Clinical Trial Details

NCT ID: NCT03131687
Date Last Changed: September 28, 2017

Overview

Research Study Summary

Patients are needed to participate in a clinical research study of LY3298176, Dulaglutide and Placebo to evaluate Type 2 Diabetes Mellitus

Research Study Title

A Phase 2 Study of Once-Weekly LY3298176 Compared With Placebo and Dulaglutide in Patients With Type 2 Diabetes Mellitus

Purpose

The purpose of this study is to evaluate the efficacy of the study drug LY3298176 in participants with type 2 diabetes mellitus.

To Learn more

Recruitment Details

Phase
2
Gender
All
Age
18 to 75 Years
Overall Status
Recruiting
Lead Sponsor
Eli Lilly and Company
Duration
12 Months
Facility Type
N/A
Compensation

Eligibility

All ages 18 Years to 75 Years

Inclusion Criteria:

  • Have had type 2 diabetes (T2D) for ≥6 months according to the World Health Organization (WHO) classification.

  • Have HbA1c of 7.0% to 10.5%, inclusive, as assessed by the central laboratory.

  • If on metformin, have been treated with stable doses of metformin for at least 3 months.

  • Have a body mass index (BMI) ≥23 and < 50 kilograms per square meter.

Exclusion Criteria:

  • Have type 1 diabetes (T1D).

  • Have used any glucose-lowering medication other than metformin within 3 months prior to study entry or during screening/lead-in period or have used any glucagon-like peptide-1 receptor agonists (GLP-1 RAs) at any time in the past.

  • Have had any of the following cardiovascular conditions: acute myocardial infarction (MI), New York Heart Association Class III or Class IV heart failure, or cerebrovascular accident (stroke).

  • Have acute or chronic hepatitis, signs and symptoms of any other liver disease other than nonalcoholic fatty liver disease (NAFLD), or alanine aminotransferase (ALT) level

2.5 times the upper limit of the reference range, as determined by the central laboratory at study entry; participants with NAFLD are eligible for participation in this trial.

  • Have had chronic or acute pancreatitis any time prior to study entry.

  • Have an estimated glomerular filtration rate (eGFR) < 45 milliliters/minute/1.73 square meter, calculated by the Chronic Kidney Disease-Epidemiology (CKD-EPI) equation.

  • Have serum calcitonin ≥20 picograms per milliliter, as determined by the central laboratory at study entry.

  • Have any condition that is a contraindication for use of the GLP-1 RA class (per country-specific labels) at study entry or develop such condition between study entry and randomization.

Site Locations (43)

Country State City Zip Facility and Contact
United States Alabama Mobile 36608 Internal Medicine Center LLC
251-410-3046

Allan Shain
Principal Investigator
United States California Anaheim 92801 Anaheim Clinical Trails
714-774-7777

Amina Haggag
Principal Investigator
United States California Fresno 93720 Valley Research
559-261-0992

Paul Norwood
Principal Investigator
United States California Huntington Park 90255 National Research Institute
323-357-3633

Stanley Hsia
Principal Investigator
United States California Los Angeles 90057 National Research Institute
213-413-2500

Juan Frias
Principal Investigator
United States California Montclair 91763 Catalina Research Institute
909-445-8451

Gilbert Martinez
Principal Investigator
United States California Northridge 91325 Valley Clinical Trails, Inc
818-280-4220

Christopher Chow
Principal Investigator
United States California San Diego 92103 Artemis Institute For Clinical Research
858-278-3647

Purvi Mehra
Principal Investigator
United States California San Marcos 92078 Artemis Institute For Clinical Research
760-266-4144

Stacey Layle
Principal Investigator
United States California Spring Valley 91978 Encompass Clinical Research
619-660-9068

Hanid Audish
Principal Investigator
United States California Tustin 92780 University Clinical Investigators INC
714-760-9317

Joanna Van
Principal Investigator
United States Connecticut Waterbury 06708 Chase Medical Research
203-419-4420

Joseph Soufer
Principal Investigator
United States Florida Coral Gables 33134 Clinical Research of South Florida
305-445-5637

Jeffrey Rosen
Principal Investigator
United States Florida Jacksonville 32216 East Coast Institute For Research
904-244-3088

Mae Sheikh- Ali
Principal Investigator
United States Florida Miami 33135 Suncoast Research Group, LCC
305-631-6704

Mark Kutner
Principal Investigator
United States Florida Miami 33175 New Horizon Research Center
305-226-3933

Francisco Miranda
Principal Investigator
United States Florida Ocoee 34761 Sensible Healthcare
407-654-2724

Kelly Taylor
Principal Investigator
United States Florida Palm Harbor 34684 Palm Harbor Medical Associate
727-785-4540

Aron Schlau
Principal Investigator
United States Idaho Meridian 83646 Solaris Clinical Research
208-288-0123

David Butuk
Principal Investigator
United States Iowa West Des Moines 50265 Iderc P.L.C.
515-643-5122

Anuj Bhargava
Principal Investigator
United States Kansas Topeka 66606 Cotton o'Neil Diabetes and Endocrin
785-368-0490

Alan Wynne
Principal Investigator
United States Massachusetts Methuen 01844 ActivMed Practices & Research
978-655-7155

Michael McCartney
Principal Investigator
United States Missouri Saint Louis 63141 Clinical Research Professionals
636-220-1200

Timothy Jennings
Principal Investigator
United States Nevada Las Vegas 89128 Palm Research Center
702-826-2795

Samer Nakhle
Principal Investigator
United States New Jersey Trenton 08611 Premier Research
609-392-6666

Jane Rohlf
Principal Investigator
United States New York New York 10016 Manhattan Medical Research
212-480-3333

Susan Zweig
Principal Investigator
United States North Dakota Fargo 58103 Lillestol Research LLC
701-232-7705

Michael Lillestol
Principal Investigator
United States Ohio Columbus 43213 Aventiv Research
614-501-6164

Samir Arora
Principal Investigator
United States Oregon Corvallis 97330 The Corvallis Clinic P.C.
541-754-1398

Michael Chen
Principal Investigator
United States South Carolina Moncks Corner 29461 PMG Research Of Charleston LLC
843-849-1880

Gordon Wilhoit
Principal Investigator
United States Tennessee Knoxville 37909 New Phase Research & Development
865-200-8364

Evelyne Davidson
Principal Investigator
United States Tennessee Knoxville 37938 PMG Research Of Knoxville
865-244-4276

Rickey Manning
Principal Investigator
United States Texas Dallas 75230 Dallas Diabetes Endocrine Center
972-566-7799

Julio Rosenstock
Principal Investigator
United States Texas Shavano Park 78231 Consano Clinical Research
210-545-4900

Michelle Welch
Principal Investigator
United States Utah Saint George 84790 Chrysalis Clinical Research
435-656-1704

Scott Barton
Principal Investigator
Puerto Rico Manati 00674 Manati Center for Clinical Research
7878541779

Ramon Ortiz- Carrasquillo
Principal Investigator
Puerto Rico San Juan 00909 Clinical Research Puerto Rico. Inc
7877235945

Sonia Vwlazquez- Navarro
Principal Investigator
Puerto Rico San Juan 00909 GCM Medical Group PSC
7877268396

Gregorio Cortes- Maisonet
Principal Investigator
Slovakia Košice 04012 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Eli Lilly and Company
Slovakia Malacky 90101 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Eli Lilly and Company
Slovakia Púchov 02001 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Eli Lilly and Company
Slovakia Trenčín 91101 "For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician."
Eli Lilly and Company
Slovakia Trenčín 91101 For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
Eli Lilly and Company

Contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
E-mail:

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