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Comparison of NN1250 With Insulin Glargine in Subjects With Type 2 Diabetes | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Comparison of NN1250 With Insulin Glargine in Subjects With Type 2 Diabetes

A 26-week Randomised, Confirmatory, Controlled, Open Label, Multicentre, Multinational Treat-to-target Trial Comparing the Efficacy and Safety of SIBA 200 U/ml Three Times Weekly Injected in the Evening and Insulin Glargine Once Daily in a Population of Insulin naïve Subjects With Type 2 Diabetes Mellitus Currently Treated With OADs Qualifying for Intensified Treatment (BEGIN™: EASY™)

NCT01076647•Novo Nordisk A/S

View on ClinicalTrials.gov

Summary

This trial was conducted in Europe and North America. The aim of this clinical trial was to compare NN1250 (insulin degludec (IDeg)), a soluble insulin basal analogue (SIBA), with insulin glargine (IGlar), as add-on to subject's ongoing treatment with metformin and/or DPP-4 (dipeptyl peptidase 4) inhibitors, in patients with type 2 diabetes being treated with oral anti-diabetic drugs (OADs).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Type 2 diabetes (diagnosed clinically) for at least 6 months
•Insulin naïve subjects (allowed are: previous short term insulin treatment up to 14 days; treatment during hospitalisation or during gestational diabetes is allowed for periods longer than 14 days)
•Current treatment: metformin monotherapy or metformin in any combination with insulin secretagogues (sulphonylurea (SU) or glinide), DPP-4 inhibitor, alpha-glucosidase-inhibitor (acarbose) with unchanged dosing for at least 3 months prior to visit 1 with the minimum doses stated: -Metformin: alone or in combination (including fixed combination) 1500 mg daily or maximum tolerated dose (at least 1000 mg daily)-Insulin secretagogue (sulfonylurea (SU) or glinide): minimum half of the daily maximal dose according to local labelling -DPP-4 inhibitor: minimum half of the daily maximal dose according to local labelling -alpha-glucosidase-inhibitor (acarbose): minimum half of the daily maximal dose or maximum tolerated dose
•HbA1c 7.0-10.0 % (both inclusive) by central laboratory analysis
•BMI (Body Mass Index) below or equal to 45.0 kg/m\^2

Exclusion Criteria

•Use within the last 3 months prior to Visit 1 of: Thiazoledinediones (TZDs), Exenatide or Liraglutide
•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 at least 180 millimetre (mm) mercury (Hg) and/or diastolic blood pressure at least 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 hereof (except basal cell skin cancer or squamous cell skin cancer)

Locations (105)

Novo Nordisk Investigational Site

Birmingham, Alabama, United States

Novo Nordisk Investigational Site

Peoria, Arizona, United States

Novo Nordisk Investigational Site

Tucson, Arizona, United States

Novo Nordisk Investigational Site

Beverly Hills, California, United States

Novo Nordisk Investigational Site

Escondido, California, United States

Novo Nordisk Investigational Site

La Jolla, California, United States

Novo Nordisk Investigational Site

Los Angeles, California, United States

Novo Nordisk Investigational Site

Los Banos, California, United States

Novo Nordisk Investigational Site

Monterey, California, United States

Novo Nordisk Investigational Site

Palm Springs, California, United States

Key Dates

Start Date

March 1, 2010

Primary Completion Date

December 1, 2010

Completion Date

December 1, 2010

Last Updated

March 6, 2017

Enrollment

467

ACTUAL participants

Conditions

DiabetesDiabetes Mellitus, Type 2

Interventions

insulin degludec

DRUG

insulin glargine

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 6, 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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