DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT04945070

IDEAL

UnknownPhase 4

INSULIN THERAPY DE-INTENSIFICATION WITH iGlarLixi

Asset

Lixisenatide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

1

Enrollment

96

estimated

Study population

Type 2 diabetes

Key I/E criterion

—

Primary endpoint

•HbA1c, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT04945070
Org study IDIDEAL V2.2

Timeline

Milestones

Study first posted2021-06-30actual
Last update posted2021-07-22actual
Study start2021-07estimated (month precision)
Primary completion2023-01estimated (month precision)
Study completion2023-06estimated (month precision)

Assets

Investigational agents

Lixisenatide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age80 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Signed written informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
•Adult participants with T2DM
•Participants who have been treated with a an MDI regimen comprising of at least 3 doses of prandial insulin per day and one dose of basal insulin per day for at least 3 months before the screening visit,
•Participants treated with metformin (unless intolerance to metformin use is present) ± SGLT2i at stable doses for at least 3 months prior screening.
•Total daily insulin dose ≤ 0.8 IU/kg,
•Fasting C peptide above the lower limit of the normal range,
•HbA1c at screening visit ≤ 75 mmol/mol (9%) as measured by local laboratory,
•HbA1c at screening visit 76-86 mmol/mol (9.1-10%) as measured by local laboratory in case of proven non-compliance with MDI regimen

Exclusion criteria

•At screening visit, age under legal age of adulthood (<18 years),
•History of other diabetes than T2DM (type 1 diabetes T1DM, monogenic, secondary..)
•Use of any oral or injectable glucose-lowering agents other than those stated in the inclusion criteria within the last 3 months before screening,
•History of discontinuation of a previous treatment with GLP-1 RA for safety/tolerability reasons or lack of efficacy,
•Use of systemic glucocorticoids (excluding topical and inhaled forms) for a total duration of 1 week or more within 3 months prior to screening visit,
•Comorbidity (such as but not limited to rheumatoid arthritis) with continuous, intermittent or expected systemic glucocorticoid therapy during the next 30 weeks after screening visit,
•Use of weight loss drugs within 3 months prior to screening visit,
•Use of any investigational drug within 1 month or 5 half-lives, whichever is longer, prior to screening visit,
•Within the last 3 months prior to screening visit: history of stroke, pulmonary embolism, myocardial infarction, unstable angina, or heart failure requiring hospitalization,
•Chronic hear failure NYHA stages III-IV
•Acute or chronic liver failure - established diagnosis of acute or chronic liver failure (Child-Pugh 3, MELD≥15) or liver cirrhosis
•Planned coronary, carotid or peripheral artery revascularisation procedures to be performed during the study period,
•Known history of drug or alcohol abuse within 6 months prior to the time of screening visit,
•Active malignancy
•Anaemia with haemoglobin < 100 g/l at baseline
•Participants with conditions/concomitant diseases making them non evaluable for the efficacy endpoints (eg, hemoglobinopathy or hemolytic anemia, receipt of blood or plasma products within the last 3 months prior to the screening visit),
•Participants with conditions/concomitant diseases precluding their safe participation in this study (eg, active malignant tumor, major systemic diseases, presence of clinically significant diabetic retinopathy or presence of macular edema likely to require treatment within the study period, etc.),
•Impossibility to meet specific protocol requirements (eg, scheduled visits, participants unable to fully understand participant's study documents and to complete them, etc.),
•Uncooperative or any condition that could make the participant potentially non-compliant to the study procedures (eg, participant unable or unwilling to do self-injections or blood glucose monitoring using the sponsor-provided blood glucose meter at home, etc.);
•Participant is the Investigator or any Sub-Investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol
•Participation in another clinical trial
•Pregnancy or lactation,
•Women of childbearing potential not protected by highly effective contraceptive method of birth control (definition see section 10.1.1.1),
•Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting, including (but not limited to): gastroparesis, unstable (ie, worsening) or not controlled (ie, prolonged nausea and vomiting) gastroesophageal reflux disease requiring medical treatment, within 6 months prior to the time of screening visit or history of surgery affecting gastric emptying
•History of pancreatitis (unless pancreatitis was related to gallstones and cholecystectomy had now been performed), pancreatitis during previous treatment with incretin therapies, chronic pancreatitis, pancreatectomy,
•Personal or immediate family history of MTC or genetic condition that predisposes to MTC (eg, multiple endocrine neoplasia syndromes),
•Participant who has a renal function impairment with creatinine clearance <30 mL/min (using the eGFR) or end-stage renal disease (ie. CKD stage IV or V),
•History of allergic reaction to any GLP-1 RA in the past

Endpoints (11)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes
5
Weight & body composition
1
MASH / liver
1
Cardiometabolic biomarkers
1
Patient-reported / QoL
1
Safety / tolerability / PK
1
Other (unclassified)
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Body weight

Time frame:6 months

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

5 endpoints
Primary/protocol endpoint

HbA1C

Time frame:6 months

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Fasting plasma glucose

Time frame:6 months

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Postprandial plasma glucose

Time frame:6 months

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Glycemic variability

Time frame:6 months

descriptive, improvement

Secondary/protocol endpoint

Time in target range of 3.9-10 mmol/l

Time frame:6 months

CGM time-in-range

descriptive, improvement

MASH / liver

1 endpoint
Other/protocol endpoint

ALT

Time frame:6 months

ALT, change

change from baseline, improvement

LOINC 1742-6

Cardiometabolic biomarkers

1 endpoint
Other/protocol endpoint

hsCRP

Time frame:6 months

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Patient-reported / QoL

1 endpoint
Secondary/protocol endpoint

Treatment Satisfaction

Time frame:6 months

descriptive, improvement

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint/low confidence

Hypoglycemia

Time frame:6 months

descriptive, event

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Compliance

Time frame:6 months

descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.