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

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)

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 terms of comparing NN1250 with insulin glargine in subjects with type 2 diabetes.

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2; Diabetes
• Intervention / Treatment: Drug: insulin degludec; Drug: insulin glargine

• Study Type: Interventional
• Enrollment (Actual): 1030
• Phase: Phase 3

Contacts and Locations

Study Locations

• Austria
  • Bregenz, Austria, A - 6900
    • Novo Nordisk Investigational Site
  • Feldkirch, Austria, 6807
    • Novo Nordisk Investigational Site
  • Wien, Austria, 1090
    • Novo Nordisk Investigational Site
  • Wien, Austria, 1130
    • Novo Nordisk Investigational Site
  • Wien, Austria, 1030
    • Novo Nordisk Investigational Site
  • Wien, Austria, A 1160
    • Novo Nordisk Investigational Site
  • Wolfsberg, Austria, 9400
    • Novo Nordisk Investigational Site
• Belgium
  • Brussels, Belgium, 1090
    • Novo Nordisk Investigational Site
  • Brussels, Belgium, 1070
    • Novo Nordisk Investigational Site
  • Gent, Belgium, 9000
    • Novo Nordisk Investigational Site
  • Leuven, Belgium, 3000
    • Novo Nordisk Investigational Site
  • Liège, Belgium, 4000
    • Novo Nordisk Investigational Site
• Canada
  • Quebec, Canada, G1V 4G2
    • Novo Nordisk Investigational Site
  • Alberta
    • Edmonton, Alberta, Canada, T5J 3N4
      • Novo Nordisk Investigational Site
  • British Columbia
    • Coquitlam, British Columbia, Canada, V3K 3P4
      • Novo Nordisk Investigational Site
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3E 3P4
      • Novo Nordisk Investigational Site
  • Newfoundland and Labrador
    • Mount Pearl, Newfoundland and Labrador, Canada, A1N 1W7
      • Novo Nordisk Investigational Site
    • St. John's, Newfoundland and Labrador, Canada, A1A 3R5
      • Novo Nordisk Investigational Site
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3K 0A4
      • Novo Nordisk Investigational Site
  • Ontario
    • London, Ontario, Canada, N6G 2M1
      • Novo Nordisk Investigational Site
    • Mississauga, Ontario, Canada, L5M 2V8
      • Novo Nordisk Investigational Site
    • Ottawa, Ontario, Canada, K1N 6N5
      • Novo Nordisk Investigational Site
    • Ottawa, Ontario, Canada, K1K 4L2
      • Novo Nordisk Investigational Site
    • Scarborough, Ontario, Canada, M1E 5E9
      • Novo Nordisk Investigational Site
    • Toronto, Ontario, Canada, M4G 3E8
      • Novo Nordisk Investigational Site
    • Toronto, Ontario, Canada, M5C 2T2
      • Novo Nordisk Investigational Site
  • Quebec
    • St-Marc-des-Carrières, Quebec, Canada, G0A 4B0
      • Novo Nordisk Investigational Site
    • St. Romuald, Quebec, Canada, G6W 5M6
      • Novo Nordisk Investigational Site
• Czech Republic
  • Brno, Czech Republic, 656 91
    • Novo Nordisk Investigational Site
  • Hradec Kralove, Czech Republic, 500 05
    • Novo Nordisk Investigational Site
  • Plzen, Czech Republic, 304 60
    • Novo Nordisk Investigational Site
  • Prague 4, Czech Republic, 140 21
    • Novo Nordisk Investigational Site
  • Praha 5, Czech Republic, 15006
    • Novo Nordisk Investigational Site
• Denmark
  • Esbjerg, Denmark, 6700
    • Novo Nordisk Investigational Site
  • Hillerød, Denmark, 3400
    • Novo Nordisk Investigational Site
  • Holbæk, Denmark, 4300
    • Novo Nordisk Investigational Site
  • København S, Denmark, 2300
    • Novo Nordisk Investigational Site
  • Odense, Denmark, 5000
    • Novo Nordisk Investigational Site
  • Silkeborg, Denmark, 8600
    • Novo Nordisk Investigational Site
• Finland
  • Helsinki, Finland, 00260
    • Novo Nordisk Investigational Site
  • Joensuu, Finland, 80100
    • Novo Nordisk Investigational Site
  • Kerava, Finland, FI-04200
    • Novo Nordisk Investigational Site
  • Lohja, Finland, 08100
    • Novo Nordisk Investigational Site
  • Oulu, Finland, 90100
    • Novo Nordisk Investigational Site
  • Tampere, Finland, 33210
    • Novo Nordisk Investigational Site
• Former Serbia and Montenegro
  • Belgrade, Former Serbia and Montenegro, 11000
    • Novo Nordisk Investigational Site
  • Kragujevac, Former Serbia and Montenegro, 34000
    • Novo Nordisk Investigational Site
  • Nis, Former Serbia and Montenegro, 18000
    • Novo Nordisk Investigational Site
  • Novi Sad, Former Serbia and Montenegro, 21000
    • Novo Nordisk Investigational Site
• France
  • Le Grau-du-Roi, France, 30240
    • Novo Nordisk Investigational Site
  • Montigny-les-Metz, France, 57950
    • Novo Nordisk Investigational Site
  • Nanterre, France, 92014
    • Novo Nordisk Investigational Site
  • Nantes, France, 44093
    • Novo Nordisk Investigational Site
  • Nimes, France, 30006
    • Novo Nordisk Investigational Site
  • Saint-denis de La Reunion, France, 97405
    • Novo Nordisk Investigational Site
  • Venissieux, France, 69200
    • Novo Nordisk Investigational Site
• Germany
  • Bad Harzburg, Germany, 38667
    • Novo Nordisk Investigational Site
  • Berlin, Germany, 12163
    • Novo Nordisk Investigational Site
  • Berlin, Germany, 13055
    • Novo Nordisk Investigational Site
  • Dormagen, Germany, 41539
    • Novo Nordisk Investigational Site
  • Dresden, Germany, 01307
    • Novo Nordisk Investigational Site
  • Essen, Germany, 45329
    • Novo Nordisk Investigational Site
  • Friedrichsthal, Germany, 66299
    • Novo Nordisk Investigational Site
  • Hamburg, Germany, 21073
    • Novo Nordisk Investigational Site
  • Hamburg, Germany, 22391
    • Novo Nordisk Investigational Site
  • Hamburg, Germany, 22587
    • Novo Nordisk Investigational Site
  • Hohenmölsen, Germany, 06679
    • Novo Nordisk Investigational Site
  • Neuwied, Germany, 56564
    • Novo Nordisk Investigational Site
  • Pohlheim, Germany, 35415
    • Novo Nordisk Investigational Site
  • Rehburg-Loccum, Germany, 31547
    • Novo Nordisk Investigational Site
  • Rehlingen-Siersburg, Germany, 66780
    • Novo Nordisk Investigational Site
  • Riesa, Germany, 01587
    • Novo Nordisk Investigational Site
  • Speyer, Germany, 67346
    • Novo Nordisk Investigational Site
  • St. Ingbert, Germany, 66386
    • Novo Nordisk Investigational Site
• Norway
  • Bekkestua, Norway, 1357
    • Novo Nordisk Investigational Site
  • Elverum, Norway, 2408
    • Novo Nordisk Investigational Site
  • Hamar, Norway, 2318
    • Novo Nordisk Investigational Site
  • Kongsvinger, Norway, 2212
    • Novo Nordisk Investigational Site
  • Oslo, Norway, 0407
    • Novo Nordisk Investigational Site
  • Stavanger, Norway, 4011
    • Novo Nordisk Investigational Site
  • Trondheim, Norway, NO-7030
    • Novo Nordisk Investigational Site
  • Ålesund, Norway, 6003
    • Novo Nordisk Investigational Site
• Puerto Rico
  • Bayamon, Puerto Rico, 00961
    • Novo Nordisk Investigational Site
• Serbia
  • Belgrade, Serbia, 11000
    • Novo Nordisk Investigational Site
  • Kragujevac, Serbia, 34000
    • Novo Nordisk Investigational Site
  • Nis, Serbia, 18000
    • Novo Nordisk Investigational Site
  • Novi Sad, Serbia, 21000
    • Novo Nordisk Investigational Site
• Slovenia
  • Koper, Slovenia, SI-6000
    • Novo Nordisk Investigational Site
  • Ljubljana, Slovenia, 1525
    • Novo Nordisk Investigational Site
  • Novo mesto, Slovenia, 8000
    • Novo Nordisk Investigational Site
• Spain
  • Almería, Spain, 04001
    • Novo Nordisk Investigational Site
  • Alzira, Spain, 46600
    • Novo Nordisk Investigational Site
  • Antequera, Spain, 29200
    • Novo Nordisk Investigational Site
  • El Ferrol, Spain, 15405
    • Novo Nordisk Investigational Site
  • Gijón, Spain, 33206
    • Novo Nordisk Investigational Site
  • Inca, Spain, 07300
    • Novo Nordisk Investigational Site
  • Palma de Mallorca, Spain, 07014
    • Novo Nordisk Investigational Site
  • Puerto del Rosario, Spain, 35600
    • Novo Nordisk Investigational Site
  • Sevilla, Spain, 41010
    • Novo Nordisk Investigational Site
  • Sevilla, Spain, 41003
    • Novo Nordisk Investigational Site
  • Valencia, Spain, 46015
    • Novo Nordisk Investigational Site
• United States
  • Alabama
    • Bay Minette, Alabama, United States, 36507-4198
      • Novo Nordisk Investigational Site
    • Birmingham, Alabama, United States, 35209
      • Novo Nordisk Investigational Site
    • Huntsville, Alabama, United States, 35801
      • Novo Nordisk Investigational Site
  • Arizona
    • Goodyear, Arizona, United States, 85395
      • Novo Nordisk Investigational Site
  • California
    • Anaheim, California, United States, 92801
      • Novo Nordisk Investigational Site
    • Concord, California, United States, 94520-1926
      • Novo Nordisk Investigational Site
    • La Jolla, California, United States, 92037
      • Novo Nordisk Investigational Site
    • Lancaster, California, United States, 93534
      • Novo Nordisk Investigational Site
    • Long Beach, California, United States, 90806
      • Novo Nordisk Investigational Site
    • Los Angeles, California, United States, 90057
      • Novo Nordisk Investigational Site
    • Mission Hills, California, United States, 91345
      • Novo Nordisk Investigational Site
    • National City, California, United States, 91950
      • Novo Nordisk Investigational Site
    • North Hollywood, California, United States, 91606
      • Novo Nordisk Investigational Site
    • Northridge, California, United States, 91325
      • Novo Nordisk Investigational Site
    • Palm Springs, California, United States, 92262
      • Novo Nordisk Investigational Site
    • San Mateo, California, United States, 94401
      • Novo Nordisk Investigational Site
    • Santa Monica, California, United States, 90404
      • Novo Nordisk Investigational Site
    • Spring Valley, California, United States, 91978
      • Novo Nordisk Investigational Site
    • Tarzana, California, United States, 91356-3551
      • Novo Nordisk Investigational Site
    • Tustin, California, United States, 92780
      • Novo Nordisk Investigational Site
  • Connecticut
    • Norwalk, Connecticut, United States, 06851
      • Novo Nordisk Investigational Site
  • Florida
    • Boynton Beach, Florida, United States, 33472
      • Novo Nordisk Investigational Site
    • Jacksonville, Florida, United States, 32208
      • Novo Nordisk Investigational Site
    • Melbourne, Florida, United States, 32901
      • Novo Nordisk Investigational Site
    • Miami, Florida, United States, 33156
      • Novo Nordisk Investigational Site
    • Miami, Florida, United States, 33169
      • Novo Nordisk Investigational Site
    • New Port Richey, Florida, United States, 34652
      • Novo Nordisk Investigational Site
    • Orange Park, Florida, United States, 32073
      • Novo Nordisk Investigational Site
    • Orlando, Florida, United States, 32806
      • Novo Nordisk Investigational Site
    • Palm Harbor, Florida, United States, 34684
      • Novo Nordisk Investigational Site
    • West Palm Beach, Florida, United States, 33401
      • Novo Nordisk Investigational Site
  • Georgia
    • Decatur, Georgia, United States, 30033
      • Novo Nordisk Investigational Site
    • Fort Valley, Georgia, United States, 31030-5008
      • Novo Nordisk Investigational Site
  • Idaho
    • Idaho Falls, Idaho, United States, 83404-7596
      • Novo Nordisk Investigational Site
  • Illinois
    • Chicago, Illinois, United States, 60607
      • Novo Nordisk Investigational Site
  • Indiana
    • Evansville, Indiana, United States, 47714
      • Novo Nordisk Investigational Site
    • Indianapolis, Indiana, United States, 46217
      • Novo Nordisk Investigational Site
  • Kentucky
    • Lexington, Kentucky, United States, 40503
      • Novo Nordisk Investigational Site
    • Paducah, Kentucky, United States, 42003
      • Novo Nordisk Investigational Site
  • Louisiana
    • Metairie, Louisiana, United States, 70002
      • Novo Nordisk Investigational Site
    • Slidell, Louisiana, United States, 70461-4231
      • Novo Nordisk Investigational Site
  • Maryland
    • Greenbelt, Maryland, United States, 20770
      • Novo Nordisk Investigational Site
    • North East, Maryland, United States, 21901
      • Novo Nordisk Investigational Site
    • Reisterstown, Maryland, United States, 21136-2516
      • Novo Nordisk Investigational Site
    • Rockville, Maryland, United States, 20852
      • Novo Nordisk Investigational Site
  • Massachusetts
    • Brockton, Massachusetts, United States, 02301
      • Novo Nordisk Investigational Site
    • North Dartmouth, Massachusetts, United States, 02747
      • Novo Nordisk Investigational Site
  • Missouri
    • St. Louis, Missouri, United States, 63141
      • Novo Nordisk Investigational Site
    • St. Louis, Missouri, United States, 63104
      • Novo Nordisk Investigational Site
  • Nevada
    • Henderson, Nevada, United States, 89052-2649
      • Novo Nordisk Investigational Site
    • Las Vegas, Nevada, United States, 89117
      • Novo Nordisk Investigational Site
  • New Jersey
    • Toms River, New Jersey, United States, 08755-8050
      • Novo Nordisk Investigational Site
  • New York
    • Northport, New York, United States, 11768
      • Novo Nordisk Investigational Site
    • Staten Island, New York, United States, 10301
      • Novo Nordisk Investigational Site
  • North Carolina
    • Asheboro, North Carolina, United States, 27203
      • Novo Nordisk Investigational Site
    • Charlotte, North Carolina, United States, 28209
      • Novo Nordisk Investigational Site
  • Ohio
    • Cincinnati, Ohio, United States, 45255
      • Novo Nordisk Investigational Site
    • Dayton, Ohio, United States, 45406
      • Novo Nordisk Investigational Site
    • Toledo, Ohio, United States, 43606-2920
      • Novo Nordisk Investigational Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73103
      • Novo Nordisk Investigational Site
  • Pennsylvania
    • Kingston, Pennsylvania, United States, 18704
      • Novo Nordisk Investigational Site
    • Langhorne, Pennsylvania, United States, 19047
      • Novo Nordisk Investigational Site
    • Melrose Park, Pennsylvania, United States, 19027
      • Novo Nordisk Investigational Site
    • Pittsburgh, Pennsylvania, United States, 15241
      • Novo Nordisk Investigational Site
    • West Reading, Pennsylvania, United States, 19611
      • Novo Nordisk Investigational Site
  • Rhode Island
    • East Providence, Rhode Island, United States, 02914
      • Novo Nordisk Investigational Site
  • South Carolina
    • Columbia, South Carolina, United States, 29203
      • Novo Nordisk Investigational Site
    • Greer, South Carolina, United States, 29651
      • Novo Nordisk Investigational Site
    • Newberry, South Carolina, United States, 29108-2249
      • Novo Nordisk Investigational Site
  • Tennessee
    • Chattanooga, Tennessee, United States, 37411
      • Novo Nordisk Investigational Site
    • Harriman, Tennessee, United States, 37748-8653
      • Novo Nordisk Investigational Site
    • Humboldt, Tennessee, United States, 38343
      • Novo Nordisk Investigational Site
    • Nashville, Tennessee, United States, 37203
      • Novo Nordisk Investigational Site
  • Texas
    • Arlington, Texas, United States, 76014
      • Novo Nordisk Investigational Site
    • Corpus Christi, Texas, United States, 78404
      • Novo Nordisk Investigational Site
    • Dallas, Texas, United States, 75230
      • Novo Nordisk Investigational Site
    • Dallas, Texas, United States, 75246
      • Novo Nordisk Investigational Site
    • El Paso, Texas, United States, 79912
      • Novo Nordisk Investigational Site
    • Hurst, Texas, United States, 76054
      • Novo Nordisk Investigational Site
    • Irving, Texas, United States, 75061-2210
      • Novo Nordisk Investigational Site
    • Lubbock, Texas, United States, 79423
      • Novo Nordisk Investigational Site
    • San Antonio, Texas, United States, 78215
      • Novo Nordisk Investigational Site
    • Sugar Land, Texas, United States, 77479
      • Novo Nordisk Investigational Site
  • Virginia
    • Richmond, Virginia, United States, 23233
      • Novo Nordisk Investigational Site
  • Washington
    • Spokane, Washington, United States, 99218
      • Novo Nordisk Investigational Site
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53209
      • Novo Nordisk Investigational Site

Participation Criteria

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
• 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)

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: IGlar OD	Drug: insulin glargine; Injected subcutaneously (under the skin) once daily. Dose was individually adjusted.
EXPERIMENTAL: IDeg OD	Drug: insulin degludec; Injected subcutaneously (under the skin) once daily. Dose was individually adjusted.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment	Change from baseline in HbA1c after 52 weeks of treatment	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.	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.	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.	Week 0 to Week 104 + 7 days of follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Week 52
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.	Week 0 to Week 52 + 7 days follow up
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.	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	Week 0, Week 104
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.	Week 104

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Helpful Links

• Clinical Trials at Novo Nordisk

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (ACTUAL): December 1, 2010
• Study Completion (ACTUAL): December 1, 2010

Study Registration Dates

• First Submitted: September 22, 2009
• First Submitted That Met QC Criteria: September 22, 2009
• First Posted (ESTIMATE): September 23, 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: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc; Insulin Glargine
• Other Study ID Numbers: NN1250-3579; 2008-005776-27 (EUDRACT_NUMBER); U1111-1111-8692 (OTHER: WHO); 2009-015754-38 (EUDRACT_NUMBER); U1111-1114-9426 (OTHER: WHO)