CompletedPhase 2, PHASE3

Exenatide and Impaired Hypoglycaemic Awareness in Type 1 Diabetes

Effect of the GLP-1 Receptor Agonist Exenatide on Impaired Hypoglycaemic Awareness in Type 1 Diabetes

Lead sponsor

Radboud University Medical Center

Assets

Exenatide / GLP-1 / incretin class catch-all

Listed sites

Recruiting sites

Actual enrollment

Study population

Type 1 diabetes

Eligibility highlights

Primary endpoint

•Symptom score in response to insulin-induced hypoglycaemia

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT02735031

Org study IDESR-15-10862

Timeline

Milestones

Study first posted2016-04-12estimated

Study start2017-02-21actual

Primary completion2018-03-28actual

Study completion2018-04-09actual

Last update posted2018-04-12actual

Assets

Investigational agents

Exenatide GLP-1 / incretin class catch-all

Who this study enrolls

Type 1 diabetes

Who can enroll

Minimum age18 Years

Maximum age70 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Type 1 diabetes, disease duration >1 year

•Age >18 years, <70 years

•Insulin treatment according to basal-bolus insulin regimen (injections or insulin pump)

•Impaired hypoglycaemic awareness as assessed by a score of 3 or more on the modified Dutch translation of the Clarke questionnaire

•Glycated haemoglobin (HbA1c) ≥42 mmol/mol (6%) and ≤75 mmol/mol (9.0%)

•Ability to provide informed consent

Exclusion criteria

•Treatment with incretin-based therapy

•Known intolerance to GLP-1RAs (including allergy)

•Treatment with glucose-modifying or immune-modifying agents, e.g. prednisolon

•Recent history of myocardial infarction or stroke (past year) or laser coagulation for proliferative retinopathy (past 6 months)

•Proliferative retinopathy

•Symptomatic diabetic neuropathy

•Diabetic nephropathy as reflected by albumin-creatinin ratio >30 mmol/mg or estimated Glomerular Filtration Rate (eGFR) <60 ml/min/1.73 m2

•Known heart failure

•History of pancreatitis (acute or chronic) or pancreatic cancer

•Body-mass index >40 kg/m2

•Use of premixed insulin or of long-acting insulin alone

•Total daily insulin dose requirements <20 units unless on pump treatment

•Pregnancy or unwillingness to undertake measures for birth control

Endpoints (17)

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

Safety / tolerability / PK

Other clinical outcomes

Other (unclassified)

Cardiometabolic biomarkers

Glycemic / diabetes

6 endpoints

Secondary/protocol endpoint

Glucagon response to insulin-induced hypoglycaemia

Time frame:30 minutes

concentration, descriptive

Secondary/protocol endpoint

Time until glycaemic recovery from hypoglycaemia

Time frame:1 hour

time to event, improvement

Secondary/protocol endpoint

Maximal glucose excursion post-hypoglycaemia

Time frame:1 hour

descriptive

Secondary/protocol endpoint/low confidence

Time until glucose peak post-hypoglycaemia

Time frame:1 hour

time to event, improvement

Secondary/protocol endpoint

Area under the glucose concentration curve post-hypoglycaemia

Time frame:1 hour

descriptive

Secondary/protocol endpoint/low confidence

Glucose variability as measured by glucose sensor monitoring

Time frame:1 week

descriptive, improvement

Cardiometabolic biomarkers

1 endpoint

Other/protocol endpoint

Pulse rate

Time frame:6 weeks

Heart rate, change

descriptive

Safety / tolerability / PK

6 endpoints

Secondary/protocol endpoint

Number of severe hypoglycaemic events during follow-up

Time frame:16 weeks

Severe hypoglycemia

event count, event

Secondary/protocol endpoint

Number of nocturnal hypoglycaemic events during follow-up

Time frame:16 weeks

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Number of any hypoglycaemic events during follow-up

Time frame:16 weeks

event count, event

Secondary/protocol endpoint

Number of hypoglycaemic events measured by glucose sensor monitoring

Time frame:1 week

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Time spent under hypoglycaemic conditions measured by glucose sensor monitoring

Time frame:1 week

CGM time-below-range

descriptive, event

Other/protocol endpoint

Gastrointestinal side effects

Time frame:16 weeks

descriptive, event

Other clinical outcomes

2 endpoints

Primary/protocol endpoint/low confidence

Symptom score in response to insulin-induced hypoglycaemia

Time frame:30 minutes

descriptive

Secondary/protocol endpoint/low confidence

Hunger score post-hypoglycaemia

Time frame:1 hour

descriptive

Other (unclassified)

2 endpoints

Secondary/protocol endpoint/low confidence

Adrenaline response to insulin-induced hypoglycaemia

Time frame:30 minutes

concentration, descriptive

Secondary/protocol endpoint/low confidence

Carbohydrate requirement after recovery from hypoglycaemia

Time frame:1 hour

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 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 6, 2026 snapshot.