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Trial record 1 of 2420 for:    SUSTAIN 4
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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)

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ClinicalTrials.gov Identifier: NCT02128932
Recruitment Status : Completed
First Posted : May 1, 2014
Results First Posted : March 8, 2018
Last Update Posted : March 8, 2018
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Diabetes
Diabetes Mellitus, Type 2
Interventions: Drug: semaglutide
Drug: insulin glargine

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The trial was conducted at196 sites in 14 countries. Argentina: 3 sites; Croatia: 3 sites; France: 5 sites; Germany: 11 sites; India: 12 sites; Macedonia: 3 sites; Mexico: 3 sites; Netherlands: 3 sites; Romania: 5 sites; Slovakia: 5 sites; Slovenia:3 sites; South Africa: 4 sites; United Kingdom: 13 sites; United States: 123 sites.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Insulin-naïve subjects diagnosed with type 2 diabetes and on stable diabetes treatment with metformin or metformin and SU (metformin ≥1500 mg or maximum tolerated dose and SU≥ half of maximum allowed dose according to national label) for at least 90 days before screening. Stable is defined as unchanged medication and unchanged dose.

Reporting Groups
  Description
Semaglutide 0.5mg/Week Subjects on semaglutide followed a fixed dose-escalation. The maintenance dose of 0.5 mg was to be reached after 4 doses (4 weeks) of 0.25 mg semaglutide. Doses could not be changed during the trial after the maintenance dose had been reached. One test pen was to be supplied per subject at the screening visit in order to ensure the subject`s willingness and ability to self-inject. The test pen contained semaglutide placebo, solution for injection, 1.5 mL prefilled PDS290 pen-injector and was to be administered once. The PDS290 pen-injector for semaglutide is a prefilled pen integrated with a 1.5 mL cartridge containing semaglutide 1.34 mg/mL and is designed to be used with NovoFine®, NovoFine® Plus and NovoTwist® disposable needles. Once weekly (same day of the week) administered by s.c. injection in thigh, abdomen or upper arm, at any time of the day.
Semaglutide 1.0 mg/Week Subjects randomised to semaglutide followed a fixed dose-escalation regimen. The maintenance dose of 1.0 mg was to be reached after 4 doses (4 weeks) of 0.25 mg, followed by 4 doses (4 weeks) of 0.5 mg semaglutide. Doses could not be changed during the trial after the maintenance dose had been reached. One test pen was to be supplied per subject at the screening visit in order to ensure the subject`s willingness and ability to self-inject. The test pen contained semaglutide placebo, solution for injection, 1.5 mL prefilled PDS290 pen-injector and was to be administered once. The PDS290 pen-injector for semaglutide is a prefilled pen integrated with a 1.5 mL cartridge containing semaglutide 1.34 mg/mL and is designed to be used with NovoFine®, NovoFine® Plus and NovoTwist® disposable needles. Once weekly (same day of the week) administered by s.c. injection in thigh, abdomen or upper arm, at any time of the day.
Insulin Glargine Subjects on insulin glargine were to start on 10 IU s.c. injected OD. The insulin dose adjustment had to aim to reach a pre-breakfast FPG of 4.0 to <5.5 mmol/L (71- <100 mg/dL). Once daily solution for injection in a 3 mL pre-filled SoloStar® pen to be administered in the thigh, abdomen or upper arm, at any time of the day

Participant Flow:   Overall Study
    Semaglutide 0.5mg/Week   Semaglutide 1.0 mg/Week   Insulin Glargine
STARTED   362   360   360 
COMPLETED   335   341   342 
NOT COMPLETED   27   19   18 
Withdrawal by Subject                11                7                8 
Death                2                0                2 
Lost to Follow-up                2                1                1 
No reason for withdrawal                12                11                7 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The full analysis set (FAS) included all randomised subjects who had received at least one dose of randomised semaglutide (s.c.) or insulin glargine. Subjects in the FAS contributed to the evaluation based on the treatment assigned at randomisation.

Reporting Groups
  Description
Semaglutide 0.5mg/Week Subjects on semaglutide followed a fixed dose-escalation. The maintenance dose of 0.5 mg was to be reached after 4 doses (4 weeks) of 0.25 mg semaglutide. Doses could not be changed during the trial after the maintenance dose had been reached. One test pen was to be supplied per subject at the screening visit in order to ensure the subject`s willingness and ability to self-inject. The test pen contained semaglutide placebo, solution for injection, 1.5 mL prefilled PDS290 pen-injector and was to be administered once. The PDS290 pen-injector for semaglutide is a prefilled pen integrated with a 1.5 mL cartridge containing semaglutide 1.34 mg/mL and is designed to be used with NovoFine®, NovoFine® Plus and NovoTwist® disposable needles. Once weekly (same day of the week) administered by s.c. injection in thigh, abdomen or upper arm, at any time of the day.
Semaglutide 1.0 mg/Week Subjects randomised to semaglutide followed a fixed dose-escalation regimen. The maintenance dose of 1.0 mg was to be reached after 4 doses (4 weeks) of 0.25 mg, followed by 4 doses (4 weeks) of 0.5 mg semaglutide. Doses could not be changed during the trial after the maintenance dose had been reached. One test pen was to be supplied per subject at the screening visit in order to ensure the subject`s willingness and ability to self-inject. The test pen contained semaglutide placebo, solution for injection, 1.5 mL prefilled PDS290 pen-injector and was to be administered once. The PDS290 pen-injector for semaglutide is a prefilled pen integrated with a 1.5 mL cartridge containing semaglutide 1.34 mg/mL and is designed to be used with NovoFine®, NovoFine® Plus and NovoTwist® disposable needles. Once weekly (same day of the week) administered by s.c. injection in thigh, abdomen or upper arm, at any time of the day.
Insulin Glargine Subjects on insulin glargine were to start on 10 IU s.c. injected OD. The insulin dose adjustment had to aim to reach a pre-breakfast FPG of 4.0 to <5.5 mmol/L (71- <100 mg/dL). Once daily solution for injection in a 3 mL pre-filled SoloStar® pen to be administered in the thigh, abdomen or upper arm, at any time of the day
Total Total of all reporting groups

Baseline Measures
   Semaglutide 0.5mg/Week   Semaglutide 1.0 mg/Week   Insulin Glargine   Total 
Overall Participants Analyzed 
[Units: Participants]
 362   360   360   1082 
Age 
[Units: Years]
Mean (Standard Deviation)
 56.5  (10.3)   56.7  (10.4)   56.2  (10.6)   56.5  (10.4) 
Age, Customized 
[Units: Participants]
       
18-64 years   278   281   281   840 
65-74 years   72   61   67   200 
75-84 years   12   18   12   42 
>=85 years   0   0   0   0 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      165  45.6%      178  49.4%      165  45.8%      508  47.0% 
Male      197  54.4%      182  50.6%      195  54.2%      574  53.0% 
HbA1c 
[Units: Percentage]
Mean (Standard Deviation)
 8.13  (0.85)   8.25  (0.94)   8.13  (0.88)   8.17  (0.89) 
Fasting plasma glucose 
[Units: mg/dL]
Mean (Standard Deviation)
 172.4  (50.52)   179.2  (53.74)   174.2  (49.06)   175.3  (51.18) 
Body weight 
[Units: Kg]
Mean (Standard Deviation)
 93.73  (21.39)   94.00  (22.48)   92.61  (21.52)   93.45  (21.79) 
Diastolic Blood pressure 
[Units: mmHg]
Mean (Standard Deviation)
 79.67  (8.04)   80.32  (8.32)   79.78  (9.20)   79.72  (8.53) 
Systolic Blood Pressure 
[Units: mmHg]
Mean (Standard Deviation)
 131.57  (14.06)   132.21  (16.05)   132.38  (15.77)   132.06  (15.31) 


  Outcome Measures

1.  Primary:   Change in HbA1c From Baseline   [ Time Frame: Week 0, week 30 ]

2.  Secondary:   Change in Body Weight From Baseline   [ Time Frame: Week 0, week 30 ]

3.  Secondary:   Change in Fasting Plasma Glucose From Baseline   [ Time Frame: Week 0, week 30 ]

4.  Secondary:   Change in Diastolic Blood Pressure.   [ Time Frame: Week 0, week 30 ]

5.  Secondary:   Change in Systolic Blood Pressure.   [ Time Frame: Week 0, week 30 ]

6.  Secondary:   Change in Patient Reported Outcome (PRO) Questionnaire, Questionnaire SF-36v2™   [ Time Frame: Week 0, week 30 ]

7.  Secondary:   Change in Patient Reported Outcome Questionnaires. (PROs), Diabetes Treatment Satisfaction Questionnaire (DTSQs)   [ Time Frame: Week 0, week 30 ]

8.  Secondary:   Subjects Who Achieve HbA1c ≤6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists (AACE)   [ Time Frame: After 30 weeks treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Global Clinical Registry (GCR, 1452)
Organization: Novo Nordisk A/S
e-mail: clinicaltrials@novonordisk.com


Publications of Results:

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT02128932     History of Changes
Other Study ID Numbers: NN9535-3625
2013-004392-12 ( EudraCT Number )
U1111-1146-0211 ( Other Identifier: WHO )
NL47781.018.14 ( Registry Identifier: National Registry in The Netherlands )
First Submitted: April 24, 2014
First Posted: May 1, 2014
Results First Submitted: December 14, 2017
Results First Posted: March 8, 2018
Last Update Posted: March 8, 2018