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

December 16, 2016 updated by: Novo Nordisk A/S

A 26 Week Randomised, Controlled, Open Label, Multicentre, Multinational, Three-arm, Treat to Target Trial Comparing Efficacy and Safety of Three Different Dosing Regimens of Either Soluble Insulin Basal Analogue (SIBA) or Insulin Glargine With or Without Combination With OAD Treatment, in Subjects With Type 2 Diabetes Mellitus (BEGIN™ : FLEX)

This trial is conducted in Africa, Asia, Europe and South America. The aim of this clinical trial is to compare NN1250 (insulin degludec (IDeg) with insulin glargine (IGlar) in patients with type 2 diabetes. Subjects treated with oral antidiabetic drug(s) (OAD(s)) should continue their current OAD treatment at the stable, prerandomisation dose level and dosing frequency.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

687

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, B1636DSU
        • Novo Nordisk Investigational Site
      • Buenos Aires, Argentina, C1425AGC
        • Novo Nordisk Investigational Site
      • Ciudad Autónoma de Bs As, Argentina, C1426ABP
        • Novo Nordisk Investigational Site
      • Rosario, Argentina, 2000
        • Novo Nordisk Investigational Site
  • Finland
      • Hanko, Finland, 10900
        • Novo Nordisk Investigational Site
      • Harjavalta, Finland, FI-29200
        • Novo Nordisk Investigational Site
      • Oulu, Finland, 90029
        • Novo Nordisk Investigational Site
      • Tampere, Finland, FI-33520
        • Novo Nordisk Investigational Site
      • Turku, Finland, 20520
        • Novo Nordisk Investigational Site
      • Turku, Finland, FI-20100
        • Novo Nordisk Investigational Site
      • Vantaa, Finland, FIN-01600
        • Novo Nordisk Investigational Site
  • Hungary
      • Budapest, Hungary, 1041
        • Novo Nordisk Investigational Site
      • Debrecen, Hungary, 4043
        • Novo Nordisk Investigational Site
      • Gyor, Hungary, 9024
        • Novo Nordisk Investigational Site
      • Szombathely, Hungary, H-9700
        • Novo Nordisk Investigational Site
  • India
      • Chennai, India, 600020
        • Novo Nordisk Investigational Site
      • Hyderabad, India, 600034
        • Novo Nordisk Investigational Site
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India, 500082
        • Novo Nordisk Investigational Site
    • Kerala
      • Kochi, Kerala, India, 682041
        • Novo Nordisk Investigational Site
    • Madhya Pradesh
      • Indore, Madhya Pradesh, India, 452010
        • Novo Nordisk Investigational Site
    • Maharashtra
      • Mumbai, Maharashtra, India, 400012
        • Novo Nordisk Investigational Site
    • New Delhi
      • New Dehli, New Delhi, India, 110029
        • Novo Nordisk Investigational Site
    • Punjab
      • Chandigarh, Punjab, India, 160012
        • Novo Nordisk Investigational Site
    • Tamil Nadu
      • Vellore, Tamil Nadu, India, 632004
        • Novo Nordisk Investigational Site
    • West Bengal
      • Kolkata, West Bengal, India, 700020
        • Novo Nordisk Investigational Site
      • Kolkata, West Bengal, India, 700038
        • Novo Nordisk Investigational Site
  • Israel
      • Beer Sheva, Israel, 84101
        • Novo Nordisk Investigational Site
      • Haifa, Israel, 31096
        • Novo Nordisk Investigational Site
      • Holon, Israel, 58100
        • Novo Nordisk Investigational Site
      • Jerusalem, Israel, 91120
        • Novo Nordisk Investigational Site
      • Kfar Saba, Israel, 44281
        • Novo Nordisk Investigational Site
      • Netanya, Israel, 42449
        • Novo Nordisk Investigational Site
      • Petah-Tikva, Israel, 49100
        • Novo Nordisk Investigational Site
      • Rehovot, Israel, 76100
        • Novo Nordisk Investigational Site
  • Macedonia, The Former Yugoslav Republic of
      • Skopje, Macedonia, The Former Yugoslav Republic of, 1000
        • Novo Nordisk Investigational Site
  • Malaysia
      • Cheras, Malaysia, 56000
        • Novo Nordisk Investigational Site
      • Kota Bharu, Kelantan, Malaysia, 16150
        • Novo Nordisk Investigational Site
      • Kuala Lumpur, Malaysia, 59100
        • Novo Nordisk Investigational Site
      • Penang, Malaysia, 10459
        • Novo Nordisk Investigational Site
      • Putrajaya, Malaysia, 62250
        • Novo Nordisk Investigational Site
  • Mexico
      • Durango, Mexico, 34000
        • Novo Nordisk Investigational Site
      • Monterrey, Mexico, 64460
        • Novo Nordisk Investigational Site
    • México, D.F.
      • Mexico City, México, D.F., Mexico, 03300
        • Novo Nordisk Investigational Site
  • Norway
      • Gjøvik, Norway, NO-2819
        • Novo Nordisk Investigational Site
      • Hamar, Norway, 2317
        • Novo Nordisk Investigational Site
      • Hønefoss, Norway, 3511
        • Novo Nordisk Investigational Site
      • Oslo, Norway, 0586
        • Novo Nordisk Investigational Site
      • Stavanger, Norway, 4005
        • Novo Nordisk Investigational Site
      • Tønsberg, Norway, 3116
        • Novo Nordisk Investigational Site
  • Russian Federation
      • Kazan, Russian Federation, 420064
        • Novo Nordisk Investigational Site
      • Moscow, Russian Federation, 119435
        • Novo Nordisk Investigational Site
      • Moscow, Russian Federation, 117036
        • Novo Nordisk Investigational Site
      • Moscow, Russian Federation, 121356
        • Novo Nordisk Investigational Site
      • Moscow, Russian Federation, 127644
        • Novo Nordisk Investigational Site
      • Saint-Peterburg, Russian Federation, 190068
        • Novo Nordisk Investigational Site
      • Saint-Petersburg, Russian Federation, 195257
        • Novo Nordisk Investigational Site
  • Serbia
      • Belgrade, Serbia, 11000
        • Novo Nordisk Investigational Site
  • South Africa
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 1829
        • Novo Nordisk Investigational Site
      • Johannesburg, Gauteng, South Africa, 2001
        • Novo Nordisk Investigational Site
    • KwaZulu-Natal
      • Durban, KwaZulu-Natal, South Africa, 4126
        • Novo Nordisk Investigational Site
  • Taiwan
      • Taipei, Taiwan, 100
        • Novo Nordisk Investigational Site
      • Taipei, Taiwan, 112
        • Novo Nordisk Investigational Site
      • Taipei, Taiwan, 114
        • Novo Nordisk Investigational Site
      • Taoyuan, Taiwan, 333
        • Novo Nordisk Investigational Site
  • United Kingdom
      • Belfast, United Kingdom, BT16 1RH
        • Novo Nordisk Investigational Site
      • Edgbaston, Birmingham, United Kingdom, B15 2TH
        • Novo Nordisk Investigational Site
      • Edinburgh, United Kingdom, EH4 2XU
        • Novo Nordisk Investigational Site
      • Glasgow, United Kingdom, G45 9AW
        • Novo Nordisk Investigational Site
      • Hull, United Kingdom, HU3 2JZ
        • Novo Nordisk Investigational Site
      • Ipswich, United Kingdom, IP4 5PD
        • Novo Nordisk Investigational Site
      • Londonderry, United Kingdom, BT47 6SB
        • Novo Nordisk Investigational Site
      • Swansea, United Kingdom, SA6 6NL
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months
  • Current treatment: oral anti-diabetic drug(s) (OAD(s)) alone, basal insulin alone or the combination of OAD(s) and basal insulin. Allowed OADs are: Metformin, insulin secretagogues (sulphonylureas (SU) or glinides), pioglitazone with unchanged dosing for at least 3 months prior to Visit 1
  • HbA1c: OADs only users 7.0-11.0 % (both inclusive), basal insulin with/without OADs users 7.0-10.0% (both inclusive) by central laboratory analysis
  • Body Mass Index (BMI) below or equal to 40.0 kg/m^2

Exclusion Criteria:

  • Cancer and medical history of cancer hereof
  • Use within the last 3 months prior to Visit 1 of: glucagon-like peptide-1(GLP-1) receptor agonist (exenatide, liraglutide), rosiglitazone, dipeptidyl peptidase IV (DPP-IV) inhibitors, alpha-glucosidase-inhibitors
  • 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 and squamous cell skin cancer)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IDeg OD FF
Drug: insulin degludec
Injected s.c. (under the skin) once daily (alternative regimen). Dose was individually adjusted.
Drug: insulin degludec
Injected s.c. (under the skin) once daily. Dose was individually adjusted.
Experimental: IDeg OD
Drug: insulin degludec
Injected s.c. (under the skin) once daily (alternative regimen). Dose was individually adjusted.
Drug: insulin degludec
Injected s.c. (under the skin) once daily. Dose was individually adjusted.
Experimental: IGlar OD
Drug: insulin glargine
Insulin glargine injected s.c. (under the skin) once daily. Dose was individually adjusted.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Glycosylated Haemoglobin (HbA1c)
Time Frame: Week 0, Week 26
Change from baseline in HbA1c after 26 weeks of treatment
Week 0, Week 26

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)
Time Frame: Week 26
Mean of SMPG after 26 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, before bedtime, at 4 am and before breakfast.
Week 26
Rate of Confirmed Hypoglycaemic Episodes
Time Frame: Week 0 to Week 26 + 7 days follow up
Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.
Week 0 to Week 26 + 7 days follow up
Rate of Nocturnal Confirmed Hypoglycaemic Episodes
Time Frame: Week 0 to Week 26 + 7 days follow up
Rate of nocturnal confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.
Week 0 to Week 26 + 7 days follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

October 30, 2009

First Submitted That Met QC Criteria

October 30, 2009

First Posted (Estimate)

November 1, 2009

Study Record Updates

Last Update Posted (Estimate)

February 9, 2017

Last Update Submitted That Met QC Criteria

December 16, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN1250-3668
  • U1111-1111-7084 (Other Identifier: WHO)
  • 2008-005771-10 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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