History of Changes for Study: NCT03548935

STEP 1: Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity (STEP 1)

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Study Record Versions

Version	Submitted Date	Changes
1	May 25, 2018	None (earliest Version on record)
2	June 7, 2018	Recruitment Status, Study Status and Contacts/Locations
3	June 18, 2018	Contacts/Locations and Study Status
4	June 20, 2018	Contacts/Locations and Study Status
5	July 3, 2018	Contacts/Locations and Study Status
6	July 5, 2018	Contacts/Locations and Study Status
7	July 10, 2018	Contacts/Locations and Study Status
8	July 12, 2018	Contacts/Locations and Study Status
9	July 16, 2018	Contacts/Locations and Study Status
10	August 7, 2018	Contacts/Locations and Study Status
11	August 10, 2018	Contacts/Locations and Study Status
12	August 13, 2018	Contacts/Locations and Study Status
13	August 16, 2018	Contacts/Locations and Study Status
14	August 21, 2018	Contacts/Locations and Study Status
15	September 4, 2018	Contacts/Locations, Study Status, Eligibility and Study Description
16	September 12, 2018	Contacts/Locations and Study Status
17	September 13, 2018	Contacts/Locations, Eligibility and Study Status
18	September 18, 2018	Contacts/Locations and Study Status
19	September 21, 2018	Contacts/Locations and Study Status
20	September 25, 2018	Contacts/Locations and Study Status
21	September 27, 2018	Contacts/Locations and Study Status
22	October 7, 2018	Study Status and Contacts/Locations
23	October 24, 2018	Study Status
24	October 30, 2018	Contacts/Locations and Study Status
25	November 1, 2018	Study Status and Contacts/Locations
26	November 5, 2018	Contacts/Locations and Study Status
27	November 27, 2018	Contacts/Locations and Study Status
28	November 29, 2018	Contacts/Locations and Study Status
29	December 2, 2018	Study Status and Contacts/Locations
30	December 6, 2018	Contacts/Locations and Study Status
31	December 11, 2018	Contacts/Locations and Study Status
32	December 13, 2018	Contacts/Locations and Study Status
33	December 17, 2018	Contacts/Locations and Study Status
34	December 20, 2018	Contacts/Locations and Study Status
35	December 21, 2018	Recruitment Status, Study Status and Contacts/Locations
36	April 3, 2019	Contacts/Locations, Study Status, Eligibility and Study Description
37	December 5, 2019	Study Status
38	December 9, 2019	Study Status
39	January 6, 2020	Study Status
40	January 15, 2020	Study Status
41	January 20, 2020	Study Status
42	January 29, 2020	Study Status
43	February 3, 2020	Study Status
44	February 5, 2020	Study Status
45	February 6, 2020	Study Status
46	February 12, 2020	Study Status
47	February 17, 2020	Study Status
48	February 20, 2020	Study Status
49	February 24, 2020	Study Status
50	February 26, 2020	Study Status
51	February 27, 2020	Study Status
52	March 9, 2020	Study Status
53	April 2, 2020	Study Status, Study Design and Contacts/Locations
54	April 15, 2020	Study Status
55	April 20, 2020	Study Status
56	April 23, 2020	Recruitment Status, Study Status and Study Design
57	April 27, 2020	Study Status
58	May 13, 2020	Study Status
59	May 28, 2020	Contacts/Locations and Study Status
60	June 2, 2020	Study Status and References
61	August 25, 2020	Recruitment Status, Study Status and Contacts/Locations
62	January 8, 2021	Contacts/Locations and Study Status
63	January 13, 2021	Study Status
64	January 19, 2021	Study Status
65	January 22, 2021	Study Status
66	January 26, 2021	Study Status
67	January 28, 2021	Study Status
68	February 8, 2021	Study Status
69	February 11, 2021	References and Study Status
70	February 22, 2021	Study Design and Study Status
71	February 23, 2021	Study Status
72	February 24, 2021	Study Status
73	March 2, 2021	Study Status
74	March 3, 2021	Study Status
75	March 3, 2021	Study Status
76	March 8, 2021	Study Status
77	March 10, 2021	Contacts/Locations and Study Status
78	March 18, 2021	Recruitment Status and Study Status
79	June 16, 2021	Quality Control Review has not concluded Returned: July 8, 2021 Contacts/Locations, Outcome Measures, Study Status, Document Section, Adverse Events, Baseline Characteristics and Participant Flow
80	July 20, 2021	Study Status, Document Section, Adverse Events and Contacts/Locations
81	November 8, 2021	Study Status
82	November 18, 2021	Contacts/Locations and Study Status

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	NN9536-4373
Brief Title:	STEP 1: Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity (STEP 1)
Official Title:	Effect and Safety of Semaglutide 2.4 mg Once-weekly in Subjects With Overweight or Obesity
Secondary IDs:	U1111-1200-8053 [World Health Organization (WHO)] 2017-003436-36 [Registry Identifier: European Medicines Agency (EudraCT)]

Study Status


Record Verification:	May 2018
Overall Status:	Not yet recruiting
Study Start:	June 4, 2018
Primary Completion:	September 23, 2019 [Anticipated]
Study Completion:	April 20, 2020 [Anticipated]

First Submitted:	May 25, 2018
First Submitted that Met QC Criteria:	May 25, 2018
First Posted:	June 7, 2018 [Actual]

Last Update Submitted that Met QC Criteria:	May 25, 2018
Last Update Posted:	June 7, 2018 [Actual]

Sponsor/Collaborators


Sponsor:	Novo Nordisk A/S
Responsible Party:	Sponsor
Collaborators:

Oversight


U.S. FDA-regulated Drug:	Yes
U.S. FDA-regulated Device:	No
Data Monitoring:	No

Study Description

Brief Summary:

This study will look at the change in participants' body weight from the start to the end of the study. The weight loss in participants taking semaglutide (a new medicine) will be compared to the weight loss of participants taking "dummy" medicine. In addition to taking the medicine, participants will have talks with study staff about healthy food choices, how to be more physically active and what you can do to lose weight.

Participants will either get semaglutide or "dummy" medicine - which treatment participants get, is decided by chance. Participants will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. The study will last for about 1.5 years. Participants will have 15 clinic visits and 10 phone calls with the study doctor.

Detailed Description:

Conditions


Conditions:	Metabolism and Nutrition Disorder Overweight or Obesity
Keywords:

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 3
Interventional Study Model:	Parallel Assignment
Number of Arms:	2
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:	Randomized
Enrollment:	1950 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
Experimental: Semaglutide s.c. 2.4 mg once weekly Participants will receive semaglutide for 68 weeks.	Drug: Semaglutide Participants will receive semaglutide subcutaneous (s.c.; under the skin) injection(s) once-weekly as well as diet and physical activity counselling for 68 weeks. Dose escalation of semaglutide will take place as follows: 0.25 mg from week 1 to 4, 0.5 mg from week 5 to 8, 1.0 mg from week 9 to 12, 1.7 mg from week 13 to 16 and 2.4 mg from week 17 to week 68.
Placebo Comparator: Semaglutide placebo Participants will receive semaglutide matching placebo for 68 weeks.	Drug: Placebo (semaglutide) Participants will receive semaglutide matching placebo s.c. injection(s) once-weekly as well as diet and physical activity counselling for 68 weeks.

Outcome Measures


Primary Outcome Measures:
1.	Change in body weight [ Time Frame: Week 0, Week 68 ] Measured in %.
2.	Subjects who achieve 5 or more percent body weight reduction (yes/no) [ Time Frame: Week 68 ] Number of subjects.
Secondary Outcome Measures:
1.	Subjects who achieve 10 or more percent body weight reduction (yes/no) [ Time Frame: Week 68 ] Number of subjects.
2.	Subjects who achieve 15 or more percent body weight reduction (yes/no) [ Time Frame: Week 68 ] Number of subjects.
3.	Change in waist circumference [ Time Frame: Week 0, Week 68 ] Measured in cm.
4.	Change in systolic blood pressure [ Time Frame: Week 0, Week 68 ] Measured in mmHg.
5.	Change in physical functioning score (SF-36) [ Time Frame: Week 0, Week 68 ] Short Form 36 v2.0 acute (SF-36) is a 36-item, patient-reported survey of patient health. SF-36 measures the subject's overall Health Related Quality of Life on 8 domains: physical functioning, role functioning, bodily pain, general health, vitality, social functioning, role emotional and mental health.
6.	Change in physical function domain (5-item) score (IWQoL-Lite for CT) [ Time Frame: Week 0, Week 68 ] The Impact of Weight on Quality of Life Lite for Clinical Trials Version (IWQoL-Lite for CT) questionnaire is a 20-item modified version of an instrument designed to assess weight-related quality of life.
7.	Change in body weight [ Time Frame: Week 0, Week 68 ] Measured in kg.
8.	Change in body mass index (BMI) [ Time Frame: Week 0, Week 68 ] Measured in kg/m2
9.	Change in glycated haemoglobin (HbA1C) [ Time Frame: Week 0, Week 68 ] Measured in %.
10.	Change in HbA1C [ Time Frame: Week 0, Week 68 ] Measured in mmol/mol.
11.	Change in fasting plasma glucose (FPG) [ Time Frame: Week 0, Week 68 ] Measured in mg/dL.
12.	Change in fasting serum insulin [ Time Frame: Week 0, Week 68 ] Measured in mIU/L.
13.	Change in diastolic blood pressure [ Time Frame: Week 0, Week 68 ] Measured in mmHg.
14.	Change in lipids (total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol, very low density lipoprotein (VLDL) cholesterol, free fatty acids and triglycerides) [ Time Frame: Week 0, Week 68 ] Measured in mg/dL.
15.	Change in high sensitivity C-Reactive Protein (hsCRP) [ Time Frame: Week 0, Week 68 ] Measured in mg/L.
16.	Change in plasminogen activator inhibitor-1 (PAI-1) activity [ Time Frame: Week 0, Week 68 ] Measured in AU/mL.
17.	Change in soluble leptin receptor [ Time Frame: Week 0, Week 68 ] Measured in ng/mL.
18.	Change in leptin [ Time Frame: Week 0, Week 68 ] Measured in ng/mL.
19.	Change in SF-36 (role-physical score) [ Time Frame: Week 0, Week 68 ] Short Form 36 v2.0 acute (SF-36) is a 36-item, patient-reported survey of patient health. SF-36 measures the subject's overall Health Related Quality of Life on 8 domains: physical functioning, role functioning, bodily pain, general health, vitality, social functioning, role emotional and mental health.
20.	Change in SF-36 (bodily pain score) [ Time Frame: Week 0, Week 68 ] Short Form 36 v2.0 acute (SF-36) is a 36-item, patient-reported survey of patient health. SF-36 measures the subject's overall Health Related Quality of Life on 8 domains: physical functioning, role functioning, bodily pain, general health, vitality, social functioning, role emotional and mental health.
21.	Change in SF-36 (general health score) [ Time Frame: Week 0, Week 68 ] Short Form 36 v2.0 acute (SF-36) is a 36-item, patient-reported survey of patient health. SF-36 measures the subject's overall Health Related Quality of Life on 8 domains: physical functioning, role functioning, bodily pain, general health, vitality, social functioning, role emotional and mental health.
22.	Change in SF-36 (vitality score) [ Time Frame: Week 0, Week 68 ] Short Form 36 v2.0 acute (SF-36) is a 36-item, patient-reported survey of patient health. SF-36 measures the subject's overall Health Related Quality of Life on 8 domains: physical functioning, role functioning, bodily pain, general health, vitality, social functioning, role emotional and mental health.
23.	Change in SF-36 (social functioning score) [ Time Frame: Week 0, Week 68 ] Short Form 36 v2.0 acute (SF-36) is a 36-item, patient-reported survey of patient health. SF-36 measures the subject's overall Health Related Quality of Life on 8 domains: physical functioning, role functioning, bodily pain, general health, vitality, social functioning, role emotional and mental health.
24.	Change in SF-36 (role-emotional score) [ Time Frame: Week 0, Week 68 ] Short Form 36 v2.0 acute (SF-36) is a 36-item, patient-reported survey of patient health. SF-36 measures the subject's overall Health Related Quality of Life on 8 domains: physical functioning, role functioning, bodily pain, general health, vitality, social functioning, role emotional and mental health.
25.	Change in SF-36 (mental health score) [ Time Frame: Week 0, Week 68 ] Short Form 36 v2.0 acute (SF-36) is a 36-item, patient-reported survey of patient health. SF-36 measures the subject's overall Health Related Quality of Life on 8 domains: physical functioning, role functioning, bodily pain, general health, vitality, social functioning, role emotional and mental health.
26.	Change in SF-36 (physical component summary) [ Time Frame: Week 0, Week 68 ] Short Form 36 v2.0 acute (SF-36) is a 36-item, patient-reported survey of patient health. SF-36 measures the subject's overall Health Related Quality of Life on 8 domains: physical functioning, role functioning, bodily pain, general health, vitality, social functioning, role emotional and mental health.
27.	Change in SF-36 (mental component summary) [ Time Frame: Week 0, Week 68 ] Short Form 36 v2.0 acute (SF-36) is a 36-item, patient-reported survey of patient health. SF-36 measures the subject's overall Health Related Quality of Life on 8 domains: physical functioning, role functioning, bodily pain, general health, vitality, social functioning, role emotional and mental health.
28.	Change in IWQoL-Lite for CT (pain/discomfort domain score) [ Time Frame: Week 0, Week 68 ] The Impact of Weight on Quality of Life Lite for Clinical Trials Version (IWQoL-Lite for CT) questionnaire is a 20-item modified version of an instrument designed to assess weight-related quality of life.
29.	Change in IWQoL-Lite for CT (psychosocial domain score) [ Time Frame: Week 0, Week 68 ] The Impact of Weight on Quality of Life Lite for Clinical Trials Version (IWQoL-Lite for CT) questionnaire is a 20-item modified version of an instrument designed to assess weight-related quality of life.
30.	Change in IWQoL-Lite for CT (total score) [ Time Frame: Week 0, Week 68 ] The Impact of Weight on Quality of Life Lite for Clinical Trials Version (IWQoL-Lite for CT) questionnaire is a 20-item modified version of an instrument designed to assess weight-related quality of life.
31.	Change in body composition (total fat mass) [ Time Frame: Week 0, Week 68 ] Assessed by dual energy X-ray absorpmetry (DEXA). Measured in %.
32.	Change in body composition (total fat mass) [ Time Frame: Week 0, Week 68 ] Assessed by DEXA. Measured in g.
33.	Change in body composition (lean body mass) [ Time Frame: Week 0, Week 68 ] Assessed by DEXA. Measured in %.
34.	Change in body composition (lean body mass) [ Time Frame: Week 0, Week 68 ] Assessed by DEXA. Measured in g.
35.	Change in body composition (visceral fat mass) [ Time Frame: Week 0, Week 68 ] Assessed by DEXA. Measured in %.
36.	Change in body composition (visceral fat mass) [ Time Frame: Week 0, Week 68 ] Assessed by DEXA. Measured in g.
37.	Subjects who achieve "responder definition value" (yes/no) for SF-36 physical functioning score [ Time Frame: Week 68 ] Number of subjects.
38.	Subjects who achieve "responder definition value" (yes/no) for IWQoL-Lite for CT physical function domain (5-items) score [ Time Frame: Week 68 ] Number of subjects.
39.	Number of treatment emergent adverse events (TEAEs) [ Time Frame: Weeks 0 to 75 ] Number of events.
40.	Number of serious adverse events (SAEs) [ Time Frame: Weeks 0 to 75 ] Number of events.
41.	Change in pulse [ Time Frame: Week 0, Week 68 ] Measured in bpm.
42.	Change in amylase [ Time Frame: Week 0, Week 68 ] Measured in U/L.
43.	Change in lipase [ Time Frame: Week 0, Week 68 ] Measured in U/L.
44.	Change in calcitonin [ Time Frame: Week 0, Week 68 ] Measured in ng/L.

Eligibility


Minimum Age:	18 Years
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	Inclusion Criteria: Male or female, age greater than or equal to 18 years at the time of signing informed consent Body mass index (BMI) greater than or equal to 30 kg/sqm or greater than or equal to 27 kg/sqm with the presence of at least one of the following weight-related comorbidities (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease History of at least one self-reported unsuccessful dietary effort to lose body weight Exclusion Criteria: Glycated haemoglobin (HbA1C) greater than or equal to 48 mmol/mol (6.5%) as measured by the central laboratory at screening A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records

Contacts/Locations


Central Contact Person:	Novo Nordisk Telephone: (+1) 866-867-7178 Email: clinicaltrials@novonordisk.com
Study Officials:	Clinical Reporting Anchor and Disclosure (1452) Study Director Novo Nordisk A/S
Locations:	United States, Alabama
	Novo Nordisk Investigational Site Anniston, Alabama, United States, 36207
	United States, California
	Novo Nordisk Investigational Site Anaheim, California, United States, 92801
	Novo Nordisk Investigational Site Lomita, California, United States, 90717
	Novo Nordisk Investigational Site Spring Valley, California, United States, 91978
	United States, Colorado
	Novo Nordisk Investigational Site Aurora, Colorado, United States, 80045
	United States, Connecticut
	Novo Nordisk Investigational Site Waterbury, Connecticut, United States, 06708
	United States, Florida
	Novo Nordisk Investigational Site Chiefland, Florida, United States, 32626
	Novo Nordisk Investigational Site Crystal River, Florida, United States, 34429
	Novo Nordisk Investigational Site Jacksonville, Florida, United States, 32205
	Novo Nordisk Investigational Site Jacksonville, Florida, United States, 32216
	Novo Nordisk Investigational Site Ocala, Florida, United States, 34470
	Novo Nordisk Investigational Site Panama City, Florida, United States, 32401
	Novo Nordisk Investigational Site Plantation, Florida, United States, 33324
	Novo Nordisk Investigational Site Ponte Vedra, Florida, United States, 32081
	United States, Georgia
	Novo Nordisk Investigational Site Roswell, Georgia, United States, 30076
	United States, Illinois
	Novo Nordisk Investigational Site Chicago, Illinois, United States, 60607
	United States, Indiana
	Novo Nordisk Investigational Site Indianapolis, Indiana, United States, 46260
	United States, Kansas
	Novo Nordisk Investigational Site Topeka, Kansas, United States, 66606
	United States, Kentucky
	Novo Nordisk Investigational Site Louisville, Kentucky, United States, 40213
	United States, Michigan
	Novo Nordisk Investigational Site Buckley, Michigan, United States, 49620
	United States, Missouri
	Novo Nordisk Investigational Site Saint Peters, Missouri, United States, 63303
	United States, Montana
	Novo Nordisk Investigational Site Butte, Montana, United States, 59701
	United States, Nebraska
	Novo Nordisk Investigational Site Omaha, Nebraska, United States, 68105
	United States, New York
	Novo Nordisk Investigational Site Rochester, New York, United States, 14609
	United States, North Carolina
	Novo Nordisk Investigational Site Salisbury, North Carolina, United States, 28144
	Novo Nordisk Investigational Site Wilmington, North Carolina, United States, 28401
	United States, South Carolina
	Novo Nordisk Investigational Site Simpsonville, South Carolina, United States, 29681
	United States, Texas
	Novo Nordisk Investigational Site Austin, Texas, United States, 78749
	Novo Nordisk Investigational Site Dallas, Texas, United States, 75230
	Novo Nordisk Investigational Site Dallas, Texas, United States, 75234
	Novo Nordisk Investigational Site Dallas, Texas, United States, 75246
	Novo Nordisk Investigational Site Round Rock, Texas, United States, 78681
	United States, Utah
	Novo Nordisk Investigational Site Bountiful, Utah, United States, 84010
	United States, Virginia
	Novo Nordisk Investigational Site Richmond, Virginia, United States, 23294
	United States, Washington
	Novo Nordisk Investigational Site Renton, Washington, United States, 98057
	Argentina
	Novo Nordisk Investigational Site Caba, Argentina, C1093AAS
	Novo Nordisk Investigational Site Ciudad de Buenos Aires, Argentina, C1204AAD
	Novo Nordisk Investigational Site Santa Rosa, Argentina, 6300
	Belgium
	Novo Nordisk Investigational Site Boussu, Belgium, 7300
	Novo Nordisk Investigational Site Bruxelles, Belgium, 1200
	Novo Nordisk Investigational Site Edegem, Belgium, 2650
	Novo Nordisk Investigational Site Leuven, Belgium, 3000
	Novo Nordisk Investigational Site Liège, Belgium, 4000
	Bulgaria
	Novo Nordisk Investigational Site Plovdiv, Bulgaria, 4002
	Novo Nordisk Investigational Site Sofia, Bulgaria, 1431
	Novo Nordisk Investigational Site Sofia, Bulgaria, 1606
	Novo Nordisk Investigational Site Sofia, Bulgaria, 1750
	Denmark
	Novo Nordisk Investigational Site Aarhus N, Denmark, 8200
	Finland
	Novo Nordisk Investigational Site Oulu, Finland, 90220
	Novo Nordisk Investigational Site University Of Helsinki, Finland, 00014
	France
	Novo Nordisk Investigational Site Le Coudray, France, 28630
	Novo Nordisk Investigational Site Narbonne, France, 11108
	Novo Nordisk Investigational Site PARIS cedex 13, France, 75651
	Novo Nordisk Investigational Site Paris, France, 75908
	Novo Nordisk Investigational Site Pessac, France, 33600
	Novo Nordisk Investigational Site Pierre Benite, France, 69495
	Novo Nordisk Investigational Site Poitiers, France, 86000
	Novo Nordisk Investigational Site Venissieux, France, 69200
	Germany
	Novo Nordisk Investigational Site Berlin, Germany, 12627
	Novo Nordisk Investigational Site Bochum, Germany, 44787
	Novo Nordisk Investigational Site Essen, Germany, 45136
	Novo Nordisk Investigational Site Essen, Germany, 45219
	Novo Nordisk Investigational Site Falkensee, Germany, 14612
	Novo Nordisk Investigational Site Frankfurt, Germany, 60313
	Novo Nordisk Investigational Site Giessen, Germany, 35392
	Novo Nordisk Investigational Site Hamburg, Germany, 22607
	Novo Nordisk Investigational Site Hohenmölsen, Germany, 06679
	Novo Nordisk Investigational Site Leipzig, Germany, 04103
	Novo Nordisk Investigational Site Saint Ingbert, Germany, 66386
	Novo Nordisk Investigational Site Stuttgart, Germany, 70378
	Novo Nordisk Investigational Site Wangen, Germany, 88239
	Japan
	Novo Nordisk Investigational Site Chiba-shi, Chiba, Japan, 260-8677
	Novo Nordisk Investigational Site Chuo-ku, Tokyo, Japan, 103 0027
	Novo Nordisk Investigational Site Shinjuku-ku, Tokyo, Japan, 160-0008
	Novo Nordisk Investigational Site Suita-shi, Osaka, Japan, 565-0853
	Novo Nordisk Investigational Site Tokyo, Japan, 103-0028
	Mexico, Jalisco
	Novo Nordisk Investigational Site Guadalajara, Jalisco, Mexico, 44670
	Mexico, Sonora
	Novo Nordisk Investigational Site Hermosillo, Sonora, Mexico, 83280
	Mexico, Yucatan
	Novo Nordisk Investigational Site Merida, Yucatan, Mexico, 97070
	Poland
	Novo Nordisk Investigational Site Gdynia, Poland, 81-338
	Novo Nordisk Investigational Site Lodz, Poland, 90-242
	Novo Nordisk Investigational Site Poznan, Poland, 60-589
	Novo Nordisk Investigational Site Szczecin, Poland, 70-376
	Puerto Rico
	Novo Nordisk Investigational Site San Juan, Puerto Rico, 00921
	Russian Federation
	Novo Nordisk Investigational Site Penza, Russian Federation, 440026
	Novo Nordisk Investigational Site Saint-Petersburg, Russian Federation, 194358
	Novo Nordisk Investigational Site Tomsk, Russian Federation, 634041
	Novo Nordisk Investigational Site Voronezh, Russian Federation, 394018
	Novo Nordisk Investigational Site Yaroslavl, Russian Federation, 150003
	Taiwan
	Novo Nordisk Investigational Site Taipei, Taiwan, 100
	United Kingdom
	Novo Nordisk Investigational Site Bristol, United Kingdom, BS10 5NB
	Novo Nordisk Investigational Site Cambridge, United Kingdom, CB2 0QQ
	Novo Nordisk Investigational Site Coventry, United Kingdom, CV2 2DX
	Novo Nordisk Investigational Site Glasgow, United Kingdom, G31 2ER
	Novo Nordisk Investigational Site Liverpool, United Kingdom, L9 7AL
	Novo Nordisk Investigational Site London, United Kingdom, SE1 9RT
	Novo Nordisk Investigational Site London, United Kingdom, W1T 7HA
	Novo Nordisk Investigational Site Norwich, United Kingdom, NR4 7TJ
	Novo Nordisk Investigational Site Rotherham, United Kingdom, S65 1DA
	Novo Nordisk Investigational Site Taunton, United Kingdom, TA1 5DA

IPDSharing


Plan to Share IPD:	Yes According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
	Supporting Information:
	Time Frame:
	Access Criteria:
	URL: http://novonordisk-trials.com/sharing-results

References


Links:
Available IPD/Information: