Clinical trial NCT03954834: A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes Not Controlled With Diet and Exercise Alone
Official title: A Randomized, Double-blind, Placebo-Controlled Trial Comparing the Efficacy and Safety of Three Tirzepatide Doses Versus Placebo in Patients With Type 2 Diabetes, Inadequately Controlled With Diet and Exercise Alone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Keywords: glucose-dependent insulinotropic polypeptide (GIP)
glucagon-like peptide-1 (GLP-1)
GIP/GLP-1 dual receptor agonist
T2DM
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2019-05-17
Enrollment: 478
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal for this study is to evaluate the efficacy and safety of tirzepatide versus placebo in participants with type 2 diabetes not under control with diet and exercise alone. The study will last approximately 47 weeks and may include about 15 visits.


Eligibility criteria: Inclusion Criteria:

* Have been diagnosed with type 2 diabetes mellitus (T2DM).
* Are naïve to diabetes injectable therapies and have not used any oral antihyperglycemic medications (OAMs) during the 3 months preceding screening.
* Have HbA1c between ≥7.0% and ≤9.5%.
* Be of stable weight (± 5%) for at least 3 months before screening.
* Have a BMI ≥23 kilograms per meter squared (kg/m²) at screening.

Exclusion Criteria:

* 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 an estimated glomerular filtration rate \<30 mL/minute/1.73 m².
* 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 weight loss drugs, including over-the-counter medications during the last 3 months.

Primary outcomes:
measure: Change From Baseline in Hemoglobin A1c (HbA1c)
timeFrame: Baseline, Week 40
Secondary outcomes:
measure: Change From Baseline in Body Weight
timeFrame: Baseline, Week 40
measure: Percentage of Participants With HbA1c Target Value of <7%
timeFrame: Week 40
measure: Change From Baseline in Fasting Serum Glucose
timeFrame: Baseline, Week 40
measure: Percentage of Participants With HbA1c Target Value of <5.7%
timeFrame: Week 40
measure: Mean Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG) Values
timeFrame: Baseline, Week 40
measure: Percentage of Participants Who Achieved Weight Loss ≥5%
timeFrame: Week 40
measure: Rate of Hypoglycemia With Blood Glucose <54 Milligram/Deciliter (mg/dL) [<3.0 Millimole/Liter (mmol/L)] or Severe Hypoglycemia
timeFrame: Baseline through end of safety follow-up (up to week 44)
measure: Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) of Tirzepatide
timeFrame: Week 7, 15 and 23
Other outcomes:
Locations:
city: Huntington Park
country: United States
facility: National Research Institute
state: California
city: Los Angeles
country: United States
facility: National Research Institute
state: California
city: Montclair
country: United States
facility: Catalina Research Institute, LLC
state: California
city: Northridge
country: United States
facility: Valley Clinical Trials, Inc.
state: California
city: Panorama City
country: United States
facility: National Research Institute
state: California
city: Santa Ana
country: United States
facility: Southern California Dermatology
state: California
city: Coral Gables
country: United States
facility: Clinical Research of South Florida
state: Florida
city: Hollywood
country: United States
facility: Encore Medical Research, LLC
state: Florida
city: Loxahatchee Groves
country: United States
facility: Axcess Medical Research
state: Florida
city: Margate
country: United States
facility: South Florida Wellness & Clinical Research Institute
state: Florida
city: Miami
country: United States
facility: Suncoast Research Group, LLC
state: Florida
city: Atlanta
country: United States
facility: Agile Clinical Research Trials
state: Georgia
city: Atlanta
country: United States
facility: Sky Clinical Research Network
state: Georgia
city: Topeka
country: United States
facility: Cotton O'Neil Clinic
state: Kansas
city: Chesterfield
country: United States
facility: Clinical Research Professionals
state: Missouri
city: Saint Peters
country: United States
facility: StudyMetrix Research, LLC
state: Missouri
city: Columbus
country: United States
facility: Aventiv Research
state: Ohio
city: Norman
country: United States
facility: Intend Research
state: Oklahoma
city: Corvallis
country: United States
facility: The Corvallis Clinic P.C.
state: Oregon
city: Beaver
country: United States
facility: Heritage Valley Medical Group, Inc.
state: Pennsylvania
city: Levittown
country: United States
facility: Family Medical Associates
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Preferred Primary Care Physicians
state: Pennsylvania
city: Uniontown
country: United States
facility: Preferred Primary Care Physicians
state: Pennsylvania
city: Dallas
country: United States
facility: Dallas Diabetes Endocrine Center
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc.
state: Texas
city: Shavano Park
country: United States
facility: Consano Clinical Research
state: Texas
city: Olympia
country: United States
facility: Capital Clinical Research Center
state: Washington
city: Spokane
country: United States
facility: Rockwood Clinic Research Center
state: Washington
city: Ahmedabad
country: India
facility: Dr. Jivraj Mehta Smarak Health Foundation
state: Gujarat
city: Bangalore
country: India
facility: Bangalore Medical College and Research Institute
state: Karnataka
city: Bangalore
country: India
facility: M S Ramaiah Medical College Hospital
state: Karnataka
city: Mumbai
country: India
facility: BSES Municipal General Hsptl
state: Maharashtra
city: Pune
country: India
facility: Ruby Hall Clinic and Grant Medical Foundation
state: Maharashtra
city: Virar
country: India
facility: Vijay Vallabh Hospital
state: Maharashtra
city: Wakad
country: India
facility: Lifepoint Multispecialty Hsptl
state: Pune
city: Hyderabad
country: India
facility: Ramdevrao Hospital
state: Telangana
city: Telangana
country: India
facility: Gandhi Hospital
city: Mito
country: Japan
facility: Minamiakatsuka Clinic
state: Ibaraki
city: Kamakura
country: Japan
facility: Takai Naika Clinic
state: Kanagawa
city: Yamato
country: Japan
facility: Tsuruma Kaneshiro Diabetes Clinic
state: Kanagawa
city: Yokohama
country: Japan
facility: Yokohama Minoru Clinic
state: Kanagawa
city: Takatsuki
country: Japan
facility: Takatsuki Red Cross Hospital
state: Osaka
city: Chiyodaku
country: Japan
facility: Meiwa Hospital
state: Tokyo
city: Chuo-ku
country: Japan
facility: Tokyo-Eki Center-building Clinic
state: Tokyo
city: Chuo-ku
country: Japan
facility: Tokyo Center Clinic
state: Tokyo
city: Minato-ku
country: Japan
facility: IHL Shinagawa East One Medical Clinic
state: Tokyo
city: Ota-ku
country: Japan
facility: Sato Naika Clinic
state: Tokyo
city: Monterrey
country: Mexico
facility: Hospital Universitario UANL
state: Nuevo León
city: Monterrey
country: Mexico
facility: Unidad Medica para la Salud Integral (UMSI)
state: Nuevo León
city: Madero
country: Mexico
facility: Centro de Estudios de Investigacion Metabolicos y Cardiovasc
state: Tamaulipas
city: Chihuahua
country: Mexico
facility: Investigacion en Salud y Metabolismo S.C
city: San Juan
country: Puerto Rico
facility: Clinical Research Puerto Rico, Inc.
city: San Juan
country: Puerto Rico
facility: GCM Medical Group PSC
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
citation: Sattar N, McGuire DK, Pavo I, Weerakkody GJ, Nishiyama H, Wiese RJ, Zoungas S. Tirzepatide cardiovascular event risk assessment: a pre-specified meta-analysis. Nat Med. 2022 Mar;28(3):591-598. doi: 10.1038/s41591-022-01707-4. Epub 2022 Feb 24.
citation: Rosenstock J, Wysham C, Frias JP, Kaneko S, Lee CJ, Fernandez Lando L, Mao H, Cui X, Karanikas CA, Thieu VT. Efficacy and safety of a novel dual GIP and GLP-1 receptor agonist tirzepatide in patients with type 2 diabetes (SURPASS-1): a double-blind, randomised, phase 3 trial. Lancet. 2021 Jul 10;398(10295):143-155. doi: 10.1016/S0140-6736(21)01324-6. Epub 2021 Jun 27.