Trial Outcomes & Findings for An Evaluation of Exenatide and Rosiglitazone in Subjects With Type 2 Diabetes Mellitus (NCT NCT00135330)
NCT ID: NCT00135330
Last Updated: 2015-04-07
Results Overview
Change in insulin incremental area under the concentration-time curve (ASIiAUC) from baseline to week 20. ASIiAUC is a measure of beta-cell function.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
137 participants
Primary outcome timeframe
20 weeks
Results posted on
2015-04-07
Participant Flow
Enrollment occurred between 18 October 2005 and 14 March 2008.
Participant milestones
| Measure |
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
45
|
47
|
45
|
|
Overall Study
COMPLETED
|
33
|
34
|
34
|
|
Overall Study
NOT COMPLETED
|
12
|
13
|
11
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
5
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
3
|
|
Overall Study
Physician Decision
|
1
|
1
|
0
|
|
Overall Study
Protocol Violation
|
4
|
3
|
3
|
|
Overall Study
Patient Decision
|
5
|
1
|
4
|
|
Overall Study
Sponsor Decision
|
0
|
1
|
0
|
Baseline Characteristics
An Evaluation of Exenatide and Rosiglitazone in Subjects With Type 2 Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
Exenatide
n=45 Participants
Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
|
Exenatide Plus Rosiglitazone
n=47 Participants
Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
|
Rosiglitazone
n=45 Participants
Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
|
Total
n=137 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
36 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
109 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Age, Continuous
|
56.99 years
STANDARD_DEVIATION 9.71 • n=5 Participants
|
54.63 years
STANDARD_DEVIATION 9.91 • n=7 Participants
|
55.54 years
STANDARD_DEVIATION 10.71 • n=5 Participants
|
55.70 years
STANDARD_DEVIATION 10.09 • n=4 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
67 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
70 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 20 weeksPopulation: All patients in full analysis set who participated in clamp test and have both baseline and endpoint measurement.
Change in insulin incremental area under the concentration-time curve (ASIiAUC) from baseline to week 20. ASIiAUC is a measure of beta-cell function.
Outcome measures
| Measure |
Exenatide
n=17 Participants
Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
|
Exenatide Plus Rosiglitazone
n=18 Participants
Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
|
Rosiglitazone
n=15 Participants
Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
|
|---|---|---|---|
|
Change in ASIiAUC During a Hyperglycemic Clamp Test.
Baseline ASIiAUC
|
643.40 uIU-min/ml
Standard Error 106.71
|
686.41 uIU-min/ml
Standard Error 103.70
|
786.12 uIU-min/ml
Standard Error 113.60
|
|
Change in ASIiAUC During a Hyperglycemic Clamp Test.
Change in ASIiAUC at week 20
|
747.26 uIU-min/ml
Standard Error 187.40
|
194.68 uIU-min/ml
Standard Error 181.59
|
-99.85 uIU-min/ml
Standard Error 200.04
|
SECONDARY outcome
Timeframe: Week 20Population: All patients in full analysis set who have both baseline and endpoint measurement.
Change in AUC(15-180 min) for glucose during a MCT baseline to week 20.
Outcome measures
| Measure |
Exenatide
n=34 Participants
Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
|
Exenatide Plus Rosiglitazone
n=35 Participants
Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
|
Rosiglitazone
n=34 Participants
Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
|
|---|---|---|---|
|
Change in AUC for Glucose During a Meal Challenge Test (MCT).
Baseline glucose AUC during MCT
|
1782.86 mmol-min/L
Standard Error 60.47
|
1799.68 mmol-min/L
Standard Error 59.60
|
1741.87 mmol-min/L
Standard Error 60.47
|
|
Change in AUC for Glucose During a Meal Challenge Test (MCT).
Change in glucose AUC during MCT at week 20
|
-560.12 mmol-min/L
Standard Error 50.95
|
-635.24 mmol-min/L
Standard Error 50.25
|
-425.59 mmol-min/L
Standard Error 51.02
|
SECONDARY outcome
Timeframe: Week 20Population: All patients in full analysis set who participated in clamp test and have both baseline and endpoint measurements.
Change of M-Value (mg/kg-min) during hyperinsulinemic euglycemic clamp test from baseline to week 20.
Outcome measures
| Measure |
Exenatide
n=16 Participants
Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
|
Exenatide Plus Rosiglitazone
n=16 Participants
Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
|
Rosiglitazone
n=15 Participants
Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
|
|---|---|---|---|
|
Change in Insulin Sensitivity Index as Measured by M-value.
M-Value at baseline
|
3.89 mg/kg-min
Standard Error 0.495
|
2.49 mg/kg-min
Standard Error 0.495
|
4.02 mg/kg-min
Standard Error 0.511
|
|
Change in Insulin Sensitivity Index as Measured by M-value.
Change in M-Value from baseline at week 20
|
0.477 mg/kg-min
Standard Error 0.425
|
2.07 mg/kg-min
Standard Error 0.440
|
1.42 mg/kg-min
Standard Error 0.442
|
SECONDARY outcome
Timeframe: Week 20Population: All patients in full analysis set who participated in clamp tests and have both baseline and 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.
Outcome measures
| Measure |
Exenatide
n=17 Participants
Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
|
Exenatide Plus Rosiglitazone
n=17 Participants
Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
|
Rosiglitazone
n=15 Participants
Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
|
|---|---|---|---|
|
Change in Insulin AUC in the First Stage From Baseline to Endpoint.
Baseline insulin AUC
|
200.50 uIU-min/ml
Standard Error 50.40
|
136.84 uIU-min/ml
Standard Error 50.40
|
157.49 uIU-min/ml
Standard Error 53.66
|
|
Change in Insulin AUC in the First Stage From Baseline to Endpoint.
Change from baseline insulin AUC at week 20
|
134.88 uIU-min/ml
Standard Error 31.71
|
32.12 uIU-min/ml
Standard Error 31.65
|
-50.81 uIU-min/ml
Standard Error 33.59
|
SECONDARY outcome
Timeframe: Week 20Population: All patients in full analysis set who participated in clamp tests and have both baseline and 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.
Outcome measures
| Measure |
Exenatide
n=17 Participants
Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
|
Exenatide Plus Rosiglitazone
n=17 Participants
Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
|
Rosiglitazone
n=15 Participants
Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
|
|---|---|---|---|
|
Change in Insulin iAUC From Baseline to Endpoint.
Baseline insulin iAUC
|
5.98 uIU-min/ml
Standard Error 14.29
|
-9.92 uIU-min/ml
Standard Error 14.29
|
23.09 uIU-min/ml
Standard Error 15.21
|
|
Change in Insulin iAUC From Baseline to Endpoint.
Change from baseline insulin iAUC at week 20
|
99.08 uIU-min/ml
Standard Error 24.23
|
53.71 uIU-min/ml
Standard Error 24.54
|
11.51 uIU-min/ml
Standard Error 26.15
|
SECONDARY outcome
Timeframe: Week 20Population: All patients in full analysis set who have both baseline and endpoint measurement.
Ratio (value at endpoint divided by value at baseline) of AUC (15-180 min) for insulin (uIU-min/ml) during MCT.
Outcome measures
| Measure |
Exenatide
n=34 Participants
Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
|
Exenatide Plus Rosiglitazone
n=35 Participants
Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
|
Rosiglitazone
n=33 Participants
Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
|
|---|---|---|---|
|
Ratio (Value at Endpoint Divided by Value at Baseline) of AUC for Insulin During a Meal Challenge Test (MCT).
Baseline AUC for insulin during MCT
|
5171.40 uIU-min/ml
Standard Error 522.82
|
4324.13 uIU-min/ml
Standard Error 430.87
|
5816.83 uIU-min/ml
Standard Error 596.91
|
|
Ratio (Value at Endpoint Divided by Value at Baseline) of AUC for Insulin During a Meal Challenge Test (MCT).
Ratio(endpoint/baseline) of insulin AUC during MCT
|
0.806 uIU-min/ml
Standard Error 0.063
|
0.664 uIU-min/ml
Standard Error 0.052
|
0.722 uIU-min/ml
Standard Error 0.058
|
SECONDARY outcome
Timeframe: Week 20Population: All patients in full analysis set who have both baseline and endpoint measurement.
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.
Outcome measures
| Measure |
Exenatide
n=34 Participants
Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
|
Exenatide Plus Rosiglitazone
n=34 Participants
Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
|
Rosiglitazone
n=32 Participants
Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
|
|---|---|---|---|
|
Change in AUC for C-peptide During a Meal Challenge Test (MCT).
Baseline C-peptide during a MCT
|
319.77 nmol-min/L
Standard Error 18.13
|
310.51 nmol-min/L
Standard Error 17.61
|
325.65 nmol-min/L
Standard Error 19.04
|
|
Change in AUC for C-peptide During a Meal Challenge Test (MCT).
Ratio(endpoint/baseline) of C-peptide during a MCT
|
0.908 nmol-min/L
Standard Error 0.040
|
0.804 nmol-min/L
Standard Error 0.036
|
0.854 nmol-min/L
Standard Error 0.039
|
SECONDARY outcome
Timeframe: Week 20Population: All patients in full analysis set who have both baseline and endpoint measurement.
Change in incremental for postprandial glucose (mmol/L) during a MCT from baseline to week 20.
Outcome measures
| Measure |
Exenatide
n=34 Participants
Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
|
Exenatide Plus Rosiglitazone
n=34 Participants
Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
|
Rosiglitazone
n=33 Participants
Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
|
|---|---|---|---|
|
Change in Incremental for Postprandial Glucose During a Meal Challenge Test (MCT).
Change fr baseline glucose at 15 min at wk 20
|
-0.651 mmol/L
Standard Error 0.151
|
-0.286 mmol/L
Standard Error 0.152
|
0.150 mmol/L
Standard Error 0.157
|
|
Change in Incremental for Postprandial Glucose During a Meal Challenge Test (MCT).
Baseline glucose at 30 min
|
2.39 mmol/L
Standard Error 0.218
|
2.54 mmol/L
Standard Error 0.221
|
2.23 mmol/L
Standard Error 0.221
|
|
Change in Incremental for Postprandial Glucose During a Meal Challenge Test (MCT).
Change fr baseline glucose at 30 min at wk 20
|
-1.46 mmol/L
Standard Error 0.248
|
-1.06 mmol/L
Standard Error 0.252
|
-0.066 mmol/L
Standard Error 0.252
|
|
Change in Incremental for Postprandial Glucose During a Meal Challenge Test (MCT).
Baseline glucose at 60 minutes
|
3.59 mmol/L
Standard Error 0.273
|
3.88 mmol/L
Standard Error 0.273
|
3.48 mmol/L
Standard Error 0.273
|
|
Change in Incremental for Postprandial Glucose During a Meal Challenge Test (MCT).
Change fr baseline glucose at 60 min at wk 20
|
-2.56 mmol/L
Standard Error 0.329
|
-2.46 mmol/L
Standard Error 0.330
|
-0.720 mmol/L
Standard Error 0.329
|
|
Change in Incremental for Postprandial Glucose During a Meal Challenge Test (MCT).
Baseline glucose at 90 minutes
|
3.24 mmol/L
Standard Error 0.231
|
3.36 mmol/L
Standard Error 0.228
|
3.48 mmol/L
Standard Error 0.239
|
|
Change in Incremental for Postprandial Glucose During a Meal Challenge Test (MCT).
Change fr baseline glucose at 90 min at wk 20
|
-2.87 mmol/L
Standard Error 0.312
|
-2.91 mmol/L
Standard Error 0.307
|
-0.952 mmol/L
Standard Error 0.322
|
|
Change in Incremental for Postprandial Glucose During a Meal Challenge Test (MCT).
Baseline glucose at 120 minutes
|
2.49 mmol/L
Standard Error 0.235
|
2.24 mmol/L
Standard Error 0.238
|
2.31 mmol/L
Standard Error 0.235
|
|
Change in Incremental for Postprandial Glucose During a Meal Challenge Test (MCT).
Change fr baseline glucose at 120 min at wk 20
|
-2.24 mmol/L
Standard Error 0.271
|
-2.52 mmol/L
Standard Error 0.275
|
-0.912 mmol/L
Standard Error 0.271
|
|
Change in Incremental for Postprandial Glucose During a Meal Challenge Test (MCT).
Baseline glucose at 150 minutes
|
1.62 mmol/L
Standard Error 0.230
|
1.14 mmol/L
Standard Error 0.230
|
1.25 mmol/L
Standard Error 0.230
|
|
Change in Incremental for Postprandial Glucose During a Meal Challenge Test (MCT).
Change fr baseline glucose at 150 min at wk 20
|
-1.42 mmol/L
Standard Error 0.288
|
-1.95 mmol/L
Standard Error 0.287
|
-0.830 mmol/L
Standard Error 0.286
|
|
Change in Incremental for Postprandial Glucose During a Meal Challenge Test (MCT).
Baseline glucose at 180 minutes
|
0.461 mmol/L
Standard Error 0.235
|
0.036 mmol/L
Standard Error 0.235
|
0.279 mmol/L
Standard Error 0.235
|
|
Change in Incremental for Postprandial Glucose During a Meal Challenge Test (MCT).
Change fr baseline glucose at 180 min at wk 20
|
-0.583 mmol/L
Standard Error 0.231
|
-0.995 mmol/L
Standard Error 0.232
|
-0.481 mmol/L
Standard Error 0.230
|
|
Change in Incremental for Postprandial Glucose During a Meal Challenge Test (MCT).
Baseline glucose at 15 min
|
0.950 mmol/L
Standard Error 0.138
|
1.12 mmol/L
Standard Error 0.138
|
0.828 mmol/L
Standard Error 0.142
|
SECONDARY outcome
Timeframe: Week 20Population: All patients in full analysis set who have both baseline and endpoint measurement.
Change in incremental for postprandial insulin (mmol/L) during meal challenge test (MCT) from baseline to week 20.
Outcome measures
| Measure |
Exenatide
n=34 Participants
Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
|
Exenatide Plus Rosiglitazone
n=35 Participants
Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
|
Rosiglitazone
n=32 Participants
Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
|
|---|---|---|---|
|
Change in Incremental for Postprandial Insulin During Meal Challenge Test (MCT).
Baseline insulin at 15 min
|
9.97 mmol/L
Standard Error 1.71
|
8.09 mmol/L
Standard Error 1.71
|
7.53 mmol/L
Standard Error 1.79
|
|
Change in Incremental for Postprandial Insulin During Meal Challenge Test (MCT).
Change fr baseline insulin at 15 min at wk 20
|
-1.71 mmol/L
Standard Error 1.45
|
-1.84 mmol/L
Standard Error 1.45
|
-0.455 mmol/L
Standard Error 1.52
|
|
Change in Incremental for Postprandial Insulin During Meal Challenge Test (MCT).
Baseline insulin at 30 min
|
19.81 mmol/L
Standard Error 2.28
|
14.79 mmol/L
Standard Error 2.25
|
18.83 mmol/L
Standard Error 2.35
|
|
Change in Incremental for Postprandial Insulin During Meal Challenge Test (MCT).
Change fr baseline insulin at 30 min at wk 20
|
-3.00 mmol/L
Standard Error 1.90
|
-2.63 mmol/L
Standard Error 1.89
|
-1.04 mmol/L
Standard Error 1.96
|
|
Change in Incremental for Postprandial Insulin During Meal Challenge Test (MCT).
Change fr baseline insulin at 60 min at wk 20
|
-11.04 mmol/L
Standard Error 2.63
|
-7.47 mmol/L
Standard Error 2.59
|
-7.42 mmol/L
Standard Error 2.67
|
|
Change in Incremental for Postprandial Insulin During Meal Challenge Test (MCT).
Baseline insulin at 90 min
|
26.06 mmol/L
Standard Error 4.10
|
21.85 mmol/L
Standard Error 4.10
|
32.25 mmol/L
Standard Error 4.36
|
|
Change in Incremental for Postprandial Insulin During Meal Challenge Test (MCT).
Change fr baseline insulin at 90 min at wk 20
|
-9.42 mmol/L
Standard Error 2.72
|
-9.27 mmol/L
Standard Error 2.74
|
-6.19 mmol/L
Standard Error 2.92
|
|
Change in Incremental for Postprandial Insulin During Meal Challenge Test (MCT).
Baseline insulin at 120 min
|
19.56 mmol/L
Standard Error 2.99
|
17.52 mmol/L
Standard Error 2.99
|
25.47 mmol/L
Standard Error 3.04
|
|
Change in Incremental for Postprandial Insulin During Meal Challenge Test (MCT).
Baseline insulin at 150 min
|
15.67 mmol/L
Standard Error 2.47
|
12.74 mmol/L
Standard Error 2.43
|
18.11 mmol/L
Standard Error 2.51
|
|
Change in Incremental for Postprandial Insulin During Meal Challenge Test (MCT).
Change fr baseline insulin at 150 min at wk 20
|
-7.48 mmol/L
Standard Error 1.74
|
-8.13 mmol/L
Standard Error 1.73
|
-5.57 mmol/L
Standard Error 1.78
|
|
Change in Incremental for Postprandial Insulin During Meal Challenge Test (MCT).
Baseline insulin at 180 min
|
10.58 mmol/L
Standard Error 1.73
|
8.18 mmol/L
Standard Error 1.73
|
10.74 mmol/L
Standard Error 1.79
|
|
Change in Incremental for Postprandial Insulin During Meal Challenge Test (MCT).
Change fr baseline insulin at 180 min at wk 20
|
0.031 mmol/L
Standard Error 1.30
|
-5.26 mmol/L
Standard Error 1.30
|
-4.04 mmol/L
Standard Error 1.34
|
|
Change in Incremental for Postprandial Insulin During Meal Challenge Test (MCT).
Baseline insulin at 60 min
|
27.92 mmol/L
Standard Error 4.68
|
27.67 mmol/L
Standard Error 4.61
|
32.09 mmol/L
Standard Error 4.75
|
|
Change in Incremental for Postprandial Insulin During Meal Challenge Test (MCT).
Change fr baseline insulin at 120 min at wk 20
|
-11.26 mmol/L
Standard Error 1.99
|
-8.69 mmol/L
Standard Error 2.00
|
-6.43 mmol/L
Standard Error 2.04
|
SECONDARY outcome
Timeframe: Week 20Population: All patients in full analysis set who have baseline and endpoint measurement.
Change in incremental for postprandial C-peptide (mmol/L) during MCT from baseline to week 20.
Outcome measures
| Measure |
Exenatide
n=34 Participants
Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
|
Exenatide Plus Rosiglitazone
n=34 Participants
Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
|
Rosiglitazone
n=32 Participants
Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
|
|---|---|---|---|
|
Change in Incremental for Postprandial C-peptide During Meal Challenge Test (MCT).
Baseline C-peptide at 15 min
|
0.238 mmol/L
Standard Error 0.049
|
0.259 mmol/L
Standard Error 0.049
|
0.206 mmol/L
Standard Error 0.051
|
|
Change in Incremental for Postprandial C-peptide During Meal Challenge Test (MCT).
Change fr baseline C-peptide at 15 min at week 20
|
-0.006 mmol/L
Standard Error 0.045
|
0.016 mmol/L
Standard Error 0.046
|
0.087 mmol/L
Standard Error 0.047
|
|
Change in Incremental for Postprandial C-peptide During Meal Challenge Test (MCT).
Baseline C-peptide at 60 min
|
0.818 mmol/L
Standard Error 0.110
|
0.871 mmol/L
Standard Error 0.110
|
0.881 mmol/L
Standard Error 0.114
|
|
Change in Incremental for Postprandial C-peptide During Meal Challenge Test (MCT).
Change fr baseline C-peptide at 60 min at week 20
|
-0.148 mmol/L
Standard Error 0.090
|
-0.025 mmol/L
Standard Error 0.090
|
0.054 mmol/L
Standard Error 0.093
|
|
Change in Incremental for Postprandial C-peptide During Meal Challenge Test (MCT).
Baseline C-peptide at 90 min
|
0.895 mmol/L
Standard Error 0.100
|
0.953 mmol/L
Standard Error 0.101
|
1.03 mmol/L
Standard Error 0.106
|
|
Change in Incremental for Postprandial C-peptide During Meal Challenge Test (MCT).
Change fr baseline C-peptide at 90 min at week 20
|
-0.185 mmol/L
Standard Error 0.099
|
-0.117 mmol/L
Standard Error 0.101
|
-0.052 mmol/L
Standard Error 0.106
|
|
Change in Incremental for Postprandial C-peptide During Meal Challenge Test (MCT).
Baseline C-peptide at 120 min
|
0.817 mmol/L
Standard Error 0.112
|
0.828 mmol/L
Standard Error 0.114
|
0.972 mmol/L
Standard Error 0.114
|
|
Change in Incremental for Postprandial C-peptide During Meal Challenge Test (MCT).
Change fr baseline C-peptide at 120 min at week 20
|
-0.259 mmol/L
Standard Error 0.100
|
-0.134 mmol/L
Standard Error 0.102
|
-0.016 mmol/L
Standard Error 0.102
|
|
Change in Incremental for Postprandial C-peptide During Meal Challenge Test (MCT).
Change fr baseline C-peptide at 150 min at week 20
|
-0.251 mmol/L
Standard Error 0.095
|
-0.254 mmol/L
Standard Error 0.095
|
-0.093 mmol/L
Standard Error 0.096
|
|
Change in Incremental for Postprandial C-peptide During Meal Challenge Test (MCT).
Baseline C-peptide at 180 min
|
0.610 mmol/L
Standard Error 0.084
|
0.482 mmol/L
Standard Error 0.085
|
0.619 mmol/L
Standard Error 0.087
|
|
Change in Incremental for Postprandial C-peptide During Meal Challenge Test (MCT).
Change fr baseline C-peptide at 180 min at week 20
|
-0.075 mmol/L
Standard Error 0.062
|
-0.238 mmol/L
Standard Error 0.063
|
-0.092 mmol/L
Standard Error 0.064
|
|
Change in Incremental for Postprandial C-peptide During Meal Challenge Test (MCT).
Baseline C-peptide at 30 min
|
0.521 mmol/L
Standard Error 0.059
|
0.517 mmol/L
Standard Error 0.059
|
0.560 mmol/L
Standard Error 0.061
|
|
Change in Incremental for Postprandial C-peptide During Meal Challenge Test (MCT).
Change fr baseline C-peptide at 30 min at week 20
|
-0.071 mmol/L
Standard Error 0.056
|
-0.036 mmol/L
Standard Error 0.056
|
0.099 mmol/L
Standard Error 0.058
|
|
Change in Incremental for Postprandial C-peptide During Meal Challenge Test (MCT).
Baseline C-peptide at 150 min
|
0.843 mmol/L
Standard Error 0.091
|
0.651 mmol/L
Standard Error 0.091
|
0.813 mmol/L
Standard Error 0.092
|
SECONDARY outcome
Timeframe: Week 20Population: All patients who have both baseline and at least one post baseline value in full analysis set.
Change in HbA1c from baseline to week 20.
Outcome measures
| Measure |
Exenatide
n=35 Participants
Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
|
Exenatide Plus Rosiglitazone
n=36 Participants
Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
|
Rosiglitazone
n=34 Participants
Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
|
|---|---|---|---|
|
Change in HbA1c
Baseline HbA1c
|
7.79 Percentage
Standard Error 0.116
|
7.84 Percentage
Standard Error 0.115
|
7.92 Percentage
Standard Error 0.116
|
|
Change in HbA1c
Change from baseline HbA1c at week 20
|
-0.908 Percentage
Standard Error 0.118
|
-1.31 Percentage
Standard Error 0.116
|
-0.968 Percentage
Standard Error 0.118
|
SECONDARY outcome
Timeframe: Week 20Population: All patients who have both baseline and at least one post baseline value in full analysis set.
Change in fasting serum glucose concentration from baseline to week 20.
Outcome measures
| Measure |
Exenatide
n=34 Participants
Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
|
Exenatide Plus Rosiglitazone
n=35 Participants
Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
|
Rosiglitazone
n=34 Participants
Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
|
|---|---|---|---|
|
Change in Fasting Serum Glucose Concentration.
Baseline fasting serum glucose
|
8.42 mmol/L
Standard Error 0.278
|
8.43 mmol/L
Standard Error 0.271
|
8.48 mmol/L
Standard Error 0.274
|
|
Change in Fasting Serum Glucose Concentration.
Change fr baseline fasting serum glucose at wk 20
|
-1.46 mmol/L
Standard Error 0.250
|
-1.60 mmol/L
Standard Error 0.244
|
-1.80 mmol/L
Standard Error 0.250
|
SECONDARY outcome
Timeframe: Week 20Population: Fasting C-peptide was initially identified as an outcome measure, but data for this measure were not subsequently collected at baseline or endpoint.
Change in fasting C-peptide from baseline to week 20.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 20Population: All patients who have both baseline and at least one post baseline value in full analysis set.
Change in fasting insulin from baseline to week 20.
Outcome measures
| Measure |
Exenatide
n=35 Participants
Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
|
Exenatide Plus Rosiglitazone
n=35 Participants
Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
|
Rosiglitazone
n=31 Participants
Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
|
|---|---|---|---|
|
Change in Fasting Insulin
Baseline fasting insulin
|
12.84 uIU/ml
Standard Error 1.55
|
10.96 uIU/ml
Standard Error 1.33
|
12.77 uIU/ml
Standard Error 1.54
|
|
Change in Fasting Insulin
Ratio (wk20/baseline)of fasting insulin
|
0.980 uIU/ml
Standard Error 0.096
|
0.599 uIU/ml
Standard Error 0.059
|
0.755 uIU/ml
Standard Error 0.078
|
SECONDARY outcome
Timeframe: Week 20Population: All patients who have both baseline and at least one post baseline value in full analysis set.
Ratio (endpoint value divided by baseline value) for fasting proinsulin, comparing endpoint (week 20) to baseline
Outcome measures
| Measure |
Exenatide
n=33 Participants
Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
|
Exenatide Plus Rosiglitazone
n=34 Participants
Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
|
Rosiglitazone
n=33 Participants
Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
|
|---|---|---|---|
|
Change in Fasting Proinsulin
Baseline fasting proinsulin
|
4.32 pmol/L
Standard Error 0.523
|
3.80 pmol/L
Standard Error 0.455
|
3.56 pmol/L
Standard Error 0.423
|
|
Change in Fasting Proinsulin
Ratio(wk20/baseline)of fasting proinsulin
|
0.663 pmol/L
Standard Error 0.073
|
0.538 pmol/L
Standard Error 0.058
|
0.623 pmol/L
Standard Error 0.068
|
SECONDARY outcome
Timeframe: Week 20Population: All patients who aave both baseline and at least one post baseline value in full analysis set.
Change in body weight from baseline to week 20.
Outcome measures
| Measure |
Exenatide
n=44 Participants
Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
|
Exenatide Plus Rosiglitazone
n=45 Participants
Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
|
Rosiglitazone
n=44 Participants
Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
|
|---|---|---|---|
|
Change in Body Weight
Baseline body weight
|
93.05 kg
Standard Error 2.39
|
93.76 kg
Standard Error 2.36
|
91.78 kg
Standard Error 2.39
|
|
Change in Body Weight
Change in body weight at week 20
|
-2.82 kg
Standard Error 0.547
|
-1.21 kg
Standard Error 0.538
|
1.48 kg
Standard Error 0.547
|
SECONDARY outcome
Timeframe: Week 20Population: All patients who have both baseline and at least one post baseline value in full analysis set.
Change in fasting total cholestrol from baseline to week 20.
Outcome measures
| Measure |
Exenatide
n=34 Participants
Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
|
Exenatide Plus Rosiglitazone
n=36 Participants
Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
|
Rosiglitazone
n=34 Participants
Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
|
|---|---|---|---|
|
Change in Fasting Total Cholesterol.
Baseline total cholesterol
|
4.42 mmol/L
Standard Error 0.150
|
4.41 mmol/L
Standard Error 0.145
|
4.62 mmol/L
Standard Error 0.149
|
|
Change in Fasting Total Cholesterol.
Change fr baseline total cholesterol at week 20
|
-0.128 mmol/L
Standard Error 0.118
|
0.258 mmol/L
Standard Error 0.114
|
0.438 mmol/L
Standard Error 0.118
|
SECONDARY outcome
Timeframe: Week 20Population: All patients who have both baseline and at least one post baseline value in full analysis set.
Change in fasting high-density lipoprotein (HDL) cholesterol from baseline to week 20.
Outcome measures
| Measure |
Exenatide
n=34 Participants
Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
|
Exenatide Plus Rosiglitazone
n=36 Participants
Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
|
Rosiglitazone
n=34 Participants
Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
|
|---|---|---|---|
|
Change in Fasting HDL Cholesterol
Baseline HDL
|
1.13 mmol/L
Standard Error 0.048
|
1.17 mmol/L
Standard Error 0.047
|
1.17 mmol/L
Standard Error 0.048
|
|
Change in Fasting HDL Cholesterol
Change from baseline HDL at week 20
|
0.022 mmol/L
Standard Error 0.030
|
0.046 mmol/L
Standard Error 0.029
|
0.055 mmol/L
Standard Error 0.030
|
SECONDARY outcome
Timeframe: Week 20Population: All patients who have both baseline and at least one post baseline value in full analysis set.
Change in fasting low-density lipoprotein (LDL) cholesterol from baseline to week 20.
Outcome measures
| Measure |
Exenatide
n=34 Participants
Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
|
Exenatide Plus Rosiglitazone
n=35 Participants
Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
|
Rosiglitazone
n=34 Participants
Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
|
|---|---|---|---|
|
Change in Fasting LDL Cholesterol
Baseline LDL
|
2.59 mmol/L
Standard Error 0.131
|
2.57 mmol/L
Standard Error 0.128
|
2.71 mmol/L
Standard Error 0.129
|
|
Change in Fasting LDL Cholesterol
Change from baseline LDL at week 20
|
-0.049 mmol/L
Standard Error 0.102
|
0.096 mmol/L
Standard Error 0.100
|
0.334 mmol/L
Standard Error 0.101
|
SECONDARY outcome
Timeframe: Week 20Population: All patients who have both baseline and at least one post baseline value in full analysis set
Ratio (endpint value divided by baseline value) of fasting triglycerides from baseline to week 20.
Outcome measures
| Measure |
Exenatide
n=34 Participants
Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
|
Exenatide Plus Rosiglitazone
n=36 Participants
Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
|
Rosiglitazone
n=34 Participants
Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
|
|---|---|---|---|
|
Change in Fasting Triglycerides
Baseline triglyceride
|
1.56 mmol/L
Standard Error 0.124
|
1.67 mmol/L
Standard Error 0.128
|
1.76 mmol/L
Standard Error 0.138
|
|
Change in Fasting Triglycerides
Ratio (endpoint/baseline) for triglycerides
|
0.861 mmol/L
Standard Error 0.060
|
0.977 mmol/L
Standard Error 0.066
|
0.992 mmol/L
Standard Error 0.069
|
SECONDARY outcome
Timeframe: 20 weeksPopulation: All Patients in Full Analysis Set Who Have Both Baseline and Endpoint Measurement
Change in percent body fat from baseline to week 20, as assessed during an MCT
Outcome measures
| Measure |
Exenatide
n=33 Participants
Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
|
Exenatide Plus Rosiglitazone
n=34 Participants
Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
|
Rosiglitazone
n=32 Participants
Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
|
|---|---|---|---|
|
Change in Percent Body Fat During a Meal Challenge Test (MCT)
Baseline percent body fat
|
33.42 percentage
Standard Error 1.16
|
34.07 percentage
Standard Error 1.15
|
32.50 percentage
Standard Error 1.18
|
|
Change in Percent Body Fat During a Meal Challenge Test (MCT)
Change in percent body fat at week 20
|
-1.40 percentage
Standard Error 1.06
|
-0.347 percentage
Standard Error 1.04
|
-1.18 percentage
Standard Error 1.08
|
SECONDARY outcome
Timeframe: 20 weeksPopulation: All Patients in Full Analysis Set Who Have Both Baseline and Endpoint Measurements
Change in body fat mass form baseline to week 20, as assessed during an MCT
Outcome measures
| Measure |
Exenatide
n=33 Participants
Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
|
Exenatide Plus Rosiglitazone
n=34 Participants
Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
|
Rosiglitazone
n=32 Participants
Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
|
|---|---|---|---|
|
Change in Body Fat Mass During a Meal Challenge Test (MCT)
Baseline body fat mass
|
32.05 kg
Standard Error 1.64
|
32.55 kg
Standard Error 1.62
|
30.54 kg
Standard Error 1.67
|
|
Change in Body Fat Mass During a Meal Challenge Test (MCT)
Change in body fat mass at week 20
|
-2.76 kg
Standard Error 1.37
|
-1.06 kg
Standard Error 1.35
|
-1.99 kg
Standard Error 1.40
|
SECONDARY outcome
Timeframe: 20 weeksPopulation: All Patients in Full Analysis Set Who Have Both Baseline and Endpoint Measurements
Change in lean body mass from baseline to week 20, as assessed during an MCT
Outcome measures
| Measure |
Exenatide
n=33 Participants
Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
|
Exenatide Plus Rosiglitazone
n=34 Participants
Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
|
Rosiglitazone
n=32 Participants
Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
|
|---|---|---|---|
|
Change in Lean Body Mass During a Meal Challenge Test (MCT)
Baseline lean body mass
|
64.62 kg
Standard Error 2.11
|
60.94 kg
Standard Error 2.08
|
61.09 kg
Standard Error 2.14
|
|
Change in Lean Body Mass During a Meal Challenge Test (MCT)
Change in lean body mass at week 20
|
-2.99 kg
Standard Error 1.39
|
0.532 kg
Standard Error 1.37
|
1.23 kg
Standard Error 1.41
|
SECONDARY outcome
Timeframe: 20 weeksPopulation: All Patients Who Have Both Baseline and At Least One Post Baseline Value in Full Analysis Set
Change in waist circumference from baseline to week 20
Outcome measures
| Measure |
Exenatide
n=33 Participants
Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
|
Exenatide Plus Rosiglitazone
n=35 Participants
Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
|
Rosiglitazone
n=33 Participants
Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
|
|---|---|---|---|
|
Change in Waist Circumference
Baseline waist circumference
|
105.98 cm
Standard Error 1.68
|
106.85 cm
Standard Error 1.67
|
105.34 cm
Standard Error 1.67
|
|
Change in Waist Circumference
Change in waist circumference at Week 20
|
-2.95 cm
Standard Error 0.975
|
-2.38 cm
Standard Error 0.955
|
-0.225 cm
Standard Error 0.969
|
SECONDARY outcome
Timeframe: 20 weeksPopulation: All Patients Who Have Both Baseline and At Least One Post Baseline Value in Full Analysis Set
Change in hip circumference form baseline to week 20
Outcome measures
| Measure |
Exenatide
n=33 Participants
Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
|
Exenatide Plus Rosiglitazone
n=35 Participants
Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
|
Rosiglitazone
n=33 Participants
Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
|
|---|---|---|---|
|
Change in Hip Circumference
Baseline hip circumference
|
113.29 cm
Standard Error 1.71
|
112.12 cm
Standard Error 1.69
|
111.90 cm
Standard Error 1.69
|
|
Change in Hip Circumference
Change in hip circumference at week 20
|
-1.28 cm
Standard Error 0.848
|
0.147 cm
Standard Error 0.827
|
1.51 cm
Standard Error 0.838
|
SECONDARY outcome
Timeframe: 20 weeksPopulation: All Patients Who Have Both Baseline and At Least One Post Baseline Value in Full Analysis Set
Change in waist-to-hip ratio (waist circumference divided by hip circumference) from baseline to week 20
Outcome measures
| Measure |
Exenatide
n=33 Participants
Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
|
Exenatide Plus Rosiglitazone
n=35 Participants
Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
|
Rosiglitazone
n=33 Participants
Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
|
|---|---|---|---|
|
Change in Waist-to-hip Ratio
Baseline waist-to-hip ratio
|
0.939 ratio (cm/cm)
Standard Error 0.012
|
0.957 ratio (cm/cm)
Standard Error 0.012
|
0.943 ratio (cm/cm)
Standard Error 0.012
|
|
Change in Waist-to-hip Ratio
Change in waist-to-hip ratio at week 20
|
-0.016 ratio (cm/cm)
Standard Error 0.011
|
-0.022 ratio (cm/cm)
Standard Error 0.010
|
-0.016 ratio (cm/cm)
Standard Error 0.011
|
SECONDARY outcome
Timeframe: 20 weeksPopulation: Full Analysis Set
Number of subjects experiencing hypoglycemia at any point during the study
Outcome measures
| Measure |
Exenatide
n=45 Participants
Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
|
Exenatide Plus Rosiglitazone
n=47 Participants
Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
|
Rosiglitazone
n=45 Participants
Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
|
|---|---|---|---|
|
Incidence of Hypoglycemia Events
|
8 participants
|
9 participants
|
6 participants
|
SECONDARY outcome
Timeframe: 20 weeksPopulation: Full Analysis Set
Average number of episodes of hypoglycemia per 30 days per patient
Outcome measures
| Measure |
Exenatide
n=45 Participants
Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
|
Exenatide Plus Rosiglitazone
n=47 Participants
Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
|
Rosiglitazone
n=45 Participants
Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
|
|---|---|---|---|
|
Hypoglycemia Rate Per 30 Days Per Patient
|
0.391 hypoglycemia events / 30 days / patient
Standard Deviation 0.298
|
0.594 hypoglycemia events / 30 days / patient
Standard Deviation 0.436
|
0.853 hypoglycemia events / 30 days / patient
Standard Deviation 1.05
|
SECONDARY outcome
Timeframe: 20 weeksPopulation: Full Analysis Set
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: 1. Slight pitting, no visible distortion, disappears rapidly 2. A somewhat deeper pit than in 1+, but again no readily detectable distortion, and it disappears in 10 - 15 seconds 3. The pit is noticeably deep and may last more than a minute; the dependent extremity looks fuller and swollen 4. The pit is very deep, lasts as long as 2 - 5 minutes, and the dependent extremity is grossly distorted
Outcome measures
| Measure |
Exenatide
n=44 Participants
Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
|
Exenatide Plus Rosiglitazone
n=45 Participants
Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
|
Rosiglitazone
n=44 Participants
Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
|
|---|---|---|---|
|
Pedal Edema Score
No edema
|
37 participants
|
34 participants
|
30 participants
|
|
Pedal Edema Score
Edema score: 1+
|
7 participants
|
11 participants
|
14 participants
|
|
Pedal Edema Score
Edema score: 2+
|
1 participants
|
3 participants
|
6 participants
|
|
Pedal Edema Score
Edema score: 3+
|
0 participants
|
0 participants
|
1 participants
|
Adverse Events
Exenatide
Serious events: 3 serious events
Other events: 35 other events
Deaths: 0 deaths
Exenatide Plus Rosiglitazone
Serious events: 4 serious events
Other events: 41 other events
Deaths: 0 deaths
Rosiglitazone
Serious events: 4 serious events
Other events: 33 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
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.
|
|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/45
|
2.1%
1/47
|
0.00%
0/45
|
|
Infections and infestations
Cellulitis
|
0.00%
0/45
|
0.00%
0/47
|
2.2%
1/45
|
|
Musculoskeletal and connective tissue disorders
Chest pain
|
2.2%
1/45
|
0.00%
0/47
|
0.00%
0/45
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/45
|
2.1%
1/47
|
0.00%
0/45
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/45
|
0.00%
0/47
|
2.2%
1/45
|
|
Infections and infestations
Gastroenteritis
|
2.2%
1/45
|
0.00%
0/47
|
0.00%
0/45
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/45
|
0.00%
0/47
|
2.2%
1/45
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.2%
1/45
|
0.00%
0/47
|
0.00%
0/45
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
2.2%
1/45
|
0.00%
0/47
|
0.00%
0/45
|
|
Infections and infestations
Helicobacter gastritis
|
2.2%
1/45
|
0.00%
0/47
|
0.00%
0/45
|
|
Psychiatric disorders
Major depression
|
0.00%
0/45
|
2.1%
1/47
|
0.00%
0/45
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/45
|
0.00%
0/47
|
2.2%
1/45
|
|
Infections and infestations
Otitis externa
|
0.00%
0/45
|
2.1%
1/47
|
0.00%
0/45
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/45
|
0.00%
0/47
|
2.2%
1/45
|
|
Infections and infestations
Staphylococcal infection
|
2.2%
1/45
|
0.00%
0/47
|
0.00%
0/45
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/45
|
2.1%
1/47
|
0.00%
0/45
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/45
|
0.00%
0/47
|
2.2%
1/45
|
Other adverse events
| Measure |
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.
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
46.7%
21/45
|
46.8%
22/47
|
4.4%
2/45
|
|
Gastrointestinal disorders
Vomiting
|
22.2%
10/45
|
19.1%
9/47
|
0.00%
0/45
|
|
Nervous system disorders
Dizziness
|
13.3%
6/45
|
14.9%
7/47
|
6.7%
3/45
|
|
General disorders
Oedema peripheral
|
4.4%
2/45
|
10.6%
5/47
|
20.0%
9/45
|
|
Gastrointestinal disorders
Diarrhoea
|
6.7%
3/45
|
21.3%
10/47
|
4.4%
2/45
|
|
Nervous system disorders
Headache
|
11.1%
5/45
|
8.5%
4/47
|
6.7%
3/45
|
|
Injury, poisoning and procedural complications
Contusion
|
6.7%
3/45
|
10.6%
5/47
|
4.4%
2/45
|
|
General disorders
Fatigue
|
11.1%
5/45
|
2.1%
1/47
|
4.4%
2/45
|
|
Infections and infestations
Upper respiratory tract infection
|
6.7%
3/45
|
2.1%
1/47
|
8.9%
4/45
|
|
General disorders
Injection site bruising
|
6.7%
3/45
|
8.5%
4/47
|
0.00%
0/45
|
|
General disorders
Asthenia
|
4.4%
2/45
|
6.4%
3/47
|
2.2%
1/45
|
|
Blood and lymphatic system disorders
Anaemia
|
2.2%
1/45
|
2.1%
1/47
|
6.7%
3/45
|
|
Gastrointestinal disorders
Constipation
|
4.4%
2/45
|
6.4%
3/47
|
0.00%
0/45
|
|
Gastrointestinal disorders
Flatulence
|
4.4%
2/45
|
6.4%
3/47
|
0.00%
0/45
|
|
General disorders
Hunger
|
6.7%
3/45
|
2.1%
1/47
|
0.00%
0/45
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.7%
3/45
|
2.1%
1/47
|
0.00%
0/45
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
2.2%
1/45
|
0.00%
0/47
|
6.7%
3/45
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/45
|
0.00%
0/47
|
6.7%
3/45
|
|
General disorders
Oedema
|
0.00%
0/45
|
0.00%
0/47
|
6.7%
3/45
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60