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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01467414
• Other study ID #: NN1250-3763
• Secondary ID: 2011-001850-27U1
• Status: Terminated
• Phase: Phase 1
• First received: October 31, 2011
• Last updated: November 26, 2013
• Start date: October 2011
• Est. completion date: December 2011

Study information

• Verified date: November 2013
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• insulin degludec
Injected s.c. (under the skin) once daily for 6 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the glucose infusion rate curve during one dosing interval at steady state		Within 0-24 hours after last dosing	No
Secondary	Maximum glucose infusion rate at steady state		Within 0-24 hours after last dosing	No
Secondary	Area under the serum insulin degludec concentration-time curve during one dosing interval at steady state		Within 0-24 hours after last dosing	No
Secondary	Maximum observed serum insulin degludec concentration at steady state		Within 0-24 hours after last dosing	No

External Links

•   Clinical Trials at Novo Nordisk