An Evaluation of Exenatide and Rosiglitazone in Subjects... | NCT00135330

Name	Class
Eli Lilly and Company	INDUSTRY

Label	Type	Intervention Names
Exenatide Arm	Experimental	Drug: exenatide
Exenatide plus Rosiglitazone Arm	Experimental	Drug: exenatide Drug: rosiglitazone
Rosiglitazone Arm	Experimental	Drug: rosiglitazone

Name	Type	Description	Arm Group Labels	Other Names
exenatide	Drug	subcutaneous injection, 5mcg or 10mcg, twice a day	Exenatide Arm Exenatide plus Rosiglitazone Arm

Measure	Description	Time Frame
Change in ASIiAUC During a Hyperglycemic Clamp Test.	Change in insulin incremental area under the concentration-time curve (ASIiAUC) from baseline to week 20. ASIiAUC is a measure of beta-cell function.	20 weeks

Measure	Description	Time Frame
Change in AUC for Glucose During a Meal Challenge Test (MCT).	Change in AUC(15-180 min) for glucose during a MCT baseline to week 20.	Week 20
Change in Insulin Sensitivity Index as Measured by M-value.

Name	Affiliation	Role
James Malone, MD	Eli Lilly and Company	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Phoenix	Arizona		United States
Research Site

PubMed Identifier	Type	Citation	Retractions
22236356	Derived	Fineman MS, Mace KF, Diamant M, Darsow T, Cirincione BB, Booker Porter TK, Kinninger LA, Trautmann ME. Clinical relevance of anti-exenatide antibodies: safety, efficacy and cross-reactivity with long-term treatment. Diabetes Obes Metab. 2012 Jun;14(6):546-54. doi: 10.1111/j.1463-1326.2012.01561.x. Epub 2012 Feb 10.
20107105	Derived

ID	Title	Description
FG000	Exenatide	Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
FG001	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.

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change in ASIiAUC During a Hyperglycemic Clamp Test.

Change in insulin incremental area under the concentration-time curve (ASIiAUC) from baseline to week 20. ASIiAUC is a measure of beta-cell function.

All patients in full analysis set who participated in clamp test and have both baseline and endpoint measurement.

Posted

Least Squares Mean

Standard Error

uIU-min/ml

20 weeks

ID	Title	Description
OG000	Exenatide	Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
OG001	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.
OG002	Rosiglitazone	Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Units	Counts
Participants	OG00017 OG00118 OG00215

Title

Denominators

Categories

Baseline ASIiAUC

Title	Measurements
	OG000643.40± 106.71 OG001686.41± 103.70 OG002786.12± 113.60

Change in ASIiAUC at week 20

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG001 OG002	The ratio of the ASI-iAUC at Week 20 to that at baseline was compared between the treatment groups.	ANCOVA		0.282							95						No	Superiority or Other

Secondary

Change in AUC for Glucose During a Meal Challenge Test (MCT).

Change in AUC(15-180 min) for glucose during a MCT baseline to week 20.

All patients in full analysis set who have both baseline and endpoint measurement.

Posted

Least Squares Mean

Standard Error

mmol-min/L

Week 20

ID	Title	Description
OG000	Exenatide	Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
OG001	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.
OG002	Rosiglitazone	Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Units	Counts
Participants

Secondary

Change in Insulin Sensitivity Index as Measured by M-value.

Change of M-Value (mg/kg-min) during hyperinsulinemic euglycemic clamp test from baseline to week 20.

All patients in full analysis set who participated in clamp test and have both baseline and endpoint measurements.

Posted

Least Squares Mean

Standard Error

mg/kg-min

Week 20

ID	Title	Description
OG000	Exenatide	Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
OG001	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.
OG002	Rosiglitazone	Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Units	Counts
Participants

Secondary

Change in Insulin AUC in the First Stage From Baseline to Endpoint.

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.

All patients in full analysis set who participated in clamp tests and have both baseline and endpoint

Posted

Least Squares Mean

Standard Error

uIU-min/ml

Week 20

ID	Title	Description
OG000	Exenatide	Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
OG001	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.
OG002	Rosiglitazone	Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Units	Counts
Participants

Secondary

Change in Insulin iAUC From Baseline to Endpoint.

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.

All patients in full analysis set who participated in clamp tests and have both baseline and endpoint.

Posted

Least Squares Mean

Standard Error

uIU-min/ml

Week 20

ID	Title	Description
OG000	Exenatide	Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
OG001	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.
OG002	Rosiglitazone	Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Units	Counts
Participants

Secondary

Ratio (Value at Endpoint Divided by Value at Baseline) of AUC for Insulin During a Meal Challenge Test (MCT).

Ratio (value at endpoint divided by value at baseline) of AUC (15-180 min) for insulin (uIU-min/ml) during MCT.

All patients in full analysis set who have both baseline and endpoint measurement.

Posted

Geometric Mean

Standard Error

uIU-min/ml

Week 20

ID	Title	Description
OG000	Exenatide	Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
OG001	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.
OG002	Rosiglitazone	Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Units	Counts
Participants

Secondary

Change in AUC for C-peptide During a Meal Challenge Test (MCT).

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.

All patients in full analysis set who have both baseline and endpoint measurement.

Posted

Geometric Mean

Standard Error

nmol-min/L

Week 20

ID	Title	Description
OG000	Exenatide	Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
OG001	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.
OG002	Rosiglitazone	Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Units	Counts
Participants

Secondary

Change in Incremental for Postprandial Glucose During a Meal Challenge Test (MCT).

Change in incremental for postprandial glucose (mmol/L) during a MCT from baseline to week 20.

All patients in full analysis set who have both baseline and endpoint measurement.

Posted

Least Squares Mean

Standard Error

mmol/L

Week 20

ID	Title	Description
OG000	Exenatide	Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
OG001	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.
OG002	Rosiglitazone	Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Units	Counts
Participants

Secondary

Change in Incremental for Postprandial Insulin During Meal Challenge Test (MCT).

Change in incremental for postprandial insulin (mmol/L) during meal challenge test (MCT) from baseline to week 20.

All patients in full analysis set who have both baseline and endpoint measurement.

Posted

Least Squares Mean

Standard Error

mmol/L

Week 20

ID	Title	Description
OG000	Exenatide	Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
OG001	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.
OG002	Rosiglitazone	Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Units	Counts
Participants

Secondary

Change in Incremental for Postprandial C-peptide During Meal Challenge Test (MCT).

Change in incremental for postprandial C-peptide (mmol/L) during MCT from baseline to week 20.

All patients in full analysis set who have baseline and endpoint measurement.

Posted

Least Squares Mean

Standard Error

mmol/L

Week 20

ID	Title	Description
OG000	Exenatide	Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
OG001	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.
OG002	Rosiglitazone	Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Units	Counts
Participants

Secondary

Change in HbA1c

Change in HbA1c from baseline to week 20.

All patients who have both baseline and at least one post baseline value in full analysis set.

Posted

Least Squares Mean

Standard Error

Percentage

Week 20

ID	Title	Description
OG000	Exenatide	Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
OG001	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.
OG002	Rosiglitazone	Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Units	Counts
Participants	OG000

Secondary

Change in Fasting Serum Glucose Concentration.

Change in fasting serum glucose concentration from baseline to week 20.

All patients who have both baseline and at least one post baseline value in full analysis set.

Posted

Least Squares Mean

Standard Error

mmol/L

Week 20

ID	Title	Description
OG000	Exenatide	Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
OG001	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.
OG002	Rosiglitazone	Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Units	Counts
Participants

Secondary

Change in Fasting C-peptide

Change in fasting C-peptide from baseline to week 20.

Fasting C-peptide was initially identified as an outcome measure, but data for this measure were not subsequently collected at baseline or endpoint.

Posted

Week 20

ID	Title	Description
OG000	Exenatide	Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
OG001	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.
OG002	Rosiglitazone	Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Units	Counts
Participants	OG000

Secondary

Change in Fasting Insulin

Change in fasting insulin from baseline to week 20.

All patients who have both baseline and at least one post baseline value in full analysis set.

Posted

Geometric Mean

Standard Error

uIU/ml

Week 20

ID	Title	Description
OG000	Exenatide	Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
OG001	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.
OG002	Rosiglitazone	Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Units	Counts
Participants	OG000

Secondary

Change in Fasting Proinsulin

Ratio (endpoint value divided by baseline value) for fasting proinsulin, comparing endpoint (week 20) to baseline

All patients who have both baseline and at least one post baseline value in full analysis set.

Posted

Geometric Mean

Standard Error

pmol/L

Week 20

ID	Title	Description
OG000	Exenatide	Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
OG001	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.
OG002	Rosiglitazone	Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Units	Counts
Participants

Secondary

Change in Body Weight

Change in body weight from baseline to week 20.

All patients who aave both baseline and at least one post baseline value in full analysis set.

Posted

Least Squares Mean

Standard Error

Week 20

ID	Title	Description
OG000	Exenatide	Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
OG001	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.
OG002	Rosiglitazone	Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Units	Counts
Participants	OG000

Secondary

Change in Fasting Total Cholesterol.

Change in fasting total cholestrol from baseline to week 20.

All patients who have both baseline and at least one post baseline value in full analysis set.

Posted

Least Squares Mean

Standard Error

mmol/L

Week 20

ID	Title	Description
OG000	Exenatide	Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
OG001	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.
OG002	Rosiglitazone	Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Units	Counts
Participants

Secondary

Change in Fasting HDL Cholesterol

Change in fasting high-density lipoprotein (HDL) cholesterol from baseline to week 20.

All patients who have both baseline and at least one post baseline value in full analysis set.

Posted

Least Squares Mean

Standard Error

mmol/L

Week 20

ID	Title	Description
OG000	Exenatide	Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
OG001	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.
OG002	Rosiglitazone	Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Units	Counts
Participants

Secondary

Change in Fasting LDL Cholesterol

Change in fasting low-density lipoprotein (LDL) cholesterol from baseline to week 20.

All patients who have both baseline and at least one post baseline value in full analysis set.

Posted

Least Squares Mean

Standard Error

mmol/L

Week 20

ID	Title	Description
OG000	Exenatide	Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
OG001	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.
OG002	Rosiglitazone	Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Units	Counts
Participants

Secondary

Change in Fasting Triglycerides

Ratio (endpint value divided by baseline value) of fasting triglycerides from baseline to week 20.

All patients who have both baseline and at least one post baseline value in full analysis set

Posted

Geometric Mean

Standard Error

mmol/L

Week 20

ID	Title	Description
OG000	Exenatide	Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
OG001	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.
OG002	Rosiglitazone	Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Units	Counts
Participants

Secondary

Change in Percent Body Fat During a Meal Challenge Test (MCT)

Change in percent body fat from baseline to week 20, as assessed during an MCT

All Patients in Full Analysis Set Who Have Both Baseline and Endpoint Measurement

Posted

Least Squares Mean

Standard Error

percentage

20 weeks

ID	Title	Description
OG000	Exenatide	Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
OG001	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.
OG002	Rosiglitazone	Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Units	Counts
Participants

Secondary

Change in Body Fat Mass During a Meal Challenge Test (MCT)

Change in body fat mass form baseline to week 20, as assessed during an MCT

All Patients in Full Analysis Set Who Have Both Baseline and Endpoint Measurements

Posted

Least Squares Mean

Standard Error

20 weeks

ID	Title	Description
OG000	Exenatide	Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
OG001	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.
OG002	Rosiglitazone	Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Units	Counts
Participants

Secondary

Change in Lean Body Mass During a Meal Challenge Test (MCT)

Change in lean body mass from baseline to week 20, as assessed during an MCT

All Patients in Full Analysis Set Who Have Both Baseline and Endpoint Measurements

Posted

Least Squares Mean

Standard Error

20 weeks

ID	Title	Description
OG000	Exenatide	Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
OG001	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.
OG002	Rosiglitazone	Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Units	Counts
Participants

Secondary

Change in Waist Circumference

Change in waist circumference from baseline to week 20

All Patients Who Have Both Baseline and At Least One Post Baseline Value in Full Analysis Set

Posted

Least Squares Mean

Standard Error

20 weeks

ID	Title	Description
OG000	Exenatide	Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
OG001	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.
OG002	Rosiglitazone	Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Units	Counts
Participants

Secondary

Change in Hip Circumference

Change in hip circumference form baseline to week 20

All Patients Who Have Both Baseline and At Least One Post Baseline Value in Full Analysis Set

Posted

Least Squares Mean

Standard Error

20 weeks

ID	Title	Description
OG000	Exenatide	Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
OG001	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.
OG002	Rosiglitazone	Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Units	Counts
Participants	OG000

Secondary

Change in Waist-to-hip Ratio

Change in waist-to-hip ratio (waist circumference divided by hip circumference) from baseline to week 20

All Patients Who Have Both Baseline and At Least One Post Baseline Value in Full Analysis Set

Posted

Least Squares Mean

Standard Error

ratio (cm/cm)

20 weeks

ID	Title	Description
OG000	Exenatide	Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
OG001	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.
OG002	Rosiglitazone	Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Units	Counts
Participants

Secondary

Incidence of Hypoglycemia Events

Number of subjects experiencing hypoglycemia at any point during the study

Full Analysis Set

Posted

Number

participants

20 weeks

ID	Title	Description
OG000	Exenatide	Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
OG001	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.
OG002	Rosiglitazone	Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Units	Counts
Participants	OG000

Secondary

Hypoglycemia Rate Per 30 Days Per Patient

Average number of episodes of hypoglycemia per 30 days per patient

Full Analysis Set

Posted

Mean

Standard Deviation

hypoglycemia events / 30 days / patient

20 weeks

ID	Title	Description
OG000	Exenatide	Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
OG001	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.
OG002	Rosiglitazone	Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Units	Counts
Participants	OG000

Secondary

Pedal Edema Score

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.)

Scale:

Slight pitting, no visible distortion, disappears rapidly
A somewhat deeper pit than in 1+, but again no readily detectable distortion, and it disappears in 10 - 15 seconds
The pit is noticeably deep and may last more than a minute; the dependent extremity looks fuller and swollen
The pit is very deep, lasts as long as 2 - 5 minutes, and the dependent extremity is grossly distorted

Full Analysis Set

Posted

Number

participants

20 weeks

ID	Title	Description
OG000	Exenatide	Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
OG001	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.
OG002	Rosiglitazone	Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 affected45 at risk EG0011 affected47 at risk EG0020 affected45 at risk
Cellulitis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected45 at risk EG0010 affected47 at risk EG0021 affected45 at risk
Chest pain	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected45 at risk EG0010 affected47 at risk EG0020 affected45 at risk
Colitis ischaemic	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected45 at risk EG0011 affected47 at risk EG0020 affected45 at risk
Diverticulitis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected45 at risk EG0010 affected47 at risk EG0021 affected45 at risk
Gastroenteritis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected45 at risk EG0010 affected47 at risk EG0020 affected45 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected45 at risk EG0010 affected47 at risk EG0021 affected45 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected45 at risk EG0010 affected47 at risk EG0020 affected45 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected45 at risk EG0010 affected47 at risk EG0020 affected45 at risk
Helicobacter gastritis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected45 at risk EG0010 affected47 at risk EG0020 affected45 at risk
Major depression	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected45 at risk EG0011 affected47 at risk EG0020 affected45 at risk
Osteomyelitis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected45 at risk EG0010 affected47 at risk EG0021 affected45 at risk
Otitis externa	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected45 at risk EG0011 affected47 at risk EG0020 affected45 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected45 at risk EG0010 affected47 at risk EG0021 affected45 at risk
Staphylococcal infection	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected45 at risk EG0010 affected47 at risk EG0020 affected45 at risk
Suicidal ideation	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected45 at risk EG0011 affected47 at risk EG0020 affected45 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected45 at risk EG0010 affected47 at risk EG0021 affected45 at risk

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nausea	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG00021 affected45 at risk EG00122 affected47 at risk EG0022 affected45 at risk
Vomiting	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG00010 affected45 at risk EG0019 affected47 at risk EG0020 affected45 at risk
Dizziness	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0006 affected45 at risk EG0017 affected47 at risk EG0023 affected45 at risk
Oedema peripheral	General disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected45 at risk EG0015 affected47 at risk EG0029 affected45 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected45 at risk EG00110 affected47 at risk EG0022 affected45 at risk
Headache	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0005 affected45 at risk EG0014 affected47 at risk EG0023 affected45 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0003 affected45 at risk EG0015 affected47 at risk EG0022 affected45 at risk
Fatigue	General disorders	MedDRA 11.0	Systematic Assessment	EG0005 affected45 at risk EG0011 affected47 at risk EG0022 affected45 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0003 affected45 at risk EG0011 affected47 at risk EG0024 affected45 at risk
Injection site bruising	General disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected45 at risk EG0014 affected47 at risk EG0020 affected45 at risk
Asthenia	General disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected45 at risk EG0013 affected47 at risk EG0021 affected45 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected45 at risk EG0011 affected47 at risk EG0023 affected45 at risk
Constipation	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected45 at risk EG0013 affected47 at risk EG0020 affected45 at risk
Flatulence	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected45 at risk EG0013 affected47 at risk EG0020 affected45 at risk
Hunger	General disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected45 at risk EG0011 affected47 at risk EG0020 affected45 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected45 at risk EG0011 affected47 at risk EG0020 affected45 at risk
Pharyngolaryngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected45 at risk EG0010 affected47 at risk EG0023 affected45 at risk
Diverticulitis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected45 at risk EG0010 affected47 at risk EG0023 affected45 at risk
Oedema	General disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected45 at risk EG0010 affected47 at risk EG0023 affected45 at risk

ID	Term
D003924	Diabetes Mellitus, Type 2
D003920	Diabetes Mellitus

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

ID	Term
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D014688	Venoms
D045424	Complex Mixtures
D014118	Toxins, Biological
D001685	Biological Factors
D045162	Thiazolidinediones
D013844	Thiazoles
D013457	Sulfur Compounds
D009930	Organic Chemicals
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

ID	Title	Description
BG000	Exenatide	Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
BG001	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.
BG002	Rosiglitazone	Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
BG003	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Other Events (Affected)
EG000	Exenatide	Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.	3	35
EG001	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.	4	41
EG002	Rosiglitazone	Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.	4	33