A Study of LY3502970 in Participants With Type 2 Diabetes Mellitus

Type 2 Diabetes Clinical Trial

Official title:

A Phase 2 Study of Once-Daily LY3502970 Compared With Placebo and Once-Weekly Dulaglutide in Participants With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05048719
• Other study ID #: 17787
• Secondary ID: J2A-MC-GZGE2021-
• Status: Completed
• Phase: Phase 2
• Start date: September 15, 2021
• Est. completion date: September 30, 2022

Study information

• Verified date: September 2023
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 383
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• LY3502970
Administered orally
• Dulaglutide
Administered subcutaneously
• Placebo
Administered orally
• Placebo
Administered subcutaneously

Locations

Country	Name	City	State
Hungary	ClinDiab Kft.	Budapest
Hungary	Clinexpert Kft.	Budapest
Hungary	Strazsahegy Medicina Bt.	Budapest
Hungary	Szent Margit Rendelointézet Nonprofit Kft	Budapest
Hungary	TRANTOR'99 Bt. Anyagcsere Centrum	Budapest
Hungary	Bugát Pál Kórház	Gyongyos	Heves
Hungary	Kanizsai Dorottya Korhaz	Nagykanizsa	Zala
Hungary	Zala Megyei Szent Rafael Kórház	Zalaegerszeg	Zala
Poland	Centrum Badan Klinicznych PI-House sp. z o.o.	Gdansk	Pomorskie
Poland	Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna	Lodz	Lódzkie
Poland	Gabinety TERPA	Lublin	Lubelskie
Poland	NZOZ Medica	Lublin	Lubelskie
Poland	NZOZ Przychodnia Specjalistyczna Andrzej Wittek, Henryk Rudzki	Ruda Slaska	Slaskie
Poland	Centralny Szpital Kliniczny MSWiA w Warszawie	Warszawa	Mazowieckie
Poland	Centrum Zdrowia Tuchów	Wierzchoslawice	Malopolskie
Poland	Wojewódzki Zespól Specjalistycznej Opieki Zdrowotnej	Wroclaw	Dolnoslaskie
Puerto Rico	Dorado Medical Complex	Dorado
Puerto Rico	Clinical Research Management Group Inc. - Hospital San Cristobal	Ponce
Puerto Rico	BRCR Global Puerto Rico-Unda	San Juan
Slovakia	Ambulancia diabetológie a porúch látkovej premeny a výživy - DIABEDA	Bratislava	Bratislavský Kraj
Slovakia	Funkystuff	Nove Zamky
Slovakia	Diabetol	Prešov	Prešovský Kraj
Slovakia	DIA-MED CENTRUM s.r.o.	Puchov	Trenciansky Kraj
Slovakia	MEDI-DIA s.r.o.	Sabinov	Prešovský Kraj
United States	Anaheim Clinical Trials, LLC	Anaheim	California
United States	Capital Area Research, LLC	Camp Hill	Pennsylvania
United States	Dallas Diabetes Research Center	Dallas	Texas
United States	New West Physicians Clinical Research	Golden	Colorado
United States	Biopharma Informatic, LLC	Houston	Texas
United States	Velocity Clinical Research, Huntington Park	Huntington Park	California
United States	Family Medical Associates	Levittown	Pennsylvania
United States	Velocity Clinical Research, Westlake	Los Angeles	California
United States	Optumcare Colorado Springs - Monument	Monument	Colorado
United States	Intend Research, LLC	Norman	Oklahoma
United States	Capital Clinical Research Center	Olympia	Washington
United States	Tristar Clinical Investigations	Philadelphia	Pennsylvania
United States	Rancho Cucamonga Clinical Research	Rancho Cucamonga	California
United States	Eastside Research Associates	Redmond	Washington
United States	Bandera Family Health Care	San Antonio	Texas
United States	Consano Clinical Research, LLC	Shavano Park	Texas
United States	Clinvest Research LLC	Springfield	Missouri
United States	Cotton O'Neil Clinical Research Center	Topeka	Kansas
United States	Premier Research	Trenton	New Jersey
United States	Touro University California	Vallejo	California

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Hungary,  Poland,  Puerto Rico,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in HbA1c in LY3502970 as Compared to Placebo	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.	Baseline, Week 26
Secondary	Change From Baseline in HbA1c in LY3502970 as Compared to Dulaglutide	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.	Baseline, Week 26
Secondary	Percentage of Participants With HbA1c = 6.5%	Percentage of Participants with HbA1c = 6.5%. Odds ratio was calculated using logistic regression model.	Week 26
Secondary	Percentage of Participants With HbA1c <7.0%	Percentage of Participants with HbA1c <7.0%. Odds ratio was calculated using logistic regression model.	Week 26
Secondary	Change From Baseline in Fasting Serum Glucose	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.	Baseline, Week 26
Secondary	Change From Baseline in Body Weight	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.	Baseline, Week 26
Secondary	Pharmacokinetics (PK): Steady State Area Under the Concentration Curve (AUC) of LY3502970	PK: Steady State 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).