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A Trial Comparing the Safety and Efficacy of Insulin Degludec and Insulin Glargine, With or Without OADs in Subjects With Type 2 Diabetes (SWITCH 2)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02030600
First Posted: January 8, 2014
Last Update Posted: August 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
Results First Submitted: December 2, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions: Diabetes
Diabetes Mellitus, Type 2
Interventions: Drug: insulin degludec
Drug: insulin glargine

  Participant Flow
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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 at 152 sites in the United States.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Insulin Degludec/Insulin Glargine (IDeg/IGlar) Subjects received insulin degludec (IDeg) in treatment period 1 and insulin glargine (IGlar) in treatment period 2. Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IDeg and IGlar were administered in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken at the same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total daily insulin dose was recommended. Doses of IDeg and IGlar were titrated individually. Adjustment of the dose was performed once weekly based on the mean of 3 preceding daily fasting self-measured plasma glucose (SMPG) values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
Insulin Glargine/Insulin Degludec (IGlar/IDeg) Subjects received IGlar in treatment period 1 and IDeg in treatment period 2. Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IGlar and IDeg were administered in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken at the same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total insulin daily dose was recommended. Doses of IGlar and IDeg were titrated individually. Adjustment of the dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).

Participant Flow for 2 periods

Period 1:   Treatment Period 1
    Insulin Degludec/Insulin Glargine (IDeg/IGlar)   Insulin Glargine/Insulin Degludec (IGlar/IDeg)
STARTED   361   360 
Exposed   356   357 
COMPLETED   308   315 
NOT COMPLETED   53   45 
Adverse Event                5                7 
Lack of Efficacy                0                1 
Lost to Follow-up                11                3 
Protocol Violation                22                17 
Withdrawal by Subject                13                17 
Casebook Unsigned                1                0 
Unclassified                1                0 

Period 2:   Treatment Period 2
    Insulin Degludec/Insulin Glargine (IDeg/IGlar)   Insulin Glargine/Insulin Degludec (IGlar/IDeg)
STARTED   308   315 
COMPLETED   283   297 
NOT COMPLETED   25   18 
Adverse Event                4                4 
Lack of Efficacy                2                1 
Lost to Follow-up                4                2 
Protocol Violation                1                2 
Withdrawal by Subject                13                9 
Unclassified                1                0 



  Baseline Characteristics
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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.
Full analysis set included all randomised subjects. One subject was excluded from the analysis due to unsigned casebook.

Reporting Groups
  Description
Insulin Degludec/Insulin Glargine (IDeg/IGlar) Subjects received IDeg in treatment period 1 and IGlar in treatment period 2. Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IDeg and IGlar were administered in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken at the same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total daily insulin dose was recommended. Doses of IDeg and IGlar were titrated individually. Adjustment of the dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
Insulin Glargine/Insulin Degludec (IGlar/IDeg) Subjects received IGlar in treatment period 1 and IDeg in treatment period 2. Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IGlar and IDeg were administered in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken at the same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total insulin daily dose was recommended. Doses of IGlar and IDeg were titrated individually. Adjustment of the dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
Total Total of all reporting groups

Baseline Measures
   Insulin Degludec/Insulin Glargine (IDeg/IGlar)   Insulin Glargine/Insulin Degludec (IGlar/IDeg)   Total 
Overall Participants Analyzed 
[Units: Participants]
 360   360   720 
Age 
[Units: Years]
Mean (Standard Deviation)
 61.5  (10.7)   61.2  (10.3)   61.4  (10.5) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      169  46.9%      169  46.9%      338  46.9% 
Male      191  53.1%      191  53.1%      382  53.1% 
Glycosylated haemoglobin 
[Units: Percentage of glycosylated haemoglobin]
Mean (Standard Deviation)
 7.6  (1.1)   7.6  (1.1)   7.6  (1.1) 
Fasting plasma glucose [1] 
[Units: mg/dL]
Mean (Standard Deviation)
 139.2  (53.5)   134.9  (51.6)   137.0  (52.6) 
[1] Number of subjects analyzed=355 for IDeg/IGlar arm, 358 for IGlar/IDeg arm and 713 for total.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Maintenance Period   [ Time Frame: After 16 weeks of treatment, in each treatment period (Week 16-32 and Week 48-64) ]

2.  Secondary:   Number of Treatment Emergent Severe or BG Confirmed Symptomatic Nocturnal Hypoglycaemic Episode During the Maintenance Period   [ Time Frame: After 16 weeks of treatment, in each treatment period (Week 16-32 and Week 48-64) ]

3.  Secondary:   Proportion of Subjects With One or More Severe Hypoglycaemic Episodes During the Maintenance Period   [ Time Frame: After 16 weeks of treatment, in each treatment period (Week 16-32 and Week 48-64) ]

4.  Secondary:   Incidence of Treatment Emergent Adverse Events   [ Time Frame: During 32 weeks of treatment for each treatment period ]

5.  Secondary:   Change From Baseline in HbA1c (Glycosylated Haemoglobin)   [ Time Frame: Week 32, Week 64 ]

6.  Secondary:   FPG (Fasting Plasma Glucose)   [ Time Frame: week 32, week 64 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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: NCT02030600     History of Changes
Other Study ID Numbers: NN1250-3998
U1111-1143-7963 ( Other Identifier: WHO )
First Submitted: January 7, 2014
First Posted: January 8, 2014
Results First Submitted: December 2, 2016
Results First Posted: January 30, 2017
Last Update Posted: August 10, 2017