Human Insulin NPH and Insulin Aspart in Type 1 Diabetes | NCT00597233

Studies
Human Insulin NPH and Insulin Aspart in Type 1 Diabetes

NCT00597233

Sponsor

Novo Nordisk A/S

Status

Completed

Last Update Posted

Dec 22, 2016Estimated

Enrollment

91Actual

Phase

Phase 4

Conditions

Diabetes
Diabetes Mellitus, Type 1

Interventions

insulin aspart
soluble human insulin
insulin NPH

Countries

Argentina

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

Dec 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

Oct 2002

Primary Completion Date

Dec 2002Actual

Completion Date

Dec 2002Actual

First Submitted Date

Jan 9, 2008

First Submission Date that Met QC Criteria

Jan 9, 2008

First Posted Date

Jan 18, 2008Estimated

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

Dec 20, 2016

Last Update Posted Date

Dec 22, 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 South America. This aim of this trial is to evaluate the comparative prandial blood glucose lowering profile in subjects with type 1 diabetes.

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

91Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prandial blood glucose lowering profile		between 1st and 2nd post prandial hours

Secondary Outcomes

Measure	Description	Time Frame
Hypoglycaemic events
Adverse events
Serious adverse events

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Type 1 diabetes for at least 12 months
Treatment with insulin NPH
Body Mass Index (BMI) below 30 kg/m2

Exclusion Criteria:

Total daily insulin dose greater than 1.40 IU/kg
Treatment with oral antidiabetic drugs (OADs)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

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		Junín			Argentina

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
	Result	Cintora H, Rodrigues M, Klyver MI, Claus-Hermerg H, González G, Kanevsky D, Medrano G, Sánchez A. Insulina Aspártica versus insulina soluble humana: Estudio comparativo cruzado en pacientes con diabetes tipo 1. Revista de la Sociedad Argentina de Diabetes 2004; 38 (4): 218-224

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

ID	Term
D061267	Insulin Aspart
D007336	Insulin, Isophane

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

Name	Type	Description	Arm Group Labels	Other Names
insulin aspart	Drug
soluble human insulin	Drug
insulin NPH	Drug

ID	Term
D003920	Diabetes Mellitus
D003922	Diabetes Mellitus, Type 1