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
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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

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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

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1. Primary:

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

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2. Secondary:

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

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3. Secondary:

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

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4. Secondary:

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

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5. Secondary:

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

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6. Secondary:

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

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7. Secondary:

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

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8. Secondary:

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

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9. Secondary:

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

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10. Secondary:

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

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11. Secondary:

Change in HbA1c [ Week 20 ]

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12. Secondary:

Change in Fasting Serum Glucose Concentration. [ Week 20 ]

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13. Secondary:

Change in Fasting C-peptide [ Week 20 ]

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14. Secondary:

Change in Fasting Insulin [ Week 20 ]

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15. Secondary:

Change in Fasting Proinsulin [ Week 20 ]

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16. Secondary:

Change in Body Weight [ Week 20 ]

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17. Secondary:

Change in Fasting Total Cholesterol. [ Week 20 ]

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18. Secondary:

Change in Fasting HDL Cholesterol [ Week 20 ]

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19. Secondary:

Change in Fasting LDL Cholesterol [ Week 20 ]

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20. Secondary:

Change in Fasting Triglycerides [ Week 20 ]

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21. Secondary:

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

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22. Secondary:

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

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23. Secondary:

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

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24. Secondary:

Change in Waist Circumference [ 20 weeks ]

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25. Secondary:

Change in Hip Circumference [ 20 weeks ]

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26. Secondary:

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

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27. Secondary:

Incidence of Hypoglycemia Events [ 20 weeks ]

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28. Secondary:

Hypoglycemia Rate Per 30 Days Per Patient [ 20 weeks ]

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29. Secondary:

Pedal Edema Score [ 20 weeks ]

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Serious Adverse Events

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Other Adverse Events

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Time Frame	No text entered.
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	≥5%

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.

Other Adverse Events

	Exenatide	Exenatide Plus Rosiglitazone	Rosiglitazone
Total, other (not including serious) adverse events
# participants affected	35	41	33
Blood and lymphatic system disorders
Anaemia ^†^A # participants affected / at risk	1/45 (2.22%)	1/47 (2.13%)	3/45 (6.67%)
Gastrointestinal disorders
Nausea ^†^A # participants affected / at risk	21/45 (46.67%)	22/47 (46.81%)	2/45 (4.44%)
Vomiting ^†^A # participants affected / at risk	10/45 (22.22%)	9/47 (19.15%)	0/45 (0.00%)
Diarrhoea ^†^A # participants affected / at risk	3/45 (6.67%)	10/47 (21.28%)	2/45 (4.44%)
Constipation ^†^A # participants affected / at risk	2/45 (4.44%)	3/47 (6.38%)	0/45 (0.00%)
Flatulence ^†^A # participants affected / at risk	2/45 (4.44%)	3/47 (6.38%)	0/45 (0.00%)
General disorders
Oedema peripheral ^†^A # participants affected / at risk	2/45 (4.44%)	5/47 (10.64%)	9/45 (20.00%)
Fatigue ^†^A # participants affected / at risk	5/45 (11.11%)	1/47 (2.13%)	2/45 (4.44%)
Injection site bruising ^†^A # participants affected / at risk	3/45 (6.67%)	4/47 (8.51%)	0/45 (0.00%)
Asthenia ^†^A # participants affected / at risk	2/45 (4.44%)	3/47 (6.38%)	1/45 (2.22%)
Hunger ^†^A # participants affected / at risk	3/45 (6.67%)	1/47 (2.13%)	0/45 (0.00%)
Oedema ^†^A # participants affected / at risk	0/45 (0.00%)	0/47 (0.00%)	3/45 (6.67%)
Infections and infestations
Upper respiratory tract infection ^†^A # participants affected / at risk	3/45 (6.67%)	1/47 (2.13%)	4/45 (8.89%)
Diverticulitis ^†^A # participants affected / at risk	0/45 (0.00%)	0/47 (0.00%)	3/45 (6.67%)
Injury, poisoning and procedural complications
Contusion ^†^A # participants affected / at risk	3/45 (6.67%)	5/47 (10.64%)	2/45 (4.44%)
Nervous system disorders
Dizziness ^†^A # participants affected / at risk	6/45 (13.33%)	7/47 (14.89%)	3/45 (6.67%)
Headache ^†^A # participants affected / at risk	5/45 (11.11%)	4/47 (8.51%)	3/45 (6.67%)
Respiratory, thoracic and mediastinal disorders
Nasal congestion ^†^A # participants affected / at risk	3/45 (6.67%)	1/47 (2.13%)	0/45 (0.00%)
Pharyngolaryngeal pain ^†^A # participants affected / at risk	1/45 (2.22%)	0/47 (0.00%)	3/45 (6.67%)

^†	Indicates events were collected by systematic assessment.
^A	Term from vocabulary, MedDRA 11.0

More Information

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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