Comparison of Insulin Glargine Against Insulin Aspart Inf... | NCT00184613

Studies
Comparison of Insulin Glargine Against Insulin Aspart Infused Under the Skin in Patients With Type 2 Diabetes

NCT00184613

Sponsor

Novo Nordisk A/S

Status

Completed

Last Update Posted

Oct 17, 2016Estimated

Enrollment

22Actual

Phase

Phase 1

Conditions

Diabetes
Diabetes Mellitus, Type 2
Delivery Systems

Interventions

pump
insulin glargine
insulin aspart

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

ID	Type	Description	Link
2005-000268-22	EudraCT Number

Status Module

Record Verification Date

Oct 2016

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

May 2005

Primary Completion Date

Jan 2006Actual

Completion Date

Jan 2006Actual

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

Sep 12, 2005

First Posted Date

Sep 16, 2005Estimated

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

Oct 14, 2016

Last Update Posted Date

Oct 17, 2016Estimated

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

This trial is conducted in Europe. The objective of the study is to investigate the effect and safety of continously basal delivered insulin aspart given by a pump versus once daily injection of insulin glargine.

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 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

22Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Variation in morning FPG		Collected in hospital on the last 5 days of 7 days hospitalization, and on the morning of discharge

Secondary Outcomes

Measure	Description	Time Frame
Variation of plasma endogenous insulin and insulin aspart/glargine collected in hospital on the last 5 days and the morning on discharged
Variation of pre-dinner plasma glucose collected in hospital on the last 3 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects with type 2 diabetes for more than 2 years
Subjects currently treated with unchanged insulin glargine dose (10 -100 units) for 2 weeks
Subjects currently treated with unchanged dose(s) for at least 1 month on one or two Oral Anti-diabetic drugs
BMI 25 - 40 kg/m2
HbA1c < 9.5 %

Exclusion Criteria:

Known or suspected allergy to trial product(s) or related products
Previous randomisation in this trial
Pregnancy, breast-feeding, intention of becoming pregnant or pre-menopausal women judged not to be using adequate contraceptive measures (Only sterilisation, intra uterine devices and contraceptive pills are considered adequate contraceptive methods)
Mental incapacity, unwillingness or language barriers precluding adequate understanding and co-operation.
Any other significant illness such as endocrine, cardiac, neurological, malignant or other pancreatic illness judged by Investigator
Participation in other studies within the last three months

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Global Clinical Registry (GCR, 1452)	Novo Nordisk A/S	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Novo Nordisk Investigational Site		Århus C		8000	Denmark

Label	URL
Clinical Trials at Novo Nordisk	View source

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus
D003924	Diabetes Mellitus, Type 2

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
D000069036	Insulin Glargine
D061267	Insulin Aspart

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided