A Study of Tirzepatide (LY3298176) Versus Placebo in Participants With Type 2 Diabetes Inadequately Controlled on Insulin Glargine With or Without Metformin

Completed · Phase 3 · Has a placebo group

Conditions studied: Type 2 Diabetes

In brief

The purpose of this study is to compare the safety and efficacy of the study drug tirzepatide to placebo in participants with type 2 diabetes that are already on insulin glargine, with or without metformin. Participants will administer tirzepatide or placebo along with their previous glucose lowering medications. The study will last approximately 47 weeks and may include about 23 visits.

Key facts

Study ID: NCT04039503
Run by: Eli Lilly and Company
People needed: 475
Starts: 2019-08-30
Expected to finish: 2021-01-13
Last updated by the study team: 2022-01-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Have been diagnosed with type 2 diabetes mellitus (T2DM) and have been treated with insulin glargine (U100), once daily with or without metformin ≥3 months prior to screening visit.
Have HbA1c between ≥7.0% and ≤10.5%.
Have a stable weight (± 5%) for at least 3 months before screening.
Have a body mass index (BMI) ≥23 kilograms per meter squared (kg/m²) at screening.

You may not qualify if…

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 [for participants on metformin, estimated glomerular filtration rate <45 mL/min/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 weight loss drugs, including over-the-counter medications during the last 3 months.

Where it is running

Valley Endocrine, Fresno — Fresno, California, United States
Sun Coast Clinical Research, Inc — New Port Richey, Florida, United States
Southern New Hampshire Diabetes and Endocrinology — Nashua, New Hampshire, United States
Manhattan Medical Research — New York, New York, United States
Intend Research — Norman, Oklahoma, United States
Milan Kvapil s.r.o. — Příbram, Central Bohemia, Czechia
Diacentrum Brandys n.L. s.r.o. — Brandys Nad Labem-Stara Bolesl, Czechia
Diabetologicka ordinace pro dospele — Krnov, Czechia
Diahelp s.r.o., Interni a diabetologicka ambulance — Pardubice, Czechia
Lekarna Dr. Max — Prague, Czechia
Milan Kvapil s.r.o. — Prague, Czechia
RESTRIAL s.r.o. — Prague, Czechia
Praxis Dr. Jörg Lüdemann — Falkensee, Brandenburg, Germany
Arztpraxis Dr. Cornelia Marck — Pohlheim, Hesse, Germany
InnoDiab Forschung GmbH — Essen, North Rhine-Westphalia, Germany
Institut für Diabetesforschung Münster GmbH — Münster, North Rhine-Westphalia, Germany
Praxis Dr. Kempe - Dr. Stemler — Ludwigshafen am Rhein, Rhineland-Palatinate, Germany
Schwerpunktpraxis Diabetes — Saint Ingbert-Oberwürzbach, Saarland, Germany
SMO.MD GmbH — Magdeburg, Saxony-Anhalt, Germany
RED-Institut GmbH — Oldenburg in Holstein, Schleswig-Holstein, Germany
Diabetologische Schwerpunktpraxis B. Scholz/Dr. B. Paschen — Hamburg, Germany
Gemeinschaftspraxis für innere Medizin und Diabetologie — Hamburg, Germany
Kashiwa hospital — Kashiwa, Chiba, Japan
Manda Hospital — Sapporo, Hokkaido, Japan
Takai Naika Clinic — Kamakura, Kanagawa, Japan

Full record on ClinicalTrials.gov

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