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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01326026
First received: March 29, 2011
Last updated: November 26, 2013
Last verified: November 2013

March 29, 2011
November 26, 2013
March 2011
December 2011   (final data collection date for primary outcome measure)
Change in Glycosylated Haemoglobin (HbA1c) [ Time Frame: Week 0, Week 26 ] [ Designated as safety issue: No ]
Change from baseline in HbA1c (glycosylated haemoglobin A1c) [ Time Frame: week 0, week 26 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01326026 on ClinicalTrials.gov Archive Site
  • Change in Fasting Plasma Glucose (FPG) [ Time Frame: Week 0, Week 26 ] [ Designated as safety issue: No ]
  • Rate of Treatment Emergent Adverse Events (AEs) [ Time Frame: Week 0 to Week 26 + 7 days follow up ] [ Designated as safety issue: No ]
  • Rate of Confirmed Hypoglycaemic Episodes [ Time Frame: Week 0 to Week 26 + 7 days follow up ] [ Designated as safety issue: No ]
  • Rate of Nocturnal Confirmed Hypoglycaemic Episodes [ Time Frame: Week 0 to Week 26 + 7 days follow up ] [ Designated as safety issue: No ]
  • Change from baseline in fasting plasma glucose (FPG) [ Time Frame: week 0, week 26 ] [ Designated as safety issue: No ]
  • Number of treatment emergent adverse events (AEs) [ Time Frame: weeks 0-26 ] [ Designated as safety issue: No ]
  • Number of severe and minor treatment emergent hypoglycaemic episodes [ Time Frame: weeks 0-26 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Comparing the Efficacy and Safety of NN1250 Once Daily When Titrated Using 2 Different Algorithms in Insulin naïve Subjects With Type 2 Diabetes Mellitus
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 2
  • Drug: insulin degludec
    Injected subcutaneously (under the skin) once daily. Dose individually adjusted.
  • Drug: insulin degludec
    Injected subcutaneously (under the skin) once daily. Dose individually adjusted in a stepwise manner.
  • Experimental: IDeg Simple
    Intervention: Drug: insulin degludec
  • Experimental: IDeg Step wise
    Intervention: Drug: insulin degludec
Philis-Tsimikas A, Brod M, Niemeyer M, Ocampo Francisco AM, Rothman J. Insulin degludec once-daily in type 2 diabetes: simple or step-wise titration (BEGIN: once simple use). Adv Ther. 2013 Jun;30(6):607-22. doi: 10.1007/s12325-013-0036-1. Epub 2013 Jun 29.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
222
December 2011
December 2011   (final data collection date for primary outcome measure)

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])
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Finland,   Germany,   Spain
 
NCT01326026
NN1250-3846, U1111-1117-0616, 2010-022337-29
No
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP