DiabetesPhase 3BEGIN™NCT00982644

Comparison of NN1250 Versus Insulin Glargine in Subjects With Type 2 Diabetes

A Phase 3 study testing insulin degludec and insulin glargine in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 187 sites in 15 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to compare NN1250 (insulin degludec (IDeg)) with insulin glargine (IGlar) in subjects with type 2 diabetes never treated with insulin followed by the extension trial investigating the long-term safety and tolerability in… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetes, Diabetes Mellitus, Type 2
What is being tested?: insulin degludec and insulin glargine
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,030 participants
Where: 187 sitesin 15 countries
Study dates: Sep 2009to Dec 2010
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Type 2 diabetes mellitus
Treatment with oral antidiabetic drugs (OADs) for at least three months before trial start at an unchanged dose
HbA1c: 7.0-10.0%
Body Mass Index (BMI) no higher than 40.0 kg/m^2
For the extension trial only: Completion of the 52 week treatment period in trial NN1250-3579 (NCT00982644)

Who cannot join

Treatment with exenatide or liraglutide within the last 3 months before trial start
Cardiovascular disease within the last 6 months
Uncontrolled treated/untreated severe hypertension
Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures
Cancer and medical history of cancer

Trial locations and contacts

187 sites in 15 countries.

Country

City, postcode or hospital

187 sites in 15 countries

United States86 sites

Novo Nordisk Investigational Site
Anaheim, California, 92801
Novo Nordisk Investigational Site
Arlington, Texas, 76014
Novo Nordisk Investigational Site
Asheboro, North Carolina, 27203
Novo Nordisk Investigational Site
Bay Minette, Alabama, 36507-4198
Novo Nordisk Investigational Site
Birmingham, Alabama, 35209
Novo Nordisk Investigational Site
Boynton Beach, Florida, 33472
Novo Nordisk Investigational Site
Brockton, Massachusetts, 02301
Novo Nordisk Investigational Site
Charlotte, North Carolina, 28209
Novo Nordisk Investigational Site
Chattanooga, Tennessee, 37411
Novo Nordisk Investigational Site
Chicago, Illinois, 60607
Novo Nordisk Investigational Site
Cincinnati, Ohio, 45255
Novo Nordisk Investigational Site
Columbia, South Carolina, 29203
Novo Nordisk Investigational Site
Concord, California, 94520-1926
Novo Nordisk Investigational Site
Corpus Christi, Texas, 78404
Novo Nordisk Investigational Site
Dallas, Texas, 75230
Novo Nordisk Investigational Site
Dallas, Texas, 75246
Novo Nordisk Investigational Site
Dayton, Ohio, 45406
Novo Nordisk Investigational Site
Decatur, Georgia, 30033
Novo Nordisk Investigational Site
East Providence, Rhode Island, 02914
Novo Nordisk Investigational Site
El Paso, Texas, 79912
Novo Nordisk Investigational Site
Evansville, Indiana, 47714
Novo Nordisk Investigational Site
Fort Valley, Georgia, 31030-5008
Novo Nordisk Investigational Site
Goodyear, Arizona, 85395
Novo Nordisk Investigational Site
Greenbelt, Maryland, 20770
Novo Nordisk Investigational Site
Greer, South Carolina, 29651
Novo Nordisk Investigational Site
Harriman, Tennessee, 37748-8653
Novo Nordisk Investigational Site
Henderson, Nevada, 89052-2649
Novo Nordisk Investigational Site
Humboldt, Tennessee, 38343
Novo Nordisk Investigational Site
Huntsville, Alabama, 35801
Novo Nordisk Investigational Site
Hurst, Texas, 76054
Novo Nordisk Investigational Site
Idaho Falls, Idaho, 83404-7596
Novo Nordisk Investigational Site
Indianapolis, Indiana, 46217
Novo Nordisk Investigational Site
Irving, Texas, 75061-2210
Novo Nordisk Investigational Site
Jacksonville, Florida, 32208
Novo Nordisk Investigational Site
Kingston, Pennsylvania, 18704
Novo Nordisk Investigational Site
La Jolla, California, 92037
Novo Nordisk Investigational Site
Lancaster, California, 93534
Novo Nordisk Investigational Site
Langhorne, Pennsylvania, 19047
Novo Nordisk Investigational Site
Las Vegas, Nevada, 89117
Novo Nordisk Investigational Site
Lexington, Kentucky, 40503
Novo Nordisk Investigational Site
Long Beach, California, 90806
Novo Nordisk Investigational Site
Los Angeles, California, 90057
Novo Nordisk Investigational Site
Lubbock, Texas, 79423
Novo Nordisk Investigational Site
Melbourne, Florida, 32901
Novo Nordisk Investigational Site
Melrose Park, Pennsylvania, 19027
Novo Nordisk Investigational Site
Metairie, Louisiana, 70002
Novo Nordisk Investigational Site
Miami, Florida, 33156
Novo Nordisk Investigational Site
Miami, Florida, 33169
Novo Nordisk Investigational Site
Milwaukee, Wisconsin, 53209
Novo Nordisk Investigational Site
Mission Hills, California, 91345
Novo Nordisk Investigational Site
Nashville, Tennessee, 37203
Novo Nordisk Investigational Site
National City, California, 91950
Novo Nordisk Investigational Site
New Port Richey, Florida, 34652
Novo Nordisk Investigational Site
Newberry, South Carolina, 29108-2249
Novo Nordisk Investigational Site
North Dartmouth, Massachusetts, 02747
Novo Nordisk Investigational Site
North East, Maryland, 21901
Novo Nordisk Investigational Site
North Hollywood, California, 91606
Novo Nordisk Investigational Site
Northport, New York, 11768
Novo Nordisk Investigational Site
Northridge, California, 91325
Novo Nordisk Investigational Site
Norwalk, Connecticut, 06851
Novo Nordisk Investigational Site
Oklahoma City, Oklahoma, 73103
Novo Nordisk Investigational Site
Orange Park, Florida, 32073
Novo Nordisk Investigational Site
Orlando, Florida, 32806
Novo Nordisk Investigational Site
Paducah, Kentucky, 42003
Novo Nordisk Investigational Site
Palm Harbor, Florida, 34684
Novo Nordisk Investigational Site
Palm Springs, California, 92262
Novo Nordisk Investigational Site
Pittsburgh, Pennsylvania, 15241
Novo Nordisk Investigational Site
Reisterstown, Maryland, 21136-2516
Novo Nordisk Investigational Site
Richmond, Virginia, 23233
Novo Nordisk Investigational Site
Rockville, Maryland, 20852
Novo Nordisk Investigational Site
San Antonio, Texas, 78215
Novo Nordisk Investigational Site
San Mateo, California, 94401
Novo Nordisk Investigational Site
Santa Monica, California, 90404
Novo Nordisk Investigational Site
Slidell, Louisiana, 70461-4231
Novo Nordisk Investigational Site
Spokane, Washington, 99218
Novo Nordisk Investigational Site
Spring Valley, California, 91978
Novo Nordisk Investigational Site
St Louis, Missouri, 63104
Novo Nordisk Investigational Site
St Louis, Missouri, 63141
Novo Nordisk Investigational Site
Staten Island, New York, 10301
Novo Nordisk Investigational Site
Sugar Land, Texas, 77479
Novo Nordisk Investigational Site
Tarzana, California, 91356-3551
Novo Nordisk Investigational Site
Toledo, Ohio, 43606-2920
Novo Nordisk Investigational Site
Toms River, New Jersey, 08755-8050
Novo Nordisk Investigational Site
Tustin, California, 92780
Novo Nordisk Investigational Site
West Palm Beach, Florida, 33401
Novo Nordisk Investigational Site
West Reading, Pennsylvania, 19611

Other trials in United States

Germany18 sites

Novo Nordisk Investigational Site
Bad Harzburg, 38667
Novo Nordisk Investigational Site
Berlin, 12163
Novo Nordisk Investigational Site
Berlin, 13055
Novo Nordisk Investigational Site
Dormagen, 41539
Novo Nordisk Investigational Site
Dresden, 01307
Novo Nordisk Investigational Site
Essen, 45329
Novo Nordisk Investigational Site
Friedrichsthal, 66299
Novo Nordisk Investigational Site
Hamburg, 21073
Novo Nordisk Investigational Site
Hamburg, 22391
Novo Nordisk Investigational Site
Hamburg, 22587
Novo Nordisk Investigational Site
Hohenmölsen, 06679
Novo Nordisk Investigational Site
Neuwied, 56564
Novo Nordisk Investigational Site
Pohlheim, 35415
Novo Nordisk Investigational Site
Rehburg-Loccum, 31547
Novo Nordisk Investigational Site
Rehlingen-Siersburg, 66780
Novo Nordisk Investigational Site
Riesa, 01587
Novo Nordisk Investigational Site
Saint Ingbert, 66386
Novo Nordisk Investigational Site
Speyer, 67346

Other trials in Germany

Canada16 sites

Novo Nordisk Investigational Site
Coquitlam, British Columbia, V3K 3P4
Novo Nordisk Investigational Site
Edmonton, Alberta, T5J 3N4
Novo Nordisk Investigational Site
Halifax, Nova Scotia, B3K 0A4
Novo Nordisk Investigational Site
London, Ontario, N6G 2M1
Novo Nordisk Investigational Site
Mississauga, Ontario, L5M 2V8
Novo Nordisk Investigational Site
Mount Pearl, Newfoundland and Labrador, A1N 1W7
Novo Nordisk Investigational Site
Ottawa, Ontario, K1K 4L2
Novo Nordisk Investigational Site
Ottawa, Ontario, K1N 6N5
Novo Nordisk Investigational Site
Québec, Quebec, G1V 4G2
Novo Nordisk Investigational Site
Saint Romuald, Quebec, G6W 5M6
Novo Nordisk Investigational Site
Saint-Marc-des-Carrieres, Quebec, G0A 4B0
Novo Nordisk Investigational Site
Scarborough Village, Ontario, M1E 5E9
Novo Nordisk Investigational Site
St. John's, Newfoundland and Labrador, A1A 3R5
Novo Nordisk Investigational Site
Toronto, Ontario, M4G 3E8
Novo Nordisk Investigational Site
Toronto, Ontario, M5C 2T2
Novo Nordisk Investigational Site
Winnipeg, Manitoba, R3E 3P4

Other trials in Canada

Spain11 sites

Novo Nordisk Investigational Site
Almería, 04001
Novo Nordisk Investigational Site
Alzira, 46600
Novo Nordisk Investigational Site
Antequera, 29200
Novo Nordisk Investigational Site
Ferrol, 15405
Novo Nordisk Investigational Site
Gijón, 33206
Novo Nordisk Investigational Site
Inca, 07300
Novo Nordisk Investigational Site
Palma de Mallorca, 07014
Novo Nordisk Investigational Site
Puerto del Rosario, 35600
Novo Nordisk Investigational Site
Seville, 41003
Novo Nordisk Investigational Site
Seville, 41010
Novo Nordisk Investigational Site
Valencia, 46015

Other trials in Spain

Norway8 sites

Novo Nordisk Investigational Site
Ålesund, 6003
Novo Nordisk Investigational Site
Bekkestua, 1357
Novo Nordisk Investigational Site
Elverum, 2408
Novo Nordisk Investigational Site
Hamar, 2318
Novo Nordisk Investigational Site
Kongsvinger, 2212
Novo Nordisk Investigational Site
Oslo, 0407
Novo Nordisk Investigational Site
Stavanger, 4011
Novo Nordisk Investigational Site
Trondheim, NO-7030

Other trials in Norway

Austria7 sites

Novo Nordisk Investigational Site
Bregenz, A - 6900
Novo Nordisk Investigational Site
Feldkirch, 6807
Novo Nordisk Investigational Site
Vienna, 1030
Novo Nordisk Investigational Site
Vienna, 1090
Novo Nordisk Investigational Site
Vienna, 1130
Novo Nordisk Investigational Site
Vienna, A 1160
Novo Nordisk Investigational Site
Wolfsberg, 9400

Other trials in Austria

France7 sites

Novo Nordisk Investigational Site
Le Grau-du-Roi, 30240
Novo Nordisk Investigational Site
Montigny-lès-Metz, 57950
Novo Nordisk Investigational Site
Nanterre, 92014
Novo Nordisk Investigational Site
Nantes, 44093
Novo Nordisk Investigational Site
Nîmes, 30006
Novo Nordisk Investigational Site
Saint-denis de La Reunion, 97405
Novo Nordisk Investigational Site
Vénissieux, 69200

Other trials in France

Denmark6 sites

Novo Nordisk Investigational Site
Esbjerg, 6700
Novo Nordisk Investigational Site
Hillerød, 3400
Novo Nordisk Investigational Site
Holbæk, 4300
Novo Nordisk Investigational Site
København S, 2300
Novo Nordisk Investigational Site
Odense, 5000
Novo Nordisk Investigational Site
Silkeborg, 8600

Other trials in Denmark

Finland6 sites

Novo Nordisk Investigational Site
Helsinki, 00260
Novo Nordisk Investigational Site
Joensuu, 80100
Novo Nordisk Investigational Site
Kerava, FI-04200
Novo Nordisk Investigational Site
Lohja, 08100
Novo Nordisk Investigational Site
Oulu, 90100
Novo Nordisk Investigational Site
Tampere, 33210

Other trials in Finland

Belgium5 sites

Novo Nordisk Investigational Site
Brussels, 1070
Novo Nordisk Investigational Site
Brussels, 1090
Novo Nordisk Investigational Site
Ghent, 9000
Novo Nordisk Investigational Site
Leuven, 3000
Novo Nordisk Investigational Site
Liège, 4000

Other trials in Belgium

Czechia5 sites

Novo Nordisk Investigational Site
Brno, 656 91
Novo Nordisk Investigational Site
Hradec Králové, 500 05
Novo Nordisk Investigational Site
Pilsen, 304 60
Novo Nordisk Investigational Site
Prague, 140 21
Novo Nordisk Investigational Site
Prague, 15006

Other trials in Czechia

Serbia and Montenegro4 sites

Novo Nordisk Investigational Site
Belgrade, 11000
Novo Nordisk Investigational Site
Kragujevac, 34000
Novo Nordisk Investigational Site
Nis, 18000
Novo Nordisk Investigational Site
Novi Sad, 21000

Other trials in Serbia and Montenegro

Serbia4 sites

Novo Nordisk Investigational Site
Belgrade, 11000
Novo Nordisk Investigational Site
Kragujevac, 34000
Novo Nordisk Investigational Site
Niš, 18000
Novo Nordisk Investigational Site
Novi Sad, 21000

Other trials in Serbia

Slovenia3 sites

Novo Nordisk Investigational Site
Koper, SI-6000
Novo Nordisk Investigational Site
Ljubljana, 1525
Novo Nordisk Investigational Site
Novo Mesto, 8000

Other trials in Slovenia

Puerto Rico1 site

Novo Nordisk Investigational Site
Bayamón, 00961

Other trials in Puerto Rico

About this study

Official title: NN1250-3579: A 52-week Randomised, Controlled, Open Label, Multicentre, Multinational Treat-to-target Trial Comparing the Efficacy and Safety of SIBA and Insulin Glargine, Both Injected Once Daily in Combination With Oral Anti-diabetic Drugs (OAD), in Subjects With Type 2 Diabetes Mellitus Currently Treated With OAD(s) and Qualifying for More Intensified Treatment / NN1250-3643: An Extension Trial to NN1250-3579 Comparing Safety and Efficacy of NN1250 Plus OAD(s) With Insulin Glargine Plus OAD(s) in Type 2 Diabetes (BEGIN™: Once Long)

All oral anti-diabetic drug (OAD) treatment will be discontinued when trial participant enters the main trial (NN1250-3579) with the exception of metformin and dipeptidyl peptidase-IV (DPP-IV) inhibitor treatment (only in countries where DPP-IV inhibitor treatment is approved for combination treatment together with insulin, otherwise DPP-IV inhibitor treatment is also discontinued). Subjects who consent to participate in the extension trial will continue the treatment (NN1250 or insulin glargine + oral antidiabetic drugs (OADs)) to which they were randomly allocated in the 52 week main trial.

The main period is registered internally at Novo Nordisk as NN1250-3579 while the extension period is registered as NN1250-3643.

Conditions: Diabetes, Diabetes Mellitus, Type 2
Being tested: insulin degludec, insulin glargine
Medical subject headings: Diabetes Mellitus, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

insulin degludecDrug
Injected subcutaneously (under the skin) once daily. Dose was individually adjusted.
insulin glargineDrug
Injected subcutaneously (under the skin) once daily. Dose was individually adjusted.

Study groups in NCT00982644
Study group	Role	What they receive
IDeg OD	Experimental	Not described Receives: Drug: insulin degludec
IGlar OD	Active comparator	Not described Receives: Drug: insulin glargine

What is being measured

The primary outcome is the main question the study is designed to answer.

Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment
Change from baseline in HbA1c after 52 weeks of treatment
Measured: Week 0, Week 52
Extension Trial (Primary Endpoint): 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.
Measured: Week 0 to Week 104 + 7 days follow up
Extension Trial (Primary Endpoint): Rate of Nocturnal 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. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.
Measured: Week 0 to Week 104 + 7 days follow up
Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs)
Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.
Measured: Week 0 to Week 104 + 7 days of follow up

Secondary outcomes (5)

Main Trial (Secondary Endpoint): 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.
Measured: Week 0 to Week 52 + 7 days follow up
Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 104 Weeks of Treatment
Change from baseline in HbA1c after 104 weeks of treatment
Measured: Week 0, Week 104
Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 52
Mean of 9-point SMPG at 52 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, bedtime, at 4 am and before breakfast.
Measured: Week 52
Extension Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 104
Mean of 9-point SMPG at 104 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, bedtime, at 4 am and before breakfast.
Measured: Week 104
Main Trial (Secondary Endpoint): Rate of Nocturnal 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. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.
Measured: Week 0 to Week 52 + 7 days follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2009Dec 2010

First posted23 Sep 2009 (estimated)
Study startSep 2009
Primary completionDec 2010
Study completionDec 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (6)Papers the sponsor has linked to this study.
Other trials for DiabetesStudies of the same condition, open and under way.
More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 1,030 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00982644
Sponsor's protocol ID: NN1250-3579
Other IDs: 2008-005776-27, U1111-1111-8692, 2009-015754-38, U1111-1114-9426, 2009, 2008
Acronym: BEGIN™
Status last verified: Dec 2016
First submitted: 22 Sep 2009
Last updated: 9 Feb 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 23130654
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.
PubMed 24170235
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.
PubMed 26121451
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.
PubMed 26232910
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.
PubMed 26663320
Rodbard HW, Cariou B, Zinman B, Handelsman Y, Philis-Tsimikas A, Skjoth TV, Rana A, Mathieu C; BEGIN Once Long trial investigators. Comparison of insulin degludec with insulin glargine in insulin-naive subjects with Type 2 diabetes: a 2-year randomized, treat-to-target trial. Diabet Med. 2013 Nov;30(11):1298-304. doi: 10.1111/dme.12303. Epub 2013 Sep 30.
PubMed 23952326

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: NN1250-3579: A 52-week Randomised, Controlled, Open Label, Multicentre, Multinational Treat-to-target Trial Comparing the Efficacy and Safety of SIBA and Insulin Glargine, Both Injected Once Daily in Combination With Oral Anti-diabetic Drugs (OAD), in Subjects With Type 2 Diabetes Mellitus Currently Treated With OAD(s) and Qualifying for More Intensified Treatment / NN1250-3643: An Extension Trial to NN1250-3579 Comparing Safety and Efficacy of NN1250 Plus OAD(s) With Insulin Glargine Plus OAD(s) in Type 2 Diabetes (BEGIN™: Once Long)
ClinicalTrials.gov ID: NCT00982644
Acronym / sponsor ID: BEGIN™ / NN1250-3579
Conditions: Diabetes, Diabetes Mellitus, Type 2
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,030 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: Sep 2009
Primary completion: Dec 2010 (actual)
Study completion: Dec 2010 (actual)
First posted: 23 Sep 2009 (estimated)
Results: Posted 13 Nov 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The main period is registered internally at Novo Nordisk as NN1250-3579 while the extension period is registered as NN1250-3643.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
IDeg OD	Experimental	Drug: insulin degludec
IGlar OD	Active comparator	Drug: insulin glargine

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Type 2 diabetes mellitus
Treatment with oral antidiabetic drugs (OADs) for at least three months before trial start at an unchanged dose
HbA1c: 7.0-10.0%
Body Mass Index (BMI) no higher than 40.0 kg/m^2
For the extension trial only: Completion of the 52 week treatment period in trial NN1250-3579 (NCT00982644)

Key exclusion criteria (5 listed)

Treatment with exenatide or liraglutide within the last 3 months before trial start
Cardiovascular disease within the last 6 months
Uncontrolled treated/untreated severe hypertension
Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures
Cancer and medical history of cancer

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
insulin degludecInjected subcutaneously (under the skin) once daily. Dose was individually adjusted.	Drug	IDeg OD
insulin glargineInjected subcutaneously (under the skin) once daily. Dose was individually adjusted.	Drug	IGlar OD

Primary outcome

Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment
Time frame: Week 0, Week 52
Change from baseline in HbA1c after 52 weeks of treatment
Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes
Time frame: Week 0 to Week 104 + 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.
Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes
Time frame: Week 0 to Week 104 + 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. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.
Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs)
Time frame: Week 0 to Week 104 + 7 days of follow up
Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.

5 secondary outcomes

Main Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes
Time frame: Week 0 to Week 52 + 7 days follow up
Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 104 Weeks of Treatment
Time frame: Week 0, Week 104
Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 52
Time frame: Week 52
Extension Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 104
Time frame: Week 104
Main Trial (Secondary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes
Time frame: Week 0 to Week 52 + 7 days follow up

Results and safety

Results posted to the registry on 13 Nov 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
IDeg OD	773	607
IGlar OD	257	197

Primary outcome: Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment

Time frame: Week 0, Week 52. Mean (Standard Deviation). Unit: percentage of glycosylated haemoglobin

Measure	IDeg OD n = 773	IGlar OD n = 257
Value	-1.06 (1.01)	-1.19 (0.97)

Population analysed: The full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF).

Primary outcome: Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes

Time frame: Week 0 to Week 104 + 7 days follow up. Number. Unit: Episodes/100 years of patient exposure

Measure	IDeg OD n = 766	IGlar OD n = 257
Value	172	205

Population analysed: The SAS included all subjects who received at least one dose of the investigational product or its comparator in the main trial including subjects carried through to the extension trial.

Primary outcome: Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes

Time frame: Week 0 to Week 104 + 7 days follow up. Number. Unit: Episodes/100 years of patient exposure

Measure	IDeg OD n = 766	IGlar OD n = 257
Value	27	46

Primary outcome: Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs)

Time frame: Week 0 to Week 104 + 7 days of follow up. Number. Unit: Events/100 years of patient exposure

Measure	IDeg OD n = 766	IGlar OD n = 257
Adverse event (AE)	362	339
Serious AE	15	17
Severe AE	14	17
Moderate AE	93	87
Mild AE	254	234
Fatal AE	0	1

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected in a time frame of 104 weeks + 7 days follow up.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
IDeg OD	116 of 766 (15.1%)	463 of 766 (60.4%)	Not reported
IGlar OD	41 of 257 (16%)	153 of 257 (59.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 23130654Ratner 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 publication: PubMed 24170235Sorli 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 publication: PubMed 26121451Einhorn 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 publication: PubMed 26232910Russell-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 publication: PubMed 26663320Vora 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.
Derived from this study: PubMed 23952326Rodbard HW, Cariou B, Zinman B, Handelsman Y, Philis-Tsimikas A, Skjoth TV, Rana A, Mathieu C; BEGIN Once Long trial investigators. Comparison of insulin degludec with insulin glargine in insulin-naive subjects with Type 2 diabetes: a 2-year randomized, treat-to-target trial. Diabet Med. 2013 Nov;30(11):1298-304. doi: 10.1111/dme.12303. Epub 2013 Sep 30.
Clinical Trials at Novo NordiskLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Global Clinical Registry (GCR, 1452) study director

Novo Nordisk A/S

187 sites in 15 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing insulin degludec and insulin glargine in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 187 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 187 sites in United States, Germany, Canada, Spain, Norway and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment (time frame: Week 0, Week 52). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00982644, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2017.