NCT01497600

Brief Summary

This trial is conducted in the United States of America (USA). The aim of this trial is to evaluate the the dose-response of insulin detemir and insulin NPH in subjects with type 2 diabetes of various race and ethnicity.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_1 diabetes

Timeline
Completed

Started Feb 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2004

Completed
7.4 years until next milestone

First Submitted

Initial submission to the registry

December 20, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 22, 2011

Completed
Last Updated

January 27, 2017

Status Verified

January 1, 2017

Enrollment Period

6 months

First QC Date

December 20, 2011

Last Update Submit

January 26, 2017

Conditions

DiabetesDiabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Area under the glucose infusion rate curve

Secondary Outcomes (8)

  • Maximum glucose infusion rate

  • Time to maximum glucose infusion rate.

  • Area under the serum insulin curve

  • Maximum serum insulin concentration

  • Time to maximum insulin concentration

  • +3 more secondary outcomes

Study Arms (2)

insulin detemir

EXPERIMENTAL
Drug: insulin detemirDrug: insulin NPH

insulin NPH

ACTIVE COMPARATOR
Drug: insulin detemirDrug: insulin NPH

Interventions

insulin detemirDRUG

Each subject will be randomly allocated to three doses: 0.3, 0.6, and 1.2 U/kg. Administrated subcutaneously (s.c., under the skin)

insulin NPHinsulin detemir
insulin NPHDRUG

Each subject will be randomly allocated to three doses: 0.3, 0.6, and 1.2 U/kg. Administrated subcutaneously (s.c., under the skin)

insulin NPHinsulin detemir

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes
  • Insulin treatment with any insulin preparation/regimen for at least three months with or without combination with below or equal to 2 oral antidiabetic agents (OADs)
  • Duration of diabetes at least 12 months
  • Body Mass Index (BMI) below 33 kg/m\^2
  • HbA1c maximum 10 % based on analysis from the central laboratory

You may not qualify if:

  • Current treatment with insulin above 1.2 U/kg/day
  • Current treatment with drugs known to interfere with glucose metabolism other than OADs such as systemic corticosteroids, non-selective beta-blockers, and monoamino oxidase (MAO) inhibitors
  • Blood donation of more than 500 mL within the last three months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Chula Vista, California, 91911, United States

Location

Related Publications (1)

  • Hompesch M, Troupin B, Heise T, Elbroend B, Endahl L, Haahr H, Heinemann L. Time-action profile of insulin detemir and NPH insulin in patients with type 2 diabetes from different ethnic groups. Diabetes Obes Metab. 2006 Sep;8(5):568-73. doi: 10.1111/j.1463-1326.2006.00643.x.

    PMID: 16918592RESULT

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2

Interventions

Insulin DetemirInsulin, Isophane

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2011

First Posted

December 22, 2011

Study Start

February 1, 2004

Primary Completion

August 1, 2004

Study Completion

August 1, 2004

Last Updated

January 27, 2017

Record last verified: 2017-01

Locations

US(1)