A Trial Comparing the Efficacy of Insulin Degludec With Insulin Glargine on Glycaemic Control Using Continuous Glucose Monitoring in Patients With Type 1 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01569841
First received: March 30, 2012
Last updated: December 16, 2015
Last verified: December 2015
Results First Received: October 16, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Diabetes
Diabetes Mellitus, Type 1
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 one site 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 basal-bolus insulin regimens at screening using insulin glargine (IGlar) and either insulin aspart (IAsp) or insulin lispro (ILis). During the run-in period, IGlar 100 U/mL was administered subcutaneously (under the skin) once daily (OD) in the morning (before breakfast) along with IAsp 100 U/mL as meal-time insulin.

Reporting Groups
  Description
IDeg/IGlar

The trial included 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks.

All randomised subjects were scheduled for 12 weeks of treatment with the trial products. After 6 weeks of treatment in period A, the subjects were crossed over to 6 weeks of the other treatment in period B.

Upon completing the 4-week run-in period, subjects randomised to the IDeg/IGlar treatment sequence received an morning dose of IDeg OD (100 U/mL, 3 mL prefilled pen) along with mealtime dosing of IAsp (100 U/mL, prefilled pen) subcutaneously (under the skin) for 6 weeks in treatment period A. Upon completion of treatment Period A, subjects crossed over to Period B and received a morning dose of IGlar OD (100 U/mL, SoloStar® prefilled pen) in combination with mealtime dosing of IAsp (100 U/mL, prefilled pen) subcutaneously (under the skin) for 6 weeks.

IGlar/IDeg

The trial included 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks.

All randomised subjects were scheduled for 12 weeks of treatment with the trial products. After 6 weeks of treatment in period A, the subjects were crossed over to 6 weeks of the other treatment in period B.

Upon completing the 4-week run-in period, subjects randomised to the IGlar/IDeg treatment sequence received an morning dose of IGlar OD (100 U/mL, 3 mL SoloStar® prefilled pen) subcutaneously (under the skin) in combination with mealtime dosing of IAsp (100 U/mL, prefilled pen) for 6 weeks in treatment Period A. Upon completion of treatment Period A, subjects crossed over to Period B and received a morning dose of IDeg OD (100 U/mL, 3 mL prefilled pen) subcutaneously (under the skin) in combination with mealtime dosing of IAsp (100 U/mL, prefilled pen) for 6 weeks.


Participant Flow for 2 periods

Period 1:   Period 1 (6 Weeks)
    IDeg/IGlar     IGlar/IDeg  
STARTED     12     12  
Exposed     12     12  
COMPLETED     12     11 [1]
NOT COMPLETED     0     1  
Withdrawal by Subject                 0                 1  
[1] One subject from IGlar to IDeg treatment sequence withdrew from treatment period A while on IGlar

Period 2:   Period 2 (6 Weeks)
    IDeg/IGlar     IGlar/IDeg  
STARTED     12     11  
Exposed     12     11  
COMPLETED     12     11  
NOT COMPLETED     0     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.
No text entered.

Reporting Groups
  Description
Full Analysis Set The full analysis set (FAS) included all randomised subjects.

Baseline Measures
    Full Analysis Set  
Number of Participants  
[units: participants]
  24  
Age  
[units: years]
Mean (Standard Deviation)
  45.3  (14.9)  
Gender  
[units: participants]
 
Female     9  
Male     15  
Fasting Plasma Glucose (FPG)  
[units: mmol/L]
Mean (Standard Deviation)
  10.7  (3.4)  
Glycosylated Haemoglobin (HbA1c)  
[units: percentage¬†of¬†glycosylated¬†haemoglobin]
Mean (Standard Deviation)
  7.1  (0.6)  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Average Time Within Glycaemic Target Range (Above 70 mg/dL and Below 130 mg/dL)   [ Time Frame: CGM occured during the last 2 weeks of the 6 weeks treatment period. ]

2.  Secondary:   Mean Interstitial Glucose (IG) Based on 14 Days of CGM   [ Time Frame: CGM monitoring occurred during the last 2 weeks of the 6-week treatment period. ]

3.  Secondary:   Fasting Plasma Glucose (FPG)   [ Time Frame: At the end of each 6 week treatment period. ]

4.  Secondary:   Glycosylated Haemoglobin (HbA1c)   [ Time Frame: At the end of each 6 week treatment period. ]

5.  Secondary:   Number of Treatment Emergent Adverse Events (AEs)   [ Time Frame: Within each week 6 treatment period ]

6.  Secondary:   Number of Treatment Emergent Confirmed Hypoglycaemic Episodes   [ Time Frame: Hypoglycemic episodes reported within each 6 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


No publications provided


Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01569841     History of Changes
Other Study ID Numbers: NN1250-3874
U1111-1125-7495 ( Other Identifier: WHO )
Study First Received: March 30, 2012
Results First Received: October 16, 2015
Last Updated: December 16, 2015
Health Authority: United States: Food and Drug Administration