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



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:March 2011
End Date:December 2011

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A Trial Comparing the Efficacy and Safety of Insulin Degludec Once Daily in Insulin naïve Subjects With Type 2 Diabetes Mellitus When Titrated Using Two Different Titration Algorithms (BEGIN™: ONCE SIMPLE USE)

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.


Inclusion Criteria:

- 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

Exclusion Criteria:

- 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])
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