Phase 3 · Tirzepatide

NCT04093752 trial results

A Randomized, Phase 3, Open-label Trial Comparing the Effect of Tirzepatide Once Weekly Versus Titrated Insulin Glargine on Glycemic Control in Patients With Type 2 Diabetes on Metformin With or Without a Sulfonylurea

Mean Change From Baseline in Hemoglobin A1c (HbA1c) (10 mg and 15 mg) (Percentage of HbA1c), Baseline, Week 40. 10 mg Tirzepatide: -2.44; 15 mg Tirzepatide: -2.49; Insulin Glargine: -0.95.

Participants
917
Status
completed
Completed
2021-11-24
Sponsor
Eli Lilly and Company

As posted on ClinicalTrials.gov (NCT04093752), updated at source Jan 6, 2023. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What NCT04093752 measured first

Mean Change From Baseline in Hemoglobin A1c (HbA1c) (10 mg and 15 mg)Percentage of HbA1c · Baseline, Week 40 · least squares mean
10 mg Tirzepatiden=19415 mg Tirzepatiden=193Insulin Glarginen=193
-2.44(0.073)-2.49(0.072)-0.95(0.073)
Side effects by arm

Side effects in NCT04093752

Percent of participants affected, Baseline Through End of Safety Follow-Up (Up To Week 44).. The most common events the registry lists.

Event5 mg Tirzepatide10 mg Tirzepatide15 mg TirzepatideInsulin Glargine
Any serious event6.5%6.1%6.6%9.1%
Decreased appetite32.2%47.8%44.5%0%
Diarrhoea33.5%45.2%44.1%1.4%
Nausea20%32.9%31.9%2.3%
Vomiting9.1%14.9%12.7%1.4%
Abdominal distension8.3%11%14.8%0.9%
Lipase increased13.9%14%13.1%2.7%
Hyperuricaemia11.7%12.3%11.8%10.9%
Dizziness4.3%5.7%10.5%4.5%
Flatulence8.7%10.1%7.9%0.9%
Fatigue5.2%10.1%7.4%1.4%
Constipation5.2%7.5%10%1.4%
Hyperglycaemia2.2%0.9%0.9%8.2%
Upper respiratory tract infection7%6.1%6.1%7.7%
Amylase increased5.2%7%6.6%1.8%
Eructation4.3%6.1%3.9%0%
Asthenia3%6.1%4.4%0.5%
Dyspepsia2.6%4.8%5.2%1.4%
Hyperlipidaemia3%3.5%3.9%5%
Secondary outcomes

What else it measured

Mean Change From Baseline in HbA1c (5 mg)Percentage of HbA1c · Baseline, Week 40 · least squares mean
5 mg Tirzepatiden=211Insulin Glarginen=193
-2.24(0.070)-0.95(0.073)
Mean Change From Baseline in Body Weightkilograms (kg) · Baseline, Week 40 · least squares mean
5 mg Tirzepatiden=21110 mg Tirzepatiden=19415 mg Tirzepatiden=193Insulin Glarginen=194
-5.0(0.32)-7.0(0.33)-7.2(0.33)1.5(0.33)
Percentage of Participants Achieving an HbA1c Target Value of <7.0%Percentage of participants · Week 40 · number
5 mg Tirzepatiden=22810 mg Tirzepatiden=22215 mg Tirzepatiden=224Insulin Glarginen=215
75.4486.0484.3823.72
Percentage of Participants Achieving an HbA1c Target Value of <5.7%Percentage of participants · Week 40 · number
5 mg Tirzepatiden=22810 mg Tirzepatiden=22215 mg Tirzepatiden=224Insulin Glarginen=215
14.9120.7227.680.00
Mean Change From Baseline in Fasting Serum Glucosemilligrams per deciliter (mg/dL) · Baseline, Week 40 · least squares mean
5 mg Tirzepatiden=20610 mg Tirzepatiden=19315 mg Tirzepatiden=192Insulin Glarginen=194
-58.6(2.13)-66.2(2.19)-64.8(2.19)-46.2(2.19)
Mean Change in Daily Glucose Average From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) Valuesmilligrams per deciliter (mg/dL) · Baseline, Week 40 · least squares mean
5 mg Tirzepatiden=20410 mg Tirzepatiden=19315 mg Tirzepatiden=186Insulin Glarginen=188
-77.0(2.09)-83.4(2.16)-84.6(2.18)-42.8(2.18)
Percentage of Participants Who Achieved Weight Loss ≥5%Percentage of participants · Week 40 · number
5 mg Tirzepatiden=22810 mg Tirzepatiden=22215 mg Tirzepatiden=224Insulin Glarginen=215
55.7071.6274.115.58
Diabetes Treatment Satisfaction as Measured by the Diabetes Treatment Satisfaction Questionnaire, Change Version (DTSQc) Hyperglycemia, Hypoglycemia and Treatment Satisfaction ScoreUnits on a scale · Baseline, Week 40 · least squares mean
Measure5 mg Tirzepatiden=21210 mg Tirzepatiden=20015 mg Tirzepatiden=195Insulin Glarginen=196
Hyperglycemia-1.8(0.12)-2.1(0.12)-2.0(0.12)-1.3(0.12)
Hypoglycemia-1.9(0.11)-1.9(0.12)-2.0(0.12)-1.8(0.12)
Treatment Satisfaction Score16.0(0.27)15.8(0.28)15.9(0.29)14.2(0.28)
Rate of Hypoglycemia With Blood Glucose < 54 mg/dL or Severe HypoglycemiaEpisodes/participant/365.25 days · Baseline through end of safety follow-up (Up To Week 44) · mean
5 mg Tirzepatiden=23010 mg Tirzepatiden=22815 mg Tirzepatiden=229Insulin Glarginen=220
0.0658(0.02603)0.0890(0.03196)0.0700(0.02273)0.0538(0.01594)
The trial

How NCT04093752 was run

The main reason for this study is to compare the study drug tirzepatide to insulin glargine in participants with type 2 diabetes on metformin with or without a sulfonylurea.

  • 5 mg Tirzepatide: Participants received 5 milligrams (mg) tirzepatide administered subcutaneously (SC) once weekly (QW).
  • 10 mg Tirzepatide: Participants received 10 mg tirzepatide administered SC QW.
  • 15 mg Tirzepatide: Participants received 15 mg tirzepatide administered SC QW.
  • Insulin Glargine: Participants received insulin glargine administered once daily (QD) SC. The starting dose of insulin glargine was 6 Insulin Units (IU)/day at bedtime, titrated to a fasting blood glucose (FBG) between 72-100 milligrams per Deciliter (mg/dL), following a treat-to-target (TTT) algorithm.
Who could join the trial

Inclusion Criteria: * Type 2 diabetes mellitus * Treated with stable metformin with or without a sulfonylurea (metformin ≥1000 milligrams/day; sulfonylurea should be at least half the maximum dose) for at least 2 months * Are insulin-naive (except for the use of insulin for treatment of gestational diabetes or short-term use \[≤14 consecutive days\] for acute conditions) * HbA1c ≥7.5% to ≤11.0% at screening * Stable weight (±5%) ≥3 months, and agree to not initiate a 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 * Body mass Index (BMI) ≥23 kilograms per meter squared Exclusion Criteria: * Type 1 diabetes mellitus * Have history of chronic or acute pancreatitis * Have history of proliferative diabetic retinopathy; or diabetic maculopathy; or non-proliferative diabetic retinopathy that requires acute treatment * Have a history of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months * Have a history of ketoacidosis or hyperosmolar state/coma * Have a known clinically significant gastric emptying abnormality, have undergone or plan to have during the course of the study, or chronically take drugs that directly affect GI motility * Have acute myocardial infarction (MI), stroke or hospitalization due to congestive heart failure (CHF) within 2 months * Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2) * Have been treated with prescription drugs that promote weight loss or similar other body weight loss medications including over the counter (OTC) within 3 months

Published papers

Papers from NCT04093752

Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.

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