NL-OMON45806CompletedPhase 2
Effect of the GLP-1 receptor agonist exenatide on impaired awareness of hypoglycemia in type 1 diabetes - Exenatide and impaired awareness of hypoglycemia in T1DM
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 13
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •* Type 1 diabetes, disease duration >1 year
- •* Age >18 years, * Insulin treatment according to basal-bolus insulin regimen (injections or insulin pump)
- •* Impaired awareness of hypoglycemia 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 (DPP-IV inhibitors or GLP-1RAs)
- •* Known intolerance to GLP-1RAs (including allergy)
- •* Treatment with glucose-modefying or immune-modefying agents, e.g. prednisolon
- •* History of cardiovascular disease (e.g. myocardial infarction, stroke, heart failure) 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 MDRD <60 ml/min/1.73 m2
- •* History of pancreatitis (acute or chronic) or pancreatic cancer
- •* Body-mass index <19 or >40 kg/m2
- •* Blood pressure >160/90 mmHg
- •* 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
Investigators
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