A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes Not Controlled With Diet and Exercise Alone - SURPASS-1

Jul 13, 2021
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Eli Lilly and Company
Date Published:
06/26/2021
Date Updated:
07/13/2021
Original Posted Date:
07/13/2021
References

Contribution To Literature:

The SURPASS-1 trial showed that tirzepatide was beneficial at improving glycemic control and weight loss in type 2 diabetes. 

Description:

The goal of the trial was to evaluate the dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide 1 (GLP-1) receptor agonist tirzepatide compared with placebo among patients with type 2 diabetes.

Study Design

  • Randomized
  • Parallel
  • Placebo
  • Blinded
  • Stratified

Patients with type 2 diabetes inadequately controlled with diet and exercise were randomized to tirzepatide (n = 363) versus placebo (n = 115). Participants assigned to tirzepatide were randomized to 5 mg, 10 mg, or 15 mg.

  • Total number of enrollees: 478
  • Duration of follow-up: 40 weeks
  • Mean patient age: 54 years
  • Percentage female: 48%
  • Percentage with diabetes: 100%

Inclusion criteria:

  • Participants ≥18 years of age with type 2 diabetes
  • Naïve to injectable diabetes therapy
  • Glycated hemoglobin 7%-8.5%
  • Body mass index ≥23 kg/m2

Exclusion criteria:

Type 1 diabetes, history of pancreatitis, history of diabetic retinopathy, diabetic maculopathy, estimated glomerular filtration rate <30 ml/min/1.73 m², and use of an oral diabetes medication for the prior 3 months

Principal Findings:

The primary outcome, change in mean glycated hemoglobin from baseline, was -1.87% in the tirzepatide 5 mg group, -1.89% in the tirzepatide 10 mg group, -2.07% in the tirzepatide 20 mg group, compared with 0.04% in the placebo group (p < 0.0001 for each group vs. placebo).

Secondary outcomes:

  • Change in weight from baseline: -7.0 kg in the tirzepatide 5 mg group, -7.8 kg in the tirzepatide 10 mg group, -9.5 kg in the tirzepatide 20 mg group, compared with -0.7 kg in the placebo group (p < 0.0001 for each group vs. placebo)
  • Serious adverse events: 4% in the tirzepatide 5 mg group, 2% in the tirzepatide 10 mg group, 1% in the tirzepatide 20 mg group, compared with 3% in the placebo group

Interpretation:

Among patients with type 2 diabetes inadequately controlled with diet and exercise, tirzepatide was beneficial. Tirzepatide is a GIP and GLP-1 receptor agonist. Tirzepatide compared with placebo resulted in improvements in glycemic control and weight loss. Serious adverse events were similar between the treatment groups.

References:

Rosenstock J, Wysham C, Frías JP, et al. Efficacy and safety of a novel dual GIP and GLP-1 receptor agonist tirzepatide in patients with type 2 diabetes (SURPASS-1): a double-blind, randomized, phase 3 trial. Lancet 2021;398:143-55.

Clinical Topics: Diabetes and Cardiometabolic Disease, Prevention, Diet, Exercise

Keywords: Diabetes Mellitus, Type 2, Diet, Exercise, Glucagon-Like Peptide 1, Glucose, Glycated Hemoglobin A, Glycemic Index, Metabolic Syndrome, Primary Prevention, Weight Loss


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