Study Details

General Information

Lilly GBDE

A Randomized, Open-Label, Parallel-Arm Study Comparing the Effect of Once-Weekly Dulaglutide with Once-Daily Liraglutide in Patients with Type 2 Diabetes (AWARD-6: Assessment of Weekly AdminstRation of LY2189265 in Diabetes – 6)

ProtocolH9X-MC-GBDE
IdentifierH9X-MC-GBDE Site Number 103
UID24e0eb21-1044-4b8a-9eb6-6f4dbd568766
StatusDone - Archived
Phase3b
CategoryDiabetes Type 2 / Adult
Launch Year2012
NCT Number-
Created2012-05-15 16:18
Last Updated2012-05-15 16:18

Description

Key Elements: • Study purpose: To demonstrate that once-weekly dulaglutide 1.5 mg is noninferior to once-daily liraglutide 1.8 mg in patients who are on monotherapy metformin (>1,500 mg daily) • Study drug: Dulaglutide is novel, long-acting GLP-1 analogue, administered once-weekly subcutaneously. GLP-1s have been shown to help reduce weight, have a positive impact on cardiovascular outcomes, and even help lower blood pressure. The most common side effect of GLP-1 has been mild-to-moderate gastrointestinal issues; nausea, vomiting, diarrhea. • 11 visits (33 weeks/8 months) • Stipend: $42 per visit • HbA1c >7.0% to <10.0%

Comment

No comment.

Target Dates

NameDateRequired
Enrollment Closed2013-04-09No
Enrollment OpenNo
First Patient First VisitNo
Site Initiation Mtg.2012-07-10No
PI Meeting StartNo
PI Meeting EndNo
PI Meeting ArrivalNo
PI Meeting DepartureNo
Closeout Date2014-03-10No
Final PatientVisitNo
PreStudy Selection VisitNo
Target Date 12No
Target Date 13No
Target Date 14No

Leadership

RoleStaffLoginRequired
PrincipalUnger, JeffreyJUngerNo
Recruiter-No
CoordinatorSoler, DanielDSolerNo
RegulatoryAguirre, SandraSAguirreNo

Custom Fields

No custom fields.

Sponsor & Organization

SponsorEli Lilly and Company
DivisionLilly
TeamLilly
Managing SiteCatalina Research Institute, LLC
Organization

Contacts

IRB RefIRB ID NO. 201203978
CROPharmanet
CRO RefCRA: Ramulfo Zapanta, Jr. Tel 818-472-9038
Correspondence0

Opportunity

Probability0
Comment
Status ColorGainsboro
Currency-
Mayra Sibley

2 Hours

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You

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My name is Anne Clarc.
Mayra Sibley

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