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Efficacy and Safety of FIAsp in a Basal-bolus Regimen Versus Basal Insulin Therapy, Both in Combination With Metformin in Adult Subjects With Type 2 Diabetes (onset® 3)

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ClinicalTrials.gov Identifier: NCT01850615
Recruitment Status : Completed
First Posted : May 9, 2013
Results First Posted : January 17, 2018
Last Update Posted : January 17, 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: Faster-acting insulin aspart
Drug: basal insulin

  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 at 51 sites in 6 countries as follows: Argentina: 4 sites; India: 8 sites; Mexico: 3 sites; Romania: 5 sites; Slovenia: 4 sites; United States: 27 sites.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 555 subjects were screened, of which 232 subjects were screening failures and 323 subjects were enrolled and entered the run-in (pre-assignment) period. Of those, 87 subjects were run-in failures. Hence, 236 subjects were randomized to the 18 weeks of treatment period.

Reporting Groups
  Description
Faster Aspart + Basal During the 18-week treatment period, subjects received subcutaneous (s.c., under the skin) injection of faster aspart (bolus insulin) along with s.c. basal insulin (insulin detemir or insulin glargine or NPH insulin) and metformin. Treatment recommendations were developed for the different trial products specifying the recommended dose adjustments at different plasma glucose (PG) levels. Trial products were titrated according to the insulin dosing recommendations provided during the study. No maximum dose of insulin was specified as doses were titrated individually. Faster aspart was administered 0-2 minutes before each main meal (i.e., breakfast, lunch and main evening meal). The basal insulin injection was to be given once daily (OD), in the evening, at approximately the same time each day.
Basal During the 18-week treatment period, subjects received s.c. injection of basal insulin (insulin detemir or insulin glargine or NPH insulin) and metformin. Treatment recommendations were developed for the different trial products specifying the recommended dose adjustments at different PG levels. Trial products were titrated according to the insulin dosing recommendations provided during the study. No maximum dose of insulin was specified as doses were titrated individually. The basal insulin injection was to be given OD, in the evening, at approximately the same time each day.

Participant Flow:   Overall Study
    Faster Aspart + Basal   Basal
STARTED   116   120 
Exposed   115   120 
COMPLETED   107   115 
NOT COMPLETED   9   5 
Protocol Violation                4                1 
Adverse Event                2                1 
Withdrawal by Subject                3                1 
Lost to Follow-up                0                1 
Unclassified                0                1 



  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.
Full analysis set (FAS) included all randomised subjects

Reporting Groups
  Description
Faster Aspart + Basal During the 18-week treatment period, subjects received subcutaneous (s.c., under the skin) injection of faster aspart (bolus insulin) along with s.c. basal insulin (insulin detemir or insulin glargine or NPH insulin) and metformin. Treatment recommendations were developed for the different trial products specifying the recommended dose adjustments at different PG levels. Trial products were titrated according to the insulin dosing recommendations provided during the study. No maximum dose of insulin was specified as doses were titrated individually. Faster aspart was administered 0-2 minutes before each main meal (i.e., breakfast, lunch and main evening meal). The basal insulin injection was to be given OD, in the evening, at approximately the same time each day.
Basal During the 18-week treatment period, subjects received s.c. injection of basal insulin (insulin detemir or insulin glargine or NPH insulin) and metformin. Treatment recommendations were developed for the different trial products specifying the recommended dose adjustments at different (PG) levels. Trial products were titrated according to the insulin dosing recommendations provided during the study. No maximum dose of insulin was specified as doses were titrated individually. The basal insulin injection was to be given OD, in the evening, at approximately the same time each day.
Total Total of all reporting groups

Baseline Measures
   Faster Aspart + Basal   Basal   Total 
Overall Participants Analyzed 
[Units: Participants]
 116   120   236 
Age 
[Units: Years]
Mean (Standard Deviation)
 57.5  (9.9)   57.4  (8.5)   57.4  (9.2) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      61  52.6%      61  50.8%      122  51.7% 
Male      55  47.4%      59  49.2%      114  48.3% 
Glycosylated haemoglobin (HbA1c) 
[Units: Percentage of glycosylated haemoglobin]
Mean (Standard Deviation)
 7.93  (0.69)   7.92  (0.68)   7.93  (0.69) 
Body weight 
[Units: Kg]
Mean (Standard Deviation)
 82.2  (16.2)   85.1  (17.3)   83.7  (16.8) 


  Outcome Measures

1.  Primary:   Change From Baseline in HbA1c   [ Time Frame: Week 0, week 18 ]

2.  Secondary:   Self-measured Plasma Glucose (SMPG) 7-point Profile: Post Prandial Plasma Glucose (PPG), Overall 2-hour Mean (of Breakfast, Lunch, Main Evening Meal)   [ Time Frame: After 18 weeks of randomised treatment ]

3.  Secondary:   Self-measured Plasma Glucose (SMPG) 7-point Profile: Prandial Plasma Glucose (PG) Increment, Overall 2-hour Mean (of Breakfast, Lunch, Main Evening Meal)   [ Time Frame: After 18 weeks of randomised treatment ]

4.  Secondary:   Change From Baseline in Body Weight   [ Time Frame: Week 0, week 18 ]

5.  Secondary:   Number of Treatment Emergent Hypoglycaemic Episodes   [ Time Frame: Weeks 0-18 ]

6.  Secondary:   Number of Adverse Events   [ Time Frame: Weeks 0-18 ]


  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: NCT01850615     History of Changes
Other Study ID Numbers: NN1218-4049
2012-005583-10 ( EudraCT Number )
U1111-1137-6242 ( Other Identifier: WHO )
CTRI/2014/01/004289 ( Registry Identifier: Clinical Trials Registry - India (CTRI) )
First Submitted: April 17, 2013
First Posted: May 9, 2013
Results First Submitted: October 2, 2017
Results First Posted: January 17, 2018
Last Update Posted: January 17, 2018