An Evaluation of Exenatide and Rosiglitazone in Subjects With Type 2 Diabetes Mellitus - Study Results

Study Type:	Interventional
Study Design:	Randomized, Open Label, Active Control, Parallel Assignment
Condition:	Diabetes Mellitus, Type 2
Interventions:	Drug: exenatide Drug: rosiglitazone

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

Show All Outcome Measures

1. Primary:

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

Show Outcome Measure 1

2. Secondary:

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

Show Outcome Measure 2

3. Secondary:

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

Show Outcome Measure 3

4. Secondary:

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

Show Outcome Measure 4

5. Secondary:

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

Show Outcome Measure 5

6. Secondary:

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

Show Outcome Measure 6

7. Secondary:

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

Show Outcome Measure 7

8. Secondary:

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

Show Outcome Measure 8

9. Secondary:

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

Show Outcome Measure 9

10. Secondary:

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

Show Outcome Measure 10

11. Secondary:

Change in HbA1c [ Week 20 ]

Show Outcome Measure 11

12. Secondary:

Change in Fasting Serum Glucose Concentration. [ Week 20 ]

Show Outcome Measure 12

13. Secondary:

Change in Fasting C-peptide [ Week 20 ]

Show Outcome Measure 13

14. Secondary:

Change in Fasting Insulin [ Week 20 ]

Show Outcome Measure 14

15. Secondary:

Change in Fasting Proinsulin [ Week 20 ]

Show Outcome Measure 15

16. Secondary:

Change in Body Weight [ Week 20 ]

Show Outcome Measure 16

17. Secondary:

Change in Fasting Total Cholesterol. [ Week 20 ]

Show Outcome Measure 17

18. Secondary:

Change in Fasting HDL Cholesterol [ Week 20 ]

Show Outcome Measure 18

19. Secondary:

Change in Fasting LDL Cholesterol [ Week 20 ]

Show Outcome Measure 19

20. Secondary:

Change in Fasting Triglycerides [ Week 20 ]

Show Outcome Measure 20

21. Secondary:

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

Show Outcome Measure 21

22. Secondary:

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

Show Outcome Measure 22

23. Secondary:

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

Show Outcome Measure 23

24. Secondary:

Change in Waist Circumference [ 20 weeks ]

Show Outcome Measure 24

25. Secondary:

Change in Hip Circumference [ 20 weeks ]

Show Outcome Measure 25

26. Secondary:

Change in Waist-to-hip Ratio [ 20 weeks ]

Show Outcome Measure 26

27. Secondary:

Incidence of Hypoglycemia Events [ 20 weeks ]

Show Outcome Measure 27

28. Secondary:

Hypoglycemia Rate Per 30 Days Per Patient [ 20 weeks ]

Hide Outcome Measure 28

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 ]

Show Outcome Measure 29

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:

	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.
	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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	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