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
Group A (Exenatide)	exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks
Group B (Placebo)	placebo (volume equivalent to exenatide injection) twice daily for 24 weeks

Participant Flow:   Overall Study

	Group A (Exenatide)	Group B (Placebo)
STARTED	96	98
COMPLETED	70	72
NOT COMPLETED	26	26
Adverse Event	4	5
Entry Criteria Not Met	0	1
Loss of Glucose Control	0	1
Lost to Follow-up	10	5
Physician Decision	0	4
Protocol Violation	6	3
Sponsor Decision	0	1
Subject Decision	6	6

Reporting Groups

	Description
Group A (Exenatide)	exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks
Group B (Placebo)	placebo (volume equivalent to exenatide injection) twice daily for 24 weeks

Baseline Measures

	Group A (Exenatide)	Group B (Placebo)	Total
Number of Participants   [units: participants]	96	98	194
Age   [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	78	82	160
>=65 years	18	16	34
Age   [units: years] Mean ± Standard Deviation	54.52 ± 10.02	55.08 ± 8.97	54.81 ± 9.48
Gender   [units: participants]
Female	60	61	121
Male	36	37	73
Baseline Body Weight   [units: kg] Mean ± Standard Deviation	94.90 ± 16.52	96.16 ± 16.53	95.53 ± 16.05
Baseline Cholesterol   [units: mmol/L] Mean ± Standard Deviation	4.67 ± 1.03	4.68 ± 0.90	4.68 ± 0.96
Baseline Glycosylated Hemoglobin (HbA1c)   [units: %] Mean ± Standard Deviation	7.74 ± 0.87	7.51 ± 0.82	7.62 ± 0.85
Baseline High Density Lipoprotein (HDL) Cholesterol   [units: mmol/L] Mean ± Standard Deviation	1.18 ± 0.32	1.21 ± 0.31	1.20 ± 0.31
Baseline Homeostatic Model Assessment-Beta Cell (HOMA-B)   [units: %] Mean ± Standard Deviation	75.15 ± 81.20	70.72 ± 53.16	72.81 ± 67.65
Baseline Homeostatic Model Assessment-Insulin Sensitivity (HOMA-S)   [units: %] Mean ± Standard Deviation	49.72 ± 32.12	62.90 ± 41.07	56.68 ± 37.57
Baseline Low Density Lipoprotein (LDL) Cholesterol   [units: mmol/L] Mean ± Standard Deviation	2.74 ± 0.88	2.78 ± 0.82	2.76 ± 0.85
Baseline Triglycerides   [units: mmol/L] Mean ± Standard Deviation	2.15 ± 0.94	2.13 ± 1.00	2.14 ± 0.97
Baseline Waist Circumference   [units: cm] Mean ± Standard Deviation	109.64 ± 11.12	108.85 ± 12.10	109.24 ± 11.60

1.  Primary:

Change in Body Weight   [ 24 weeks ]

2.  Secondary:

Change in Glycosylated Hemoglobin (HbA1c)   [ 24 weeks ]

3.  Secondary:

Change in 6-point Self Monitored Blood Glucose (SMBG) Profile.   [ 24 weeks ]

4.  Secondary:

Change in Waist Circumference.   [ 24 weeks ]

5.  Secondary:

Change in Homeostatic Model Assessment-Beta Cell (HOMA-B)   [ 24 weeks ]

6.  Secondary:

Change in Homeostatic Model Assessment-Insulin Sensitivity (HOMA-S)   [ 24 weeks ]

7.  Secondary:

Change in High Density Lipoprotein (HDL) Cholesterol   [ 24 weeks ]

8.  Secondary:

Change in Low Density Lipoprotein (LDL) Cholesterol   [ 24 weeks ]

9.  Secondary:

Change in Total Cholesterol   [ 24 weeks ]

10.  Secondary:

Change in Triglycerides   [ 24 weeks ]

11.  Secondary:

Incidence of Hypoglycemic Events   [ 24 weeks ]

12.  Secondary:

Rate of Hypoglycemic Events   [ 24 weeks ]