DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT01610934

CompletedPhase 2, PHASE3

The Effects of GLP-1 in Maturity-Onset Diabetes of The Young (MODY)

Phase 2 Study: A Double-blind, Randomised, Clinical Cross-over Trial to Investigate the Treatment Potential of Liraglutide Compared to Glimepiride in MODY Patients

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

15

actual

Study population

Diabetes (other / unspecified)

Key I/E criterion

•BMI ≥19

Primary endpoint

•Fasting glucose, 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 IDNCT01610934
Org study IDMODY-TREAT
Secondary ID2012-000592-17

Timeline

Milestones

Study first posted2012-06-04estimated
Last update posted2013-09-05estimated
Study start2012-08 (month precision)
Primary completion2013-08actual (month precision)
Study completion2013-08actual (month precision)

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Diabetes (other / unspecified)

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Caucasian above 18 years of age
•Well characterised MODY3
•Body mass index (BMI) > 19 kg/m2
•Normal haemoglobin (males > 8.2 mM, females > 7.2 mM)
•Normal blood pressure (< 160/100 mmHg)
•Informed consent
•Capability to perform a light cycling test (heart rate 100-120 beats per minute during 30 minutes)
•Females: use of anticonception (IUC or hormonal)

Exclusion criteria

•Heart failure: New York Heart Association class III-IV
•Uraemia, end-stage renal disease, or any other cause of impaired renal function with s-creatinine > 130 µM and/or albuminuria
•Liver disease (alanine amino transferase (ALAT) and/or aspartate amino transferase (ASAT) > 2 × upper normal serum levels)
•Anaemia
•Acute or chronic pancreatitis
•Stroma or thyroid cancer
•Pregnancy or breast feeding
•Inability to complete the study
•Treatment naïve patients with HbA1c < 7.0 %
•Treatment with medicine that can not be paused for 12 hours
•Known allergic reaction to study medication
•Intention to become pregnant
•Unwillingness to complete the protocol

Endpoints (6)

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
3
Safety / tolerability / PK
2
Other (unclassified)
1

Glycemic / diabetes

3 endpoints
Primary/protocol endpoint

Fasting Plasma Glucose

Time frame:14 weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Serum Fructosamine

Time frame:14 weeks

change from baseline, improvement

Secondary/protocol endpoint

Plasma concentrations of insulin and C-peptide

Time frame:14 weeks

concentration, descriptive

componentsC-peptide AUC

Safety / tolerability / PK

2 endpoints
Secondary/protocol endpoint

Hypoglycemic events

Time frame:14 weeks

event count, event

Secondary/protocol endpoint

Plasma concentrations of incretin hormones

Time frame:14 weeks

Plasma concentration (steady state)

concentration, descriptive

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Plasma glucagon

Time frame:14 weeks

concentration, 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.