DelfaGLP-1 Atlas

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EXENDA

CompletedPhase 4

Effects of Combined Dapagliflozin and Exenatide Versus Dapagliflozin and Placebo on Ectopic Lipids in Patients With Uncontrolled Type 2 Diabetes Mellitus.

A 24 Week Monocentric Prospective Randomized, Placebo-controlled Trial to Evaluate Efficacy of Combination of Exenatide and Dapagliflozin Compared to Dapagliflozin and Placebo and Its Effects on Hepatic, Myocardial and Pancreatic Fat Distribution in Patients With Uncontrolled Type 2 Diabetes Mellitus.

Assets

Exenatide / GLP-1 / incretin class catch-all

Listed sites

1

Recruiting sites

—

Enrollment

34

actual

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criteria

•BMI ≥25•HbA1c 6.5-11%

Primary endpoint

•Liver fat content, 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 IDNCT03007329
Org study IDESR-15-10882

Timeline

Milestones

Study first posted2017-01-02estimated
Study start2017-03-08actual
Primary completion2019-11-26actual
Study completion2020-01-16actual
Last update posted2022-04-15actual

Assets

Investigational agents

ExenatideGLP-1 / incretin class catch-all

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

T2DM

•Sex: male and female
•HbA1c >=6.5 and <=11
•Age >=18 and <=75 years
•BMI>=25kg/m2
•Metformin>=1000mg daily, 8 weeks stable dose Please note: Type 2 diabetes mellitus patients treated with less than 1000 mg metformin per day can only be included if the investigator considers the patient to be on the maximum tolerated dose and the investigator has documented the reason why uptitration to 1000 mg was not possible
•able and willing to not change diet and physical activity during enrollment in study
•consent and able to give informed consent.

Exclusion criteria

•other diabetes diagnosis than T2DM
•patients on other antidiabetic medication (Sulfonylurea, Glitazone, insulin for more than 2 weeks (see below), SGLT2 inhibitors, GLP1 agonist, nateglinide, repaglinide, acarbose, DPP4 inhibitors)
•Subjects currently or previously treated with insulin (with the exception of emergency situations in which insulin was given for less than 14 consecutive days, but not within the last 3 months before screening)
•known intolerance against study medication
•Contraindications including hypersensitivity known to metformin according to the local label
•recurrent urinary tract infections
•GFR < 60
•Liver enzymes above 3 fold normal range
•Bilirubin higher 3 fold normal range
•Any other clinical condition that would jeopardize patients safety while participating in this clinical trial
•disease at screening (other than NAFLD) such as relevant cardiovascular, gastrointestinal, hepatic, neurologic, psychiatric, endocrine (i.e. pancreatic) except T2DM, hematologic, malignant, infection or other major systemic diseases making implementation of the protocol or interpretation of the study results difficult
•history of pancreatitis
•Known autoimmune disease or chronic inflammatory condition
•Myocardial infarction or stroke within 6 months prior to screening
•Blood dyscrasias or any disorders causing haemolysis or unstable Red Blood Cell (e.g.malaria, babesiosis, haemolytic anaemia)
•Other liver disease including chronic viral hepatitis (B or C), alcohol abuse, hemochromatosis, alpha-1antitrypsin deficiency, autoimmune hepatitis, Wilson's disease, primary sclerosing cholangitis or primary biliary cirrhosis, or liver cirrhosis of any etiology
•malignancy within the last 5 years before randomisation
•medullary thyroid cancer
•family history of multiple endocrine neoplasia syndrome
•Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study drug intake
•Presence of any absolute or relative contraindication for the conduct of an MRI investigation, such as cardiac pacemakers, ferromagnetic haemostatic clips in the central nervous system, metallic splinters in the eye, ferromagnetic or electronically operated active devices like automatic cardioverter defibrillators,cochlear implants, insulin pumps and nerve stimulators, prosthetic heart valves etc.
•History of bariatric surgery
•Treatment with anti-obesity drugs (e.g. sibutramine, orlistat) 3 months prior to informed consent or any other treatment at the time of screening (i.e. surgery, aggressive diet regimen, etc.) leading to unstable body weight
•Subjects receiving antihypertensive medication and/or thyroid hormones, the dose(s) of which have not been stable for at least 6 weeks prior to baseline
•Current treatment with systemic steroids at time of informed consent (Treatment with local and inhaled steroids is allowed)
•Use of drugs potentially associated with NAFLD for more than 2 consecutive weeks in the 6 months prior to screening.
•Use of anti-NASH drugs (thiazolidinediones, vitamin E, UDCA, SAM-e, betaine, milk thistle, anti-TNF therapies,) in the 3 months prior to randomization.
•Donation of blood (> 400 mL) during the previous 3 months prior to the screening visit or during the duration of the study
•Participation in another trial with an investigational drug within 30 days prior to informed consent.
•Any subject who is the investigator or any coinvestigator, research assistant, pharmacist, study coordinator, other staff thereof, directly involved in the conduct of the protocol.
•Pre-menopausal women (last menstruation ≤1 year prior to informed consent) who:
•are nursing or pregnant or
•are of child-bearing potential and are not practising an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial. Acceptable methods of birth control include tubal ligation, transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives,sexual abstinence,( if acceptable by local authorities) double barrier method and vasectomised partner.

Endpoints (20)

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

Weight & body composition
5
Glycemic / diabetes
4
Other (unclassified)
4
Cardiometabolic biomarkers
3
MASH / liver
1
Renal / kidney
1
Patient-reported / QoL
1
Safety / tolerability / PK
1

Weight & body composition

5 endpoints
Secondary/protocol endpoint

weight loss

Time frame:baseline - week 24.

change from baseline, improvement

Other/protocol endpoint

weight

Time frame:baseline - week 24

Body weight, absolute change (kg)

change from baseline, improvement

Other/protocol endpoint

hip circumference

Time frame:baseline - week 24

change from baseline, improvement

Other/protocol endpoint

waist circumference

Time frame:baseline - week 24

Waist circumference, change

change from baseline, improvement

Other/protocol endpoint

weight reduction >= 5%

Time frame:baseline - week 24

≥5% weight-loss responders

threshold achievement, improvement

Glycemic / diabetes

4 endpoints
Secondary/protocol endpoint

change in insulin resistance

Time frame:baseline - week 24

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Secondary/protocol endpoint

change in insulin sensitivity

Time frame:baseline - week 24

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Other/protocol endpoint

fasting glucose

Time frame:baseline - week 24

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Other/protocol endpoint

HbA1c reduction >= 0.5%

Time frame:baseline - week 24

HbA1c, change

threshold achievement, improvement

LOINC 4548-4

MASH / liver

1 endpoint
Primary/protocol endpoint

change in hepatic lipid content measured with magnetic resonance spectroscopy in %

Time frame:baseline - week 24

Liver fat content, change

percent change from baseline, improvement

Renal / kidney

1 endpoint
Secondary/protocol endpoint

change in glomerular filtration rate

Time frame:baseline -week 24

eGFR, change

change from baseline, improvement

Cardiometabolic biomarkers

3 endpoints
Secondary/protocol endpoint

blood pressure

Time frame:baseline - week 24

change from baseline, improvement

Other/protocol endpoint

change in triglycerides

Time frame:baseline - week 24

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Other/protocol endpoint

change in cholesterol

Time frame:baseline - week 24

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Patient-reported / QoL

1 endpoint
Secondary/protocol endpoint

Quality of Life questionnaire

Time frame:baseline - week 24

change from baseline, improvement

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Time frame:baseline- week 24

Treatment-emergent AEs (any)

event count, event

Other (unclassified)

4 endpoints
Secondary/protocol endpoint/low confidence

change in myocardial lipid content measured with magnetic resonance spectroscopy in %

Time frame:baseline - week 24

percent change from baseline, improvement

Secondary/protocol endpoint/low confidence

change in pancreatic lipid content measured with magnetic resonance spectroscopy in %

Time frame:baseline - week 24

percent change from baseline, improvement

Secondary/protocol endpoint/low confidence

energy expenditure

Time frame:baseline -week 24

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

energy intake

Time frame:baseline -week 24

change from baseline, improvement

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.