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

Primary Purpose

Diabetes, Diabetes Mellitus, Type 2

Status

Terminated

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

insulin degludec

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NN1250

Arm Description

Outcomes

Primary Outcome Measures

Area under the glucose infusion rate curve during one dosing interval at steady state

Secondary Outcome Measures

Maximum glucose infusion rate at steady state

Area under the serum insulin degludec concentration-time curve during one dosing interval at steady state

Maximum observed serum insulin degludec concentration at steady state

Full Information

NCT ID

NCT01467414

First Posted

October 31, 2011

Last Updated

November 26, 2013

Sponsor

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT01467414

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2013

Overall Recruitment Status

Terminated

Why Stopped

This trial was terminated due to low recruitment

Study Start Date

October 2011 (undefined)

Primary Completion Date

December 2011 (Actual)

Study Completion Date

December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novo Nordisk A/S

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes, Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

NN1250

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

insulin degludec

Intervention Description

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

Primary Outcome Measure Information:

Title

Area under the glucose infusion rate curve during one dosing interval at steady state

Time Frame

Within 0-24 hours after last dosing

Secondary Outcome Measure Information:

Title

Maximum glucose infusion rate at steady state

Time Frame

Within 0-24 hours after last dosing

Title

Area under the serum insulin degludec concentration-time curve during one dosing interval at steady state

Time Frame

Within 0-24 hours after last dosing

Title

Maximum observed serum insulin degludec concentration at steady state

Time Frame

Within 0-24 hours after last dosing

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Global Clinical Registry (GCR, 1452)

Organizational Affiliation

Novo Nordisk A/S

Official's Role

Study Director

Facility Information:

City

Neuss

ZIP/Postal Code

41460

Country

Germany

12. IPD Sharing Statement

Links:

URL

http://novonordisk-trials.com

Description

Clinical Trials at Novo Nordisk

Learn more about this trial

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

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