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Comparison of Two NN1250 Formulations Versus Insulin Glargine, All in Combination With Insulin Aspart in Subjects With Type 1 Diabetes | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Comparison of Two NN1250 Formulations Versus Insulin Glargine, All in Combination With Insulin Aspart in Subjects With Type 1 Diabetes

A 16 Week Randomised, Open Labelled, 3-armed, Treat-to-target, Parallel Group Trial Comparing SIBA (D) Once Daily + NovoRapid®, SIBA (E) Once Daily + NovoRapid® and Insulin Glargine Once Daily + NovoRapid®, All in a Basal/Bolus Regimen in Subjects With Type 1 Diabetes

NCT00612040•Novo Nordisk A/S

View on ClinicalTrials.gov

Summary

This trial is conducted in Europe, Oceania and the United States of America (USA). The aim of this trial is to compare two NN1250 (insulin degludec) formulations with each other and with insulin glargine, all in combination with insulin aspart in subjects with type 1 diabetes.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Type 1 diabetes for at least one year
•HbA1c 7-11% (both inclusive)
•Treated with insulin for at least six months - any regimen

Exclusion Criteria

•Any systemic treatment with products which in the Investigator's opinion could interfere with glucose or lipid metabolism (eg systemic corticosteroids) 3 months prior to randomisation
•Subject has a clinically significant, active (during the past 12 months) disease of the gastrointestinal, pulmonary, neurological, genitourinary, or haematological system that, in the opinion of the Investigator, may confound the results of the trial or pose additional risk in administering trial product

Locations (33)

Novo Nordisk Investigational Site

Walnut Creek, California, United States

Novo Nordisk Investigational Site

Honolulu, Hawaii, United States

Novo Nordisk Investigational Site

Idaho Falls, Idaho, United States

Novo Nordisk Investigational Site

Des Moines, Iowa, United States

Novo Nordisk Investigational Site

Hyattsville, Maryland, United States

Novo Nordisk Investigational Site

Chattanooga, Tennessee, United States

Novo Nordisk Investigational Site

Dallas, Texas, United States

Novo Nordisk Investigational Site

Dallas, Texas, United States

Novo Nordisk Investigational Site

Renton, Washington, United States

Novo Nordisk Investigational Site

Wollongong, New South Wales, Australia

Key Dates

Start Date

January 1, 2008

Primary Completion Date

June 1, 2008

Completion Date

June 1, 2008

Last Updated

March 3, 2017

Enrollment

178

ACTUAL participants

Conditions

DiabetesDiabetes Mellitus, Type 1

Interventions

insulin degludec

DRUG

insulin degludec

DRUG

insulin glargine

DRUG

insulin aspart

DRUG

Sponsors

Lead Sponsor

Novo Nordisk A/S

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 3, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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