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

NCT ID: NCT01467414

Last Updated: 2013-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2011-12-31

Brief Summary

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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

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Conditions

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Diabetes Diabetes Mellitus, Type 2

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NN1250

Group Type EXPERIMENTAL

insulin degludec

Intervention Type DRUG

Injected s.c. (under the skin) once daily for 6 days

Interventions

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insulin degludec

Injected s.c. (under the skin) once daily for 6 days

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Neuss, , Germany

Site Status

Countries

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Germany

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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2011-001850-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1120-7444

Identifier Type: OTHER

Identifier Source: secondary_id

NN1250-3763

Identifier Type: -

Identifier Source: org_study_id