A Study of Tirzepatide (LY3298176) Versus Placebo in Participants With Type 2 Diabetes Inadequately Controlled on Insulin Glargine With or Without Metformin (SURPASS-5)

Lilly

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes

Treatments: Drug: Placebo; Drug: Tirzepatide

Study type: Interventional

Funder types: Industry

Identifiers

NCT04039503

I8F-MC-GPGI (Other Identifier)

2019-000860-99 (EudraCT Number)

16998

Details and patient eligibility

About

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.

Enrollment: 475 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

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 [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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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475 participants in 4 patient groups, including a placebo group

5 mg Tirzepatide

Experimental group

Description:

5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.

Treatment:

Drug: Tirzepatide

10 mg Tirzepatide

Experimental group

Description:

10 mg tirzepatide administered SC once a week.

Treatment:

Drug: Tirzepatide

15 mg Tirzepatide

Experimental group

Description:

15 mg tirzepatide administered SC once a week.

Treatment:

Drug: Tirzepatide

Placebo

Placebo Comparator group

Description:

Placebo administered SC once a week.

Treatment:

Drug: Placebo