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A Trial Comparing the Efficacy, Patient-reported Outcomes and Safety of Insulin Degludec 200 U/mL vs Insulin Glargine in Subjects With Type 2 Diabetes Mellitus Requiring High-dose Insulin

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01570751
First received: April 2, 2012
Last updated: January 26, 2016
Last verified: January 2016
Results First Received: October 16, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   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 37 sites in the United States of America (USA).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All subjects were on insulin glargine (IGlar, ≥ 65 U and ≤ 100 U/mL in 10 mL vials) treatment once daily (OD) administered subcutaneously at any time of day preferred by the subject for 16 week run-in period along with the daily pre-trial metformin dose.

Reporting Groups
  Description
IDeg/IGlar The subjects in this arm for treatment period A received IDeg OD (200 U/mL in pre-filled pen device) subcutaneously (under the skin) for 16 weeks (treatment period A) followed by IGlar OD (100 U/mL in SoloStar® pen) for 16 weeks (treatment period B). Subjects were crossed over to IGlar without a wash-out period between the two treatment sequences. Subjects continued on metformin (pre-trial dose) throughout the trial. There was a follow-up visit 7 days following the last treatment visit.
IGlar/IDeg The subjects in this arm for treatment period A received IGlar OD (100 U/mL in SoloStar® pen) subcutaneously (under the skin) for 16 weeks (treatment period A) followed by IDeg OD (200 U/mL in pre-filled pen device) for 16 weeks (treatment period B). Subjects were crossed over to IDeg without a wash-out period between the two treatment sequences. Subjects continued on metformin (pre-trial dose) throughout the trial. There was a follow-up visit 7 days following the last treatment visit.

Participant Flow for 2 periods

Period 1:   Period A (16 Weeks)
    IDeg/IGlar     IGlar/IDeg  
STARTED     73     72  
Exposed     73     72  
COMPLETED     70     67  
NOT COMPLETED     3     5  
Protocol Violation                 1                 1  
Withdrawal criteria                 0                 1  
Unclassified                 2                 3  

Period 2:   Period B (16 Weeks)
    IDeg/IGlar     IGlar/IDeg  
STARTED     70     67  
Exposed     70     67  
COMPLETED     69     66  
NOT COMPLETED     1     1  
Adverse Event                 1                 0  
Protocol Violation                 0                 1  



  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.
For 4 subjects baseline fasting plasma glucose (FPG) values were missing, hence did not contribute to the FPG summary.

Reporting Groups
  Description
IDeg/IGlar The subjects in this arm for treatment period A received IDeg OD (200 U/mL in pre-filled pen device) subcutaneously (under the skin) for 16 weeks (treatment period A) followed by IGlar OD (100 U/mL in SoloStar® pen) for 16 weeks (treatment period B). Subjects were crossed over to IGlar without a wash-out period between the two treatment sequences. Subjects continued on metformin (pre-trial dose) throughout the trial. There was a follow-up visit 7 days following the last treatment visit.
IGlar/IDeg The subjects in this arm for treatment period A received IGlar OD (100 U/mL in SoloStar® pen) subcutaneously (under the skin) for 16 weeks (treatment period A) followed by IDeg OD (200 U/mL in pre-filled pen device) for 16 weeks (treatment period B). Subjects were crossed over to IDeg without a wash-out period between the two treatment sequences. Subjects continued on metformin (pre-trial dose) throughout the trial. There was a follow-up visit 7 days following the last treatment visit.
Total Total of all reporting groups

Baseline Measures
    IDeg/IGlar     IGlar/IDeg     Total  
Number of Participants  
[units: participants]
  73     72     145  
Age  
[units: years]
Mean (Standard Deviation)
  54.7  (10.2)     55.8  (9.0)     55.3  (9.6)  
Gender  
[units: participants]
     
Female     31     24     55  
Male     42     48     90  
Glycosylated haemoglobin (HbA1c)  
[units: percentage of glycosylated haemoglobin]
Mean (Standard Deviation)
  8.0  (1.1)     8.3  (1.4)     8.2  (1.3)  
Fasting plasma glucose (FPG)  
[units: mmol/L]
Mean (Standard Deviation)
  7.5  (3.3)     8.5  (4.1)     8.0  (3.7)  



  Outcome Measures
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1.  Primary:   Change From Baseline (Visit 18) in Glycosylated Haemoglobin (HbA1c) at the End of Each 16 Week Treatment Period   [ Time Frame: Week 0, week 16 of each treatment period. ]

2.  Secondary:   Change in Patient Reported Outcome (PRO) Scores From Baseline to the End of Each 16 Week Treatment Period   [ Time Frame: Week 0, week 16 of each treatment period. ]

3.  Secondary:   Change in PRO Scores From the End of Treatment Period A Until After 4 Weeks of Treatment in Treatment Period B   [ Time Frame: Week 16, week 20 ]

4.  Secondary:   Change From Baseline in Central Laboratory Measured Fasting Plasma Glucose (FPG) at the End of Each 16 Week Treatment Period   [ Time Frame: Week 0, week 16, week 32 ]

5.  Secondary:   Change in FPG From the End of Treatment Period A Until After 4 Weeks of Treatment in Treatment Period B   [ Time Frame: Week 16, week 20 ]

6.  Secondary:   Number of Adverse Events (AEs)   [ Time Frame: From baseline to the end of each 16 week treatment period. ]


  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
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  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: Public Access to Clinical Trials
Organization: Novo Nordisk A/S
e-mail: clinicaltrials@novonordisk.com



Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01570751     History of Changes
Other Study ID Numbers: NN1250-3943
U1111-1123-4774 ( Other Identifier: WHO )
Study First Received: April 2, 2012
Results First Received: October 16, 2015
Last Updated: January 26, 2016
Health Authority: United States: Food and Drug Administration