Safety and Efficacy of Insulin Aspart in Type 2 Diabetes | NCT01649570

Studies
Safety and Efficacy of Insulin Aspart in Type 2 Diabetes

NCT01649570

Sponsor

Novo Nordisk A/S

Status

Completed

Last Update Posted

Jul 25, 2012Estimated

Enrollment

123Actual

Phase

Phase 4

Conditions

Diabetes
Diabetes Mellitus, Type 2

Interventions

insulin aspart

Countries

Japan

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

Jul 2012

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

Mar 2002

Primary Completion Date

Aug 2003Actual

Completion Date

Aug 2003Actual

First Submitted Date

Nov 25, 2011

First Submission Date that Met QC Criteria

Jul 24, 2012

First Posted Date

Jul 25, 2012Estimated

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

Jul 24, 2012

Last Update Posted Date

Jul 25, 2012Estimated

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 Japan. The aim of this trial is to investigate the safety and efficacy of NovoRapid® (insulin aspart) as meal time insulin in subjects with type 2 diabetes treated on a basal-bolus regimen with Neutral Protamine Hagedorn (NPH) human insulin.

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

123Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Insulin aspart	Experimental		Drug: insulin aspart

Interventions

Name	Type	Description	Arm Group Labels	Other Names
insulin aspart	Drug	Administrated subcutaneously (s.c., under the skin) three times a day before each meal for 24 weeks	Insulin aspart

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of hypoglycaemia

Secondary Outcomes

Measure	Description	Time Frame
Incidence of adverse events (AEs)
Clinical laboratory tests: Haematology and biochemistry
Insulin antibodies

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Type 2 diabetes
Treated with insulin for at least 12 months and currently on a basal-bolus regimen for at least 12 weeks
HbA1c below or equal to 11.0%
BMI (body mass index) below 30 kg/m^2

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Henning Andersen	Novo Nordisk A/S	Study Director

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
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