DelfaGLP-1 Atlas

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MAG1C

CompletedPhase 2

Meal-time Administration of Exenatide for Glycaemic Control in Type 1 Diabetic Cases

Meal-time Administration of Exenatide for Glycaemic Control in Type 1 Diabetic Cases: A Randomised, Placebo-controlled Trial

Lead sponsor

Filip Krag Knop

Asset

Exenatide

GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

108

actual

Study population

Type 1 diabetes

Key I/E criteria

•BMI ≥22•HbA1c 7.5-10%

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 IDNCT03017352
Org study IDEudract-nr.: 2016-001365-92

Timeline

Milestones

Study first posted2017-01-11estimated
Last update posted2019-07-10actual
Study start2016-12 (month precision)
Primary completion2019-06actual (month precision)
Study completion2019-06actual (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Type 1 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age80 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•T1D according to WHO criteria with duration of ≥1 year
•Age ≥18 years
•BMI >22.0 kg/m2
•HbA1c >7.5% and <10.0% at visit 0 (screening)
•Able to count carbohydrates

Exclusion criteria

•Insulin pump treatment
•Hypoglycaemia unawareness (inability to register low blood glucose)
•Diabetic gastroparesis
•Compromised kidney function (eGFR <60 ml/min/1.73m2, dialysis or kidney transplantation)
•Liver disease with elevated plasma alanine aminotransferase (ALT) > three times the upper limit of normal (measured at visit 0 with the possibility of one repeat analysis within a week, and the last measured value as being conclusive)
•History of acute and/or chronic pancreatitis
•Subjects with personal or family history of medullary carcinoma or MEN syndrome
•Inflammatory bowel disease
•Cancer unless in complete remission for >5 years
•Proliferative retinopathy
•Other concomitant disease or treatment that according to the investigator's assessment makes the patient unsuitable for study participation
•Alcohol/drug abuse
•Fertile women not using chemical (tablet/pill, depot injection of progesterone, subdermal gestagen implantation, hormonal vaginal ring or transdermal hormonal patch) or mechanical (spirals) contraceptives
•Pregnant or nursing women
•Known or suspected hypersensitivity to trial product or related products
•Receipt of an investigational drug within 30 days prior to visit 0
•Simultaneous participation in any other clinical intervention trial

Endpoints (22)

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

Cardiometabolic biomarkers
6
Weight & body composition
5
Glycemic / diabetes
5
Patient-reported / QoL
3
Heart failure
1
Safety / tolerability / PK
1
Other clinical outcomes
1

Weight & body composition

5 endpoints
Secondary/protocol endpoint

changes in body weight

Time frame:6 months

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

changes in BMI

Time frame:6 months

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

changes in body composition

Time frame:6 months

change from baseline, improvement

Secondary/protocol endpoint

changes in body composition

Time frame:6 months

Lean mass

change from baseline, improvement

Secondary/protocol endpoint

changes in body composition

Time frame:6 months

Total fat mass

change from baseline, improvement

Glycemic / diabetes

5 endpoints
Primary/protocol endpoint

Change in HbA1c

Time frame:6 months

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

changes in insulin dosage

Time frame:6 months

change from baseline, improvement

Secondary/protocol endpoint

changes in fasting plasma glucose

Time frame:6 months

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

changes in post prandial plasma glucose

Time frame:6 months

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint/low confidence

changes in fasting plasma levels of C-peptide

Time frame:6 months

change from baseline, improvement

Heart failure

1 endpoint
Secondary/protocol endpoint

proBNP (Pro-Brain Natriuretic Peptide)

Time frame:6 months

NT-proBNP, change

change from baseline, improvement

Cardiometabolic biomarkers

6 endpoints
Secondary/protocol endpoint

HDL (High Density Lipoprotein)

Time frame:6 months

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Secondary/protocol endpoint

LDL (Low Density Lipoprotein)

Time frame:6 months

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Secondary/protocol endpoint

VLDL (Very Low Density Lipoprotein)

Time frame:6 months

VLDL, change

change from baseline, improvement

Secondary/protocol endpoint

total cholesterol

Time frame:6 months

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

triglycerides

Time frame:6 months

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

hsCRP (High-Sensitivity C-Reactive Protein)

Time frame:6 months

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Patient-reported / QoL

3 endpoints
Secondary/protocol endpoint

Quality of life self reported

Time frame:6 months

descriptive, improvement

Secondary/protocol endpoint

Treatment satisfaction

Time frame:6 months

descriptive, improvement

Secondary/protocol endpoint

Treatment satisfaction

Time frame:6 months

change from baseline, improvement

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

adverse events (including hypoglycaemic episodes)

Time frame:6 months

Treatment-emergent AEs (any)

descriptive, event

Other clinical outcomes

1 endpoint
Secondary/protocol endpoint/low confidence

dietary patterns

Time frame:6 months

descriptive

Publications (2)

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.