A Study of LY3502970 in Participants With Type 2 Diabetes Mellitus
- Registration Number
- NCT05048719
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
The main purpose of this study is to evaluate the efficacy and safety of LY3502970 in participants with type 2 diabetes (T2D) who failed to achieve adequate glycemic control on diet and exercise alone or on a stable dose of metformin. This study will last about 30 weeks.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 383
- Have been diagnosed with Type 2 Diabetes on diet and exercise and/or a stable dose of metformin
- Have a stable body weight for the 3 months prior to randomization
- Have a body mass index (BMI) ≥23 kilogram/square meter (kg/m²)
- Males must agree to use highly effective methods of contraception
- Women not of childbearing potential (WNOCBP) may participate in this trial
- Note: Hormone replacement therapy in post-menopausal women is allowed but women must be on stable therapy for 3 months prior to day 1.
- Have Type 1 diabetes mellitus (T1DM) or history of ketoacidosis or hyperosmolar coma
- Have a history of diabetic retinopathy, diabetic maculopathy, or severe non-proliferative diabetic retinopathy that requires immediate treatment intervention
- Have had more than 1 episode of severe hypoglycemia and aware of hypoglycemic symptoms
- Have acute or chronic pancreatitis
- Have obesity induced other endocrine disorders (Cushing's syndrome or Prader - Willi syndrome)
- Have gastric emptying abnormality or chronically take medications impacting GI motility
- Have poorly controlled hypertension
- Have the following heart conditions within the last 6 months: myocardial infarction (MI), unstable angina, coronary artery bypass graft, percutaneous coronary intervention (diagnostic angiograms are permitted), transient ischemic attack (TIA), cerebrovascular accident (stroke)or decompensated congestive heart failure, or IV heart failure
- Have any symptoms of other liver diseases besides nonalcoholic fatty liver disease (NAFLD)
- Have HIV, or Hepatitis B or Hepatitis C
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 3 milligrams (mg) LY3502970 LY3502970 Participants received maintenance dose of 3 mg with dose escalation starting from 2 mg LY3502970 administered orally once daily (QD). 24 mg LY3502970 LY3502970 Participants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally QD. 36 mg LY3502970 - 1 LY3502970 Participants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 administered orally QD. 36 mg LY3502970 - 2 LY3502970 Participants received maintenance dose 36 mg with dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 administered orally QD. 45 mg LY3502970 - 1 LY3502970 Participants received maintenance dose 45 mg with dose escalation starting from 3 mg, 6 mg, 8 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 administered orally QD. 1.5 mg Dulaglutide Dulaglutide Participants received 1.5 mg Dulaglutide administered subcutaneously (SC) once weekly (QW). Placebo Placebo Participants received matching placebo. 12 mg LY3502970 LY3502970 Participants received maintenance dose 12 mg with dose escalation starting from 2 mg, 6 mg and then 12 mg LY3502970 administered orally QD. 45 mg LY3502970 - 2 LY3502970 Participants received maintenance dose 45 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 administered orally QD.
- Primary Outcome Measures
Name Time Method Change From Baseline in HbA1c in LY3502970 as Compared to Placebo Baseline, Week 26 HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured 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 + Country + Baseline HbA1c Group (\<=8.0%, \>8.0%) + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
- Secondary Outcome Measures
Name Time Method Change From Baseline in HbA1c in LY3502970 as Compared to Dulaglutide Baseline, Week 26 HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured 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 + Country + Baseline HbA1c Group (\<=8.0%, \>8.0%) + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Percentage of Participants With HbA1c ≤ 6.5% Week 26 Percentage of Participants with HbA1c ≤ 6.5%. Odds ratio was calculated using logistic regression model.
Percentage of Participants With HbA1c <7.0% Week 26 Percentage of Participants with HbA1c \<7.0%. Odds ratio was calculated using logistic regression model.
Change From Baseline in Fasting Serum Glucose Baseline, Week 26 Fasting glucose is a test to determine sugar levels in blood sample after an overnight fast. LS mean was determined by MMRM model with Baseline + Country + Baseline HbA1c Group (\<=8.0%, 8.0%) + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Pharmacokinetics (PK): Steady State Area Under the Concentration Curve (AUC) of LY3502970 Pre-dose (Week (wk) 0, wk 8, wk 12, and wk 26); Post-dose (wk 4, wk 8, wk 16, wk 20, and end of treatment). PK: Steady State AUC of LY3502970
Change From Baseline in Body Weight Baseline, Week 26 LS mean was determined by MMRM model with Baseline + Country + Baseline HbA1c Group (\<=8.0%, \>8.0%) + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Trial Locations
- Locations (44)
MEDI-DIA s.r.o.
🇸🇰Sabinov, Prešovský Kraj, Slovakia
Funkystuff
🇸🇰Nove Zamky, Slovakia
Cotton O'Neil Clinical Research Center
🇺🇸Topeka, Kansas, United States
Anaheim Clinical Trials, LLC
🇺🇸Anaheim, California, United States
Capital Area Research, LLC
🇺🇸Camp Hill, Pennsylvania, United States
Clinvest Research LLC
🇺🇸Springfield, Missouri, United States
Touro University California
🇺🇸Vallejo, California, United States
New West Physicians Clinical Research
🇺🇸Golden, Colorado, United States
Intend Research, LLC
🇺🇸Norman, Oklahoma, United States
BRCR Global Puerto Rico-Unda
🇵🇷San Juan, Puerto Rico
Dallas Diabetes Research Center
🇺🇸Dallas, Texas, United States
Eastside Research Associates
🇺🇸Redmond, Washington, United States
Bugát Pál Kórház
🇭🇺Gyongyos, Heves, Hungary
Kanizsai Dorottya Korhaz
🇭🇺Nagykanizsa, Zala, Hungary
TRANTOR'99 Bt. Anyagcsere Centrum
🇭🇺Budapest, Hungary
Wojewódzki Zespól Specjalistycznej Opieki Zdrowotnej
🇵🇱Wrocław, Dolnośląskie, Poland
Velocity Clinical Research, Westlake
🇺🇸Los Angeles, California, United States
Velocity Clinical Research, Huntington Park
🇺🇸Huntington Park, California, United States
Rancho Cucamonga Clinical Research
🇺🇸Rancho Cucamonga, California, United States
Optumcare Colorado Springs - Monument
🇺🇸Monument, Colorado, United States
Family Medical Associates
🇺🇸Levittown, Pennsylvania, United States
Premier Research
🇺🇸Trenton, New Jersey, United States
Tristar Clinical Investigations
🇺🇸Philadelphia, Pennsylvania, United States
Biopharma Informatic, LLC
🇺🇸Houston, Texas, United States
Capital Clinical Research Center
🇺🇸Olympia, Washington, United States
Bandera Family Health Care
🇺🇸San Antonio, Texas, United States
Szent Margit Rendelőintézet Nonprofit Kft
🇭🇺Budapest, Hungary
Clinexpert Kft.
🇭🇺Budapest, Hungary
Zala Megyei Szent Rafael Kórház
🇭🇺Zalaegerszeg, Zala, Hungary
ClinDiab Kft.
🇭🇺Budapest, Hungary
Strazsahegy Medicina Bt.
🇭🇺Budapest, Hungary
Gabinety TERPA
🇵🇱Lublin, Lubelskie, Poland
NZOZ Medica
🇵🇱Lublin, Lubelskie, Poland
Centrum Zdrowia Tuchów
🇵🇱Wierzchosławice, Małopolskie, Poland
Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna
🇵🇱Lodz, Łódzkie, Poland
Centralny Szpital Kliniczny MSWiA w Warszawie
🇵🇱Warszawa, Mazowieckie, Poland
NZOZ Przychodnia Specjalistyczna Andrzej Wittek, Henryk Rudzki
🇵🇱Ruda Slaska, Śląskie, Poland
Ambulancia diabetológie a porúch látkovej premeny a výživy - DIABEDA
🇸🇰Bratislava, Bratislavský Kraj, Slovakia
Dorado Medical Complex
🇵🇷Dorado, Puerto Rico
Clinical Research Management Group Inc. - Hospital San Cristobal
🇵🇷Ponce, Puerto Rico
Diabetol
🇸🇰Prešov, Prešovský Kraj, Slovakia
DIA-MED CENTRUM s.r.o.
🇸🇰Puchov, Trenčiansky Kraj, Slovakia
Consano Clinical Research, LLC
🇺🇸Shavano Park, Texas, United States
Centrum Badan Klinicznych PI-House sp. z o.o.
🇵🇱Gdansk, Pomorskie, Poland