A Study of Tirzepatide (LY3298176) Versus Insulin Degludec in Participants With Type 2 Diabetes



Status:Not yet recruiting
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:4/5/2019
Start Date:April 1, 2019
End Date:November 19, 2020
Contact:There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Email:clinicaltrials.gov@lilly.com
Phone:1-317-615-4559

Use our guide to learn which trials are right for you!

A Randomized, Phase 3, Open-Label Trial Comparing the Effect of LY3298176 Versus Titrated Insulin Degludec on Glycemic Control in Patients With Type 2 Diabetes

The purpose of this study is to compare the effect of the study drug tirzepatide to insulin
degludec on blood sugar levels in participants with type 2 diabetes. The study will last
about 59 weeks and may include up to 22 visits.


Inclusion Criteria:

- Participants must:

- Have been diagnosed with type 2 diabetes mellitus (T2DM)

- Have HbA1c between ≥7.0% and ≤10.5%

- Be on stable treatment with unchanged dose of metformin or metformin plus an
SGLT-2 inhibitor for at least 3 months before screening

- Be of stable weight (± 5%) for at least 3 months before screening

- Have a BMI ≥25 kilograms per meter squared (kg/m2) at screening

Exclusion Criteria:

- Participants must not:

- Have type 1 diabetes mellitus

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

- Have proliferative diabetic retinopathy or diabetic maculopathy or
nonproliferative diabetic retinopathy requiring acute treatment

- Have disorders associated with slowed emptying of the stomach, or have had any
stomach surgeries for the purpose of weight loss

- Have acute or chronic hepatitis, signs and symptoms of any other liver disease,
or blood alanine transaminase (ALT) enzyme level >3.0 times the upper limit of
normal (ULN) for the reference range, as determined by the central laboratory.
Participants with nonalcoholic fatty liver disease (NAFLD) are eligible for
participation in this trial only if there ALT level is ≤3.0 the ULN for the
reference range

- Have an estimated glomerular filtration rate <45 mL/minute/1.73 m2 (or lower than
the country specific threshold for using the protocol required dose of metformin
per local label)

- Have had a heart attack, stroke, or hospitalization for congestive heart failure
in the past 2 months

- Have a personal or family history of medullary thyroid carcinoma or personal
history of multiple endocrine neoplasia syndrome type 2

- Have been taking any other diabetes medicines other than metformin, or metformin
plus an SGLT-2 inhibitor during the last 3 months

- Have been taking weight loss drugs, including over-the-counter medications during
the last 3 months
We found this trial at
34
sites
Troy, Michigan 48098
Principal Investigator: Neil Fraser
Phone: 248-312-0025
?
mi
from
Troy, MI
Click here to add this to my saved trials
11701 San Jose Blvd # 32
Jacksonville, Florida 32223
Principal Investigator: Mae Sheikh-Ali
Phone: 904-854-1354
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
2010 Wilshire Boulevard
Los Angeles, California 90057
213-413-2500
Principal Investigator: Juan P Frias
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
500 Chase Parkway
Waterbury, Connecticut 06708
203-419-4420
Principal Investigator: Joseph Soufer
?
mi
from
Waterbury, CT
Click here to add this to my saved trials
Beaver, Pennsylvania 15009
Principal Investigator: Michael J Oliver
Phone: 724-774-7743
?
mi
from
Beaver, PA
Click here to add this to my saved trials
Blackfoot, Idaho 83221
Principal Investigator: Gary Soucie
Phone: 208-643-0006
?
mi
from
Blackfoot, ID
Click here to add this to my saved trials
Boise, Idaho 83701
Principal Investigator: Sherwin D'Souza
Phone: 208-287-9429
?
mi
from
Boise, ID
Click here to add this to my saved trials
Caba, Buenos Aires
Principal Investigator: Elizabeth Gelersztein
Phone: 541148238701
?
mi
from
Caba,
Click here to add this to my saved trials
Chesterfield, Missouri 63141
Principal Investigator: Timothy W. Jennings
Phone: 636-220-1200
?
mi
from
Chesterfield, MO
Click here to add this to my saved trials
Columbus, Ohio 43213
Principal Investigator: Samir Arora
Phone: 614-501-6164
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Corpus Christi, Texas 78414
Principal Investigator: Osvaldo A Brusco
Phone: 361-885-0448
?
mi
from
Corpus Christi, TX
Click here to add this to my saved trials
Corvallis, Oregon 97330
Principal Investigator: Michael C Chen
Phone: 541-754-1398
?
mi
from
Corvallis, OR
Click here to add this to my saved trials
Fresno, California 93720
Principal Investigator: Paul C Norwood
Phone: 559-261-0992
?
mi
from
Fresno, CA
Click here to add this to my saved trials
Hialeah, Florida 33012
Principal Investigator: Jose Cardona
Phone: 305-825-6588
?
mi
from
Hialeah, FL
Click here to add this to my saved trials
Huntington Park, California 90255
Principal Investigator: Stanley Hsia
Phone: 323-588-1968
?
mi
from
Huntington Park, CA
Click here to add this to my saved trials
Idaho Falls, Idaho 83404
Principal Investigator: Carl D Vance
Phone: 208-542-6005
?
mi
from
Idaho Falls, ID
Click here to add this to my saved trials
Jacksonville, Florida 32204
Principal Investigator: James S Magee
Phone: 904-384-2240
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
1970 North Broad Street
Lansdale, Pennsylvania 19446
Principal Investigator: Evan Kessler
Phone: 215-368-1900
?
mi
from
Lansdale, PA
Click here to add this to my saved trials
Las Vegas, Nevada 89102
Principal Investigator: Betsy M Palal
Phone: 702-736-5163
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
Little Rock, Arkansas 72205
Principal Investigator: Kevin D Roberts
Phone: 501-907-9170
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
Macon, Georgia 31210
Principal Investigator: Thomas C Jones
Phone: 478-746-8626
?
mi
from
Macon, GA
Click here to add this to my saved trials
Metairie, Louisiana 70006
Principal Investigator: Harold Miller
Phone: 985-273-5158
?
mi
from
Metairie, LA
Click here to add this to my saved trials
Minneapolis, Minnesota 55416
Principal Investigator: Thomas Martens
Phone: 952-993-1517
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
Montclair, California 91763
Principal Investigator: Rizwana H. Mohseni
Phone: 909-590-8409
?
mi
from
Montclair, CA
Click here to add this to my saved trials
New Orleans, Louisiana 70121
Principal Investigator: Lawrence Blonde
Phone: 504-894-2863
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
7114 Congress Street
New Port Richey, Florida 34655
Principal Investigator: Tatiana Hernandez Guerrero
Phone: 727-853-1800
?
mi
from
New Port Richey, FL
Click here to add this to my saved trials
Northridge, California 91325
Principal Investigator: Christopher Chow
Phone: 818-280-4220
?
mi
from
Northridge, CA
Click here to add this to my saved trials
2010 Wilshire Boulevard
Panorama City, California 91402
Principal Investigator: Parvin D Syal
Phone: 818-532-6880
?
mi
from
Panorama City, CA
Click here to add this to my saved trials
3200 Tower Oaks Boulevard
Rockville, Maryland 20852
Principal Investigator: Michael Dempsey
Phone: 301-770-7373
?
mi
from
Rockville, MD
Click here to add this to my saved trials
Shavano Park, Texas 78231
Principal Investigator: Michelle Welch
Phone: 210-545-4900
?
mi
from
Shavano Park, TX
Click here to add this to my saved trials
Spring Valley, California 91978
Principal Investigator: Hanid Audish
Phone: 619-660-9068
?
mi
from
Spring Valley, CA
Click here to add this to my saved trials
Springfield, Illinois 62704
Principal Investigator: Frank L Mikell
Phone: 217-787-8870
?
mi
from
Springfield, IL
Click here to add this to my saved trials
Tustin, California 92780
Principal Investigator: Joanna T Van
Phone: 714-734-7944
?
mi
from
Tustin, CA
Click here to add this to my saved trials
Union City, Georgia 30291
Principal Investigator: Dwight Blake
Phone: 888-659-4363
?
mi
from
Union City, GA
Click here to add this to my saved trials