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Efficacy and Safety of Semaglutide Once-weekly Versus Sitagliptin Once-daily as add-on to Metformin and/or TZD in Subjects With Type 2 Diabetes (SUSTAIN™ 2)

Primary Purpose

Diabetes, Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
semaglutide
sitagliptin
placebo
placebo
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: - Japan: Age minimum 20 years - Subjects diagnosed with type 2 diabetes and on stable treatment in a period of 90 days prior to screening with either metformin above or equal to 1500 mg (or maximum tolerated dose), pioglitazone above or equal to 30 mg (or maximum tolerated dose), rosiglitazone above or equal to 4 mg (or maximum tolerated dose) or a combination of either metformin/pioglitazone or metformin/rosiglitazone (doses as for individual therapies). Stable is defined as unchanged medication and unchanged dose - HbA1c 7.0 - 10.5 % (53 - 91 mmol/mol) (both inclusive) Exclusion Criteria: - Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using an adequate contraceptive method throughout the trial including the 5 weeks follow-up period (adequate contraceptive measures as required by local law or practice) - Any chronic disorder or severe disease which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol - Treatment with 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 (below or equal to 7 days in total) with insulin in connection with inter-current illness - History of chronic or idiopathic acute pancreatitis - Screening calcitonin value above or equal to 50 ng/L (pg/mL) - Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2) - Impaired renal function defined as estimated glomerular filtration rate (eGFR) below 60 ml/min/1.73 m2 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 (NYHA) class IV

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Active Comparator

Arm Label

Semaglutide 0.5 mg + sitagliptin placebo

Semaglutide 1.0 mg + sitagliptin placebo

Sitagliptin 100 mg + semaglutide placebo 1.0 mg

Sitagliptin 100 mg + semaglutide placebo 0.5 mg

Arm Description

Outcomes

Primary Outcome Measures

Change in HbA1c (Glycosylated Haemoglobin) From Baseline
Change in HbA1c from baseline until week 56.Full analysis set (FAS=1225) included all randomised subjects who had received at least one dose of randomised semaglutide or sitagliptin.

Secondary Outcome Measures

Change in Body Weight From Baseline
Change in body weight from baseline to week 56. Full analysis set (FAS=1225) included all randomised subjects who had received at least one dose of semaglutide or sitagliptin.
Change in Fasting Plasma Glucose (FPG) From Baseline
Change in fasting plasma glucose from baseline to week 56. Full analysis set (FAS=1225) included all randomised subjects who had received at least one dose of semaglutide or sitagliptin.
Change in Systolic and Diastolic Blood Pressure From Baseline
Change in systolic and diastolic blood pressure from baseline to week 56. Full analysis set (FAS=1225) included all randomised subjects who had received at least one dose of semaglutide or sitagliptin
Change in Patient Reported Outcome (PRO) Questionnaire Diabetes Treatment Satisfaction Questionnaire Status (DTSQs) From Baseline
Full analysis set (FAS=1225) included all randomised subjects who had received at least one dose of semaglutide or sitagliptin. The DTSQs questionnaire was used to assess subjects' treatment satisfaction. This questionnaire contained 8 components and evaluates the diabetes treatment (including insulin, tablets and/or diet) in terms of convenience, flexibility and general feelings towards the treatment. The result 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.
Subjects Who Achieved HbA1c Below or Equal to 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists (AACE) Target (Yes/no)
Subjects who achieved HbA1c ≤6.5% (48 mmol/mol) American Association of Clinical Endocrinologists (AACE) target (yes/no) after week 56 weeks of treatment.

Full Information

First Posted
August 23, 2013
Last Updated
May 28, 2019
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT01930188
Brief Title
Efficacy and Safety of Semaglutide Once-weekly Versus Sitagliptin Once-daily as add-on to Metformin and/or TZD in Subjects With Type 2 Diabetes
Acronym
SUSTAIN™ 2
Official Title
Efficacy and Safety of Semaglutide Once-weekly Versus Sitagliptin Once-daily as add-on to Metformin and/or TZD in Subjects With Type 2 Diabetes (SUSTAIN™ 2 - vs. DPP-4 Inhibitor)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
December 2, 2013 (Actual)
Primary Completion Date
October 12, 2015 (Actual)
Study Completion Date
October 12, 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, Asia, Europe and South America. The aim of the trial is to evaluate efficacy and safety of semaglutide once-weekly versus sitagliptin once-daily as add-on to metformin and/or TZD (thiazolidinedione) in 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
ParticipantInvestigator
Allocation
Randomized
Enrollment
1231 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Semaglutide 0.5 mg + sitagliptin placebo
Arm Type
Experimental
Arm Title
Semaglutide 1.0 mg + sitagliptin placebo
Arm Type
Experimental
Arm Title
Sitagliptin 100 mg + semaglutide placebo 1.0 mg
Arm Type
Active Comparator
Arm Title
Sitagliptin 100 mg + semaglutide placebo 0.5 mg
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
semaglutide
Intervention Description
For subcutaneous injection (s.c., under the skin) once weekly. Will follow a fixed dose escalation regimen. The trial drug will be added on to the subject's stable pre-trial medication.
Intervention Type
Drug
Intervention Name(s)
sitagliptin
Intervention Description
Tablets for oral administration once daily. The trial drug will be added on to the subject's stable pre-trial medication.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Tablets for oral administration once daily. The trial drug will be added on to the subject's stable pre-trial medication.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
For subcutaneous injection (s.c., under the skin) once weekly. Will follow a fixed dose escalation regimen. The trial drug will be added on to the subject's stable pre-trial medication.
Primary Outcome Measure Information:
Title
Change in HbA1c (Glycosylated Haemoglobin) From Baseline
Description
Change in HbA1c from baseline until week 56.Full analysis set (FAS=1225) included all randomised subjects who had received at least one dose of randomised semaglutide or sitagliptin.
Time Frame
Week 0, week 56
Secondary Outcome Measure Information:
Title
Change in Body Weight From Baseline
Description
Change in body weight from baseline to week 56. Full analysis set (FAS=1225) included all randomised subjects who had received at least one dose of semaglutide or sitagliptin.
Time Frame
Week 0, week 56
Title
Change in Fasting Plasma Glucose (FPG) From Baseline
Description
Change in fasting plasma glucose from baseline to week 56. Full analysis set (FAS=1225) included all randomised subjects who had received at least one dose of semaglutide or sitagliptin.
Time Frame
Week 0, week 56
Title
Change in Systolic and Diastolic Blood Pressure From Baseline
Description
Change in systolic and diastolic blood pressure from baseline to week 56. Full analysis set (FAS=1225) included all randomised subjects who had received at least one dose of semaglutide or sitagliptin
Time Frame
Week 0, week 56
Title
Change in Patient Reported Outcome (PRO) Questionnaire Diabetes Treatment Satisfaction Questionnaire Status (DTSQs) From Baseline
Description
Full analysis set (FAS=1225) included all randomised subjects who had received at least one dose of semaglutide or sitagliptin. The DTSQs questionnaire was used to assess subjects' treatment satisfaction. This questionnaire contained 8 components and evaluates the diabetes treatment (including insulin, tablets and/or diet) in terms of convenience, flexibility and general feelings towards the treatment. The result 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.
Time Frame
Week 0, week 56
Title
Subjects Who Achieved HbA1c Below or Equal to 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists (AACE) Target (Yes/no)
Description
Subjects who achieved HbA1c ≤6.5% (48 mmol/mol) American Association of Clinical Endocrinologists (AACE) target (yes/no) after week 56 weeks of treatment.
Time Frame
After 56 weeks treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - Japan: Age minimum 20 years - Subjects diagnosed with type 2 diabetes and on stable treatment in a period of 90 days prior to screening with either metformin above or equal to 1500 mg (or maximum tolerated dose), pioglitazone above or equal to 30 mg (or maximum tolerated dose), rosiglitazone above or equal to 4 mg (or maximum tolerated dose) or a combination of either metformin/pioglitazone or metformin/rosiglitazone (doses as for individual therapies). Stable is defined as unchanged medication and unchanged dose - HbA1c 7.0 - 10.5 % (53 - 91 mmol/mol) (both inclusive) Exclusion Criteria: - Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using an adequate contraceptive method throughout the trial including the 5 weeks follow-up period (adequate contraceptive measures as required by local law or practice) - Any chronic disorder or severe disease which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol - Treatment with 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 (below or equal to 7 days in total) with insulin in connection with inter-current illness - History of chronic or idiopathic acute pancreatitis - Screening calcitonin value above or equal to 50 ng/L (pg/mL) - Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2) - Impaired renal function defined as estimated glomerular filtration rate (eGFR) below 60 ml/min/1.73 m2 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 (NYHA) class IV
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
Buenos Aires
ZIP/Postal Code
C1425AGC
Country
Argentina
Facility Name
Novo Nordisk Investigational Site
City
Caba
ZIP/Postal Code
C1179AAB
Country
Argentina
Facility Name
Novo Nordisk Investigational Site
City
Caba
Country
Argentina
Facility Name
Novo Nordisk Investigational Site
City
Mar del Plata
ZIP/Postal Code
B7600GNY
Country
Argentina
Facility Name
Novo Nordisk Investigational Site
City
Burgas
ZIP/Postal Code
8000
Country
Bulgaria
Facility Name
Novo Nordisk Investigational Site
City
Haskovo
ZIP/Postal Code
6300
Country
Bulgaria
Facility Name
Novo Nordisk Investigational Site
City
Petrich
ZIP/Postal Code
2850
Country
Bulgaria
Facility Name
Novo Nordisk Investigational Site
City
Ruse
ZIP/Postal Code
7000
Country
Bulgaria
Facility Name
Novo Nordisk Investigational Site
City
Sliven
ZIP/Postal Code
8800
Country
Bulgaria
Facility Name
Novo Nordisk Investigational Site
City
Smolyan
ZIP/Postal Code
4700
Country
Bulgaria
Facility Name
Novo Nordisk Investigational Site
City
Sofia
ZIP/Postal Code
1233
Country
Bulgaria
Facility Name
Novo Nordisk Investigational Site
City
Sofia
ZIP/Postal Code
1336
Country
Bulgaria
Facility Name
Novo Nordisk Investigational Site
City
Stara Zagora
ZIP/Postal Code
6000
Country
Bulgaria
Facility Name
Novo Nordisk Investigational Site
City
Vratsa
ZIP/Postal Code
3001
Country
Bulgaria
Facility Name
Novo Nordisk Investigational Site
City
Chrudim
ZIP/Postal Code
537 01
Country
Czechia
Facility Name
Novo Nordisk Investigational Site
City
Ostrava
ZIP/Postal Code
707 02
Country
Czechia
Facility Name
Novo Nordisk Investigational Site
City
Plzen
ZIP/Postal Code
304 60
Country
Czechia
Facility Name
Novo Nordisk Investigational Site
City
Praha 4- Chodov
ZIP/Postal Code
149 00
Country
Czechia
Facility Name
Novo Nordisk Investigational Site
City
Praha 5
ZIP/Postal Code
150 00
Country
Czechia
Facility Name
Novo Nordisk Investigational Site
City
Shatin, New Territories
Country
Hong Kong
Facility Name
Novo Nordisk Investigational Site
City
Budapest
ZIP/Postal Code
1076
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Budapest
ZIP/Postal Code
H-1134
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Debrecen
ZIP/Postal Code
4043
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Szeged
ZIP/Postal Code
H-6720
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Szombathely
ZIP/Postal Code
H-9700
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500003
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380006
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560034
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560054
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Kochi
State/Province
Kerala
ZIP/Postal Code
682041
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Kozhikode
State/Province
Kerala
ZIP/Postal Code
673017
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Trivandrum
State/Province
Kerala
ZIP/Postal Code
695011
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
Pune
State/Province
Maharashtra
ZIP/Postal Code
411001
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411004
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411040
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Bhubaneswar
State/Province
Orissa
ZIP/Postal Code
751019
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Ludhiana
State/Province
Punjab
ZIP/Postal Code
141001
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302004
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Chennai
State/Province
Tamil Nadu
ZIP/Postal Code
600116
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Kolkata
State/Province
West Bengal
ZIP/Postal Code
700020
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Kolkata
State/Province
West Bengal
ZIP/Postal Code
700054
Country
India
Facility Name
Novo Nordisk Investigational Site
City
New Delhi
ZIP/Postal Code
110017
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Asahikawa-shi, Hokkaido
ZIP/Postal Code
070-0002
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Ibaraki
ZIP/Postal Code
311-0113
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Kashiwara-shi, Osaka
ZIP/Postal Code
582-0005
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Kitakyushu-shi, Fukuoka
ZIP/Postal Code
800 0252
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Mitaka-shi, Tokyo
ZIP/Postal Code
181-0013
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Mito-shi, Ibaraki
ZIP/Postal Code
310-0826
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Miyazaki
ZIP/Postal Code
880-0034
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Okayama-shi, Okayama
ZIP/Postal Code
700 8505
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Osaka-shi, Osaka
ZIP/Postal Code
532 0003
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Osaka-shi, Osaka
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Osaka
ZIP/Postal Code
569-1045
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Sapporo-shi, Hokkaido
ZIP/Postal Code
060-0001
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Tokyo
ZIP/Postal Code
103-0027
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Tokyo
ZIP/Postal Code
125-0054
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Pachuca
State/Province
Hidalgo
ZIP/Postal Code
42084
Country
Mexico
Facility Name
Novo Nordisk Investigational Site
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44670
Country
Mexico
Facility Name
Novo Nordisk Investigational Site
City
Monterrey
State/Province
Nuevo León
ZIP/Postal Code
64620
Country
Mexico
Facility Name
Novo Nordisk Investigational Site
City
Aguascalientes
ZIP/Postal Code
20129
Country
Mexico
Facility Name
Novo Nordisk Investigational Site
City
Aguascalientes
ZIP/Postal Code
20230
Country
Mexico
Facility Name
Novo Nordisk Investigational Site
City
Hamar
ZIP/Postal Code
2317
Country
Norway
Facility Name
Novo Nordisk Investigational Site
City
Kløfta
ZIP/Postal Code
2040
Country
Norway
Facility Name
Novo Nordisk Investigational Site
City
Kongsvinger
ZIP/Postal Code
2212
Country
Norway
Facility Name
Novo Nordisk Investigational Site
City
Stavanger
ZIP/Postal Code
4005
Country
Norway
Facility Name
Novo Nordisk Investigational Site
City
Ålesund
ZIP/Postal Code
6003
Country
Norway
Facility Name
Novo Nordisk Investigational Site
City
Almada
ZIP/Postal Code
2805-267
Country
Portugal
Facility Name
Novo Nordisk Investigational Site
City
Coimbra
ZIP/Postal Code
3046-853
Country
Portugal
Facility Name
Novo Nordisk Investigational Site
City
Lisboa
ZIP/Postal Code
1250-230
Country
Portugal
Facility Name
Novo Nordisk Investigational Site
City
Lisboa
ZIP/Postal Code
1500-650
Country
Portugal
Facility Name
Novo Nordisk Investigational Site
City
Matosinhos
ZIP/Postal Code
4464-513
Country
Portugal
Facility Name
Novo Nordisk Investigational Site
City
Tomar
ZIP/Postal Code
2304-909
Country
Portugal
Facility Name
Novo Nordisk Investigational Site
City
Viana do Castelo
ZIP/Postal Code
4901-858
Country
Portugal
Facility Name
Novo Nordisk Investigational Site
City
Vila Nova de Gaia
ZIP/Postal Code
4434-502
Country
Portugal
Facility Name
Novo Nordisk Investigational Site
City
Baia Mare
State/Province
Maramures
ZIP/Postal Code
430123
Country
Romania
Facility Name
Novo Nordisk Investigational Site
City
Ploiesti
State/Province
Prahova
ZIP/Postal Code
100342
Country
Romania
Facility Name
Novo Nordisk Investigational Site
City
Brasov
ZIP/Postal Code
500365
Country
Romania
Facility Name
Novo Nordisk Investigational Site
City
Bucharest
ZIP/Postal Code
020359
Country
Romania
Facility Name
Novo Nordisk Investigational Site
City
Bucharest
ZIP/Postal Code
022441
Country
Romania
Facility Name
Novo Nordisk Investigational Site
City
Barnaul
ZIP/Postal Code
656024
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Moscow
ZIP/Postal Code
117036
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Moscow
ZIP/Postal Code
119435
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Moscow
ZIP/Postal Code
125367
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Moscow
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Nizhniy Novgorod
ZIP/Postal Code
603011
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Novosibirsk
ZIP/Postal Code
630047
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Novosibirsk
ZIP/Postal Code
630099
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Saint-Petersburg
ZIP/Postal Code
197762
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Samara
ZIP/Postal Code
443041
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Saratov
ZIP/Postal Code
410018
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Smolensk
ZIP/Postal Code
214019
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Tomsk
ZIP/Postal Code
634063
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Tumen
ZIP/Postal Code
625023
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Ufa
ZIP/Postal Code
450083
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Volgograd
ZIP/Postal Code
400138
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Voronezh
ZIP/Postal Code
394018
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Yaroslavl
ZIP/Postal Code
150003
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
East London
State/Province
Eastern Cape
ZIP/Postal Code
5201
Country
South Africa
Facility Name
Novo Nordisk Investigational Site
City
Bloemfontein
State/Province
Free State
ZIP/Postal Code
9301
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
Krugersdorp
State/Province
Gauteng
ZIP/Postal Code
1739
Country
South Africa
Facility Name
Novo Nordisk Investigational Site
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0002
Country
South Africa
Facility Name
Novo Nordisk Investigational Site
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0084
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
Durban
State/Province
KwaZulu-Natal
ZIP/Postal Code
4092
Country
South Africa
Facility Name
Novo Nordisk Investigational Site
City
Almería
ZIP/Postal Code
04001
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Centelles (Barcelona)
ZIP/Postal Code
08540
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
La Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
La Roca del Vallés
ZIP/Postal Code
08430
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Lleida
ZIP/Postal Code
25198
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Palma de Mallorca
ZIP/Postal Code
07010
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Sevilla
ZIP/Postal Code
41003
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Kristianstad
ZIP/Postal Code
291 85
Country
Sweden
Facility Name
Novo Nordisk Investigational Site
City
Lund
ZIP/Postal Code
222 22
Country
Sweden
Facility Name
Novo Nordisk Investigational Site
City
Malmö
ZIP/Postal Code
205 02
Country
Sweden
Facility Name
Novo Nordisk Investigational Site
City
Stockholm
ZIP/Postal Code
113 24
Country
Sweden
Facility Name
Novo Nordisk Investigational Site
City
Bangkoknoi, Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Novo Nordisk Investigational Site
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Name
Novo Nordisk Investigational Site
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Novo Nordisk Investigational Site
City
Nakhon Ratchasima
ZIP/Postal Code
30000
Country
Thailand
Facility Name
Novo Nordisk Investigational Site
City
Ankara
ZIP/Postal Code
06110
Country
Turkey
Facility Name
Novo Nordisk Investigational Site
City
Antalya
ZIP/Postal Code
07058
Country
Turkey
Facility Name
Novo Nordisk Investigational Site
City
Istanbul
ZIP/Postal Code
34303
Country
Turkey
Facility Name
Novo Nordisk Investigational Site
City
Istanbul
ZIP/Postal Code
34371
Country
Turkey
Facility Name
Novo Nordisk Investigational Site
City
Istanbul
ZIP/Postal Code
34718
Country
Turkey
Facility Name
Novo Nordisk Investigational Site
City
Istanbul
ZIP/Postal Code
34722
Country
Turkey
Facility Name
Novo Nordisk Investigational Site
City
Istanbul
ZIP/Postal Code
34752
Country
Turkey
Facility Name
Novo Nordisk Investigational Site
City
Istanbul
ZIP/Postal Code
34890
Country
Turkey
Facility Name
Novo Nordisk Investigational Site
City
Konya
ZIP/Postal Code
42090
Country
Turkey
Facility Name
Novo Nordisk Investigational Site
City
Rize
ZIP/Postal Code
53020
Country
Turkey
Facility Name
Novo Nordisk Investigational Site
City
Trabzon
ZIP/Postal Code
61040
Country
Turkey
Facility Name
Novo Nordisk Investigational Site
City
Çorum
ZIP/Postal Code
19200
Country
Turkey
Facility Name
Novo Nordisk Investigational Site
City
Cherkasy
ZIP/Postal Code
18009
Country
Ukraine
Facility Name
Novo Nordisk Investigational Site
City
Ivano-Frankivsk
ZIP/Postal Code
76018
Country
Ukraine
Facility Name
Novo Nordisk Investigational Site
City
Kyiv
ZIP/Postal Code
04114
Country
Ukraine
Facility Name
Novo Nordisk Investigational Site
City
Odesa
ZIP/Postal Code
65114
Country
Ukraine
Facility Name
Novo Nordisk Investigational Site
City
Vinnytsia
ZIP/Postal Code
21010
Country
Ukraine
Facility Name
Novo Nordisk Investigational Site
City
Zaporizhia
ZIP/Postal Code
69600
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
30938762
Citation
Fonseca VA, Capehorn MS, Garg SK, Jodar Gimeno E, Hansen OH, Holst AG, Nayak G, Seufert J. Reductions in Insulin Resistance are Mediated Primarily via Weight Loss in Subjects With Type 2 Diabetes on Semaglutide. J Clin Endocrinol Metab. 2019 Sep 1;104(9):4078-4086. doi: 10.1210/jc.2018-02685. Erratum In: J Clin Endocrinol Metab. 2020 Jan 1;105(1):
Results Reference
background
PubMed Identifier
30865526
Citation
Rodbard HW, Bellary S, Hramiak I, Seino Y, Silver R, Damgaard LH, Nayak G, Zacho J, Aroda VR. GREATER COMBINED REDUCTIONS IN HbA1C >/=1.0% AND WEIGHT >/=5.0% WITH SEMAGLUTIDE VERSUS COMPARATORS IN TYPE 2 DIABETES. Endocr Pract. 2019 Jun;25(6):589-597. doi: 10.4158/EP-2018-0444. Epub 2019 Mar 13.
Results Reference
background
Citation
Ahrén B, Comas LM, Kumar H, Sargin M, Derving Karsbøl J, Jacobsen SH, Chow F. Efficacy and Safety of Once-weekly Semaglutide vs Sitagliptin as add-on to Metformin and/or Thiazolidinediones After 56 Weeks in Subjects With Type 2 Diabetes (SUSTAIN 2). Oral Presentation 12 Jun 2016 at American Diabetes Association - 76th Annual Scientific Sessions.
Results Reference
result
Citation
Ahrén B, Masmiquel L, Kumar H, Sargin M, Derving Karsbøl J, Jacobsen SH, Chow F. Efficacy and Safety of Once-weekly Semaglutide vs Sitagliptin as add-on to Metformin and/or Thiazolidinediones After 56 Weeks in Subjects With Type 2 Diabetes (SUSTAIN 2). ePoster #767 presented 12 Sep 2016 at European Association for the Study of Diabetes - 52nd Annual Meeting.
Results Reference
result
PubMed Identifier
28385659
Citation
Ahren B, Masmiquel L, Kumar H, Sargin M, Karsbol JD, Jacobsen SH, Chow F. Efficacy and safety of once-weekly semaglutide versus once-daily sitagliptin as an add-on to metformin, thiazolidinediones, or both, in patients with type 2 diabetes (SUSTAIN 2): a 56-week, double-blind, phase 3a, randomised trial. Lancet Diabetes Endocrinol. 2017 May;5(5):341-354. doi: 10.1016/S2213-8587(17)30092-X. Epub 2017 Apr 3.
Results Reference
result
PubMed Identifier
29748996
Citation
Petri KCC, Ingwersen SH, Flint A, Zacho J, Overgaard RV. Exposure-response analysis for evaluation of semaglutide dose levels in type 2 diabetes. Diabetes Obes Metab. 2018 Sep;20(9):2238-2245. doi: 10.1111/dom.13358. Epub 2018 Jun 15.
Results Reference
result
PubMed Identifier
29766634
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.
Results Reference
result
PubMed Identifier
29764222
Citation
Sharma R, Wilkinson L, Vrazic H, Popoff E, Lopes S, Kanters S, Druyts E. Comparative efficacy of once-weekly semaglutide and SGLT-2 inhibitors in type 2 diabetic patients inadequately controlled with metformin monotherapy: a systematic literature review and network meta-analysis. Curr Med Res Opin. 2018 Sep;34(9):1595-1603. doi: 10.1080/03007995.2018.1476332. Epub 2018 May 29.
Results Reference
result
PubMed Identifier
29862621
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.
Results Reference
result
PubMed Identifier
29907893
Citation
Carlsson Petri KC, Ingwersen SH, Flint A, Zacho J, Overgaard RV. Semaglutide s.c. Once-Weekly in Type 2 Diabetes: A Population Pharmacokinetic Analysis. Diabetes Ther. 2018 Aug;9(4):1533-1547. doi: 10.1007/s13300-018-0458-5. Epub 2018 Jun 15.
Results Reference
result
PubMed Identifier
30615985
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.
Results Reference
result
PubMed Identifier
32998732
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.
Results Reference
derived
PubMed Identifier
32827435
Citation
Lingvay I, Capehorn MS, Catarig AM, Johansen P, Lawson J, Sandberg A, Shaw R, Paine A. Efficacy of Once-Weekly Semaglutide vs Empagliflozin Added to Metformin in Type 2 Diabetes: Patient-Level Meta-analysis. J Clin Endocrinol Metab. 2020 Dec 1;105(12):e4593-604. doi: 10.1210/clinem/dgaa577.
Results Reference
derived
PubMed Identifier
32193837
Citation
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.
Results Reference
derived
PubMed Identifier
31903692
Citation
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.
Results Reference
derived
PubMed Identifier
31769496
Citation
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.
Results Reference
derived
PubMed Identifier
31215727
Citation
Jendle J, Birkenfeld AL, Polonsky WH, Silver R, Uusinarkaus K, Hansen T, Hakan-Bloch J, Tadayon S, Davies MJ. Improved treatment satisfaction in patients with type 2 diabetes treated with once-weekly semaglutide in the SUSTAIN trials. Diabetes Obes Metab. 2019 Oct;21(10):2315-2326. doi: 10.1111/dom.13816. Epub 2019 Jul 12.
Results Reference
derived
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 Sitagliptin Once-daily as add-on to Metformin and/or TZD in Subjects With Type 2 Diabetes

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