How Glargine Insulin, Oral Diabetes Medications and Exenatide May Improve Blood Sugar Control and Weight Gain in Type 2 Diabetics (MEXELIN)

This study has been completed.

Sponsor:

Collaborators:

Amylin Pharmaceuticals, LLC.

Eli Lilly and Company

Information provided by (Responsible Party):

Matthew C. Riddle, Oregon Health and Science University

ClinicalTrials.gov Identifier:

NCT00667732

First received: April 24, 2008

Last updated: February 4, 2013

Last verified: February 2013

History of Changes

Results First Received: December 11, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Double Blind (Subject, Caregiver, Investigator); Primary Purpose: Treatment
Condition:	Type 2 Diabetes
Interventions:	Drug: exenatide Drug: placebo

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
Recruitment: March 2007 - February 2009 Participant source: medical clinics, local communities

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
There were 8 weeks of open-label exenatide use before enrollment into the randomized portion of the study to ensure patients ability to tolerate medication before adding insulin to the medication regimen.

Reporting Groups

	Description
Run-In Group	All participants took exenatide twice daily in addition to their Metformin dose. A subset of participants agreed to a substudy (20 pts) and had a glucose and metabolic profile done at this time.
Exenatide Group	After run-in participants were randomized to exenatide. exenatide : 5mcg twice a day, increasing to 10mcg twice a day for 24 weeks metformin: continued at same dose participant entered study on. Lantus Insulin: titrated per protocol depending on blood sugar levels In extension period, participants continued regular regimen with open label exenatide
Placebo Group	After run-in participants were randomized to placebo. placebo : 5mcg twice a day, increased to 10mcg twice a day for 24 weeks metformin: continued at same dose participant entered study on. Lantus Insulin: titrated per protocol depending on blood sugar levels In extension period, participants continued regular regimen with open label exenatide instead of placebo

Description

Run-In Group

All participants took exenatide twice daily in addition to their Metformin dose.

A subset of participants agreed to a substudy (20 pts) and had a glucose and metabolic profile done at this time.

Exenatide Group

After run-in participants were randomized to exenatide.

exenatide : 5mcg twice a day, increasing to 10mcg twice a day for 24 weeks

metformin: continued at same dose participant entered study on.

Lantus Insulin: titrated per protocol depending on blood sugar levels

In extension period, participants continued regular regimen with open label exenatide

Placebo Group

After run-in participants were randomized to placebo.

placebo : 5mcg twice a day, increased to 10mcg twice a day for 24 weeks

metformin: continued at same dose participant entered study on.

Lantus Insulin: titrated per protocol depending on blood sugar levels

In extension period, participants continued regular regimen with open label exenatide instead of placebo

Participant Flow for 3 periods

Period 1: Run -In (8 Weeks)

	Run-In Group	Exenatide Group	Placebo Group
STARTED	41	0	0
Participants Enrolled in Substudy	20	0	0
COMPLETED	34	0	0
NOT COMPLETED	7	0	0
Adverse Event	4	0	0
Withdrawal by Subject	3	0	0

Period 2: Randomization (24 Weeks)

	Exenatide Group	Placebo Group
STARTED	17	17
Participants Enrolled in Substudy	11	9
COMPLETED	16	17
NOT COMPLETED	1	0
Withdrawal by Subject	1	0

Period 3: Extension (26 Weeks)

	Exenatide Group	Placebo Group
STARTED	14	17
COMPLETED	14	17
NOT COMPLETED	0	0

Baseline Characteristics

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Reporting Groups

	Description
Exenatide Group	Participants will receive exenatide as part of their diabetes treatment exenatide : 5mcg twice a day, increasing to 10mcg twice a day for 24 weeks
Placebo Group	Participants will receive placebo rather than exenatide as part of their diabetes treatment placebo : 5mcg twice a day, increased to 10mcg twice a day for 24 weeks
Total	Total of all reporting groups

Description

Exenatide Group

Participants will receive exenatide as part of their diabetes treatment

exenatide : 5mcg twice a day, increasing to 10mcg twice a day for 24 weeks

Placebo Group

Participants will receive placebo rather than exenatide as part of their diabetes treatment

placebo : 5mcg twice a day, increased to 10mcg twice a day for 24 weeks

Total

Total of all reporting groups

Baseline Measures

	Exenatide Group	Placebo Group	Total
Number of Participants [units: participants]	17	17	34
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	15	15	30
>=65 years	2	2	4
Gender [units: participants]
Female	9	11	20
Male	8	6	14

Outcome Measures

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1. Primary:

The Percentage of Intent to Treat Participants Randomized and Treated in Each Arm Who Had Lab-measured A1c <6.5% at 24 Weeks of Treatment [ Time Frame: After 24 weeks of randomized treatment ]

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2. Secondary:

The Percentage of Per Protocol Participants Randomized and Treated in Each Arm Who Had Lab-measured A1c <6.5% at 24 Weeks of Treatment [ Time Frame: After 24 weeks of randomized treatment ]

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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
No text entered.

Results Point of Contact:

Name/Title: Dr. Matthew Riddle
Organization: Oregon Health and Science University
phone: 503-494-0557
e-mail: riddlem@ohsu.edu

No publications provided

Responsible Party:	Matthew C. Riddle, Oregon Health and Science University
ClinicalTrials.gov Identifier:	NCT00667732 History of Changes
Other Study ID Numbers:	IND 75,235
Study First Received:	April 24, 2008
Results First Received:	December 11, 2012
Last Updated:	February 4, 2013
Health Authority:	United States: Institutional Review Board

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