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

Primary Purpose

Diabetes, Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
insulin degludec
insulin degludec
insulin glargine
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
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  • Novo Nordisk Investigational Site
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  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
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  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

IDeg OD FF

IDeg OD

IGlar OD

Arm Description

Outcomes

Primary Outcome Measures

Change in Glycosylated Haemoglobin (HbA1c)
Change from baseline in HbA1c after 26 weeks of treatment

Secondary Outcome Measures

Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)
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.
Rate of Confirmed Hypoglycaemic Episodes
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.
Rate of Nocturnal Confirmed Hypoglycaemic Episodes
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.

Full Information

First Posted
October 30, 2009
Last Updated
December 16, 2016
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT01006291
Brief Title
Comparison of NN1250 With Insulin Glargine in Type 2 Diabetes
Acronym
BEGIN™
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
687 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IDeg OD FF
Arm Type
Experimental
Arm Title
IDeg OD
Arm Type
Experimental
Arm Title
IGlar OD
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
insulin degludec
Intervention Description
Injected s.c. (under the skin) once daily (alternative regimen). Dose was individually adjusted.
Intervention Type
Drug
Intervention Name(s)
insulin degludec
Intervention Description
Injected s.c. (under the skin) once daily. Dose was individually adjusted.
Intervention Type
Drug
Intervention Name(s)
insulin glargine
Intervention Description
Insulin glargine injected s.c. (under the skin) once daily. Dose was individually adjusted.
Primary Outcome Measure Information:
Title
Change in Glycosylated Haemoglobin (HbA1c)
Description
Change from baseline in HbA1c after 26 weeks of treatment
Time Frame
Week 0, Week 26
Secondary Outcome Measure Information:
Title
Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)
Description
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.
Time Frame
Week 26
Title
Rate of Confirmed Hypoglycaemic Episodes
Description
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.
Time Frame
Week 0 to Week 26 + 7 days follow up
Title
Rate of Nocturnal Confirmed Hypoglycaemic Episodes
Description
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.
Time Frame
Week 0 to Week 26 + 7 days follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Buenos Aires
ZIP/Postal Code
B1636DSU
Country
Argentina
Facility Name
Novo Nordisk Investigational Site
City
Buenos Aires
ZIP/Postal Code
C1425AGC
Country
Argentina
Facility Name
Novo Nordisk Investigational Site
City
Ciudad Autónoma de Bs As
ZIP/Postal Code
C1426ABP
Country
Argentina
Facility Name
Novo Nordisk Investigational Site
City
Rosario
ZIP/Postal Code
2000
Country
Argentina
Facility Name
Novo Nordisk Investigational Site
City
Hanko
ZIP/Postal Code
10900
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Harjavalta
ZIP/Postal Code
FI-29200
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Oulu
ZIP/Postal Code
90029
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Tampere
ZIP/Postal Code
FI-33520
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Turku
ZIP/Postal Code
20520
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Turku
ZIP/Postal Code
FI-20100
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Vantaa
ZIP/Postal Code
FIN-01600
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Budapest
ZIP/Postal Code
1041
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Debrecen
ZIP/Postal Code
4043
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Gyor
ZIP/Postal Code
9024
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Szombathely
ZIP/Postal Code
H-9700
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500082
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Kochi
State/Province
Kerala
ZIP/Postal Code
682041
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Indore
State/Province
Madhya Pradesh
ZIP/Postal Code
452010
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400012
Country
India
Facility Name
Novo Nordisk Investigational Site
City
New Dehli
State/Province
New Delhi
ZIP/Postal Code
110029
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Chandigarh
State/Province
Punjab
ZIP/Postal Code
160012
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Vellore
State/Province
Tamil Nadu
ZIP/Postal Code
632004
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Kolkata
State/Province
West Bengal
ZIP/Postal Code
700020
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Kolkata
State/Province
West Bengal
ZIP/Postal Code
700038
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Chennai
ZIP/Postal Code
600020
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Hyderabad
ZIP/Postal Code
600034
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Beer Sheva
ZIP/Postal Code
84101
Country
Israel
Facility Name
Novo Nordisk Investigational Site
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Novo Nordisk Investigational Site
City
Holon
ZIP/Postal Code
58100
Country
Israel
Facility Name
Novo Nordisk Investigational Site
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Novo Nordisk Investigational Site
City
Kfar Saba
ZIP/Postal Code
44281
Country
Israel
Facility Name
Novo Nordisk Investigational Site
City
Netanya
ZIP/Postal Code
42449
Country
Israel
Facility Name
Novo Nordisk Investigational Site
City
Petah-Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Novo Nordisk Investigational Site
City
Rehovot
ZIP/Postal Code
76100
Country
Israel
Facility Name
Novo Nordisk Investigational Site
City
Skopje
ZIP/Postal Code
1000
Country
Macedonia, The Former Yugoslav Republic of
Facility Name
Novo Nordisk Investigational Site
City
Cheras
ZIP/Postal Code
56000
Country
Malaysia
Facility Name
Novo Nordisk Investigational Site
City
Kota Bharu, Kelantan
ZIP/Postal Code
16150
Country
Malaysia
Facility Name
Novo Nordisk Investigational Site
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Facility Name
Novo Nordisk Investigational Site
City
Penang
ZIP/Postal Code
10459
Country
Malaysia
Facility Name
Novo Nordisk Investigational Site
City
Putrajaya
ZIP/Postal Code
62250
Country
Malaysia
Facility Name
Novo Nordisk Investigational Site
City
Mexico City
State/Province
México, D.F.
ZIP/Postal Code
03300
Country
Mexico
Facility Name
Novo Nordisk Investigational Site
City
Durango
ZIP/Postal Code
34000
Country
Mexico
Facility Name
Novo Nordisk Investigational Site
City
Monterrey
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Novo Nordisk Investigational Site
City
Gjøvik
ZIP/Postal Code
NO-2819
Country
Norway
Facility Name
Novo Nordisk Investigational Site
City
Hamar
ZIP/Postal Code
2317
Country
Norway
Facility Name
Novo Nordisk Investigational Site
City
Hønefoss
ZIP/Postal Code
3511
Country
Norway
Facility Name
Novo Nordisk Investigational Site
City
Oslo
ZIP/Postal Code
0586
Country
Norway
Facility Name
Novo Nordisk Investigational Site
City
Stavanger
ZIP/Postal Code
4005
Country
Norway
Facility Name
Novo Nordisk Investigational Site
City
Tønsberg
ZIP/Postal Code
3116
Country
Norway
Facility Name
Novo Nordisk Investigational Site
City
Kazan
ZIP/Postal Code
420064
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Moscow
ZIP/Postal Code
117036
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Moscow
ZIP/Postal Code
119435
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Moscow
ZIP/Postal Code
121356
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Moscow
ZIP/Postal Code
127644
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Saint-Peterburg
ZIP/Postal Code
190068
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Saint-Petersburg
ZIP/Postal Code
195257
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Novo Nordisk Investigational Site
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
1829
Country
South Africa
Facility Name
Novo Nordisk Investigational Site
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2001
Country
South Africa
Facility Name
Novo Nordisk Investigational Site
City
Durban
State/Province
KwaZulu-Natal
ZIP/Postal Code
4126
Country
South Africa
Facility Name
Novo Nordisk Investigational Site
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Novo Nordisk Investigational Site
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Novo Nordisk Investigational Site
City
Taipei
ZIP/Postal Code
114
Country
Taiwan
Facility Name
Novo Nordisk Investigational Site
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Novo Nordisk Investigational Site
City
Belfast
ZIP/Postal Code
BT16 1RH
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Edgbaston, Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Edinburgh
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Glasgow
ZIP/Postal Code
G45 9AW
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Hull
ZIP/Postal Code
HU3 2JZ
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Ipswich
ZIP/Postal Code
IP4 5PD
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Londonderry
ZIP/Postal Code
BT47 6SB
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Swansea
ZIP/Postal Code
SA6 6NL
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
23130654
Citation
Ratner RE, Gough SC, Mathieu C, Del Prato S, Bode B, Mersebach H, Endahl L, Zinman B. Hypoglycaemia risk with insulin degludec compared with insulin glargine in type 2 and type 1 diabetes: a pre-planned meta-analysis of phase 3 trials. Diabetes Obes Metab. 2013 Feb;15(2):175-84. doi: 10.1111/dom.12032. Epub 2012 Dec 3.
Results Reference
result
PubMed Identifier
24170235
Citation
Sorli C, Warren M, Oyer D, Mersebach H, Johansen T, Gough SC. Elderly patients with diabetes experience a lower rate of nocturnal hypoglycaemia with insulin degludec than with insulin glargine: a meta-analysis of phase IIIa trials. Drugs Aging. 2013 Dec;30(12):1009-18. doi: 10.1007/s40266-013-0128-2.
Results Reference
result
PubMed Identifier
26121451
Citation
Einhorn D, Handelsman Y, Bode BW, Endahl LA, Mersebach H, King AB. PATIENTS ACHIEVING GOOD GLYCEMIC CONTROL (HBA1c <7%) EXPERIENCE A LOWER RATE OF HYPOGLYCEMIA WITH INSULIN DEGLUDEC THAN WITH INSULIN GLARGINE: A META-ANALYSIS OF PHASE 3A TRIALS. Endocr Pract. 2015 Aug;21(8):917-26. doi: 10.4158/EP14523.OR. Epub 2015 Jun 29.
Results Reference
result
PubMed Identifier
26232910
Citation
Russell-Jones D, Gall MA, Niemeyer M, Diamant M, Del Prato S. Insulin degludec results in lower rates of nocturnal hypoglycaemia and fasting plasma glucose vs. insulin glargine: A meta-analysis of seven clinical trials. Nutr Metab Cardiovasc Dis. 2015 Oct;25(10):898-905. doi: 10.1016/j.numecd.2015.06.005. Epub 2015 Jun 18.
Results Reference
result
PubMed Identifier
26663320
Citation
Vora J, Seufert J, Solberg H, Kinduryte O, Johansen T, Hollander P. Insulin degludec does not increase antibody formation versus insulin glargine: an evaluation of phase IIIa trials. Diabetes Obes Metab. 2016 Jul;18(7):716-20. doi: 10.1111/dom.12621. Epub 2016 Feb 8.
Results Reference
result
PubMed Identifier
23340894
Citation
Meneghini L, Atkin SL, Gough SC, Raz I, Blonde L, Shestakova M, Bain S, Johansen T, Begtrup K, Birkeland KI; NN1250-3668 (BEGIN FLEX) Trial Investigators. The efficacy and safety of insulin degludec given in variable once-daily dosing intervals compared with insulin glargine and insulin degludec dosed at the same time daily: a 26-week, randomized, open-label, parallel-group, treat-to-target trial in individuals with type 2 diabetes. Diabetes Care. 2013 Apr;36(4):858-64. doi: 10.2337/dc12-1668. Epub 2013 Jan 22.
Results Reference
derived
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

Learn more about this trial

Comparison of NN1250 With Insulin Glargine in Type 2 Diabetes

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