Effects of Exenatide and Insulin Glargine in Subjects With Type 2 Diabetes

This study has been completed.

Study NCT00097500 Information provided by Amylin Pharmaceuticals, Inc.

First Received on November 24, 2004. Last Updated on December 24, 2010 History of Changes

Results First Received: December 24, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Type 2 Diabetes Mellitus
Interventions:	Drug: exenatide Drug: Insulin glargine

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Exenatide Arm	5 mcg twice a day for 4 weeks, followed by 10 mcg twice a day for 8 weeks. After 12 weeks, exenatide is titrated (up to a maximum of 20 mcg three times a day) based on periodic glycosylated hemoglobin (HbA1c) measurements and tolerability.
Insulin Glargine Arm	Dosing starts at 10 IU/day, and is then titrated, based on daily fasting blood glucose measurements.

Participant Flow for 2 periods

Period 1: On-drug Period (Week 0 to Week 52)

	Exenatide Arm	Insulin Glargine Arm
STARTED	36	33
COMPLETED	30 ^[1]	30 ^[1]
NOT COMPLETED	6	3
Withdrawal of consent	1	1
Adverse Event	5	0
Physician Decision	0	1
Lost to Follow-up	0	1

[1]	Subjects experiencing loss of glucose control after Week 52 are considered to have completed study.

Period 2: Off-drug Period (Week 52 to Week 64)

	Exenatide Arm	Insulin Glargine Arm
STARTED	30	30
COMPLETED	25	26
NOT COMPLETED	5	4
Withdrawal of consent	2	1
Physician Decision	0	1
Loss of glucose control	3	2

Baseline Characteristics

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Reporting Groups

	Description
Exenatide Arm	5 mcg twice a day for 4 weeks, followed by 10 mcg twice a day for 8 weeks. After 12 weeks, exenatide is titrated (up to a maximum of 20 mcg three times a day) based on periodic glycosylated hemoglobin (HbA1c) measurements and tolerability.
Insulin Glargine Arm	Dosing starts at 10 IU/day, and is then titrated, based on daily fasting blood glucose measurements.

Baseline Measures

	Exenatide Arm	Insulin Glargine Arm	Total
Number of Participants [units: participants]	36	33	69
Age [units: years] Mean ± Standard Deviation	58.4 ± 8.4	58.3 ± 7.3	58.4 ± 7.8
Gender [units: participants]
Female	13	11	24
Male	23	22	45
Body Mass Index (BMI) [units: kg/m^2] Mean ± Standard Deviation	30.87 ± 4.15	30.13 ± 3.49	30.52 ± 3.84
Body weight [units: kg] Mean ± Standard Deviation	90.56 ± 12.66	92.39 ± 13.56	91.44 ± 13.03
Glycosylated hemoglobin (HbA1c) [units: percentage] Mean ± Standard Deviation	7.58 ± 0.89	7.41 ± 0.81	7.50 ± 0.85
Duration of diabetes [units: years] Mean ± Standard Deviation	5.72 ± 4.70	3.97 ± 3.62	4.88 ± 4.28

Outcome Measures

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1. Primary:

Beta-cell Function After 52 Weeks of Therapy [ Time Frame: Baseline (week -2) and 52 weeks ]

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2. Secondary:

Beta-cell Function 4 Weeks After Cessation of Therapy [ Time Frame: Baseline (week -2) and 56 weeks ]

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3. Secondary:

Change in First Phase C-peptide Release [ Time Frame: baseline (week -2), 52 weeks, and 56 weeks ]

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4. Secondary:

Change in Second Phase C-peptide Release [ Time Frame: baseline (-2 weeks), 52 weeks, and 56 weeks ]

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5. Secondary:

Change in Glycosylated Hemoglobin (HbA1c) [ Time Frame: Week 0 and week 52 ]

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6. Secondary:

Change in Fasting Plasma Glucose [ Time Frame: 0 weeks and 52 weeks ]

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7. Secondary:

Seven Point Self Monitored Blood Glucose (SMBG) Measurements [ Time Frame: 0 weeks and 52 weeks ]

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8. Secondary:

Change in Body Weight [ Time Frame: 0 weeks and 52 weeks ]

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9. Secondary:

M-value at Baseline, Week 52 and Week 56 [ Time Frame: baseline (week -2), 52 weeks, and 56 weeks ]

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Serious Adverse Events

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Other Adverse Events

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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
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Results Point of Contact:

Name/Title: Vice President, Research and Development
Organization: Amylin Pharmaceuticals, Inc.
e-mail: clinicaltrials@amylin.com

No publications provided by Amylin Pharmaceuticals, Inc.

Publications automatically indexed to this study:

Bunck MC, Cornér A, Eliasson B, Heine RJ, Shaginian RM, Taskinen MR, Smith U, Yki-Järvinen H, Diamant M. Effects of exenatide on measures of ?-cell function after 3 years in metformin-treated patients with type 2 diabetes. Diabetes Care. 2011 Sep;34(9):2041-7.

Bunck MC, Cornér A, Eliasson B, Heine RJ, Shaginian RM, Wu Y, Yan P, Smith U, Yki-Järvinen H, Diamant M, Taskinen MR. One-year treatment with exenatide vs. insulin glargine: effects on postprandial glycemia, lipid profiles, and oxidative stress. Atherosclerosis. 2010 Sep;212(1):223-9. Epub 2010 Apr 29.

Responsible Party:	Vice President, Research and Development, MD, Study Director, Amylin Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00097500 History of Changes
Other Study ID Numbers:	2993-114
Study First Received:	November 24, 2004
Results First Received:	December 24, 2010
Last Updated:	December 24, 2010
Health Authority:	United States: Food and Drug Administration Finland: Finnish Medicines Agency Netherlands: Medicines Evaluation Board (MEB) Sweden: Medical Products Agency