Efficacy of Biphasic Insulin Aspart 30 in Subjects With T... | NCT01486862

Studies
Efficacy of Biphasic Insulin Aspart 30 in Subjects With Type 2 Diabetes Failing on OADs

NCT01486862

Sponsor

Novo Nordisk A/S

Status

Completed

Last Update Posted

Nov 2, 2023Actual

Enrollment

26Actual

Phase

Phase 4

Conditions

Diabetes
Diabetes Mellitus, Type 2

Interventions

biphasic insulin aspart 30

Countries

Mexico

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

Oct 2023

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 2005

Primary Completion Date

Jul 2006Actual

Completion Date

Jul 2006Actual

First Submitted Date

Dec 5, 2011

First Submission Date that Met QC Criteria

Dec 5, 2011

First Posted Date

Dec 7, 2011Estimated

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 31, 2023

Last Update Posted Date

Nov 2, 2023Actual

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 North America. The aim of this trial is to investigate the efficacy of biphasic insulin aspart 30 in subjects with type 2 diabetes not achieving glycaemic targets on OADs (oral anti-diabetic drugs).

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

26Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BIAsp 30	Experimental		Drug: biphasic insulin aspart 30

Interventions

Name	Type	Description	Arm Group Labels	Other Names
biphasic insulin aspart 30	Drug	Dose individually adjusted. Administered once daily for 16 weeks. If HbA1c after 16 weeks of treatment is above 7.0%, insulin is administered twice daily for additional 16 weeks.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of subjects achieving HbA1c (glycosylated haemoglobin A1c) below 7.0%

Secondary Outcomes

Measure	Description	Time Frame
Change in HbA1c
Total number of hypoglycemic events
Adverse events

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Type 2 diabetes mellitus for at least 12 months
HbA1c between 7.5-14.5% (inclusive) at screening
Insulin naïve
An antidiabetic regimen that has been stable for at least 3 months prior to screening
An antidiabetic regimen that includes a minimum of 2 OADs

Exclusion Criteria:

Use of any insulin preparations within the past 6 months
Active proliferative retinopathy or maculopathy requiring treatment within 6 months prior to screening

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
		Pachuca		42060	Mexico

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
C557564	insulin aspart, insulin aspart protamine drug combination 30:70

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided