Comparing the Efficacy and Safety of NN1250 Once Daily When Titrated Using 2 Different Algorithms in Insulin naïve Subjects With Type 2 Diabetes Mellitus

Completed · Phase 3

Conditions studied: Diabetes, Diabetes Mellitus, Type 2

In brief

This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to compare the efficacy and safety of NN1250 (insulin degludec (IDeg)) once daily in insulin naïve subjects with type 2 diabetes mellitus when titrated using two different self-titration algorithms (dose individually adjusted) in combination with metformin.

Key facts

Study ID

NCT01326026

Run by

Novo Nordisk A/S

People needed

222

Starts

2011-03-01

Expected to finish

2011-12-01

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…

• Type 2 diabetes (diagnosed clinically) for at least 24 weeks prior to randomisation (Visit 2)
• Current treatment: metformin monotherapy or metformin in any combination with 1 or 2 other OADs including an insulin secretagogue (sulfonylurea or glinide), dipeptidyl peptidase IV (DPP-IV) inhibitors, alpha-glucosidase inhibitors, thiazolidinediones (TZDs) all with unchanged dosing for at least 12 weeks prior to randomisation (Visit 2)-metformin: alone or in combination (including fixed combination) must be at least 1000 mg daily
• HbA1c 7.0-10.0% (both inclusive) by central laboratory analysis
• BMI (Body Mass Index) no higher than 45.0 kg/m\^2

You may not qualify if…

• Treatment with glucagon-like peptide 1 (GLP-1) receptor agonist within the last 12 weeks prior to Visit 2
• Suffer from a life threatening disease (e.g. cancer)
• Females of childbearing potential who are pregnant (as determined by central laboratory beta-human chorionic gonadotropin (beta-hCG), breast feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive methods as required by law or practise [for Germany, adequate contraceptive methods are: implants, injectables, combined oral contraceptives, hormonal IUD, sexual abstinence or vasectomised partner])

Where it is running

• Novo Nordisk Investigational Site — Birmingham, Alabama, United States
• Novo Nordisk Investigational Site — Huntsville, Alabama, United States
• Novo Nordisk Investigational Site — Anaheim, California, United States
• Novo Nordisk Investigational Site — La Jolla, California, United States
• Novo Nordisk Investigational Site — Mission Hills, California, United States
• Novo Nordisk Investigational Site — National City, California, United States
• Novo Nordisk Investigational Site — North Hollywood, California, United States
• Novo Nordisk Investigational Site — San Diego, California, United States
• Novo Nordisk Investigational Site — Golden, Colorado, United States
• Novo Nordisk Investigational Site — Kissimmee, Florida, United States
• Novo Nordisk Investigational Site — Tampa, Florida, United States
• Novo Nordisk Investigational Site — Columbus, Georgia, United States
• Novo Nordisk Investigational Site — Springfield, Illinois, United States
• Novo Nordisk Investigational Site — Evansville, Indiana, United States
• Novo Nordisk Investigational Site — Slidell, Louisiana, United States
• Novo Nordisk Investigational Site — Billings, Montana, United States
• Novo Nordisk Investigational Site — Staten Island, New York, United States
• Novo Nordisk Investigational Site — Greensboro, North Carolina, United States
• Novo Nordisk Investigational Site — Franklin, Ohio, United States
• Novo Nordisk Investigational Site — Melrose Park, Pennsylvania, United States
• Novo Nordisk Investigational Site — East Providence, Rhode Island, United States
• Novo Nordisk Investigational Site — Humboldt, Tennessee, United States
• Novo Nordisk Investigational Site — Houston, Texas, United States
• Novo Nordisk Investigational Site — Killeen, Texas, United States
• Novo Nordisk Investigational Site — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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