Pharmacokinetics of IAsp Following CSII in Patients With... | NCT00497536

Studies
Pharmacokinetics of IAsp Following CSII in Patients With T1DM

NCT00497536

Sponsor

University of Aarhus

Status

Completed

Last Update Posted

Feb 5, 2009Estimated

Enrollment

12Estimated

Phase

Phase 4

Conditions

Type 1 Diabetes Mellitus

Interventions

Insulin Aspart (IAsp)
Insulin Aspart (IAsp).
Insulin Aspart (IAsp)

Countries

Denmark

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

Feb 2009

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

Jul 2007

Primary Completion Date

Jul 2008Actual

Completion Date

Jul 2008Actual

First Submitted Date

Jul 4, 2007

First Submission Date that Met QC Criteria

Jul 4, 2007

First Posted Date

Jul 6, 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

Feb 4, 2009

Last Update Posted Date

Feb 5, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The primary objective of the study is to compare SSPIAsp during CSII giving one bolus per hour compared with multiple boluses per hour.

The secondary objective is to compare SSPIAsp during continuous subcutaneous insulin infusion (CSII) versus continuous intravenous insulin infusion (CIII).

Detailed Description

Rapid acting insulin, like insulin aspart, can be administered as CSII. The insulin can be administered as a basal rate with additional insulin administration from the pump related to mealtimes.

Insulin is physiologically secreted in a pulsate manner from the pancreatic β-cells with a period of 5-10 minutes, and this is responsible for plasma insulin oscillations with similar frequency. The oscillatory pattern is believed to optimize control mechanisms of insulin to enhance its action on metabolism.

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

12Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	≈ bolus protocol.	Drug: Insulin Aspart (IAsp)
2	Active Comparator	≈ CSII protocol	Drug: Insulin Aspart (IAsp).
3	Active Comparator	≈ CIII protocol.	Drug: Insulin Aspart (IAsp)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Insulin Aspart (IAsp)	Drug	IAsp 100 U. ≈ bolus protocol: From 6 pm until 6 am • 50 % of habitual 24 hour insulin need/24 hours = basal rate (per hour) From 8 am until 6 pm 1 dose/h + 50 % s.c. (≈ bolus).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
CV SSPIasp		6 hours

Secondary Outcomes

Measure	Description	Time Frame
• Δ SSPIAsp (S.C. /I.V.) • AUC IAsp • Tmax IAsp • Cmax IAsp - Bioequivalence of Iasp under SS (GIR, S-FFA, S-glycerol)		6 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Type 1 diabetes mellitus (T1DM)
Insulin pump users' ≥ 48 hours, 24 h dose < 80 U
Insulin dose ≥ 0,4 IE/kg/24hours
18 years < age < 50 years
Time since diagnosis of T1DM ≥ 5 years
HbA1c ≤ 8,5 %
Safe anticonceptive for fertile women
Being able to understand and read Danish

Exclusion Criteria:

Dysregulation of endocrine disorders other than type 1 diabetes mellitus
Severe dysregulation of diabetes mellitus
Other severe adverse disease
Pregnancy, planning pregnancy, or nursing

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Torsten Lauritzen, MD	University of Aarhus	Study Director
Torben Laursen, MD	University of Aarhus	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medicinsk Endokrinologisk Afdeling M		Aarhus C	Central Jutland	8000	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D003922	Diabetes Mellitus, Type 1

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

Intervention Browse Module

MeSH Terms

ID	Term
D061267	Insulin Aspart

Ancestor Terms

ID	Term
D061266	Insulin, Short-Acting
D061385	Insulins
D010187	Pancreatic Hormones
D036361	Peptide Hormones

Browse Leaves

Not provided

Browse Branches

Not provided