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

Completed · Phase 3

Conditions studied: Diabetes, Diabetes Mellitus, Type 2

In brief

This trial is conducted in Africa, Asia, Europe, and North America. The aim of this clinical trial is to compare the efficacy and safety of NN1250 (insulin degludec (IDeg)) with insulin glargine (IGlar) in subjects with type 2 diabetes currently treated with metformin alone or with metformin combined with an oral anti-diabetic drug (OAD) qualifying for intensified treatment.

Key facts

Study ID

NCT01068678

Run by

Novo Nordisk A/S

People needed

460

Starts

2010-02-01

Expected to finish

2010-11-01

Last updated by the study team

2017-03-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Insulin naïve subject (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 three 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 secretaguogue (sulfonylurea 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
• Body Mass Index (BMI) below or equal to 45.0 kg/m\^2

You may not qualify if…

• Use within the last 3 months prior to Visit 1 of: thiazoledinediones, 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 (for UK: adequate contraceptive measures are defined as established use of oral, injected or implanted hormonal methods of contraception, sterilisation, intrauterine device or intrauterine system, or consistent use of barrier methods)
• Cancer and medical history of cancer hereof (except basal cell skin cancer or squamous cell skin cancer)

Where it is running

• Novo Nordisk Investigational Site — Palm Springs, California, United States
• Novo Nordisk Investigational Site — Paramount, California, United States
• Novo Nordisk Investigational Site — Santa Ana, California, United States
• Novo Nordisk Investigational Site — Spring Valley, California, United States
• Novo Nordisk Investigational Site — Tustin, California, United States
• Novo Nordisk Investigational Site — Melbourne, Florida, United States
• Novo Nordisk Investigational Site — Atlanta, Georgia, United States
• Novo Nordisk Investigational Site — Columbus, Georgia, United States
• Novo Nordisk Investigational Site — Perry, Georgia, United States
• Novo Nordisk Investigational Site — Olympia Fields, Illinois, United States
• Novo Nordisk Investigational Site — Avon, Indiana, United States
• Novo Nordisk Investigational Site — Fishers, Indiana, United States
• Novo Nordisk Investigational Site — Franklin, Indiana, United States
• Novo Nordisk Investigational Site — Indianapolis, Indiana, United States
• Novo Nordisk Investigational Site — Muncie, Indiana, United States
• Novo Nordisk Investigational Site — Des Moines, Iowa, United States
• Novo Nordisk Investigational Site — Lexington, Kentucky, United States
• Novo Nordisk Investigational Site — Paducah, Kentucky, United States
• Novo Nordisk Investigational Site — Hyattsville, Maryland, United States
• Novo Nordisk Investigational Site — Rockville, Maryland, United States
• Novo Nordisk Investigational Site — Interlochen, Michigan, United States
• Novo Nordisk Investigational Site — Jackson, Mississippi, United States
• Novo Nordisk Investigational Site — Chesterfield, Missouri, United States
• Novo Nordisk Investigational Site — City of Saint Peters, Missouri, United States
• Novo Nordisk Investigational Site — Northridge, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.