A Trial Investigating the Effect of NN1250 in Japanese Su... | NCT01467414

Studies
A Trial Investigating the Effect of NN1250 in Japanese Subjects With Type 2 Diabetes

NCT01467414

Sponsor

Novo Nordisk A/S

Status

Terminated

Last Update Posted

Nov 27, 2013Estimated

Enrollment

1Actual

Phase

Phase 1

Conditions

Diabetes
Diabetes Mellitus, Type 2

Interventions

insulin degludec

Countries

Germany

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
2011-001850-27	EudraCT Number
U1111-1120-7444	Other Identifier	WHO

Status Module

Record Verification Date

Nov 2013

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

This trial was terminated due to low recruitment

Expanded Access Info

Start Date

Oct 2011

Primary Completion Date

Dec 2011Actual

Completion Date

Dec 2011Actual

First Submitted Date

Oct 31, 2011

First Submission Date that Met QC Criteria

Nov 4, 2011

First Posted Date

Nov 8, 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

Nov 26, 2013

Last Update Posted Date

Nov 27, 2013Estimated

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 clinical trial is to investigate the pharmacodynamic (the effect of the investigated drug on the body) properties of NN1250 (insulin degludec) in Japanese 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 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NN1250	Experimental		Drug: insulin degludec

Interventions

Name	Type	Description	Arm Group Labels	Other Names
insulin degludec	Drug	Injected s.c. (under the skin) once daily for 6 days	NN1250

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Area under the glucose infusion rate curve during one dosing interval at steady state		Within 0-24 hours after last dosing

Secondary Outcomes

Measure	Description	Time Frame
Maximum glucose infusion rate at steady state		Within 0-24 hours after last dosing
Area under the serum insulin degludec concentration-time curve during one dosing interval at steady state		Within 0-24 hours after last dosing

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female Japanese subject aged 20-70 years (both inclusive)
Japanese passport holder
Japanese-born parents
Type 2 diabetes mellitus (as diagnosed clinically) for at least 12 months
Treated with insulin for at least 3 months
Body Mass Index (BMI) maximum 33.0 kg/m^2
Glycosylated haemoglobin A1c (HbA1c) maximum 10.0%
Fasting C-peptide below 1.0 nmol/L

Exclusion Criteria:

Use of oral antidiabetic drugs (OADs) and/or glucagon like peptide-1 (GLP-1) receptor agonists (exenatide, liraglutide) within 3 months prior to screening
Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period
Supine blood pressure at screening (after resting for 5 min) minimum 180 mmHg for systolic and/or minimum 100 mmHg for diastolic

Accepts Healthy Volunteers

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

Name	Affiliation	Role
Global Clinical Registry (GCR, 1452)	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
C571886	insulin degludec

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided