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

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

1.  Primary:

Change in ASIiAUC During a Hyperglycemic Clamp Test.   [ Time Frame: 20 weeks ]

2.  Secondary:

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

3.  Secondary:

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

4.  Secondary:

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

5.  Secondary:

Change in Insulin iAUC From Baseline to Endpoint.   [ Time Frame: Week 20 ]

6.  Secondary:

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

7.  Secondary:

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

8.  Secondary:

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

9.  Secondary:

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

10.  Secondary:

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

11.  Secondary:

Change in HbA1c   [ Time Frame: Week 20 ]

12.  Secondary:

Change in Fasting Serum Glucose Concentration.   [ Time Frame: Week 20 ]

13.  Secondary:

Change in Fasting C-peptide   [ Time Frame: Week 20 ]

14.  Secondary:

Change in Fasting Insulin   [ Time Frame: Week 20 ]

15.  Secondary:

Change in Fasting Proinsulin   [ Time Frame: Week 20 ]

16.  Secondary:

Change in Body Weight   [ Time Frame: Week 20 ]

17.  Secondary:

Change in Fasting Total Cholesterol.   [ Time Frame: Week 20 ]

18.  Secondary:

Change in Fasting HDL Cholesterol   [ Time Frame: Week 20 ]

19.  Secondary:

Change in Fasting LDL Cholesterol   [ Time Frame: Week 20 ]

20.  Secondary:

Change in Fasting Triglycerides   [ Time Frame: Week 20 ]

21.  Secondary:

Change in Percent Body Fat During a Meal Challenge Test (MCT)   [ Time Frame: 20 weeks ]

22.  Secondary:

Change in Body Fat Mass During a Meal Challenge Test (MCT)   [ Time Frame: 20 weeks ]

23.  Secondary:

Change in Lean Body Mass During a Meal Challenge Test (MCT)   [ Time Frame: 20 weeks ]

24.  Secondary:

Change in Waist Circumference   [ Time Frame: 20 weeks ]

25.  Secondary:

Change in Hip Circumference   [ Time Frame: 20 weeks ]

26.  Secondary:

Change in Waist-to-hip Ratio   [ Time Frame: 20 weeks ]

27.  Secondary:

Incidence of Hypoglycemia Events   [ Time Frame: 20 weeks ]

28.  Secondary:

Hypoglycemia Rate Per 30 Days Per Patient   [ Time Frame: 20 weeks ]

29.  Secondary:

Pedal Edema Score   [ Time Frame: 20 weeks ]