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

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ClinicalTrials.gov Identifier: NCT01076647
Recruitment Status : Completed
First Posted : February 26, 2010
Results First Posted : November 10, 2015
Last Update Posted : March 6, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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Brief Summary:
This trial was conducted in Europe and North America. The aim of this clinical trial was to compare NN1250 (insulin degludec (IDeg)), a soluble insulin basal analogue (SIBA), with insulin glargine (IGlar), as add-on to subject's ongoing treatment with metformin and/or DPP-4 (dipeptyl peptidase 4) inhibitors, in patients with type 2 diabetes being treated with oral anti-diabetic drugs (OADs).

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 2 Drug: insulin degludec Drug: insulin glargine Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 467 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 26-week Randomised, Confirmatory, Controlled, Open Label, Multicentre, Multinational Treat-to-target Trial Comparing the Efficacy and Safety of SIBA 200 U/ml Three Times Weekly Injected in the Evening and Insulin Glargine Once Daily in a Population of Insulin naïve Subjects With Type 2 Diabetes Mellitus Currently Treated With OADs Qualifying for Intensified Treatment (BEGIN™: EASY™)
Study Start Date : March 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

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Arms and Interventions
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Arm Intervention/treatment
Experimental: IDeg 3TW Drug: insulin degludec
Will be injected subcutaneously (under the skin) once daily three times weekly.
Active Comparator: IGlar OD Drug: insulin glargine
Will be injected subcutaneously (under the skin) once daily administered at the same time each day.


Outcome Measures
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Primary Outcome Measures :
  1. Change in Glycosylated Haemoglobin (HbA1c) [ Time Frame: Week 0, Week 26 ]
    Change from baseline in HbA1c after 26 weeks of treatment


Secondary Outcome Measures :
  1. Change in Body Weight [ Time Frame: Week 0, Week 26 ]
    Change from baseline in body weight after 26 weeks of treatment


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes (diagnosed clinically) for at least 6 months
  • Insulin naïve subjects (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 3 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 secretagogue (sulfonylurea (SU) 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
  • BMI (Body Mass Index) below or equal to 45.0 kg/m^2

Exclusion Criteria:

  • Use within the last 3 months prior to Visit 1 of: Thiazoledinediones (TZDs), 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
  • Cancer and medical history of cancer hereof (except basal cell skin cancer or squamous cell skin cancer)
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01076647


Locations
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Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
More Information
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Additional Information:

Publications of Results:

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01076647    
Other Study ID Numbers: NN1250-3718
2009-011399-31 ( EudraCT Number )
U1111-1112-8770 ( Other Identifier: WHO )
First Posted: February 26, 2010    Key Record Dates
Results First Posted: November 10, 2015
Last Update Posted: March 6, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Insulin
Insulin, Globin Zinc
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs