Tirzepatide Versus Intensified Conventional Care After 2 Years of Treatment in Early Type 2 Diabetes : A Randomized Clinical Trial.

Del Prato S, Heine RJ, Pérez Manghi FC, Hsia SH, Gomez-Valderas E, Zeytinoglu M, Razzoli E, Kiljanski J, Sharma P, Knights A, Thieu VT

Annals of internal medicine26 May 2026

PMID42184419DOI10.7326/annals-25-05602PepBankPUB-42184419

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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 study5

5 results from studies that gave the peptide. 5 results from people.

01HumanRandomized controlled trialEfficacy outcome
In adults with early type 2 diabetes on metformin, tirzepatide lowered HbA1c more than intensified conventional care over 2 years (estimated treatment difference -0.68 percentage points).
In plain wordsIn adults with early type 2 diabetes, tirzepatide lowered blood sugar (HbA1c) more than intensified conventional care over 2 years.
Peptide
Tirzepatide
Outcome
DecreaseHbA1c change from baseline to 2 years
Study
n = 794
Comparator
Intensified conventional care
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
15 mg or maximum tolerated dose · 2 yearsAs given in this study (human).
Measurements
HbA1c change
−1.99 percentage points
tirzepatide
HbA1c change
−1.32 percentage points
intensified conventional care
ETD
−0.68 percentage points
tirzepatide vs ICC
Source sentences
Summary
Tirzepatide was superior to ICC for mean changes from baseline to 2 years in HbA_1c (-1.99 percentage points [95% CI, -2.12 to -1.87 percentage points] vs. -1.32 percentage points [CI, -1.44 to -1.19 percentage points]; estimated treatment difference [ETD], -0.68 percentage points [CI, -0.…
3 context sentences(design, population, supporting numbers)
Summary · context
The primary objective was to show the noninferiority of tirzepatide to ICC for change in hemoglobin A_1c (HbA_1c) from baseline to 2 years.
Summary · context
794 adults with at most 4 years of T2D history treated with metformin.
Summary · context
Tirzepatide (15 mg or maximum tolerated dose) or ICC (including GLP-1RAs but excluding tirzepatide) used in clinical practice and supported by local treatment guidelines.
Report a problemFND-4218441901
02HumanRandomized controlled trialEfficacy outcome
In adults with early type 2 diabetes on metformin, tirzepatide reduced weight more than intensified conventional care over 2 years (estimated treatment difference -8.0 kg).
In plain wordsIn adults with early type 2 diabetes, tirzepatide led to more weight loss than intensified conventional care over 2 years.
Peptide
Tirzepatide
Outcome
DecreaseWeight change from baseline to 2 years
Study
n = 794
Comparator
Intensified conventional care
Analysis
Secondary
Outcome group
Body weight · Metabolic and weight
Studied dose
15 mg or maximum tolerated dose · 2 yearsAs given in this study (human).
Measurements
ETD
−8 kg
tirzepatide vs ICC
Source sentences
Summary
weight (ETD, -8.0 kg [CI, -9.39 to -6.50 kg]
3 context sentences(design, population, supporting numbers)
Summary · context
Secondary objectives were to show the superiority of tirzepatide for change in HbA_1c, weight, and waist circumference.
Summary · context
794 adults with at most 4 years of T2D history treated with metformin.
Summary · context
Tirzepatide (15 mg or maximum tolerated dose) or ICC (including GLP-1RAs but excluding tirzepatide) used in clinical practice and supported by local treatment guidelines.
Report a problemFND-4218441902
03HumanRandomized controlled trialEfficacy outcome
In adults with early type 2 diabetes on metformin, tirzepatide reduced waist circumference more than intensified conventional care over 2 years (estimated treatment difference -6.2 cm).
In plain wordsIn adults with early type 2 diabetes, tirzepatide shrank waist size more than intensified conventional care over 2 years.
Peptide
Tirzepatide
Outcome
DecreaseWaist circumference change from baseline to 2 years
Study
n = 794
Comparator
Intensified conventional care
Analysis
Secondary
Outcome group
Body weight · Metabolic and weight
Studied dose
15 mg or maximum tolerated dose · 2 yearsAs given in this study (human).
Measurements
ETD
−6.2 cm
tirzepatide vs ICC
Source sentences
Summary
waist circumference (ETD, -6.2 cm [CI, -7.54 to -4.93 cm]
3 context sentences(design, population, supporting numbers)
Summary · context
Secondary objectives were to show the superiority of tirzepatide for change in HbA_1c, weight, and waist circumference.
Summary · context
794 adults with at most 4 years of T2D history treated with metformin.
Summary · context
Tirzepatide (15 mg or maximum tolerated dose) or ICC (including GLP-1RAs but excluding tirzepatide) used in clinical practice and supported by local treatment guidelines.
Report a problemFND-4218441903
04HumanRandomized controlled trialEfficacy outcome
In adults with early type 2 diabetes on metformin, more participants reached normoglycemia (HbA1c below 5.7%) with tirzepatide (60.2%) than with intensified conventional care (24.0%).
In plain wordsIn adults with early type 2 diabetes, more people reached normal blood sugar with tirzepatide than with intensified conventional care.
Peptide
Tirzepatide
Outcome
IncreaseNormoglycemia (HbA1c below 5.7%) at 2 years
Study
n = 794
Comparator
Intensified conventional care
Outcome group
Glycemic control · Metabolic and weight
Studied dose
15 mg or maximum tolerated dose · 2 yearsAs given in this study (human).
Measurements
Proportion with HbA1c <5.7%
60.2%
tirzepatide
Proportion with HbA1c <5.7%
24%
intensified conventional care
Source sentences
Summary
More participants achieved normoglycemia (HbA_1c <5.7%) with tirzepatide (60.2%) than ICC (24.0%).
2 context sentences(design, population, supporting numbers)
Summary · context
794 adults with at most 4 years of T2D history treated with metformin.
Summary · context
Tirzepatide (15 mg or maximum tolerated dose) or ICC (including GLP-1RAs but excluding tirzepatide) used in clinical practice and supported by local treatment guidelines.
Report a problemFND-4218441904
05HumanRandomized controlled trialSafety outcome
In adults with early type 2 diabetes, the most common adverse events were gastrointestinal in both the tirzepatide and intensified conventional care groups.
In plain wordsIn adults with early type 2 diabetes, stomach and bowel problems were the most common side effects in both groups.
Peptide
Tirzepatide
Outcome
Not applicableGastrointestinal adverse events
Study
n = 794
Comparator
Intensified conventional care
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
15 mg or maximum tolerated dose · 2 yearsAs given in this study (human).
Source sentences
Summary
The most common adverse events were gastrointestinal in both groups.
2 context sentences(design, population, supporting numbers)
Summary · context
794 adults with at most 4 years of T2D history treated with metformin.
Summary · context
Tirzepatide (15 mg or maximum tolerated dose) or ICC (including GLP-1RAs but excluding tirzepatide) used in clinical practice and supported by local treatment guidelines.
Report a problemFND-4218441905

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 ongoing · source ClinicalTrials.gov (opens in a new tab)

Active, not recruitingPhase 4NCT05433584

A Study of Tirzepatide Compared With Intensified Conventional Care in Adult Participants With Type 2 Diabetes

Eli Lilly and Companyn = 7801 Aug 2022 to est. Nov 2027

Type 2 Diabetes

Trial page ClinicalTrials.govUpdated 12 Dec 2025

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.

Version 2Current
12 Oct 2026, 12:10 UTC
Study results updated
Version 1
9 Oct 2026, 03:07 UTC
First added · source update from Europe PMC

Subjects

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