A Study of Tirzepatide (LY3298176) Compared to Dulaglutide in Participants With Type 2 Diabetes (SURPASS J-mono)

Lilly

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes

Treatments: Drug: Dulaglutide; Drug: Tirzepatide

Study type: Interventional

Funder types: Industry

Identifiers

NCT03861052

17077

I8F-JE-GPGO (Other Identifier)

Details and patient eligibility

About

The reason for this study is to see if the study drug tirzepatide (LY3298176) is effective and safe compared to dulaglutide in participants with type 2 diabetes in Japan.

Enrollment: 636 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Participant must:

• Have been diagnosed with type 2 diabetes mellitus based on the World Health Organization classification before the screening visit.

• Have HbA1c meeting the following criteria, as determined by the central laboratory at screening and baseline:

  • for participants who are oral antihyperglycemic medication (OAM)-naïve at screening, ≥7.0% to ≤10.0% at both screening and baseline.
  • for participants who have been taking OAM monotherapy at screening, ≥6.5% to ≤9.0% at screening, and ≥7.0% to ≤10.0% at baseline.

• Have body mass index (BMI) of ≥23 kilograms per meter squared at screening.

• Be of stable weight (±5%) during 3 months preceding screening; and agree to not initiate an intensive diet and/or exercise program during the study with the intent of reducing body weight other than the lifestyle and dietary measures for diabetes treatment.

Exclusion criteria

Participant must not:

• 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 immediate or urgent treatment.
• Have disorders associated with slowed emptying of the stomach, or have had any stomach surgeries for the purpose of weight loss.
• Have acute or chronic hepatitis, signs and symptoms of any other liver disease, or blood alanine transaminase (ALT) enzyme level >3.0 times the upper limit of normal (ULN) for the reference range, as determined by the central laboratory. Participants with nonalcoholic fatty liver disease (NAFLD) are eligible for participation in this trial only if there ALT level is ≤3.0 the ULN for the reference range.
• 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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636 participants in 4 patient groups

5 mg Tirzepatide

Experimental group

Description:

Participants received 5 milligram (mg) tirzepatide administered subcutaneously (SC) once weekly for 52 weeks.

Treatment:

Drug: Tirzepatide

10 mg Tirzepatide

Experimental group

Description:

Participants received 10 mg tirzepatide administered SC once weekly for 52 weeks.

Treatment:

Drug: Tirzepatide

15 mg Tirzepatide

Experimental group

Description:

Participants received 15 mg tirzepatide administered SC once weekly for 52 weeks.

Treatment:

Drug: Tirzepatide

0.75 mg Dulaglutide

Active Comparator group

Description:

Participants received 0.75 mg dulaglutide administered SC once weekly for 52 weeks.

Treatment:

Drug: Dulaglutide