Comparison of NN1250 With Insulin Glargine in Subjects With Type 2 Diabetes (BEGIN™)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01068678
First received: February 12, 2010
Last updated: November 26, 2013
Last verified: November 2013

February 12, 2010
November 26, 2013
February 2010
November 2010   (final data collection date for primary outcome measure)
Change in Glycosylated Haemoglobin (HbA1c) [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
HbA1c change from baseline [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01068678 on ClinicalTrials.gov Archive Site
Change in Body Weight [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
Body weight change from baseline [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Comparison of NN1250 With Insulin Glargine in Subjects With Type 2 Diabetes
A Trial Comparing Efficacy and Safety of NN1250 and Insulin Glargine in Subjects With Type 2 Diabetes (BEGIN™: EASY AM)

This trial is conducted in Africa, Asia, Europe, and North America. The aim of this clinical trial is to compare the safety and efficacy 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.

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) three times weekly. Dose was individually adjusted.
  • Drug: insulin glargine
    Injected subcutaneously (under the skin) once daily. Dose was individually adjusted.
  • Experimental: IDeg 3TW
    Intervention: Drug: insulin degludec
  • Active Comparator: IGlar OD
    Intervention: Drug: insulin glargine
Zinman B, DeVries JH, Bode B, Russell-Jones D, Leiter LA, Moses A, Johansen T, Ratner R; NN1250-3724 (BEGIN:EASY AM) and NN1250-3718 (BEGIN:EASY PM) Trial Investigators. Efficacy and safety of insulin degludec three times a week versus insulin glargine once a day in insulin-naive patients with type 2 diabetes: results of two phase 3, 26 week, randomised, open-label, treat-to-target, non-inferiority trials. Lancet Diabetes Endocrinol. 2013 Oct;1(2):123-31. doi: 10.1016/S2213-8587(13)70013-5. Epub 2013 Jul 9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
460
November 2010
November 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
South Africa,   Slovakia,   Israel,   Czech Republic,   Canada,   United Kingdom,   United States
 
NCT01068678
NN1250-3724, 2009-011398-33, U1111-1113-2412
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