Hypoglycemia Counterregulation and Symptom Perception Wit... | NCT00490893

Studies
Hypoglycemia Counterregulation and Symptom Perception With Insulin Detemir

NCT00490893

Sponsor

University Hospital Tuebingen

Status

Terminated

Last Update Posted

Jun 25, 2007Estimated

Enrollment

12Actual

Phase

Phase 4

Conditions

Diabetes Mellitus
Hypoglycemia

Interventions

Detemir

Countries

Germany

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

Jun 2007

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2006

Primary Completion Date

Not provided

Completion Date

Dec 2006Actual

First Submitted Date

Jun 22, 2007

First Submission Date that Met QC Criteria

Jun 22, 2007

First Posted Date

Jun 25, 2007Estimated

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

Jun 22, 2007

Last Update Posted Date

Jun 25, 2007Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Hypoglycemia and unawareness of hypoglycemia are major problems of insulin therapy in patients with diabetes mellitus. The long acting insulin analogue Detemir has structural and physicochemical properties which differ from human insulin. The aim of the present study is to test whether this leads to altered hormone and symptom response during hypoglycemia.

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Name	Type	Description	Arm Group Labels	Other Names
Detemir	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hormone response to hypoglycemia (Glucagon)
Hormone response to hypoglycemia (glucagon) Symptom response to hypoglycemia

Secondary Outcomes

Measure	Description	Time Frame
Hormone response to glucagon (epinephrine, growth hormne, cortisol)
Hormone response (epinephrine, growth hormone, cortisol) to hypoglycemia

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy subjects male or female
Age 18-50 years
Female subjects save contraception
Ability to take part in the study
Signed consent

Exclusion Criteria:

Chronic disease
Acute disease during 4 weeks prior to the study
Pregnancy
Drug treatment other than hormonal contraception

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Andreas Fritsche, MD	University Hospital Tuebingen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Tübingen, Medical Department		Tübingen		72076	Germany

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus
D007003	Hypoglycemia

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069057	Insulin Detemir

Ancestor Terms

ID	Term
D049528	Insulin, Long-Acting
D061385	Insulins
D010187	Pancreatic Hormones
D036361	Peptide Hormones

Browse Leaves

Not provided

Browse Branches

Not provided