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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01043510
First received: January 5, 2010
Last updated: June 29, 2012
Last verified: June 2012
History of Changes
  Purpose

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 in subjects with type 2 diabetes of different race and/or ethnicity.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
 Drug: NN1250
Drug: insulin detemir
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • Area under the glucose infusion rate curve during one dosing interval at steady state [ Time Frame: 0-24 hours (derived on treatment day 6) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Area under the NN1250 concentration-time curve during one dosing interval at steady state [ Time Frame: 0-24 hours (derived on treatment day 6) ] [ Designated as safety issue: No ]

Enrollment: 63
Study Start Date: January 2010
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A1, first period Drug: NN1250
0.6 U/kg body weight injected subcutaneously (under the skin), once daily for 6 days
Active Comparator: A2, second period Drug: insulin detemir
0.6 U/kg body weight injected subcutaneously (under the skin), once daily for 6 days
Active Comparator: B1, first period Drug: insulin detemir
0.6 U/kg body weight injected subcutaneously (under the skin), once daily for 6 days
Experimental: B2, second period Drug: NN1250
0.6 U/kg body weight injected subcutaneously (under the skin), once daily for 6 days

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 for at least 12 months
  • Treated with insulin for at least 3 months, alone or in combination with one or two oral antidiabetic drugs (OADs)
  • Body mass index (BMI) of maximum 40.0 kg/m2

Exclusion Criteria:

  • Use of GLP-1 receptor agonists (exenatide, liraglutide), thiazolidinediones or 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01043510

Locations
United States, California
Novo Nordisk Clinical Trial Call Center
Chula Vista, California, United States, 91911
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Carsten Roepstorff, PhD Novo Nordisk
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Novo Nordisk
ClinicalTrials.gov Identifier: NCT01043510     History of Changes
Other Study ID Numbers: NN1250-3762, U1111-1112-6185
Study First Received: January 5, 2010
Last Updated: June 29, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 21, 2013