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Efficacy and Safety of Semaglutide Once Weekly Versus Insulin Glargine Once Daily as add-on to Metformin With or Without Sulphonylurea in Insulin-naïve Subjects With Type 2 Diabetes (SUSTAIN™ 4)

Primary Purpose

Diabetes, Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
semaglutide
insulin glargine
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female, 18 years or older at the time of signing informed consent
  • Insulin-naïve subjects diagnosed with type 2 diabetes and on stable diabetes treatment with metformin or metformin and SU (metformin 1500 mg or higher or maximum tolerated dose and SU half of maximum allowed dose according to national label or higher) for at least 90 days before screening. Stable is defined as unchanged medication and unchanged dose
  • HbA1c 7.0 - 10.0% (53 - 86 mmol/mol) both inclusive

Exclusion Criteria:

  • Female who is pregnant, breast-feeding or intends to become pregnant or of childbearing potential not using adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice) throughout the trial including the 5 week follow-up period
  • Any disorder which, in the opinion of the Investigator might jeopardise subject's safety or compliance with the protocol
  • Treatment with any glucose lowering agent(s) other than stated in the inclusion criteria in a period of 90 days before screening. An exception is short-term treatment (7 days or less in total) with insulin in connection with intercurrent illness
  • History of chronic or idiopathic acute pancreatitis
  • Screening calcitonin value greater than or equal to 50 ng/L
  • Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome 2
  • Severe renal impairment defined as estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73 m^2 per modification of diet in renal disease (MDRD) formula (4 variable version)
  • Acute coronary or cerebrovascular event within 90 days before randomisation
  • Heart failure, New York Heart Association Class IV
  • Known proliferative retinopathy or maculopathy requiring acute treatment according to the opinion of the investigator
  • Diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer)
  • Mental inability, unwillingness or language barrier precluding adequate understanding of or compliance with study procedures

Sites / Locations

  • Novo Nordisk Investigational Site
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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Semaglutide 0.5 mg/week

Semaglutide 1.0 mg/week

Insulin glargine

Arm Description

Outcomes

Primary Outcome Measures

Change in HbA1c From Baseline
Change in HbA1c from baseline to week 30.

Secondary Outcome Measures

Change in Body Weight From Baseline
Change in body weight from baseline to week 30.
Change in Fasting Plasma Glucose From Baseline
Change in fasting plasma glucose from baseline to week 30.
Change in Diastolic Blood Pressure.
Change in diastolic blood pressure from baseline to week 30.
Change in Systolic Blood Pressure.
Change in systolic blood pressure from baseline to week 30.
Change in Patient Reported Outcome (PRO) Questionnaire, Questionnaire SF-36v2™
The Short Form (SF)-36v2™ patient reported outcomes (PRO) questionnaire was used to assess the subject's overall health related quality of life (HRQoL. PRO questionnaire (SF-36v2™) measured the HRQoL on 8 domains on individual scale ranges. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to a norm-based score using a T-score transformation in order to obtain a direct interpretation in relation to the distribution of the scores in the 1998 U.S. general population. The (SF-36v2™) values displayed are the estimated mean change from baseline to week 30.
Change in Patient Reported Outcome Questionnaires. (PROs), Diabetes Treatment Satisfaction Questionnaire (DTSQs)
The Diabetes Treatment Satisfaction Questionnaire (DTSQs) questionnaire was to be used to assess a subject's treatment satisfaction. This questionnaire contained 8 components and measured the treatment for diabetes (including insulin, tablets and/or diet) in terms of convenience, flexibility and general feelings regarding treatment. The value presented is the 'Treatment Satisfaction' summary score, which is the sum of 6 of the 8 items of the DTSQs questionnaire. Response options range from 6 (best case) to 0 (worst case). Total scores for treatment satisfaction range from 0-36. Higher scores indicate higher satisfaction. The values displayed are the estimated mean change from baseline to week 30.
Subjects Who Achieve HbA1c ≤6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists (AACE)
Subjects who achieve HbA1c ≤6.5% (48 mmol/mol), American Association of Clinical Endocrinologists (AACE) after 30 weeks of treatment

Full Information

First Posted
April 24, 2014
Last Updated
May 28, 2019
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT02128932
Brief Title
Efficacy and Safety of Semaglutide Once Weekly Versus Insulin Glargine Once Daily as add-on to Metformin With or Without Sulphonylurea in Insulin-naïve Subjects With Type 2 Diabetes
Acronym
SUSTAIN™ 4
Official Title
Efficacy and Safety of Semaglutide Once Weekly Versus Insulin Glargine Once Daily as Add on to Metformin With or Without Sulphonylurea in Insulin-naïve Subjects With Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
August 4, 2014 (Actual)
Primary Completion Date
September 3, 2015 (Actual)
Study Completion Date
September 3, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This trial is conducted in Africa, North and South America, Asia and Europe. The purpose of the trial is to compare the effect of once-weekly dosing of two dose levels of semaglutide versus insulin glargine once-daily on glycaemic control after 30 weeks of treatment in insulin-naïve subjects with type 2 diabetes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1089 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Semaglutide 0.5 mg/week
Arm Type
Experimental
Arm Title
Semaglutide 1.0 mg/week
Arm Type
Experimental
Arm Title
Insulin glargine
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
semaglutide
Intervention Description
Injected subcutaneously (under the skin) once weekly. Following 4 doses (4 weeks) of 0.25 mg semaglutide weekly subjects will receive 0.5 mg semaglutide weekly for 26 weeks.
Intervention Type
Drug
Intervention Name(s)
insulin glargine
Intervention Description
Injected subcutaneously (under the skin) once daily. Subjects will start on 10 IU once daily and the dose will be adjusted according to fasting plasma glucose.
Primary Outcome Measure Information:
Title
Change in HbA1c From Baseline
Description
Change in HbA1c from baseline to week 30.
Time Frame
Week 0, week 30
Secondary Outcome Measure Information:
Title
Change in Body Weight From Baseline
Description
Change in body weight from baseline to week 30.
Time Frame
Week 0, week 30
Title
Change in Fasting Plasma Glucose From Baseline
Description
Change in fasting plasma glucose from baseline to week 30.
Time Frame
Week 0, week 30
Title
Change in Diastolic Blood Pressure.
Description
Change in diastolic blood pressure from baseline to week 30.
Time Frame
Week 0, week 30
Title
Change in Systolic Blood Pressure.
Description
Change in systolic blood pressure from baseline to week 30.
Time Frame
Week 0, week 30
Title
Change in Patient Reported Outcome (PRO) Questionnaire, Questionnaire SF-36v2™
Description
The Short Form (SF)-36v2™ patient reported outcomes (PRO) questionnaire was used to assess the subject's overall health related quality of life (HRQoL. PRO questionnaire (SF-36v2™) measured the HRQoL on 8 domains on individual scale ranges. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to a norm-based score using a T-score transformation in order to obtain a direct interpretation in relation to the distribution of the scores in the 1998 U.S. general population. The (SF-36v2™) values displayed are the estimated mean change from baseline to week 30.
Time Frame
Week 0, week 30
Title
Change in Patient Reported Outcome Questionnaires. (PROs), Diabetes Treatment Satisfaction Questionnaire (DTSQs)
Description
The Diabetes Treatment Satisfaction Questionnaire (DTSQs) questionnaire was to be used to assess a subject's treatment satisfaction. This questionnaire contained 8 components and measured the treatment for diabetes (including insulin, tablets and/or diet) in terms of convenience, flexibility and general feelings regarding treatment. The value presented is the 'Treatment Satisfaction' summary score, which is the sum of 6 of the 8 items of the DTSQs questionnaire. Response options range from 6 (best case) to 0 (worst case). Total scores for treatment satisfaction range from 0-36. Higher scores indicate higher satisfaction. The values displayed are the estimated mean change from baseline to week 30.
Time Frame
Week 0, week 30
Title
Subjects Who Achieve HbA1c ≤6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists (AACE)
Description
Subjects who achieve HbA1c ≤6.5% (48 mmol/mol), American Association of Clinical Endocrinologists (AACE) after 30 weeks of treatment
Time Frame
After 30 weeks treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female, 18 years or older at the time of signing informed consent Insulin-naïve subjects diagnosed with type 2 diabetes and on stable diabetes treatment with metformin or metformin and SU (metformin 1500 mg or higher or maximum tolerated dose and SU half of maximum allowed dose according to national label or higher) for at least 90 days before screening. Stable is defined as unchanged medication and unchanged dose HbA1c 7.0 - 10.0% (53 - 86 mmol/mol) both inclusive Exclusion Criteria: Female who is pregnant, breast-feeding or intends to become pregnant or of childbearing potential not using adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice) throughout the trial including the 5 week follow-up period Any disorder which, in the opinion of the Investigator might jeopardise subject's safety or compliance with the protocol Treatment with any glucose lowering agent(s) other than stated in the inclusion criteria in a period of 90 days before screening. An exception is short-term treatment (7 days or less in total) with insulin in connection with intercurrent illness History of chronic or idiopathic acute pancreatitis Screening calcitonin value greater than or equal to 50 ng/L Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome 2 Severe renal impairment defined as estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73 m^2 per modification of diet in renal disease (MDRD) formula (4 variable version) Acute coronary or cerebrovascular event within 90 days before randomisation Heart failure, New York Heart Association Class IV Known proliferative retinopathy or maculopathy requiring acute treatment according to the opinion of the investigator Diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer) Mental inability, unwillingness or language barrier precluding adequate understanding of or compliance with study procedures
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Ozark
State/Province
Alabama
ZIP/Postal Code
36360
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Tuscumbia
State/Province
Alabama
ZIP/Postal Code
35674
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85295
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Carmichael
State/Province
California
ZIP/Postal Code
95608
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Elk Grove
State/Province
California
ZIP/Postal Code
95758
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Inglewood
State/Province
California
ZIP/Postal Code
90301
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Long Beach
State/Province
California
ZIP/Postal Code
90807
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Orange
State/Province
California
ZIP/Postal Code
92868-2863
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Pomona
State/Province
California
ZIP/Postal Code
91767-3008
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Rialto
State/Province
California
ZIP/Postal Code
92376
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Rolling Hills Estates
State/Province
California
ZIP/Postal Code
90274
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92111
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
San Mateo
State/Province
California
ZIP/Postal Code
94401
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Spring Valley
State/Province
California
ZIP/Postal Code
91978
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80239-3133
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Cooper City
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32205
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33156
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Spring Hill
State/Province
Florida
ZIP/Postal Code
34609
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Winter Haven
State/Province
Florida
ZIP/Postal Code
33880
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Conyers
State/Province
Georgia
ZIP/Postal Code
30013
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Johns Creek
State/Province
Georgia
ZIP/Postal Code
30097
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Norcross
State/Province
Georgia
ZIP/Postal Code
30092
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83646
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Gurnee
State/Province
Illinois
ZIP/Postal Code
60031
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61602
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Avon
State/Province
Indiana
ZIP/Postal Code
46123
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46254
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Council Bluffs
State/Province
Iowa
ZIP/Postal Code
51501
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Park City
State/Province
Kansas
ZIP/Postal Code
67219
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Madisonville
State/Province
Kentucky
ZIP/Postal Code
42431
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42003
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70601
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70002
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Natchitoches
State/Province
Louisiana
ZIP/Postal Code
71457-5881
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71107
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Hyattsville
State/Province
Maryland
ZIP/Postal Code
20782
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Buckley
State/Province
Michigan
ZIP/Postal Code
49620
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Flint
State/Province
Michigan
ZIP/Postal Code
48504
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Sterling Heights
State/Province
Michigan
ZIP/Postal Code
48310-3503
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Troy
State/Province
Michigan
ZIP/Postal Code
48098
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89120
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755-8050
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Trenton
State/Province
New Jersey
ZIP/Postal Code
08611
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87108
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11229
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
New Windsor
State/Province
New York
ZIP/Postal Code
12553
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
West Seneca
State/Province
New York
ZIP/Postal Code
14224
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Morganton
State/Province
North Carolina
ZIP/Postal Code
28655
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Shelby
State/Province
North Carolina
ZIP/Postal Code
28150
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Statesville
State/Province
North Carolina
ZIP/Postal Code
28625
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Canal Fulton
State/Province
Ohio
ZIP/Postal Code
44614
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Carlisle
State/Province
Ohio
ZIP/Postal Code
45005
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45227
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45255
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Mason
State/Province
Ohio
ZIP/Postal Code
45040-6815
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Maumee
State/Province
Ohio
ZIP/Postal Code
43537
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Corvallis
State/Province
Oregon
ZIP/Postal Code
97330-3737
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Altoona
State/Province
Pennsylvania
ZIP/Postal Code
16602
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Beaver
State/Province
Pennsylvania
ZIP/Postal Code
15009
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Clairton
State/Province
Pennsylvania
ZIP/Postal Code
15025-3730
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Jersey Shore
State/Province
Pennsylvania
ZIP/Postal Code
17740
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Lansdale
State/Province
Pennsylvania
ZIP/Postal Code
19446-1002
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19114
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Gaffney
State/Province
South Carolina
ZIP/Postal Code
29341
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Murrells Inlet
State/Province
South Carolina
ZIP/Postal Code
29576
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37912
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75251
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76117
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77040
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77055
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77058
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77070
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Humble
State/Province
Texas
ZIP/Postal Code
77338
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Hurst
State/Province
Texas
ZIP/Postal Code
76054
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Irving
State/Province
Texas
ZIP/Postal Code
75061-2210
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Longview
State/Province
Texas
ZIP/Postal Code
75605
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Marshall
State/Province
Texas
ZIP/Postal Code
75670
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Plano
State/Province
Texas
ZIP/Postal Code
75075
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Saint George
State/Province
Utah
ZIP/Postal Code
84790
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Arlington
State/Province
Virginia
ZIP/Postal Code
22206
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Winchester
State/Province
Virginia
ZIP/Postal Code
22601
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Olympia
State/Province
Washington
ZIP/Postal Code
98502
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Renton
State/Province
Washington
ZIP/Postal Code
98057
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Wenatchee
State/Province
Washington
ZIP/Postal Code
98801-2028
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Kenosha
State/Province
Wisconsin
ZIP/Postal Code
53144
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Buenos Aires
ZIP/Postal Code
C1425AGC
Country
Argentina
Facility Name
Novo Nordisk Investigational Site
City
Caba
ZIP/Postal Code
C1119ACN
Country
Argentina
Facility Name
Novo Nordisk Investigational Site
City
Capital Federal
ZIP/Postal Code
C1056ABJ
Country
Argentina
Facility Name
Novo Nordisk Investigational Site
City
Godoy Cruz
ZIP/Postal Code
M5501ARP
Country
Argentina
Facility Name
Novo Nordisk Investigational Site
City
Cakovec
ZIP/Postal Code
40000
Country
Croatia
Facility Name
Novo Nordisk Investigational Site
City
Karlovac
ZIP/Postal Code
47000
Country
Croatia
Facility Name
Novo Nordisk Investigational Site
City
Krapinske Toplice
ZIP/Postal Code
49217
Country
Croatia
Facility Name
Novo Nordisk Investigational Site
City
Zagreb
ZIP/Postal Code
10 000
Country
Croatia
Facility Name
Novo Nordisk Investigational Site
City
Bobigny
ZIP/Postal Code
93009
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Bois-Guillaume
ZIP/Postal Code
76320
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Bourgoin-jallieu
ZIP/Postal Code
38302
Country
France
Facility Name
Novo Nordisk Investigational Site
City
LA ROCHE-sur-YON cedex 9
ZIP/Postal Code
85295
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Le Creusot
ZIP/Postal Code
71200
Country
France
Facility Name
Novo Nordisk Investigational Site
City
MARSEILLE cedex 08
ZIP/Postal Code
13285
Country
France
Facility Name
Novo Nordisk Investigational Site
City
MARSEILLE Cédex 05
ZIP/Postal Code
13385
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Nanterre
ZIP/Postal Code
92014
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Narbonne
ZIP/Postal Code
11108
Country
France
Facility Name
Novo Nordisk Investigational Site
City
NICE cedex 3
ZIP/Postal Code
06202
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Pierre-Bénite
ZIP/Postal Code
69495
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Pointe À Pitre
ZIP/Postal Code
97159
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Rang-du-fliers
ZIP/Postal Code
62180
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Saint Herblain
ZIP/Postal Code
44800
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Saint Nazaire
ZIP/Postal Code
44600
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Trinité - La Martinique
ZIP/Postal Code
97235
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Venissieux
ZIP/Postal Code
69200
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Berlin
ZIP/Postal Code
10409
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Essen
ZIP/Postal Code
45276
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Jerichow
ZIP/Postal Code
39319
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Lampertheim
ZIP/Postal Code
68623
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Ludwigshafen
ZIP/Postal Code
67059
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Münster
ZIP/Postal Code
48145
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Neuwied
ZIP/Postal Code
56564
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Rehlingen-Siersburg
ZIP/Postal Code
66780
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Rostock
ZIP/Postal Code
18057
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Saint Ingbert-Oberwürzbach
ZIP/Postal Code
66386
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Stuttgart
ZIP/Postal Code
70378
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Wangen
ZIP/Postal Code
88239
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380006
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380007
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560092
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Mysore
State/Province
Karnataka
ZIP/Postal Code
570001
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Mysore
State/Province
Karnataka
ZIP/Postal Code
570004
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Indore
State/Province
Madhya Pradesh
ZIP/Postal Code
452010
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400008
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400010
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400012
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400022
Country
India
Facility Name
Novo Nordisk Investigational Site
City
New Dehli
State/Province
New Delhi
ZIP/Postal Code
110029
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Chennai
State/Province
Tamil Nadu
ZIP/Postal Code
600031
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Kolkata
State/Province
West Bengal
ZIP/Postal Code
700107
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Kolkata
ZIP/Postal Code
700026
Country
India
Facility Name
Novo Nordisk Investigational Site
City
New Delhi
ZIP/Postal Code
110001
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44150
Country
Mexico
Facility Name
Novo Nordisk Investigational Site
City
Distrito Federal
State/Province
México, D.F.
ZIP/Postal Code
14080
Country
Mexico
Facility Name
Novo Nordisk Investigational Site
City
México D.F.
State/Province
México, D.F.
ZIP/Postal Code
11550
Country
Mexico
Facility Name
Novo Nordisk Investigational Site
City
Aguascalientes
ZIP/Postal Code
20230
Country
Mexico
Facility Name
Novo Nordisk Investigational Site
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Hoofddorp
ZIP/Postal Code
2134 TM
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Rotterdam
ZIP/Postal Code
3039 BD
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Skopje
ZIP/Postal Code
1000
Country
North Macedonia
Facility Name
Novo Nordisk Investigational Site
City
Tetovo
ZIP/Postal Code
1220
Country
North Macedonia
Facility Name
Novo Nordisk Investigational Site
City
Ponce
ZIP/Postal Code
00717
Country
Puerto Rico
Facility Name
Novo Nordisk Investigational Site
City
Pitesti
State/Province
Arges
ZIP/Postal Code
110084
Country
Romania
Facility Name
Novo Nordisk Investigational Site
City
Oradea
State/Province
Bihor
ZIP/Postal Code
410469
Country
Romania
Facility Name
Novo Nordisk Investigational Site
City
Cluj Napoca
State/Province
Cluj
ZIP/Postal Code
400006
Country
Romania
Facility Name
Novo Nordisk Investigational Site
City
Bucharest
ZIP/Postal Code
011234
Country
Romania
Facility Name
Novo Nordisk Investigational Site
City
Iasi
ZIP/Postal Code
700469
Country
Romania
Facility Name
Novo Nordisk Investigational Site
City
Kosice
ZIP/Postal Code
04011
Country
Slovakia
Facility Name
Novo Nordisk Investigational Site
City
Moldava nad Bodvou
ZIP/Postal Code
045 01
Country
Slovakia
Facility Name
Novo Nordisk Investigational Site
City
Piestany
ZIP/Postal Code
92101
Country
Slovakia
Facility Name
Novo Nordisk Investigational Site
City
Puchov
ZIP/Postal Code
02001
Country
Slovakia
Facility Name
Novo Nordisk Investigational Site
City
Trencin
ZIP/Postal Code
91101
Country
Slovakia
Facility Name
Novo Nordisk Investigational Site
City
Koper
ZIP/Postal Code
SI-6000
Country
Slovenia
Facility Name
Novo Nordisk Investigational Site
City
Ljubljana
ZIP/Postal Code
1525
Country
Slovenia
Facility Name
Novo Nordisk Investigational Site
City
Novo mesto
ZIP/Postal Code
8000
Country
Slovenia
Facility Name
Novo Nordisk Investigational Site
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
1829
Country
South Africa
Facility Name
Novo Nordisk Investigational Site
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2001
Country
South Africa
Facility Name
Novo Nordisk Investigational Site
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0183
Country
South Africa
Facility Name
Novo Nordisk Investigational Site
City
Durban
State/Province
KwaZulu-Natal
ZIP/Postal Code
4001
Country
South Africa
Facility Name
Novo Nordisk Investigational Site
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7450
Country
South Africa
Facility Name
Novo Nordisk Investigational Site
City
Basingstoke
ZIP/Postal Code
RG24 9GT
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Bristol
ZIP/Postal Code
BS10 5NB
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Harrogate, North Yorkshire
ZIP/Postal Code
HG2 7SX
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Haxey
ZIP/Postal Code
DN9 2HY
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Hull
ZIP/Postal Code
HU3 2RW
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Ipswich
ZIP/Postal Code
IP4 5PD
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Northwood
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Plymouth
ZIP/Postal Code
PL6 8BQ
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Salford
ZIP/Postal Code
M6 8HD
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Sidcup
ZIP/Postal Code
DA14 6LT
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Soham
ZIP/Postal Code
CB7 5JD
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Swansea
ZIP/Postal Code
SA2 8PP
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Taunton
ZIP/Postal Code
TA1 5DA
Country
United Kingdom

12. IPD Sharing Statement

Citations:
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Citation
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Citation
Kapitza C, Dahl K, Jacobsen JB, Axelsen MB, Flint A. Effects of semaglutide on beta cell function and glycaemic control in participants with type 2 diabetes: a randomised, double-blind, placebo-controlled trial. Diabetologia. 2017 Aug;60(8):1390-1399. doi: 10.1007/s00125-017-4289-0. Epub 2017 May 19.
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Citation
Warren M, Chaykin L, Trachtenbarg D, Nayak G, Wijayasinghe N, Cariou B. Semaglutide as a therapeutic option for elderly patients with type 2 diabetes: Pooled analysis of the SUSTAIN 1-5 trials. Diabetes Obes Metab. 2018 Sep;20(9):2291-2297. doi: 10.1111/dom.13331. Epub 2018 Jun 7.
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Citation
Ahren B, Atkin SL, Charpentier G, Warren ML, Wilding JPH, Birch S, Holst AG, Leiter LA. Semaglutide induces weight loss in subjects with type 2 diabetes regardless of baseline BMI or gastrointestinal adverse events in the SUSTAIN 1 to 5 trials. Diabetes Obes Metab. 2018 Sep;20(9):2210-2219. doi: 10.1111/dom.13353. Epub 2018 Jun 12.
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PubMed Identifier
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Citation
DeVries JH, Desouza C, Bellary S, Unger J, Hansen OKH, Zacho J, Woo V. Achieving glycaemic control without weight gain, hypoglycaemia, or gastrointestinal adverse events in type 2 diabetes in the SUSTAIN clinical trial programme. Diabetes Obes Metab. 2018 Oct;20(10):2426-2434. doi: 10.1111/dom.13396. Epub 2018 Jul 9.
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Citation
Aroda VR, Ahmann A, Cariou B, Chow F, Davies MJ, Jodar E, Mehta R, Woo V, Lingvay I. Comparative efficacy, safety, and cardiovascular outcomes with once-weekly subcutaneous semaglutide in the treatment of type 2 diabetes: Insights from the SUSTAIN 1-7 trials. Diabetes Metab. 2019 Oct;45(5):409-418. doi: 10.1016/j.diabet.2018.12.001. Epub 2019 Jan 4.
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PubMed Identifier
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Citation
Husain M, Bain SC, Holst AG, Mark T, Rasmussen S, Lingvay I. Effects of semaglutide on risk of cardiovascular events across a continuum of cardiovascular risk: combined post hoc analysis of the SUSTAIN and PIONEER trials. Cardiovasc Diabetol. 2020 Sep 30;19(1):156. doi: 10.1186/s12933-020-01106-4.
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Capehorn M, Ghani Y, Hindsberger C, Johansen P, Jodar E. Once-Weekly Semaglutide Reduces HbA1c and Body Weight in Patients with Type 2 Diabetes Regardless of Background Common OAD: a Subgroup Analysis from SUSTAIN 2-4 and 10. Diabetes Ther. 2020 May;11(5):1061-1075. doi: 10.1007/s13300-020-00796-z. Epub 2020 Mar 19.
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Husain M, Bain SC, Jeppesen OK, Lingvay I, Sorrig R, Treppendahl MB, Vilsboll T. Semaglutide (SUSTAIN and PIONEER) reduces cardiovascular events in type 2 diabetes across varying cardiovascular risk. Diabetes Obes Metab. 2020 Mar;22(3):442-451. doi: 10.1111/dom.13955. Epub 2020 Feb 5.
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DeSouza C, Cariou B, Garg S, Lausvig N, Navarria A, Fonseca V. Efficacy and Safety of Semaglutide for Type 2 Diabetes by Race and Ethnicity: A Post Hoc Analysis of the SUSTAIN Trials. J Clin Endocrinol Metab. 2020 Feb 1;105(2):dgz072. doi: 10.1210/clinem/dgz072.
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Citation
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Results Reference
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Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

Learn more about this trial

Efficacy and Safety of Semaglutide Once Weekly Versus Insulin Glargine Once Daily as add-on to Metformin With or Without Sulphonylurea in Insulin-naïve Subjects With Type 2 Diabetes

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