The Effect of NN1250 in Subjects With Type 2 Diabetes of Different Race and/or Ethnic Origin

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A Trial Investigating the Pharmacodynamic and Pharmacokinetic Properties of NN1250 at Steady State Conditions in Subjects With Type 2 Diabetes of Different Race and/or Ethnicity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01043510
• Other study ID #: NN1250-3762
• Secondary ID: U1111-1112-6185
• Status: Completed
• Phase: Phase 1
• First received: January 5, 2010
• Last updated: January 20, 2017
• Start date: January 2010
• Est. completion date: October 2010

Study information

• Verified date: January 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This trial is conducted in the United States of America (USA). The aim of this trial is to investigate the pharmacodynamic (effect) and pharmacokinetic (exposure of drug) properties of NN1250 (insulin degludec, IDeg) in subjects with type 2 diabetes of different race and/or ethnicity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Either - Black or African American not of Hispanic or Latino origin or - White of Hispanic or Latino origin or - White not of Hispanic or Latino origin

• Type 2 diabetes mellitus (as diagnosed clinically) for at least 12 months

• Treated with insulin for at least 3 months, alone or in combination with maximum 2 oral antidiabetic drugs (OADs)

• Body mass index maximum 40.0 kg/m^2

Exclusion Criteria:

• Use of GLP-1 receptor agonists (exenatide, liraglutide), thiazolidinediones or dipeptidyl peptidase-4 (DPP-4) inhibitors within 3 months prior to screening

• History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction

• Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• insulin degludec
0.6 U/kg body weight injected subcutaneously (under the skin), once daily for 6 days
• insulin detemir
0.6 U/kg body weight injected subcutaneously (under the skin), once daily for 6 days

Locations

Country	Name	City	State
United States	Novo Nordisk Investigational Site	Chula Vista	California

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

References & Publications (2)

Heise T, Korsatko S, Nosek L, Coester HV, Deller S, Roepstorff C, Segel S, Kapur R, Haahr H, Hompesch M. Steady state is reached within 2-3 days of once-daily administration of degludec, a basal insulin with an ultralong duration of action. J Diabetes. 20 — View Citation

Hompesch M, Morrow L, Watkins E, Roepstorff C, Thomsen HF, Haahr H. Pharmacokinetic and pharmacodynamic responses of insulin degludec in African American, white, and Hispanic/Latino patients with type 2 diabetes mellitus. Clin Ther. 2014 Apr 1;36(4):507-1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the glucose infusion rate curve during one dosing interval at steady state		0-24 hours (derived on treatment day 6)
Secondary	Area under the Insulin Degludec concentration-time curve during one dosing interval at steady state		0-24 hours (derived on treatment day 6)

External Links

•   Clinical Trials at Novo Nordisk