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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00982644
First received: September 22, 2009
Last updated: December 16, 2016
Last verified: December 2016
  Purpose

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.


Condition Intervention Phase
Diabetes Diabetes Mellitus, Type 2 Drug: insulin degludec Drug: insulin glargine Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Main Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes [ Time Frame: Week 0 to Week 52 + 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 (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 104 Weeks of Treatment [ Time Frame: Week 0, Week 104 ]
    Change from baseline in HbA1c after 104 weeks of treatment

  • Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 52 [ Time Frame: 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.

  • Extension Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 104 [ Time Frame: 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.

  • Main Trial (Secondary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes [ Time Frame: Week 0 to Week 52 + 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.


Enrollment: 1030
Study Start Date: September 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IDeg OD Drug: insulin degludec
Injected subcutaneously (under the skin) once daily. Dose was individually adjusted.
Active Comparator: IGlar OD Drug: insulin glargine
Injected subcutaneously (under the skin) once daily. Dose was individually adjusted.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00982644

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Locations
United States, Alabama
Novo Nordisk Investigational Site
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
United States, Arizona
Novo Nordisk Investigational Site
Goodyear, Arizona, United States, 85395
United States, California
Novo Nordisk Investigational Site
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
United States, Connecticut
Novo Nordisk Investigational Site
Norwalk, Connecticut, United States, 06851
United States, Florida
Novo Nordisk Investigational Site
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
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Orange Park, Florida, United States, 32073
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Orlando, Florida, United States, 32806
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Palm Harbor, Florida, United States, 34684
Novo Nordisk Investigational Site
West Palm Beach, Florida, United States, 33401
United States, Georgia
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Decatur, Georgia, United States, 30033
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Fort Valley, Georgia, United States, 31030-5008
United States, Idaho
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Idaho Falls, Idaho, United States, 83404-7596
United States, Illinois
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Chicago, Illinois, United States, 60607
United States, Indiana
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Evansville, Indiana, United States, 47714
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Indianapolis, Indiana, United States, 46217
United States, Kentucky
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Lexington, Kentucky, United States, 40503
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Paducah, Kentucky, United States, 42003
United States, Louisiana
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Metairie, Louisiana, United States, 70002
Novo Nordisk Investigational Site
Slidell, Louisiana, United States, 70461-4231
United States, Maryland
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Greenbelt, Maryland, United States, 20770
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North East, Maryland, United States, 21901
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Reisterstown, Maryland, United States, 21136-2516
Novo Nordisk Investigational Site
Rockville, Maryland, United States, 20852
United States, Massachusetts
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Brockton, Massachusetts, United States, 02301
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North Dartmouth, Massachusetts, United States, 02747
United States, Missouri
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St. Louis, Missouri, United States, 63104
Novo Nordisk Investigational Site
St. Louis, Missouri, United States, 63141
United States, Nevada
Novo Nordisk Investigational Site
Henderson, Nevada, United States, 89052-2649
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Las Vegas, Nevada, United States, 89117
United States, New Jersey
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Toms River, New Jersey, United States, 08755-8050
United States, New York
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Northport, New York, United States, 11768
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Staten Island, New York, United States, 10301
United States, North Carolina
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Asheboro, North Carolina, United States, 27203
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Charlotte, North Carolina, United States, 28209
United States, Ohio
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Cincinnati, Ohio, United States, 45255
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Dayton, Ohio, United States, 45406
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Toledo, Ohio, United States, 43606-2920
United States, Oklahoma
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Oklahoma City, Oklahoma, United States, 73103
United States, Pennsylvania
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Kingston, Pennsylvania, United States, 18704
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Langhorne, Pennsylvania, United States, 19047
Novo Nordisk Investigational Site
Melrose Park, Pennsylvania, United States, 19027
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Pittsburgh, Pennsylvania, United States, 15241
Novo Nordisk Investigational Site
West Reading, Pennsylvania, United States, 19611
United States, Rhode Island
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East Providence, Rhode Island, United States, 02914
United States, South Carolina
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Columbia, South Carolina, United States, 29203
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Greer, South Carolina, United States, 29651
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Newberry, South Carolina, United States, 29108-2249
United States, Tennessee
Novo Nordisk Investigational Site
Chattanooga, Tennessee, United States, 37411
Novo Nordisk Investigational Site
Harriman, Tennessee, United States, 37748-8653
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Humboldt, Tennessee, United States, 38343
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Nashville, Tennessee, United States, 37203
United States, Texas
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Arlington, Texas, United States, 76014
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Corpus Christi, Texas, United States, 78404
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Dallas, Texas, United States, 75230
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Dallas, Texas, United States, 75246
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El Paso, Texas, United States, 79912
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Hurst, Texas, United States, 76054
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Irving, Texas, United States, 75061-2210
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Lubbock, Texas, United States, 79423
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San Antonio, Texas, United States, 78215
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Sugar Land, Texas, United States, 77479
United States, Virginia
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Richmond, Virginia, United States, 23233
United States, Washington
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Spokane, Washington, United States, 99218
United States, Wisconsin
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Milwaukee, Wisconsin, United States, 53209
Austria
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Bregenz, Austria, A - 6900
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Feldkirch, Austria, 6807
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Wien, Austria, 1030
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Wien, Austria, 1090
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Wien, Austria, 1130
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Wien, Austria, A 1160
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Wolfsberg, Austria, 9400
Belgium
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Brussels, Belgium, 1070
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Brussels, Belgium, 1090
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Gent, Belgium, 9000
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Leuven, Belgium, 3000
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Liège, Belgium, 4000
Canada, Alberta
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Edmonton, Alberta, Canada, T5J 3N4
Canada, British Columbia
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Coquitlam, British Columbia, Canada, V3K 3P4
Canada, Manitoba
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Winnipeg, Manitoba, Canada, R3E 3P4
Canada, Newfoundland and Labrador
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Mount Pearl, Newfoundland and Labrador, Canada, A1N 1W7
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St. John's, Newfoundland and Labrador, Canada, A1A 3R5
Canada, Nova Scotia
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Halifax, Nova Scotia, Canada, B3K 0A4
Canada, Ontario
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London, Ontario, Canada, N6G 2M1
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Mississauga, Ontario, Canada, L5M 2V8
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Ottawa, Ontario, Canada, K1K 4L2
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Ottawa, Ontario, Canada, K1N 6N5
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Scarborough, Ontario, Canada, M1E 5E9
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Toronto, Ontario, Canada, M4G 3E8
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Toronto, Ontario, Canada, M5C 2T2
Canada, Quebec
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St-Marc-des-Carrières, Quebec, Canada, G0A 4B0
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St. Romuald, Quebec, Canada, G6W 5M6
Canada
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Quebec, Canada, G1V 4G2
Czech Republic
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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
Denmark
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Esbjerg, Denmark, 6700
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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
Finland
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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
Former Serbia and Montenegro
Novo Nordisk Investigational Site
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
France
Novo Nordisk Investigational Site
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
Germany
Novo Nordisk Investigational Site
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
Norway
Novo Nordisk Investigational Site
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
Puerto Rico
Novo Nordisk Investigational Site
Bayamon, Puerto Rico, 00961
Serbia
Novo Nordisk Investigational Site
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
Slovenia
Novo Nordisk Investigational Site
Koper, Slovenia, SI-6000
Novo Nordisk Investigational Site
Ljubljana, Slovenia, 1525
Novo Nordisk Investigational Site
Novo mesto, Slovenia, 8000
Spain
Novo Nordisk Investigational Site
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, 41003
Novo Nordisk Investigational Site
Sevilla, Spain, 41010
Novo Nordisk Investigational Site
Valencia, Spain, 46015
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00982644     History of Changes
Obsolete Identifiers: NCT01193309
Other Study ID Numbers: NN1250-3579
2008-005776-27 ( EudraCT Number )
U1111-1111-8692 ( Other Identifier: WHO )
2009-015754-38 ( EudraCT Number )
U1111-1114-9426 ( Other Identifier: WHO )
Study First Received: September 22, 2009
Results First Received: October 14, 2015
Last Updated: December 16, 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 21, 2017