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