Evidence map›Paper›PMID 42473259›Full record

Trial reportDiabetes, obesity & metabolism2026

Insulin, Semaglutide and Dapagliflozin in Adults With Type 1 Diabetes: Design and Methods of Triple Therapy for Type 1 Diabetes (TTT1)-An International Phase 3 Clinical Trial.

Joseph G Timmons, Husam Ghanim, James G Boyle, Nicola Greenlaw, Ajay Chaudhuri, Manav A Batra, Robert S Lindsay, Lisa Jolly, Caroline Bonner, Alex McConnachie and 2 more

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in Diabetes, obesity & metabolism, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT03899402. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03899402 phase2 / phase3active not recruiting

Triple Therapy for Type 1 Diabetes With Insulin, Semaglutide, and Dapagliflozin

Ran2019Enrolled78Registered outcomes23Posted comparisons0ConditionsType 1 Diabetes MellitusArmsdapagliflozin, Insulin, Placebo to Dapagliflozin, semaglutide
Open the trial in the graph
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Trial
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Joseph G TimmonsSchool of Cardiovascular and Medical Sciences, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, UK.ORCID 0000-0003-3506-359X
Husam GhanimState University of New York at Buffalo, Buffalo, New York, USA.ORCID 0000-0002-6333-6033
James G BoyleSchool of Medicine, Dentistry and Nursing, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, UK.
Nicola GreenlawRobertson Centre for Biostatistics/Glasgow Clinical Trials Unit, School of Health and Wellbeing, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, Scotland, UK.
Ajay ChaudhuriState University of New York at Buffalo, Buffalo, New York, USA.
Manav A BatraState University of New York at Buffalo, Buffalo, New York, USA.
Robert S LindsaySchool of Cardiovascular and Medical Sciences, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, UK.
Lisa JollyDepartment of Research and Innovation, NHS Greater Glasgow and Clyde, Gartnavel Royal Hospital, Glasgow, UK.
Caroline BonnerUniversity of Lille, CHU Lille, Inserm U1190, European Genomic Institute for Diabetes (EGID), Institut Pasteur de Lille, Lille, France.
Alex McConnachieRobertson Centre for Biostatistics/Glasgow Clinical Trials Unit, School of Health and Wellbeing, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, Scotland, UK.
John R PetrieRobertson Centre for Biostatistics/Glasgow Clinical Trials Unit, School of Health and Wellbeing, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, Scotland, UK.
Paresh DandonaState University of New York at Buffalo, Buffalo, New York, USA.

Funding

Breakthrough T1D 3-SRA-2019-669-M-B
6 · The paper itself

Abstract

aimsAttaining target glycaemia can be a challenge in Type 1 Diabetes (T1D) due to insulin-induced weight gain. Adjunct therapy with modern glucose-lowering agents developed for type 2 diabetes (T2D) has great potential but may be insufficiently efficacious and carries risks of hypoglycaemia and ketosis. We designed the first Phase 3 clinical trial to assess the efficacy and safety of adding a Glucagon-Like Peptide 1 receptor agonist (GLP-1RA) and a Sodium-Glucose Co-transporter (SGLT2) Inhibitor to insulin therapy in overweight and obese adults with T1D and glycaemia above target (HbA1c 7.5%-11.0% inclusive) (NCT03899402). MATERIALS AND

methodsIn Period 1, participants are randomized 2:1 (open label) for 26 weeks to semaglutide and insulin (uptitrated to 1.0 mg weekly) or standard insulin therapy. In Period 2, those randomized to semaglutide and insulin in Period 1 are further randomized (double-blind) for 26 weeks to dapagliflozin (10 mg daily) or placebo, in addition to semaglutide. The primary objective is to compare change in HbA1c on 'triple therapy' (dapagliflozin, semaglutide and insulin) with 'dual therapy' (placebo, semaglutide and insulin). Secondary objectives include comparisons of triple therapy with standard insulin therapy and dual therapy (semaglutide and insulin) with standard insulin therapy. Safety outcomes include hypoglycaemia and ketosis. A sample size recalculation during the trial based on analysis of masked data revised the original recruitment target from 114 to 82 participants.

conclusionThe TTT1 trial will provide clinically useful information on combination adjunct therapy in the treatment of T1D.

Indexed as

Benzhydryl CompoundsDiabetes Mellitus, Type 1Glucagon-Like PeptidesGlucosidesHypoglycemic AgentsInsulinAdultBlood GlucoseDouble-Blind MethodDrug Therapy, CombinationFemaleGlycated HemoglobinHumansHypoglycemiaMaleMiddle AgedBenzhydryl CompoundsBlood GlucosedapagliflozinGlucagon-Like PeptidesGlucosidesGlycated HemoglobinHypoglycemic AgentsInsulinSemaglutideSodium-Glucose Transporter 2 Inhibitorsadjunctive therapyadjunct therapycombination therapy dapagliflozinketosissemaglutidetype 1 diabetes

Identifiers

PMID42473259
PMCPMC13538731

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.