Insulin Profile of Biphasic Insulin Aspart 70 to That of... | NCT01538511

Studies
Insulin Profile of Biphasic Insulin Aspart 70 to That of Biphasic Insulin Aspart 30 in Healthy Volunteers

NCT01538511

Sponsor

Novo Nordisk A/S

Status

Completed

Last Update Posted

Oct 6, 2017Actual

Enrollment

59Actual

Phase

Phase 1

Conditions

Diabetes
Diabetes Mellitus, Type 2

Interventions

biphasic insulin aspart 70
biphasic insulin aspart 30

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

Oct 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

Jun 5, 2006Actual

Primary Completion Date

Mar 13, 2007Actual

Completion Date

Mar 13, 2007Actual

First Submitted Date

Feb 20, 2012

First Submission Date that Met QC Criteria

Feb 20, 2012

First Posted Date

Feb 24, 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

Oct 4, 2017

Last Update Posted Date

Oct 6, 2017Actual

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

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 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

59Actual

Label	Type	Description	Intervention Names
BIAsp 70	Experimental		Drug: biphasic insulin aspart 70
BIAsp 30	Experimental		Drug: biphasic insulin aspart 30

Name	Type	Description	Arm Group Labels	Other Names
biphasic insulin aspart 70	Drug	Administered subcutaneously (s.c., under the skin) three times daily immediately before breakfast, lunch and dinner for 4 weeks. Dose individually adjusted

Measure	Description	Time Frame
Area under the plasma insulin concentration curve from 0 to 24 hours

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

SUBJECTS WITH TYPE 2 DIABETES

Subjects with type 2 diabetes mellitus
Current treatment using intermediate-acting, long-acting or pre-mixed/biphasic insulin preparation (including insulin analogues) in once or twice daily (before breakfast and dinner) treatment regimen for at least 12 weeks (a temporary use [maximum of one week in total] of rapid-acting human insulin will be allowed)
Age between 20-69 years, both inclusive
HbA1c (glycosylated haemoglobin A1c) below 9.0%
Body Mass Index (BMI) 18.5-25.0 kg/m^2
Total daily insulin dose (per day) above 0.2 U or IU/kg body weight and below 1.0 U or IU/kg body weight HEALTHY VOLUNTEERS
Japanese subjects with considered generally healthy based on medical history and physical examination
Age between 20-29 years, both inclusive
Body Mass Index (BMI) 18.5-25.0 kg/m^2
Subjects with normal glucose tolerance (NGT); defined as fasting plasma glucose below 110 mg/dL and 2-hour post OGTT (oral glucose tolerance test) plasma glucose below 140 mg/dL

Exclusion Criteria:

SUBJECTS WITH TYPE 2 DIABETES

Proliferative retinopathy or maculopathy requiring acute treatment
Impaired hepatic function
Impaired renal function
Serious cardiac diseases
Uncontrolled hypertension
Known hypoglycaemia unawareness or recurrent major hypoglycaemia
Current treatment or expected at the screening to start treatment with systemic corticosteroids HEALTHY VOLUNTEERS
Any clinical laboratory values deviated from the reference range at the laboratory (except for cases within physiological change) at the screening
History or presence of diabetes, cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, dermatological, venereal, haematological, neurological, or psychiatric diseases or disorders
Subjects with a first-degree relative with diabetes mellitus

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

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

Measure	Description	Time Frame
Area under the concentration curve of plasma insulin from 0 to 4 hours after meals
Maximum plasma insulin concentration observed from 0 to 4 hours after meals

ID	Term
D003920	Diabetes Mellitus
D003924	Diabetes Mellitus, Type 2