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NCT Number: NCT01043510

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

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Chula Vista, California, 91911, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

insulin degludec

Drug

0.6 U/kg body weight injected subcutaneously (under the skin), once daily for 6 days

insulin detemir

Drug

0.6 U/kg body weight injected subcutaneously (under the skin), once daily for 6 days

Primary outcomes

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

    Time frame: 0-24 hours (derived on treatment day 6)

Secondary outcomes

  1. Area under the Insulin Degludec concentration-time curve during one dosing interval at steady state

    Time frame: 0-24 hours (derived on treatment day 6)

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jan 6, 2010
Registry last updated
Jan 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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