Comparison of Two Biphasic Insulin Aspart Treatments in S... | NCT01520753

Studies
Comparison of Two Biphasic Insulin Aspart Treatments in Subjects With Type 2 Diabetes

NCT01520753

Sponsor

Novo Nordisk A/S

Status

Completed

Last Update Posted

Jan 4, 2017Estimated

Enrollment

16Actual

Phase

Phase 3

Conditions

Diabetes
Diabetes Mellitus, Type 2

Interventions

biphasic insulin aspart 70
biphasic insulin aspart 70
biphasic insulin aspart 50

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

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

Mar 1999

Primary Completion Date

Jun 1999Actual

Completion Date

Jun 1999Actual

First Submitted Date

Jan 25, 2012

First Submission Date that Met QC Criteria

Jan 25, 2012

First Posted Date

Jan 30, 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

Jan 3, 2017

Last Update Posted Date

Jan 4, 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 Europe. The aim of this trial is to compare two different active treatment regimens of biphasic insulin aspart 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

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BIAsp 70	Experimental		Drug: biphasic insulin aspart 70
BIAsp 70 + BIAsp 50	Experimental		Drug: biphasic insulin aspart 70 Drug: biphasic insulin aspart 50

Interventions

Name	Type	Description	Arm Group Labels	Other Names
biphasic insulin aspart 70	Drug	Administered subcutaneously (s.c., under the skin) at breakfast, lunch and dinner	BIAsp 70

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Fasting serum glucose

Secondary Outcomes

Measure	Description	Time Frame
24-hour serum glucose profiles
24-hour insulin profiles
Incidence of hypoglycaemic episodes

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Type 2 diabetes
Duration of diabetes for longer than 12 months
Body mass index (BMI) below 35.0 kg/m^2
HbA1c below 11.0 %
Treatment with BHI (biphasic human insulin) 20 or 30 twice daily for at least three months and in the last month as sole anti-diabetic treatment (i.e., no additional oral hypoglycaemic medication or daily use of short-acting insulin supplement)

Exclusion Criteria:

Current treatment with agents affecting glucose metabolism
History of drug or alcohol dependence
Impaired hepatic function
Impaired renal function
Cardiac disease
Proliferative retinopathy
Recurrent severe hypoglycaemia or advanced neuropathy

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		Århus C		8000	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
14617230	Result	Ejskjaer N, Rasmussen M, Kamp N, Lindholm A, Christiansen JS. Comparison of thrice daily 'high' vs. 'medium' premixed insulin aspart with respect to evening and overnight glycaemic control in patients with type 2 diabetes. Diabetes Obes Metab. 2003 Nov;5(6):438-45. doi: 10.1046/j.1463-1326.2003.00299.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