A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes Not Controlled With Diet and Exercise Alone
- Registration Number
- NCT03954834
- Lead Sponsor
- Eli Lilly and Company
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 478
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Participants received placebo as subcutaneous injection once a week. 15 mg Tirzepatide Tirzepatide Participants received 15mg of tirzepatide as subcutaneous injection once a week. 5 mg Tirzepatide Tirzepatide Participants received 5 milligrams (mg) of tirzepatide as subcutaneous injection once a week. 10 mg Tirzepatide Tirzepatide Participants received 10mg of tirzepatide as subcutaneous injection once a week.
- Primary Outcome Measures
Name Time Method Change From Baseline in Hemoglobin A1c (HbA1c) Baseline, Week 40 HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Pooled Country + Prior Use of oral antihyperglycemic medication (OAM) (Yes, No) + Treatment + Time + Treatment\*Time (Type III sum of squares).
- Secondary Outcome Measures
Name Time Method Percentage of Participants With HbA1c Target Value of <5.7% Week 40 Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.
Mean Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG) Values Baseline, Week 40 The self-monitored plasma glucose (SMBG) data were collected at the following 7 time points: Morning Premeal - Fasting, Morning 2-hour Postmeal, Midday Premeal, Midday 2-hour Postmeal, Evening Premeal, Evening 2-hour Postmeal and Bedtime. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Pooled Country + Baseline HbA1c Group (\<=8.5%, \>8.5%) + Prior Use of OAM (Yes, No) + Treatment + Time + Treatment\*Time (Type III sum of squares).
Rate of Hypoglycemia With Blood Glucose <54 Milligram/Deciliter (mg/dL) [<3.0 Millimole/Liter (mmol/L)] or Severe Hypoglycemia Baseline through end of safety follow-up (up to week 44) The hypoglycemia events were defined by participant reported events with blood glucose \<54mg/dL) (\<3.0 mmol/L\] or severe hypoglycemia. Severe hypoglycemia is defined as an episode with severe cognitive impairment requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. These episodes may be associated with sufficient neuroglycopenia to induce seizure or coma. The rate of postbaseline hypoglycemia was estimated by negative binomial model: number of episodes = Pooled Country + Baseline HbA1c Group (\<=8.5%, \>8.5%) + Prior Use of OAM (Yes, No) + Treatment, with log (exposure in days/365.25) as an offset variable.
Percentage of Participants Who Achieved Weight Loss ≥5% Week 40 Percentage of Participants who Achieved Weight Loss ≥5%.
Change From Baseline in Body Weight Baseline, Week 40 Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Pooled Country + Baseline HbA1c Group (\<=8.5%, \>8.5%) + Prior Use of OAM (Yes, No) + Treatment + Time + Treatment\*Time (Type III sum of squares).
Percentage of Participants With HbA1c Target Value of <7% Week 40 Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.
Change From Baseline in Fasting Serum Glucose Baseline, Week 40 Fasting serum glucose (FSG) is a test to determine sugar levels in serum sample after an overnight fast. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Pooled Country + Baseline HbA1c Group (\<=8.5%, \>8.5%) + Prior Use of OAM (Yes, No) + Treatment + Time + Treatment\*Time (Type III sum of squares).
Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) of Tirzepatide Week 7, 15 and 23 Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) of Tirzepatide. AUC is a combined measure obtained from Week 7, 15 and 23, and a single averaged measure of AUC was reported.
Trial Locations
- Locations (50)
BSES Municipal General Hsptl
🇮🇳Mumbai, Maharashtra, India
Meiwa Hospital
🇯🇵Chiyodaku, Tokyo, Japan
Tokyo Center Clinic
🇯🇵Chuo-ku, Tokyo, Japan
Sato Naika Clinic
🇯🇵Ota-ku, Tokyo, Japan
IHL Shinagawa East One Medical Clinic
🇯🇵Minato-ku, Tokyo, Japan
Lifepoint Multispecialty Hsptl
🇮🇳Wakad, Pune, India
GCM Medical Group PSC
🇵🇷San Juan, Puerto Rico
Ramdevrao Hospital
🇮🇳Hyderabad, Telangana, India
Suncoast Research Group, LLC
🇺🇸Miami, Florida, United States
Encore Medical Research, LLC
🇺🇸Hollywood, Florida, United States
Aventiv Research
🇺🇸Columbus, Ohio, United States
Capital Clinical Research Center
🇺🇸Olympia, Washington, United States
Southern California Dermatology
🇺🇸Santa Ana, California, United States
Sky Clinical Research Network
🇺🇸Atlanta, Georgia, United States
Clinical Research of South Florida
🇺🇸Coral Gables, Florida, United States
Gandhi Hospital
🇮🇳Telangana, India
Valley Clinical Trials, Inc.
🇺🇸Northridge, California, United States
Agile Clinical Research Trials
🇺🇸Atlanta, Georgia, United States
Preferred Primary Care Physicians
🇺🇸Uniontown, Pennsylvania, United States
StudyMetrix Research, LLC
🇺🇸Saint Peters, Missouri, United States
Minamiakatsuka Clinic
🇯🇵Mito, Ibaraki, Japan
Cotton O'Neil Clinic
🇺🇸Topeka, Kansas, United States
Bangalore Medical College and Research Institute
🇮🇳Bangalore, Karnataka, India
Tsuruma Kaneshiro Diabetes Clinic
🇯🇵Yamato, Kanagawa, Japan
Takai Naika Clinic
🇯🇵Kamakura, Kanagawa, Japan
M S Ramaiah Medical College Hospital
🇮🇳Bangalore, Karnataka, India
Unidad Medica para la Salud Integral (UMSI)
🇲🇽Monterrey, Nuevo León, Mexico
Intend Research
🇺🇸Norman, Oklahoma, United States
South Florida Wellness & Clinical Research Institute
🇺🇸Margate, Florida, United States
Axcess Medical Research
🇺🇸Loxahatchee Groves, Florida, United States
Consano Clinical Research
🇺🇸Shavano Park, Texas, United States
National Research Institute
🇺🇸Panorama City, California, United States
Dallas Diabetes Endocrine Center
🇺🇸Dallas, Texas, United States
Rockwood Clinic Research Center
🇺🇸Spokane, Washington, United States
Dr. Jivraj Mehta Smarak Health Foundation
🇮🇳Ahmedabad, Gujarat, India
Tokyo-Eki Center-building Clinic
🇯🇵Chuo-ku, Tokyo, Japan
Clinical Research Puerto Rico, Inc.
🇵🇷San Juan, Puerto Rico
Investigacion en Salud y Metabolismo S.C
🇲🇽Chihuahua, Mexico
Catalina Research Institute, LLC
🇺🇸Montclair, California, United States
Clinical Research Professionals
🇺🇸Chesterfield, Missouri, United States
Yokohama Minoru Clinic
🇯🇵Yokohama, Kanagawa, Japan
Heritage Valley Medical Group, Inc.
🇺🇸Beaver, Pennsylvania, United States
The Corvallis Clinic P.C.
🇺🇸Corvallis, Oregon, United States
Takatsuki Red Cross Hospital
🇯🇵Takatsuki, Osaka, Japan
Family Medical Associates
🇺🇸Levittown, Pennsylvania, United States
Centro de Estudios de Investigacion Metabolicos y Cardiovasc
🇲🇽Madero, Tamaulipas, Mexico
Ruby Hall Clinic and Grant Medical Foundation
🇮🇳Pune, Maharashtra, India
Vijay Vallabh Hospital
🇮🇳Virar, Maharashtra, India
Hospital Universitario UANL
🇲🇽Monterrey, Nuevo León, Mexico
Clinical Trials of Texas, Inc.
🇺🇸San Antonio, Texas, United States