Efficacy and Safety of Three Times a Day BIAsp-70 Compare... | NCT00318786

Studies
Efficacy and Safety of Three Times a Day BIAsp-70 Compared to Two Times a Day BIAsp-30 in Subjects With Type 2 Diabetes

NCT00318786

Sponsor

Novo Nordisk A/S

Status

Completed

Last Update Posted

Jan 6, 2017Estimated

Enrollment

289Actual

Phase

Phase 3

Conditions

Diabetes
Diabetes Mellitus, Type 2

Interventions

biphasic 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

ID	Type	Description	Link
JapicCTI-060241	Registry Identifier	japic

Status Module

Record Verification Date

Jan 2017

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

Apr 2006

Primary Completion Date

Jun 2007Actual

Completion Date

Jun 2007Actual

First Submitted Date

Apr 26, 2006

First Submission Date that Met QC Criteria

Apr 26, 2006

First Posted Date

Apr 27, 2006Estimated

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

Jan 5, 2017

Last Update Posted Date

Jan 6, 2017Estimated

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. This a clinical trial to study the efficacy and safety of three times a day BIAsp-70 compared to two times a day BIAsp-30 in subjects with type 2 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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

289Actual

Name	Type	Description	Arm Group Labels	Other Names
biphasic insulin aspart	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hemoglobin A1C (HbA1C)		After 16 weeks of treatment

Secondary Outcomes

Measure	Description	Time Frame
HbA1C, after 28 weeks of treatment; Plasma glucose levels

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects with type 2 diabetes
Current treatment using intermediate-acting, long-acting insulin (including long-acting insulin analogue) or pre-mixed human insulin for at least 24 weeks
HbA1c at least 7.5% and below 10.0%

Exclusion Criteria:

Proliferative retinopathy or maculopathy requiring acute treatment
Impaired hepatic and/or renal function
Cardiac diseases
Uncontrolled hypertension
Known hypoglycemia unawareness or recurrent major hypoglycemia

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

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		Tokyo		1000005	Japan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24843416	Result	Kadowaki T, Nishida T, Kaku K. 28-week, randomized, multicenter, open-label, parallel-group phase III trial to investigate the efficacy and safety of biphasic insulin aspart 70 thrice-daily injections vs twice-daily injections of biphasic insulin aspart 30 in patients with type 2 diabetes. J Diabetes Investig. 2010 Jun 1;1(3):103-10. doi: 10.1111/j.2040-1124.2010.00015.x.

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

ID	Term
D003920	Diabetes Mellitus
D003924	Diabetes Mellitus, Type 2