change fr baseline glucose at 90 min at wk 20 -2.87 ± 0.312 -2.91 ± 0.307 -0.952 ± 0.322
Baseline glucose at 120 minutes 2.49 ± 0.235 2.24 ± 0.238 2.31 ± 0.235
Change fr baseline glucose at 120 min at wk 20 -2.24 ± 0.271 -2.52 ± 0.275 -0.912 ± 0.271
Baseline glucose at 150 minutes 1.62 ± 0.230 1.14 ± 0.230 1.25 ± 0.230
Change fr baseline glucose at 150 min at wk 20 -1.42 ± 0.288 -1.95 ± 0.287 -0.830 ± 0.286
Baseline glucose at 180 minutes 0.461 ± 0.235 0.036 ± 0.235 0.279 ± 0.235
Change fr baseline glucose at 180 min at wk 20 -0.583 ± 0.231 -0.995 ± 0.232 -0.481 ± 0.230

No statistical analysis provided for Change in Incremental for Postprandial Glucose During a Meal Challenge Test (MCT).



9.  Secondary:   Change in Incremental for Postprandial Insulin During Meal Challenge Test (MCT).   [ Week 20 ]

Measure Type Secondary
Measure Title Change in Incremental for Postprandial Insulin During Meal Challenge Test (MCT).
Measure Description Change in incremental for postprandial insulin (mmol/L) during meal challenge test (MCT) from baseline to week 20.
Time Frame Week 20  
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.
All patients in full analysis set who have both baseline and endpoint measurement.

Reporting Groups
  Description
Exenatide Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
Exenatide Plus Rosiglitazone Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
Rosiglitazone Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Measured Values
  Exenatide Exenatide Plus Rosiglitazone Rosiglitazone
Number of Participants Analyzed
[units: participants] 		34 35 32
Change in Incremental for Postprandial Insulin During Meal Challenge Test (MCT).
[units: mmol/L]
Least Squares Mean ± Standard Error 		     
Baseline insulin at 15 min 9.97 ± 1.71 8.09 ± 1.71 7.53 ± 1.79
Change fr baseline insulin at 15 min at wk 20 -1.71 ± 1.45 -1.84 ± 1.45 -0.455 ± 1.52
Baseline insulin at 30 min 19.81 ± 2.28 14.79 ± 2.25 18.83 ± 2.35
Change fr baseline insulin at 30 min at wk 20 -3.00 ± 1.90 -2.63 ± 1.89 -1.04 ± 1.96
Baseline insulin at 60 min 27.92 ± 4.68 27.67 ± 4.61 32.09 ± 4.75
Change fr baseline insulin at 60 min at wk 20 -11.04 ± 2.63 -7.47 ± 2.59 -7.42 ± 2.67
Baseline insulin at 90 min 26.06 ± 4.10 21.85 ± 4.10 32.25 ± 4.36
Change fr baseline insulin at 90 min at wk 20 -9.42 ± 2.72 -9.27 ± 2.74 -6.19 ± 2.92
Baseline insulin at 120 min 19.56 ± 2.99 17.52 ± 2.99 25.47 ± 3.04
Change fr baseline insulin at 120 min at wk 20 -11.26 ± 1.99 -8.69 ± 2.00 -6.43 ± 2.04
Baseline insulin at 150 min 15.67 ± 2.47 12.74 ± 2.43 18.11 ± 2.51
Change fr baseline insulin at 150 min at wk 20 -7.48 ± 1.74 -8.13 ± 1.73 -5.57 ± 1.78
Baseline insulin at 180 min 10.58 ± 1.73 8.18 ± 1.73 10.74 ± 1.79
Change fr baseline insulin at 180 min at wk 20 0.031 ± 1.30 -5.26 ± 1.30 -4.04 ± 1.34

No statistical analysis provided for Change in Incremental for Postprandial Insulin During Meal Challenge Test (MCT).



10.  Secondary:   Change in Incremental for Postprandial C-peptide During Meal Challenge Test (MCT).   [ Week 20 ]

Measure Type Secondary
Measure Title Change in Incremental for Postprandial C-peptide During Meal Challenge Test (MCT).
Measure Description Change in incremental for postprandial C-peptide (mmol/L) during MCT from baseline to week 20.
Time Frame Week 20  
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.
All patients in full analysis set who have baseline and endpoint measurement.

Reporting Groups
  Description
Exenatide Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
Exenatide Plus Rosiglitazone Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
Rosiglitazone Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Measured Values
  Exenatide Exenatide Plus Rosiglitazone Rosiglitazone
Number of Participants Analyzed
[units: participants] 		34 34 32
Change in Incremental for Postprandial C-peptide During Meal Challenge Test (MCT).
[units: mmol/L]
Least Squares Mean ± Standard Error 		     
Baseline C-peptide at 15 min 0.238 ± 0.049 0.259 ± 0.049 0.206 ± 0.051
Change fr baseline C-peptide at 15 min at week 20 -0.006 ± 0.045 0.016 ± 0.046 0.087 ± 0.047
Baseline C-peptide at 30 min 0.521 ± 0.059 0.517 ± 0.059 0.560 ± 0.061
Change fr baseline C-peptide at 30 min at week 20 -0.071 ± 0.056 -0.036 ± 0.056 0.099 ± 0.058
Baseline C-peptide at 60 min 0.818 ± 0.110 0.871 ± 0.110 0.881 ± 0.114
Change fr baseline C-peptide at 60 min at week 20 -0.148 ± 0.090 -0.025 ± 0.090 0.054 ± 0.093
Baseline C-peptide at 90 min 0.895 ± 0.100 0.953 ± 0.101 1.03 ± 0.106
Change fr baseline C-peptide at 90 min at week 20 -0.185 ± 0.099 -0.117 ± 0.101 -0.052 ± 0.106
Baseline C-peptide at 120 min 0.817 ± 0.112 0.828 ± 0.114 0.972 ± 0.114
Change fr baseline C-peptide at 120 min at week 20 -0.259 ± 0.100 -0.134 ± 0.102 -0.016 ± 0.102
Baseline C-peptide at 150 min 0.843 ± 0.091 0.651 ± 0.091 0.813 ± 0.092
Change fr baseline C-peptide at 150 min at week 20 -0.251 ± 0.095 -0.254 ± 0.095 -0.093 ± 0.096
Baseline C-peptide at 180 min 0.610 ± 0.084 0.482 ± 0.085 0.619 ± 0.087
Change fr baseline C-peptide at 180 min at week 20 -0.075 ± 0.062 -0.238 ± 0.063 -0.092 ± 0.064

No statistical analysis provided for Change in Incremental for Postprandial C-peptide During Meal Challenge Test (MCT).



11.  Secondary:   Change in HbA1c   [ Week 20 ]

Measure Type Secondary
Measure Title Change in HbA1c
Measure Description Change in HbA1c from baseline to week 20.
Time Frame Week 20  
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.
All patients who have both baseline and at least one post baseline value in full analysis set.

Reporting Groups
  Description
Exenatide Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
Exenatide Plus Rosiglitazone Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
Rosiglitazone Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Measured Values
  Exenatide Exenatide Plus Rosiglitazone Rosiglitazone
Number of Participants Analyzed
[units: participants] 		35 36 34
Change in HbA1c
[units: Percentage]
Least Squares Mean ± Standard Error 		     
Baseline HbA1c 7.79 ± 0.116 7.84 ± 0.115 7.92 ± 0.116
Change from baseline HbA1c at week 20 -0.908 ± 0.118 -1.31 ± 0.116 -0.968 ± 0.118


Statistical Analysis 1 for Change in HbA1c
Groups [1] Exenatide Plus Rosiglitazone vs. Rosiglitazone
Method [2] Mixed Model Repeated Measures (MMRM)
P Value [3] 0.039
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



12.  Secondary:   Change in Fasting Serum Glucose Concentration.   [ Week 20 ]

Measure Type Secondary
Measure Title Change in Fasting Serum Glucose Concentration.
Measure Description Change in fasting serum glucose concentration from baseline to week 20.
Time Frame Week 20  
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.
All patients who have both baseline and at least one post baseline value in full analysis set.

Reporting Groups
  Description
Exenatide Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
Exenatide Plus Rosiglitazone Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
Rosiglitazone Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Measured Values
  Exenatide Exenatide Plus Rosiglitazone Rosiglitazone
Number of Participants Analyzed
[units: participants] 		34 35 34
Change in Fasting Serum Glucose Concentration.
[units: mmol/L]
Least Squares Mean ± Standard Error 		     
Baseline fasting serum glucose 8.42 ± 0.278 8.43 ± 0.271 8.48 ± 0.274
Change fr baseline fasting serum glucose at wk 20 -1.46 ± 0.250 -1.60 ± 0.244 -1.80 ± 0.250


Statistical Analysis 1 for Change in Fasting Serum Glucose Concentration.
Groups [1] Exenatide Plus Rosiglitazone vs. Rosiglitazone
Method [2] MMRM
P Value [3] 0.555
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



13.  Secondary:   Change in Fasting C-peptide   [ Week 20 ]

Measure Type Secondary
Measure Title Change in Fasting C-peptide
Measure Description Change in fasting C-peptide from baseline to week 20.
Time Frame Week 20  
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.
Fasting C-peptide was initially identified as an outcome measure, but data for this measure were not subsequently collected at baseline or endpoint.

Reporting Groups
  Description
Exenatide Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
Exenatide Plus Rosiglitazone Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
Rosiglitazone Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Measured Values
  Exenatide Exenatide Plus Rosiglitazone Rosiglitazone
Number of Participants Analyzed
[units: participants] 		0 0 0
Change in Fasting C-peptide
[units: nmol/L]
Geometric Mean ± Standard Error 		     
Baseline fasting C-peptide
Change in fasting C-peptide fr baseline to week 20

No statistical analysis provided for Change in Fasting C-peptide



14.  Secondary:   Change in Fasting Insulin   [ Week 20 ]

Measure Type Secondary
Measure Title Change in Fasting Insulin
Measure Description Change in fasting insulin from baseline to week 20.
Time Frame Week 20  
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.
All patients who have both baseline and at least one post baseline value in full analysis set.

Reporting Groups
  Description
Exenatide Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
Exenatide Plus Rosiglitazone Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
Rosiglitazone Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Measured Values
  Exenatide Exenatide Plus Rosiglitazone Rosiglitazone
Number of Participants Analyzed
[units: participants] 		35 35 31
Change in Fasting Insulin
[units: uIU/ml]
Geometric Mean ± Standard Error 		     
Baseline fasting insulin 12.84 ± 1.55 10.96 ± 1.33 12.77 ± 1.54
Ratio (wk20/baseline)of fasting insulin(unitless) 0.980 ± 0.096 0.599 ± 0.059 0.755 ± 0.078


Statistical Analysis 1 for Change in Fasting Insulin
Groups [1] Exenatide Plus Rosiglitazone vs. Rosiglitazone
Method [2] MMRM
P Value [3] 0.106
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



15.  Secondary:   Change in Fasting Proinsulin   [ Week 20 ]

Measure Type Secondary
Measure Title Change in Fasting Proinsulin
Measure Description Ratio (endpoint value divided by baseline value) for fasting proinsulin, comparing endpoint (week 20) to baseline
Time Frame Week 20  
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.
All patients who have both baseline and at least one post baseline value in full analysis set.

Reporting Groups
  Description
Exenatide Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
Exenatide Plus Rosiglitazone Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
Rosiglitazone Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Measured Values
  Exenatide Exenatide Plus Rosiglitazone Rosiglitazone
Number of Participants Analyzed
[units: participants] 		33 34 33
Change in Fasting Proinsulin
[units: pmol/L]
Geometric Mean ± Standard Error 		     
Baseline fasting proinsulin 4.32 ± 0.523 3.80 ± 0.455 3.56 ± 0.423
Ratio(wk20/baseline)of fasting proinsulin(unitless 0.663 ± 0.073 0.538 ± 0.058 0.623 ± 0.068


Statistical Analysis 1 for Change in Fasting Proinsulin
Groups [1] Exenatide Plus Rosiglitazone vs. Rosiglitazone
Method [2] MMRM
P Value [3] 0.341
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



16.  Secondary:   Change in Body Weight   [ Week 20 ]

Measure Type Secondary
Measure Title Change in Body Weight
Measure Description Change in body weight from baseline to week 20.
Time Frame Week 20  
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.
All patients who aave both baseline and at least one post baseline value in full analysis set.

Reporting Groups
  Description
Exenatide Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
Exenatide Plus Rosiglitazone Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
Rosiglitazone Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Measured Values
  Exenatide Exenatide Plus Rosiglitazone Rosiglitazone
Number of Participants Analyzed
[units: participants] 		44 45 44
Change in Body Weight
[units: kg]
Least Squares Mean ± Standard Error 		     
Baseline body weight 93.05 ± 2.39 93.76 ± 2.36 91.78 ± 2.39
Change in body weight at week 20 -2.82 ± 0.547 -1.21 ± 0.538 1.48 ± 0.547


Statistical Analysis 1 for Change in Body Weight
Groups [1] Exenatide Plus Rosiglitazone vs. Rosiglitazone
Method [2] MMRM
P Value [3] <0.001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



17.  Secondary:   Change in Fasting Total Cholesterol.   [ Week 20 ]

Measure Type Secondary
Measure Title Change in Fasting Total Cholesterol.
Measure Description Change in fasting total cholestrol from baseline to week 20.
Time Frame Week 20  
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.
All patients who have both baseline and at least one post baseline value in full analysis set.

Reporting Groups
  Description
Exenatide Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
Exenatide Plus Rosiglitazone Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
Rosiglitazone Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Measured Values
  Exenatide Exenatide Plus Rosiglitazone Rosiglitazone
Number of Participants Analyzed
[units: participants] 		34 36 34
Change in Fasting Total Cholesterol.
[units: mmol/L]
Least Squares Mean ± Standard Error 		     
Baseline total cholesterol 4.42 ± 0.150 4.41 ± 0.145 4.62 ± 0.149
Change fr baseline total cholesterol at week 20 -0.128 ± 0.118 0.258 ± 0.114 0.438 ± 0.118


Statistical Analysis 1 for Change in Fasting Total Cholesterol.
Groups [1] Exenatide Plus Rosiglitazone vs. Rosiglitazone
Method [2] MMRM
P Value [3] 0.276
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



18.  Secondary:   Change in Fasting HDL Cholesterol   [ Week 20 ]

Measure Type Secondary
Measure Title Change in Fasting HDL Cholesterol
Measure Description Change in fasting high-density lipoprotein (HDL) cholesterol from baseline to week 20.
Time Frame Week 20  
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.
All patients who have both baseline and at least one post baseline value in full analysis set.

Reporting Groups
  Description
Exenatide Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
Exenatide Plus Rosiglitazone Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
Rosiglitazone Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Measured Values
  Exenatide Exenatide Plus Rosiglitazone Rosiglitazone
Number of Participants Analyzed
[units: participants] 		34 36 34
Change in Fasting HDL Cholesterol
[units: mmol/L]
Least Squares Mean ± Standard Error 		     
Baseline HDL 1.13 ± 0.048 1.17 ± 0.047 1.17 ± 0.048
Change from baseline HDL at week 20 0.022 ± 0.030 0.046 ± 0.029 0.055 ± 0.030


Statistical Analysis 1 for Change in Fasting HDL Cholesterol
Groups [1] Exenatide Plus Rosiglitazone vs. Rosiglitazone
Method [2] MMRM
P Value [3] 0.840
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



19.  Secondary:   Change in Fasting LDL Cholesterol   [ Week 20 ]

Measure Type Secondary
Measure Title Change in Fasting LDL Cholesterol
Measure Description Change in fasting low-density lipoprotein (LDL) cholesterol from baseline to week 20.
Time Frame Week 20  
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.
All patients who have both baseline and at least one post baseline value in full analysis set.

Reporting Groups
  Description
Exenatide Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
Exenatide Plus Rosiglitazone Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
Rosiglitazone Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Measured Values
  Exenatide Exenatide Plus Rosiglitazone Rosiglitazone
Number of Participants Analyzed
[units: participants] 		34 35 34
Change in Fasting LDL Cholesterol
[units: mmol/L]
Least Squares Mean ± Standard Error 		     
Baseline LDL 2.59 ± 0.131 2.57 ± 0.128 2.71 ± 0.129
Change from baseline LDL at week 20 -0.049 ± 0.102 0.096 ± 0.100 0.334 ± 0.101


Statistical Analysis 1 for Change in Fasting LDL Cholesterol
Groups [1] Exenatide Plus Rosiglitazone vs. Rosiglitazone
Method [2] MMRM
P Value [3] 0.096
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



20.  Secondary:   Change in Fasting Triglycerides   [ Week 20 ]

Measure Type Secondary
Measure Title Change in Fasting Triglycerides
Measure Description Ratio (endpint value divided by baseline value) of fasting triglycerides from baseline to week 20.
Time Frame Week 20  
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.
All patients who have both baseline and at least one post baseline value in full analysis set

Reporting Groups
  Description
Exenatide Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
Exenatide Plus Rosiglitazone Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
Rosiglitazone Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Measured Values
  Exenatide Exenatide Plus Rosiglitazone Rosiglitazone
Number of Participants Analyzed
[units: participants] 		34 36 34
Change in Fasting Triglycerides
[units: mmol/L]
Geometric Mean ± Standard Error 		     
Baseline triglyceride 1.56 ± 0.124 1.67 ± 0.128 1.76 ± 0.138
Ratio (endpoint/baseline) for triglycerides 0.861 ± 0.060 0.977 ± 0.066 0.992 ± 0.069


Statistical Analysis 1 for Change in Fasting Triglycerides
Groups [1] Exenatide Plus Rosiglitazone vs. Rosiglitazone
Method [2] MMRM
P Value [3] 0.875
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



21.  Secondary:   Change in Percent Body Fat During a Meal Challenge Test (MCT)   [ 20 weeks ]

Measure Type Secondary
Measure Title Change in Percent Body Fat During a Meal Challenge Test (MCT)
Measure Description Change in percent body fat from baseline to week 20, as assessed during an MCT
Time Frame 20 weeks  
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.
All Patients in Full Analysis Set Who Have Both Baseline and Endpoint Measurement

Reporting Groups
  Description
Exenatide Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
Exenatide Plus Rosiglitazone Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
Rosiglitazone Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Measured Values
  Exenatide Exenatide Plus Rosiglitazone Rosiglitazone
Number of Participants Analyzed
[units: participants] 		33 34 32
Change in Percent Body Fat During a Meal Challenge Test (MCT)
[units: percentage]
Least Squares Mean ± Standard Error 		     
Baseline percent body fat 33.42 ± 1.16 34.07 ± 1.15 32.50 ± 1.18
Change in percent body fat at week 20 -1.40 ± 1.06 -0.347 ± 1.04 -1.18 ± 1.08


Statistical Analysis 1 for Change in Percent Body Fat During a Meal Challenge Test (MCT)
Groups [1] Exenatide Plus Rosiglitazone vs. Rosiglitazone
Method [2] ANCOVA
P Value [3] 0.581
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



22.  Secondary:   Change in Body Fat Mass During a Meal Challenge Test (MCT)   [ 20 weeks ]

Measure Type Secondary
Measure Title Change in Body Fat Mass During a Meal Challenge Test (MCT)
Measure Description Change in body fat mass form baseline to week 20, as assessed during an MCT
Time Frame 20 weeks  
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.
All Patients in Full Analysis Set Who Have Both Baseline and Endpoint Measurements

Reporting Groups
  Description
Exenatide Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
Exenatide Plus Rosiglitazone Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
Rosiglitazone Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Measured Values
  Exenatide Exenatide Plus Rosiglitazone Rosiglitazone
Number of Participants Analyzed
[units: participants] 		33 34 32
Change in Body Fat Mass During a Meal Challenge Test (MCT)
[units: kg]
Least Squares Mean ± Standard Error 		     
Baseline body fat mass 32.05 ± 1.64 32.55 ± 1.62 30.54 ± 1.67
Change in body fat mass at week 20 -2.76 ± 1.37 -1.06 ± 1.35 -1.99 ± 1.40


Statistical Analysis 1 for Change in Body Fat Mass During a Meal Challenge Test (MCT)
Groups [1] Exenatide Plus Rosiglitazone vs. Rosiglitazone
Method [2] ANCOVA
P Value [3] 0.631
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



23.  Secondary:   Change in Lean Body Mass During a Meal Challenge Test (MCT)   [ 20 weeks ]

Measure Type Secondary
Measure Title Change in Lean Body Mass During a Meal Challenge Test (MCT)
Measure Description Change in lean body mass from baseline to week 20, as assessed during an MCT
Time Frame 20 weeks  
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.
All Patients in Full Analysis Set Who Have Both Baseline and Endpoint Measurements

Reporting Groups
  Description
Exenatide Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
Exenatide Plus Rosiglitazone Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
Rosiglitazone Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Measured Values
  Exenatide Exenatide Plus Rosiglitazone Rosiglitazone
Number of Participants Analyzed
[units: participants] 		33 34 32
Change in Lean Body Mass During a Meal Challenge Test (MCT)
[units: kg]
Least Squares Mean ± Standard Error 		     
Baseline lean body mass 64.62 ± 2.11 60.94 ± 2.08 61.09 ± 2.14
Change in lean body mass at week 20 -2.99 ± 1.39 0.532 ± 1.37 1.23 ± 1.41


Statistical Analysis 1 for Change in Lean Body Mass During a Meal Challenge Test (MCT)
Groups [1] Exenatide Plus Rosiglitazone vs. Rosiglitazone
Method [2] ANCOVA
P Value [3] 0.724
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



24.  Secondary:   Change in Waist Circumference   [ 20 weeks ]

Measure Type Secondary
Measure Title Change in Waist Circumference
Measure Description Change in waist circumference from baseline to week 20
Time Frame 20 weeks  
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.
All Patients Who Have Both Baseline and At Least One Post Baseline Value in Full Analysis Set

Reporting Groups
  Description
Exenatide Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
Exenatide Plus Rosiglitazone Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
Rosiglitazone Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Measured Values
  Exenatide Exenatide Plus Rosiglitazone Rosiglitazone
Number of Participants Analyzed
[units: participants] 		33 35 33
Change in Waist Circumference
[units: cm]
Least Squares Mean ± Standard Error 		     
Baseline waist circumference 105.98 ± 1.68 106.85 ± 1.67 105.34 ± 1.67
Change in waist circumference at Week 20 -2.95 ± 0.975 -2.38 ± 0.955 -0.225 ± 0.969


Statistical Analysis 1 for Change in Waist Circumference
Groups [1] Exenatide Plus Rosiglitazone vs. Rosiglitazone
Method [2] MMRM
P Value [3] 0.117
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



25.  Secondary:   Change in Hip Circumference   [ 20 weeks ]

Measure Type Secondary
Measure Title Change in Hip Circumference
Measure Description Change in hip circumference form baseline to week 20
Time Frame 20 weeks  
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.
All Patients Who Have Both Baseline and At Least One Post Baseline Value in Full Analysis Set

Reporting Groups
  Description
Exenatide Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
Exenatide Plus Rosiglitazone Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
Rosiglitazone Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Measured Values
  Exenatide Exenatide Plus Rosiglitazone Rosiglitazone
Number of Participants Analyzed
[units: participants] 		33 35 33
Change in Hip Circumference
[units: cm]
Least Squares Mean ± Standard Error 		     
Baseline hip circumference 113.29 ± 1.71 112.12 ± 1.69 111.90 ± 1.69
Change in hip circumference at week 20 -1.28 ± 0.848 0.147 ± 0.827 1.51 ± 0.838


Statistical Analysis 1 for Change in Hip Circumference
Groups [1] Exenatide Plus Rosiglitazone vs. Rosiglitazone
Method [2] MMRM
P Value [3] 0.251
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



26.  Secondary:   Change in Waist-to-hip Ratio   [ 20 weeks ]

Measure Type Secondary
Measure Title Change in Waist-to-hip Ratio
Measure Description Change in waist-to-hip ratio (waist circumference divided by hip circumference) from baseline to week 20
Time Frame 20 weeks  
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.
All Patients Who Have Both Baseline and At Least One Post Baseline Value in Full Analysis Set

Reporting Groups
  Description
Exenatide Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
Exenatide Plus Rosiglitazone Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
Rosiglitazone Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Measured Values
  Exenatide Exenatide Plus Rosiglitazone Rosiglitazone
Number of Participants Analyzed
[units: participants] 		33 35 33
Change in Waist-to-hip Ratio
[units: ratio (cm/cm)]
Least Squares Mean ± Standard Error 		     
Baseline waist-to-hip ratio 0.939 ± 0.012 0.957 ± 0.012 0.943 ± 0.012
Change in waist-to-hip ratio at week 20 -0.016 ± 0.011 -0.022 ± 0.010 -0.016 ± 0.011


Statistical Analysis 1 for Change in Waist-to-hip Ratio
Groups [1] Exenatide Plus Rosiglitazone vs. Rosiglitazone
Method [2] MMRM
P Value [3] 0.710
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



27.  Secondary:   Incidence of Hypoglycemia Events   [ 20 weeks ]

Measure Type Secondary
Measure Title Incidence of Hypoglycemia Events
Measure Description Number of subjects experiencing hypoglycemia at any point during the study
Time Frame 20 weeks  
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.
Full Analysis Set

Reporting Groups
  Description
Exenatide Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
Exenatide Plus Rosiglitazone Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
Rosiglitazone Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Measured Values
  Exenatide Exenatide Plus Rosiglitazone Rosiglitazone
Number of Participants Analyzed
[units: participants] 		45 47 45
Incidence of Hypoglycemia Events
[units: participants]
 		8 9 6


Statistical Analysis 1 for Incidence of Hypoglycemia Events
Groups [1] Exenatide Plus Rosiglitazone vs. Rosiglitazone
Method [2] Fisher Exact
P Value [3] 0.575
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



28.  Secondary:   Hypoglycemia Rate Per 30 Days Per Patient   [ 20 weeks ]

Measure Type Secondary
Measure Title Hypoglycemia Rate Per 30 Days Per Patient
Measure Description Average number of episodes of hypoglycemia per 30 days per patient
Time Frame 20 weeks  
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.
Full Analysis Set

Reporting Groups
  Description
Exenatide Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
Exenatide Plus Rosiglitazone Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
Rosiglitazone Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Measured Values
  Exenatide Exenatide Plus Rosiglitazone Rosiglitazone
Number of Participants Analyzed
[units: participants] 		45 47 45
Hypoglycemia Rate Per 30 Days Per Patient
[units: hypoglycemia events / 30 days / patient]
Mean ± Standard Deviation 		0.391 ± 0.298 0.594 ± 0.436 0.853 ± 1.05


Statistical Analysis 1 for Hypoglycemia Rate Per 30 Days Per Patient
Groups [1] Exenatide Plus Rosiglitazone vs. Rosiglitazone
Method [2] ANOVA
P Value [3] 0.436
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



29.  Secondary:   Pedal Edema Score   [ 20 weeks ]

Measure Type Secondary
Measure Title Pedal Edema Score
Measure Description Pedal edema scores experienced by each patient throughout the study ("1+" indicates a patient experienced a pedal edema score of 1 , 2, or 3; "2+" indicates a patient experienced a pedal edema score of 2 or 3, etc.)
Time Frame 20 weeks  
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.
Full Analysis Set

Reporting Groups
  Description
Exenatide Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
Exenatide Plus Rosiglitazone Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
Rosiglitazone Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Measured Values
  Exenatide Exenatide Plus Rosiglitazone Rosiglitazone
Number of Participants Analyzed
[units: participants] 		44 45 44
Pedal Edema Score
[units: participants]
 		     
No edema 37 34 30
Edema score: 1+ 7 11 14
Edema score: 2+ 1 3 6
Edema score: 3+ 0 0 1


Statistical Analysis 1 for Pedal Edema Score
Groups [1] Exenatide Plus Rosiglitazone vs. Rosiglitazone
Method [2] Genmod
P Value [3] 0.168
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.




  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  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 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.


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.  


Results Point of Contact:  
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 1-800-LILLYRX
e-mail: clinicaltrials@amylin.com


No publications provided


Responsible Party: Eli Lilly and Company ( James Malone, MD, Study Director )
Study ID Numbers: H8O-US-GWAY
Study First Received: August 24, 2005
Results First Received: July 21, 2009
Last Updated: July 21, 2009
ClinicalTrials.gov Identifier: NCT00135330     History of Changes
Health Authority: United States: Food and Drug Administration





Contact Help Desk
Lister Hill National Center for Biomedical Communications,  U.S. National Library of Medicine,
U.S. National Institutes of Health,  U.S. Department of Health & Human Services,
USA.gov,  Copyright,  Privacy,  Accessibility,  Freedom of Information Act

U.S. National Institutes of Health U.S. National Library of Medicine U.S. Department of Health & Human Services