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Comparison of NN1250 With Insulin Glargine in Type 1 Diabetes | Clinical Trials | Clareo Health

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Comparison of NN1250 With Insulin Glargine in Type 1 Diabetes

A 26-week Trial Investigating the Dosing Flexibility, Efficacy and Safety of NN1250 in Subjects With Type 1 Diabetes With a 26-week Extension (Begin™: Flex T1)

NCT01079234•Novo Nordisk A/S

View on ClinicalTrials.gov

Summary

This trial is conducted in Europe and in the United States of America (USA). The aim of this trial is to investigate the efficacy and safety of NN1250 (insulin degludec) in subjects with type 1 diabetes.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Type 1 diabetes for 12 months or longer, hereof the last 3 months with injection based therapies
•Current treatment with any basal insulin (e.g. insulin glargine, insulin detemir, NPH insulin) using one or two daily injections and with three or more daily meal-time insulin injections (e.g. insulin aspart, insulin lispro, insulin glulisine, human insulin) used as bolus insulin therapy
•HbA1c maximum 10.0 % by central laboratory analysis
•Body Mass Index (BMI) below or equal to 35.0 kg/m\^2
•Ability to self-manage insulin therapy as assessed by confirmation (verbal confirmation at screening visit) of a changed insulin dose in the preceding two months prior to screening
•Ability and willingness to adhere to the protocol including performance of self measured plasma glucose (SMPG) profiles and self adjustment of insulin doses

Exclusion Criteria

•Use within the last 3 months prior to Visit 1 of any antidiabetic glucose lowering drug other than insulin
•Cardiovascular disease, within the last 6 months prior to visit 1, defined as: stroke; decompensated heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
•Uncontrolled treated/ untreated severe hypertension (systolic blood pressure above or equal to 180 millimetre (mm) mercury (Hg) and/or diastolic blood pressure above or equal to 100 mmHg)
•Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
•Cancer and medical history of cancer (except basal cell skin cancer or squamous cell skin cancer)

Locations (82)

Novo Nordisk Investigational Site

Encino, California, United States

Novo Nordisk Investigational Site

Fresno, California, United States

Novo Nordisk Investigational Site

Huntington Beach, California, United States

Novo Nordisk Investigational Site

Long Beach, California, United States

Novo Nordisk Investigational Site

Redondo Beach, California, United States

Novo Nordisk Investigational Site

Walnut Creek, California, United States

Novo Nordisk Investigational Site

Aurora, Colorado, United States

Novo Nordisk Investigational Site

Denver, Colorado, United States

Novo Nordisk Investigational Site

DeLand, Florida, United States

Novo Nordisk Investigational Site

Hollywood, Florida, United States

Key Dates

Start Date

March 1, 2010

Primary Completion Date

November 1, 2010

Completion Date

May 1, 2011

Last Updated

February 9, 2017

Enrollment

493

ACTUAL participants

Conditions

DiabetesDiabetes Mellitus, Type 1

Interventions

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: February 9, 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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