Exenatide and Impaired Hypoglycaemic Awareness in Type 1... | NCT02735031

Studies
Exenatide and Impaired Hypoglycaemic Awareness in Type 1 Diabetes

NCT02735031

Sponsor

Radboud University Medical Center

Status

Completed

Last Update Posted

Apr 12, 2018Actual

Enrollment

10Actual

Phase

Phase 2Phase 3

Conditions

Diabetes Mellitus, Type 1
Hypoglycemia

Interventions

Exenatide
Placebo

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 21, 2017Actual

Primary Completion Date

Mar 28, 2018Actual

Completion Date

Apr 9, 2018Actual

First Submitted Date

Feb 22, 2016

First Submission Date that Met QC Criteria

Apr 6, 2016

First Posted Date

Apr 12, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 11, 2018

Last Update Posted Date

Apr 12, 2018Actual

Name	Class
AstraZeneca	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Approximately 25% of patients with type 1 diabetes have lost the capacity to timely detect hypoglycaemia, a condition referred to as impaired hypoglycaemic awareness (IHA) that causes a six-fold higher risk of severe, potentially hazardous, hypoglycaemia. IHA is usually the end-result of a process of habituation to recurrent hypoglycemia that is potentially reversible. Treatment with glucagon-like peptide (GLP)-1 Receptor Agonists (1RAs) in addition to insulin therapy may decrease the incidence of hypoglycaemia in patients with type 1 diabetes. This study will test the hypothesis that treatment with the GLP-1RA, exenatide, added to basal-bolus insulin therapy will improve awareness of hypoglycaemia in patients with type 1 diabetes and IHA. In a randomized doubleblind placebo-controlled cross-over trial, patients will be treated for 6 weeks with exenatide (or placebo), after which hypoglycemic symptoms and counterregulatory hormone responses will be examined during a hyperinsulinemic hypoglycemic glucose clamp study.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
EXENATIDE	Active Comparator	Exenatide week 1-2: 5 µg twice daily week 3-6: 10 µg twice daily (if tolerated)	Drug: Exenatide
PLACEBO	Placebo Comparator	Placebo matched to exenatide week 1-2: 5 µg twice daily week 3-6: 10 µg twice daily (if tolerated)	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Exenatide	Drug	6 weeks treatment with exenatide on top of insulin treatment	EXENATIDE

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Symptom score in response to insulin-induced hypoglycaemia	Measured during hyperinsulinemic hypoglycaemic glucose clamps	30 minutes

Secondary Outcomes

Measure	Description	Time Frame
Adrenaline response to insulin-induced hypoglycaemia	Measured in plasma during hyperinsulinemic hypoglycaemic glucose clamps	30 minutes
Glucagon response to insulin-induced hypoglycaemia	Measured in plasma during hyperinsulinemic hypoglycaemic glucose clamps

Other Outcomes

Measure	Description	Time Frame
Pulse rate	Measured during hyperinsulinemic hypoglycaemic glucose clamps	6 weeks
Gastrointestinal side effects		16 weeks

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003922	Diabetes Mellitus, Type 1
D007003	Hypoglycemia

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Term
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D014688	Venoms
D045424	Complex Mixtures