Comparison of NN1250 With Insulin Glargine Plus Insulin Aspart With/Without Metformin and With/Without Pioglitazone in Type 2 Diabetes (BEGIN™)

NN1250-3582: A 52-week Randomised, Controlled, Open Label, Multicentre, Multinational Treat-to-target Trial Comparing Efficacy and Safety of SIBA and Insulin Glargine Both Administered Once Daily in a Basal-bolus Regimen With Insulin Aspart as Mealtime Insulin ± Treatment With Metformin, ± Pioglitazone in Subjects With Type 2 Diabetes Currently Treated With Insulin Qualifying for Intensified Treatment/NN1250-3667: An Extension Trial to NN1250-3582 Comparing Safety and Efficacy of NN1250 and Insulin Glargine, Both With Insulin Aspart as Meal-time Insulin ± OADs in Type 2 Diabetes (BEGIN™: BB)

This trial is conducted in Africa, Asia, Europe, and the United States of America (USA).

The aim of this clinical trial is to compare NN1250 (insulin degludec (IDeg)) with insulin glargine (IGlar) plus insulin aspart (IAsp) with/without metformin and with/without pioglitazone in subjects with type 2 diabetes (main period) followed by investigating the long-term safety in terms of comparing NN1250 with insulin glargine plus insulin aspart with or without metformin and with or without pioglitazone in subjects with type 2 diabetes.

All oral anti-diabetic drug (OAD) treatment will be discontinued, if applicable, when trial participant enters the trial (NN1250-3582) with the exception of metformin and pioglitazone.

Subjects who consent to participate in the extension trial (NN1250-3667) will continue to receive the treatment to which they were randomly allocated in the 52 week trial NN1250-3582.

The main period is registered internally at Novo Nordisk as NN1250-3582 while the extension period is registered as NN1250-3667.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 1006
• Phase: Phase 3

Contacts and Locations

Study Locations

• Bulgaria
  • Dimitrovgrad, Bulgaria, 6400
    • Novo Nordisk Investigational Site
  • Ruse, Bulgaria, 7000
    • Novo Nordisk Investigational Site
  • Sofia, Bulgaria, 1431
    • Novo Nordisk Investigational Site
  • Sofia, Bulgaria, 1606
    • Novo Nordisk Investigational Site
  • Sofia, Bulgaria, 1233
    • Novo Nordisk Investigational Site
  • Stara Zagora, Bulgaria, 6000
    • Novo Nordisk Investigational Site
  • Varna, Bulgaria, 9010
    • Novo Nordisk Investigational Site
• Germany
  • Dresden, Germany, 01219
    • Novo Nordisk Investigational Site
  • Dresden, Germany, 01307
    • Novo Nordisk Investigational Site
  • Frankfurt, Germany, 60388
    • Novo Nordisk Investigational Site
  • Hamburg, Germany, 22587
    • Novo Nordisk Investigational Site
  • Ludwigshafen, Germany, 67059
    • Novo Nordisk Investigational Site
  • Münster, Germany, 48145
    • Novo Nordisk Investigational Site
  • Völklingen, Germany, 66333
    • Novo Nordisk Investigational Site
  • Wangen, Germany, 88239
    • Novo Nordisk Investigational Site
  • Warburg, Germany, 34414
    • Novo Nordisk Investigational Site
• Hong Kong
  • Shatin, New Territories, Hong Kong
    • Novo Nordisk Investigational Site
• Ireland
  • Dublin, Ireland, DUBLIN 15
    • Novo Nordisk Investigational Site
  • Dublin, Ireland, DUBLIN 7
    • Novo Nordisk Investigational Site
  • Dublin, Ireland, DUBLIN 8
    • Novo Nordisk Investigational Site
  • Dublin, Ireland
    • Novo Nordisk Investigational Site
• Italy
  • Bari, Italy, 70124
    • Novo Nordisk Investigational Site
  • Bergamo, Italy, 24127
    • Novo Nordisk Investigational Site
  • Catania, Italy, 95124
    • Novo Nordisk Investigational Site
  • Chieti Scalo, Italy, 66100
    • Novo Nordisk Investigational Site
  • Firenze, Italy, 50141
    • Novo Nordisk Investigational Site
  • Foggia, Italy, 71100
    • Novo Nordisk Investigational Site
  • Gazi, Italy, 98124
    • Novo Nordisk Investigational Site
  • Messina, Italy, 98123
    • Novo Nordisk Investigational Site
  • Milano, Italy, 20132
    • Novo Nordisk Investigational Site
  • Perugia, Italy, 06126
    • Novo Nordisk Investigational Site
  • Pisa, Italy, 56100
    • Novo Nordisk Investigational Site
  • Roma, Italy, 00161
    • Novo Nordisk Investigational Site
  • Torino, Italy, 10126
    • Novo Nordisk Investigational Site
• Romania
  • Bucharest, Romania, 011234
    • Novo Nordisk Investigational Site
  • Constanta, Romania, 900591
    • Novo Nordisk Investigational Site
  • Suceava, Romania, 720237
    • Novo Nordisk Investigational Site
  • Timisoara, Romania, 300736
    • Novo Nordisk Investigational Site
  • Maramures
    • Baia Mare, Maramures, Romania, 430123
      • Novo Nordisk Investigational Site
• Russian Federation
  • Arkhangelsk, Russian Federation, 163001
    • Novo Nordisk Investigational Site
  • Barnaul, Russian Federation, 656045
    • Novo Nordisk Investigational Site
  • Krasnoyarsk, Russian Federation, 660022
    • Novo Nordisk Investigational Site
  • Moscow, Russian Federation, 119435
    • Novo Nordisk Investigational Site
  • Moscow, Russian Federation, 125367
    • Novo Nordisk Investigational Site
  • Perm, Russian Federation, 614990
    • Novo Nordisk Investigational Site
  • Saint-Petersburg, Russian Federation, 194354
    • Novo Nordisk Investigational Site
  • Yaroslavl, Russian Federation, 150003
    • Novo Nordisk Investigational Site
• Slovakia
  • Bratislava, Slovakia, 851 01
    • Novo Nordisk Investigational Site
  • Bratislava, Slovakia, 82102
    • Novo Nordisk Investigational Site
  • Bratislava, Slovakia, 851 05
    • Novo Nordisk Investigational Site
  • Lucenec, Slovakia, 984 01
    • Novo Nordisk Investigational Site
• South Africa
  • Bloemfontein, South Africa, 9301
    • Novo Nordisk Investigational Site
  • Gauteng
    • Pretoria, Gauteng, South Africa, 0181
      • Novo Nordisk Investigational Site
  • KwaZulu-Natal
    • Durban, KwaZulu-Natal, South Africa, 4450
      • Novo Nordisk Investigational Site
    • Durban, KwaZulu-Natal, South Africa
      • Novo Nordisk Investigational Site
• Spain
  • Alcorcón, Spain, 28922
    • Novo Nordisk Investigational Site
  • Almería, Spain, 04001
    • Novo Nordisk Investigational Site
  • Barcelona, Spain, 08035
    • Novo Nordisk Investigational Site
  • Granada, Spain, 18012
    • Novo Nordisk Investigational Site
  • Hospitalet de Llobregat, Spain, 08907
    • Novo Nordisk Investigational Site
  • La Coruña, Spain, 15006
    • Novo Nordisk Investigational Site
  • Madrid, Spain, 28040
    • Novo Nordisk Investigational Site
  • Mostoles - Madrid -, Spain, 28935
    • Novo Nordisk Investigational Site
  • Sabadell, Spain, 08208
    • Novo Nordisk Investigational Site
  • San Juan, Spain, 03550
    • Novo Nordisk Investigational Site
  • Valencia, Spain, 46026
    • Novo Nordisk Investigational Site
• Turkey
  • Antalya, Turkey, 07058
    • Novo Nordisk Investigational Site
  • Istanbul, Turkey, 34098
    • Novo Nordisk Investigational Site
  • Istanbul, Turkey, 34390
    • Novo Nordisk Investigational Site
  • Mersin, Turkey, 33070
    • Novo Nordisk Investigational Site
• United States
  • Alabama
    • Alexander City, Alabama, United States, 35010
      • Novo Nordisk Investigational Site
    • Birmingham, Alabama, United States, 35209
      • Novo Nordisk Investigational Site
  • Arizona
    • Goodyear, Arizona, United States, 85395
      • Novo Nordisk Investigational Site
    • Peoria, Arizona, United States, 85381
      • Novo Nordisk Investigational Site
  • California
    • Anaheim, California, United States, 92801
      • Novo Nordisk Investigational Site
    • Huntington Beach, California, United States, 92648
      • Novo Nordisk Investigational Site
    • Los Gatos, California, United States, 95032
      • Novo Nordisk Investigational Site
    • Salinas, California, United States, 93901
      • Novo Nordisk Investigational Site
    • Santa Monica, California, United States, 90404
      • Novo Nordisk Investigational Site
    • Spring Valley, California, United States, 91978
      • Novo Nordisk Investigational Site
    • Tustin, California, United States, 92780
      • Novo Nordisk Investigational Site
    • Walnut Creek, California, United States, 94598
      • Novo Nordisk Investigational Site
  • Connecticut
    • Milford, Connecticut, United States, 06460
      • Novo Nordisk Investigational Site
    • Norwalk, Connecticut, United States, 06851
      • Novo Nordisk Investigational Site
    • Waterbury, Connecticut, United States, 06712
      • Novo Nordisk Investigational Site
  • District of Columbia
    • Washington, District of Columbia, United States, 20060
      • Novo Nordisk Investigational Site
  • Florida
    • Gainesville, Florida, United States, 32610
      • Novo Nordisk Investigational Site
    • Jacksonville, Florida, United States, 32205
      • Novo Nordisk Investigational Site
    • Lake Mary, Florida, United States, 32746
      • Novo Nordisk Investigational Site
    • Orlando, Florida, United States, 32804
      • Novo Nordisk Investigational Site
    • Plantation, Florida, United States, 33324
      • Novo Nordisk Investigational Site
    • West Palm Beach, Florida, United States, 33401
      • Novo Nordisk Investigational Site
  • Georgia
    • Atlanta, Georgia, United States, 30318
      • Novo Nordisk Investigational Site
    • Fort Valley, Georgia, United States, 31030-5008
      • Novo Nordisk Investigational Site
  • Hawaii
    • Honolulu, Hawaii, United States, 96814
      • Novo Nordisk Investigational Site
  • Idaho
    • Nampa, Idaho, United States, 83686-6011
      • Novo Nordisk Investigational Site
  • Indiana
    • Evansville, Indiana, United States, 47714
      • Novo Nordisk Investigational Site
    • Indianapolis, Indiana, United States, 46217
      • Novo Nordisk Investigational Site
    • New Albany, Indiana, United States, 47150
      • Novo Nordisk Investigational Site
  • Louisiana
    • Metairie, Louisiana, United States, 70002
      • Novo Nordisk Investigational Site
    • Metairie, Louisiana, United States, 70006-2930
      • Novo Nordisk Investigational Site
  • Maryland
    • Hyattsville, Maryland, United States, 20782
      • Novo Nordisk Investigational Site
    • North East, Maryland, United States, 21901
      • Novo Nordisk Investigational Site
    • Rockville, Maryland, United States, 20852
      • Novo Nordisk Investigational Site
  • Minnesota
    • Eagan, Minnesota, United States, 55123
      • Novo Nordisk Investigational Site
  • Missouri
    • Jefferson City, Missouri, United States, 65109
      • Novo Nordisk Investigational Site
    • St. Louis, Missouri, United States, 63104
      • Novo Nordisk Investigational Site
  • Nebraska
    • Lincoln, Nebraska, United States, 68521
      • Novo Nordisk Investigational Site
    • Omaha, Nebraska, United States, 68114
      • Novo Nordisk Investigational Site
  • Nevada
    • Las Vegas, Nevada, United States, 89117
      • Novo Nordisk Investigational Site
  • New Jersey
    • Lawrenceville, New Jersey, United States, 08648
      • Novo Nordisk Investigational Site
    • Toms River, New Jersey, United States, 08755-8050
      • Novo Nordisk Investigational Site
  • North Carolina
    • Charlotte, North Carolina, United States, 28209
      • Novo Nordisk Investigational Site
    • Greenville, North Carolina, United States, 27834
      • Novo Nordisk Investigational Site
  • Ohio
    • Columbus, Ohio, United States, 43203
      • Novo Nordisk Investigational Site
    • Toledo, Ohio, United States, 43606-2920
      • Novo Nordisk Investigational Site
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822
      • Novo Nordisk Investigational Site
    • Kingston, Pennsylvania, United States, 18704
      • Novo Nordisk Investigational Site
    • Melrose Park, Pennsylvania, United States, 19027
      • Novo Nordisk Investigational Site
    • Philadelphia, Pennsylvania, United States, 19107
      • Novo Nordisk Investigational Site
    • Wilkes Barre, Pennsylvania, United States, 18711
      • Novo Nordisk Investigational Site
  • South Carolina
    • Charleston, South Carolina, United States, 29455
      • 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, 37404
      • Novo Nordisk Investigational Site
    • Kingsport, Tennessee, United States, 37660
      • Novo Nordisk Investigational Site
  • Texas
    • Corpus Christi, Texas, United States, 78412
      • Novo Nordisk Investigational Site
    • Dallas, Texas, United States, 75230
      • Novo Nordisk Investigational Site
    • Dallas, Texas, United States, 75246
      • Novo Nordisk Investigational Site
    • Fort Worth, Texas, United States, 76113
      • Novo Nordisk Investigational Site
    • Houston, Texas, United States, 77030
      • Novo Nordisk Investigational Site
    • Round Rock, Texas, United States, 78681
      • Novo Nordisk Investigational Site
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • Novo Nordisk Investigational Site
  • Virginia
    • Richmond, Virginia, United States, 23233
      • Novo Nordisk Investigational Site
  • Washington
    • Olympia, Washington, United States, 98502
      • Novo Nordisk Investigational Site
    • Renton, Washington, United States, 98057
      • 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:

• For MAIN period (NN1250-3582):
• Type 2 diabetes mellitus for at least 6 months
• Ongoing daily treatment with insulin (premix, self-mix, basal only, basal bolus) for at least 3 months with/without oral anti-diabetics drug (OAD) prior to trial start
• HbA1c 7.0-10.0 % (both inclusive)
• Body Mass Index (BMI) below or equal to 40.0 kg/m^2
• For EXTENSION period (NN1250-3667):
• Completion of the 52 week treatment period in NN1250-3582

Exclusion Criteria:

• For MAIN period (NN1250-3582):
• Treatment with other insulin regimens than premix, self-mix, basal only, basal bolus within 3 months
• 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 aspart; Injected subcutaneously (under the skin) at each main meal. Dose was individually adjusted.; Drug: insulin glargine; Injected subcutanoeusly (under the skin) according to approved label. Dose was individually adjusted.
EXPERIMENTAL: IDeg OD	Drug: insulin degludec; Injected subcutaneously (under the skin) with main evening meal. Dose was individually adjusted.; Drug: insulin aspart; Injected subcutaneously (under the skin) at each main meal. 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 78 + 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 78 + 7 days follow up
Rate of Treatment Emergent Adverse Events (AEs)	Corresponds to rate of AEs per 100 patient years of exposure. Mild AEs: no or transient symptoms, no interference with subject's daily activities. Moderate AEs: marked symptoms, moderate interference with subject's daily activities. Severe AEs: considerable interference with subject's daily activities, unacceptable. Serious adverse event (SAE): 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 78 + 7 days follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 78 Weeks of Treatment	Change from baseline in HbA1c after 78 weeks of treatment	Week 0, Week 78
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
Extension Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 78	Mean of the SMPG at 78 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, before breakfast.	Week 78
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

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Publications and helpful links

General Publications

• Freemantle N, Mamdani M, Vilsboll T, Kongso JH, Kvist K, Bain SC. IDegLira Versus Alternative Intensification Strategies in Patients with Type 2 Diabetes Inadequately Controlled on Basal Insulin Therapy. Diabetes Ther. 2015 Dec;6(4):573-591. doi: 10.1007/s13300-015-0142-y. Epub 2015 Nov 18.
• 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.
• Heller S, Mathieu C, Kapur R, Wolden ML, Zinman B. A meta-analysis of rate ratios for nocturnal confirmed hypoglycaemia with insulin degludec vs. insulin glargine using different definitions for hypoglycaemia. Diabet Med. 2016 Apr;33(4):478-87. doi: 10.1111/dme.13002. Epub 2015 Dec 13.
• 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, Christensen T, Rana A, Bain SC. Insulin degludec versus insulin glargine in type 1 and type 2 diabetes mellitus: a meta-analysis of endpoints in phase 3a trials. Diabetes Ther. 2014 Dec;5(2):435-46. doi: 10.1007/s13300-014-0076-9. Epub 2014 Aug 1.
• Aye MM, Atkin SL. Patient safety and minimizing risk with insulin administration - role of insulin degludec. Drug Healthc Patient Saf. 2014 Apr 30;6:55-67. doi: 10.2147/DHPS.S59566. eCollection 2014.
• Garber AJ, King AB, Del Prato S, Sreenan S, Balci MK, Munoz-Torres M, Rosenstock J, Endahl LA, Francisco AM, Hollander P; NN1250-3582 (BEGIN BB T2D) Trial Investigators. Insulin degludec, an ultra-longacting basal insulin, versus insulin glargine in basal-bolus treatment with mealtime insulin aspart in type 2 diabetes (BEGIN Basal-Bolus Type 2): a phase 3, randomised, open-label, treat-to-target non-inferiority trial. Lancet. 2012 Apr 21;379(9825):1498-507. doi: 10.1016/S0140-6736(12)60205-0.
• Hollander P, King AB, Del Prato S, Sreenan S, Balci MK, Munoz-Torres M, Rosenstock J, Hansen CT, Niemeyer M, Garber AJ. Insulin degludec improves long-term glycaemic control similarly to insulin glargine but with fewer hypoglycaemic episodes in patients with advanced type 2 diabetes on basal-bolus insulin therapy. Diabetes Obes Metab. 2015 Feb;17(2):202-6. doi: 10.1111/dom.12411. Epub 2014 Nov 27.
• Evans M, Chubb B, Gundgaard J. Cost-effectiveness of Insulin Degludec Versus Insulin Glargine in Adults with Type 1 and Type 2 Diabetes Mellitus. Diabetes Ther. 2017 Apr;8(2):275-291. doi: 10.1007/s13300-017-0236-9. Epub 2017 Feb 16.

Helpful Links

• Clinical Trials at Novo Nordisk

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2009
• Primary Completion (ACTUAL): October 28, 2010
• Study Completion (ACTUAL): October 28, 2010

Study Registration Dates

• First Submitted: September 3, 2009
• First Submitted That Met QC Criteria: September 3, 2009
• First Posted (ESTIMATE): September 4, 2009

Study Record Updates

• Last Update Posted (ACTUAL): April 6, 2017
• Last Update Submitted That Met QC Criteria: March 8, 2017
• Last Verified: March 1, 2017

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 Aspart; Insulin Glargine
• Other Study ID Numbers: NN1250-3582; 2008-005777-35 (EUDRACT_NUMBER); U1111-1111-8648 (OTHER: WHO); 2009-015816-17 (EUDRACT_NUMBER); U1111-1114-9067 (OTHER: WHO)