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Study · Randomized controlled trial · n = 475 · 2022

6 results

Effect of Subcutaneous Tirzepatide vs Placebo Added to Titrated Insulin Glargine on Glycemic Control in Patients With Type 2 Diabetes: The SURPASS-5 Randomized Clinical Trial.

Dahl D, Onishi Y, Norwood P, Huh R, Bray R, Patel H, Rodríguez Á

JAMA1 Feb 2022Cited by 475 (Europe PMC)

Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study6

6 results from studies that gave the peptide. 6 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In adults with type 2 diabetes on insulin glargine, adding tirzepatide 5, 10 or 15 mg once weekly lowered HbA1c at week 40 more than adding placebo (change from baseline -2.40% with 10 mg and -2.34% with 15 mg versus -0.86% with placebo; significant for every dose).

    In plain wordsIn adults with type 2 diabetes using insulin glargine, adding tirzepatide lowered long-term blood sugar (HbA1c) more than adding placebo.

    Outcome
    DecreaseHbA1c change from baseline at week 40
    Study

    n = 475

    Comparator
    Volume-matched placebo added to titrated insulin glargine
    Analysis
    Primary
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    5 mg, 10 mg or 15 mg once weekly (started at 2.5 mg/week, escalated by 2.5 mg every 4 weeks) · subcutaneous · 40 weeksAs given in this study (human).

    Measurements

    HbA1c reduction from baseline at week 40
    2.4%
    tirzepatide 10 mg
    HbA1c reduction from baseline at week 40
    2.34%
    tirzepatide 15 mg
    HbA1c reduction from baseline at week 40
    0.86%
    placebo
    HbA1c difference vs placebo (reduction)
    1.53%
    tirzepatide 10 mg
    HbA1c difference vs placebo (reduction)
    1.47%
    tirzepatide 15 mg

    Source sentences

    Summary
    At week 40, mean HbA1c change from baseline was -2.40% with 10-mg tirzepatide and -2.34% with 15-mg tirzepatide vs -0.86% with placebo (10 mg: difference vs placebo, -1.53% [97.5% CI, -1.80% to -1.27%]; 15 mg: difference vs placebo, -1.47% [97.5% CI, -1.75% to -1.20%]; P < .001 for both).
    3 context sentences
    Summary · context
    Mean HbA1c change from baseline was -2.11% with 5-mg tirzepatide (difference vs placebo, -1.24% [95% CI, -1.48% to -1.01%]; P < .001]).
    Summary · context
    in 475 adults with type 2 diabetes and inadequate glycemic control while treated with once-daily insulin glargine with or without metformin
    Summary · context
    Patients were randomized in a 1:1:1:1 ratio to receive once-weekly subcutaneous injections of 5-mg (n = 116), 10-mg (n = 119), or 15-mg (n = 120) tirzepatide or volume-matched placebo (n = 120) over 40 weeks.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In adults with type 2 diabetes on insulin glargine, body weight fell with tirzepatide 5, 10 and 15 mg and rose with placebo, with significant differences for every dose.

    In plain wordsIn adults with type 2 diabetes using insulin glargine, adding tirzepatide led to weight loss, while weight rose with placebo.

    Outcome
    DecreaseBody weight change from baseline at week 40
    Study

    n = 475

    Comparator
    Volume-matched placebo added to titrated insulin glargine
    Analysis
    Secondary
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    5 mg, 10 mg or 15 mg once weekly (started at 2.5 mg/week, escalated by 2.5 mg every 4 weeks) · subcutaneous · 40 weeksAs given in this study (human).

    Source sentences

    Summary
    Mean body weight change from baseline was -5.4 kg with 5-mg tirzepatide, -7.5 kg with 10-mg tirzepatide, -8.8 kg with 15-mg tirzepatide and 1.6 kg with placebo (5 mg: difference, -7.1 kg [95% CI, -8.7 to -5.4]; 10 mg: difference, -9.1 kg [95% CI, -10.7 to -7.5]; 15 mg: difference, -10.5 kg [95% CI,…
    2 context sentences
    Summary · context
    in 475 adults with type 2 diabetes and inadequate glycemic control while treated with once-daily insulin glargine with or without metformin
    Summary · context
    Patients were randomized in a 1:1:1:1 ratio to receive once-weekly subcutaneous injections of 5-mg (n = 116), 10-mg (n = 119), or 15-mg (n = 120) tirzepatide or volume-matched placebo (n = 120) over 40 weeks.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In adults with type 2 diabetes on insulin glargine, a higher percentage of patients on tirzepatide than on placebo reached an HbA1c below seven percent.

    In plain wordsIn adults with type 2 diabetes using insulin glargine, more people reached the HbA1c goal of below seven percent with tirzepatide than with placebo.

    Outcome
    IncreaseProportion with HbA1c below 7%
    Study

    n = 475

    Comparator
    Volume-matched placebo added to titrated insulin glargine
    Analysis
    Secondary
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    5 mg, 10 mg or 15 mg once weekly (started at 2.5 mg/week, escalated by 2.5 mg every 4 weeks) · subcutaneous · 40 weeksAs given in this study (human).

    Source sentences

    Summary
    Higher percentages of patients treated with tirzepatide vs those treated with placebo had HbA1c less than 7% (85%-90% vs 34%; P < .001 for all).
    2 context sentences
    Summary · context
    in 475 adults with type 2 diabetes and inadequate glycemic control while treated with once-daily insulin glargine with or without metformin
    Summary · context
    Patients were randomized in a 1:1:1:1 ratio to receive once-weekly subcutaneous injections of 5-mg (n = 116), 10-mg (n = 119), or 15-mg (n = 120) tirzepatide or volume-matched placebo (n = 120) over 40 weeks.
  4. 04HumanRandomized controlled trialSafety outcome

    In adults with type 2 diabetes on insulin glargine, diarrhea was among the most common treatment-emergent adverse events, occurring in at least 12% of patients in the tirzepatide groups versus 10% on placebo (no test reported).

    In plain wordsIn adults with type 2 diabetes using insulin glargine, diarrhea was a common side effect of tirzepatide and occurred more often than with placebo.

    Outcome
    IncreaseDiarrhea
    Study

    n = 475

    Comparator
    Volume-matched placebo added to titrated insulin glargine
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    5 mg, 10 mg or 15 mg once weekly (started at 2.5 mg/week, escalated by 2.5 mg every 4 weeks) · subcutaneous · 40 weeksAs given in this study (human).

    Measurements

    Diarrhea incidence
    12 to 21%
    tirzepatide groups (range)
    Diarrhea incidence
    10%
    placebo

    Source sentences

    Summary
    The most common treatment-emergent adverse events in the tirzepatide groups vs placebo group were diarrhea (12%-21% vs 10%) and nausea (13%-18% vs 3%).
    2 context sentences
    Summary · context
    in 475 adults with type 2 diabetes and inadequate glycemic control while treated with once-daily insulin glargine with or without metformin
    Summary · context
    Patients were randomized in a 1:1:1:1 ratio to receive once-weekly subcutaneous injections of 5-mg (n = 116), 10-mg (n = 119), or 15-mg (n = 120) tirzepatide or volume-matched placebo (n = 120) over 40 weeks.
  5. 05HumanRandomized controlled trialSafety outcome

    In adults with type 2 diabetes on insulin glargine, nausea was among the most common treatment-emergent adverse events, in 13% to 18% of patients on tirzepatide versus 3% on placebo (no test reported).

    In plain wordsIn adults with type 2 diabetes using insulin glargine, nausea was a common side effect of tirzepatide and occurred more often than with placebo.

    Outcome
    IncreaseNausea
    Study

    n = 475

    Comparator
    Volume-matched placebo added to titrated insulin glargine
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    5 mg, 10 mg or 15 mg once weekly (started at 2.5 mg/week, escalated by 2.5 mg every 4 weeks) · subcutaneous · 40 weeksAs given in this study (human).

    Measurements

    Nausea incidence
    13 to 18%
    tirzepatide groups (range)
    Nausea incidence
    3%
    placebo

    Source sentences

    Summary
    The most common treatment-emergent adverse events in the tirzepatide groups vs placebo group were diarrhea (12%-21% vs 10%) and nausea (13%-18% vs 3%).
    2 context sentences
    Summary · context
    in 475 adults with type 2 diabetes and inadequate glycemic control while treated with once-daily insulin glargine with or without metformin
    Summary · context
    Patients were randomized in a 1:1:1:1 ratio to receive once-weekly subcutaneous injections of 5-mg (n = 116), 10-mg (n = 119), or 15-mg (n = 120) tirzepatide or volume-matched placebo (n = 120) over 40 weeks.
  6. 06HumanRandomized controlled trialSafety outcome

    In adults with type 2 diabetes on insulin glargine, treatment was stopped early by 10%, 12% and 18% of participants on tirzepatide 5, 10 and 15 mg versus 3% on placebo (reason and test not reported).

    In plain wordsIn adults with type 2 diabetes using insulin glargine, more people stopped tirzepatide early than stopped placebo, especially at the highest dose.

    Outcome
    IncreasePremature treatment discontinuation
    Study

    n = 475

    Comparator
    Volume-matched placebo added to titrated insulin glargine
    Outcome group
    Adverse events · Whole body
    Studied dose
    5 mg, 10 mg or 15 mg once weekly (started at 2.5 mg/week, escalated by 2.5 mg every 4 weeks) · subcutaneous · 40 weeksAs given in this study (human).

    Measurements

    Premature treatment discontinuation
    10%
    tirzepatide 5 mg
    Premature treatment discontinuation
    12%
    tirzepatide 10 mg
    Premature treatment discontinuation
    18%
    tirzepatide 15 mg
    Premature treatment discontinuation
    3%
    placebo

    Source sentences

    Summary
    Treatment was prematurely discontinued by 10% of participants in the 5-mg tirzepatide group, 12% in the 10-mg tirzepatide group, 18% in the 15-mg tirzepatide group, and 3% in the placebo group.
    2 context sentences
    Summary · context
    in 475 adults with type 2 diabetes and inadequate glycemic control while treated with once-daily insulin glargine with or without metformin
    Summary · context
    Patients were randomized in a 1:1:1:1 ratio to receive once-weekly subcutaneous injections of 5-mg (n = 116), 10-mg (n = 119), or 15-mg (n = 120) tirzepatide or volume-matched placebo (n = 120) over 40 weeks.

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3Results postedNCT04039503

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

Eli Lilly and Companyn = 47530 Aug 2019 to 13 Jan 2021

Type 2 Diabetes

Trial pageClinicalTrials.govUpdated 12 Jan 2022

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    9 Oct 2026, 12:39 UTC

    Study results updated

  2. Version 1

    9 Oct 2026, 03:07 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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