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Efficacy and Safety of FIAsp Compared to Insulin Aspart in Combination With Insulin Glargine and Metformin in Adults With Type 2 Diabetes (onset® 2)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01819129
First Posted: March 27, 2013
Last Update Posted: December 5, 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: October 2, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions: Diabetes
Diabetes Mellitus, Type 2
Interventions: Drug: Faster-acting insulin aspart
Drug: Insulin aspart
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
Out of 150 sites, which were selected for recruitment, 128 sites in 9 countries enrolled subjects in the run-in period, of which 123 sites later assigned subjects to randomized treatment: Canada:9 sites; Croatia:6 sites; India:6 sites; Israel:6 sites; Russia:12 sites; Serbia:9 sites; Slovakia:5 sites; United Kingdom:7 sites; United States:63 sites.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The trial included an 8-week run-in period and a 26-week treatment period. During the run-in period, the subjects received insulin glargine along with metformin. In total, 881 subjects entered the run-in period, of these 192 subjects were run-in failures. Hence, 689 subjects entered the 26-week treatment period.

Reporting Groups
  Description
Faster Aspart At randomization, all subjects started on 4 units of mealtime faster aspart (bolus insulin) in combination with once-daily subcutaneous (sc) injection of insulin glargine (basal insulin) and metformin (oral) in a basal-bolus regiment. Faster aspart was administered (sc) 0-2 minutes before each main meal and dose was titrated to the pre-prandial glycaemic target of 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion according to the titration guideline. Dose adjustments were considered daily based on the pre-prandial and bedtime self-measured plasma glucose (SMPG) on the previous day. The dose adjustments were -1 or +1 if the pre-prandial or bedtime plasma glucose was <4.0 mmol/L or >6.0 mmol/L respectively. Basal insulin dose adjustments were allowed when needed. Metformin treatment continued without changing the frequency or dose.
NovoRapid At randomization, all subjects started on 4 units of mealtime NovoRapid®/NovoLog® (insulin aspart; bolus insulin) in combination with once-daily sc injection of insulin glargine (basal insulin) and metformin (oral) in a basal-bolus regimen. NovoRapid®/ NovoLog® was administered (sc) 0-2 minutes before each main meal, was titrated to the pre-prandial glycaemic target of 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion according to the titration guideline. Dose adjustments were considered daily based on the pre-prandial and bedtime SMPG on the previous day. The dose adjustments were -1 or +1 if the pre-prandial or bedtime plasma glucose was <4.0 mmol/L or >6.0 mmol/L respectively. Basal insulin dose adjustments were allowed when needed. Metformin treatment continued without changing the frequency or dose.

Participant Flow:   Overall Study
    Faster Aspart   NovoRapid
STARTED   345   344 
Exposed   341   341 
COMPLETED   301   305 
NOT COMPLETED   44   39 
Other, Subject wanted HbA1c to be > 7%                1                0 
Other, weight gain, hypoglycaemic events                1                0 
Other, Subject moved out of the country                0                1 
Withdrawal by Subject                15                15 
Lost to Follow-up                5                2 
Lack of Efficacy                0                1 
Adverse Event                1                4 
Death                1                1 
Withdrawal Criteria                20                15 



  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 randomized subjects.

Reporting Groups
  Description
Faster Aspart At randomization, all subjects started on 4 units of mealtime faster aspart (bolus insulin) in combination with once-daily sc injection of insulin glargine (basal insulin) and metformin (oral) in a basal-bolus regiment. Faster aspart was administered (sc) 0-2 minutes before each main meal and dose was titrated to the pre-prandial glycaemic target of 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion according to the titration guideline. Dose adjustments were considered daily based on the pre-prandial and bedtime SMPG on the previous day. The dose adjustments were -1 or +1 if the pre-prandial or bedtime plasma glucose was <4.0 mmol/L or >6.0 mmol/L respectively. Basal insulin dose adjustments were allowed when needed. Metformin treatment continued without changing the frequency or dose.
NovoRapid At randomization, all subjects started on 4 units of mealtime NovoRapid®/NovoLog® (insulin aspart; bolus insulin) in combination with once-daily sc injection of insulin glargine (basal insulin) and metformin (oral) in a basal-bolus regimen. NovoRapid®/ NovoLog® was administered (sc) 0-2 minutes before each main meal, was titrated to the pre-prandial glycaemic target of 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion according to the titration guideline. Dose adjustments were considered daily based on the pre-prandial and bedtime SMPG on the previous day. The dose adjustments were -1 or +1 if the pre-prandial or bedtime plasma glucose was <4.0 mmol/L or >6.0 mmol/L respectively. Basal insulin dose adjustments were allowed when needed. Metformin treatment continued without changing the frequency or dose.
Total Total of all reporting groups

Baseline Measures
   Faster Aspart   NovoRapid   Total 
Overall Participants Analyzed 
[Units: Participants]
 345   344   689 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      241  69.9%      248  72.1%      489  71.0% 
>=65 years      104  30.1%      96  27.9%      200  29.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 59.6  (9.3)   59.4  (9.6)   59.5  (9.4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      182  52.8%      171  49.7%      353  51.2% 
Male      163  47.2%      173  50.3%      336  48.8% 
Glycosylated haemoglobin A1c (HbA1c) 
[Units: Percentage of glycosylated haemoglobin]
Mean (Standard Deviation)
 7.96  (0.68)   7.89  (0.71)   7.92  (0.70) 
Body Weight 
[Units: Kg]
Mean (Standard Deviation)
 89.0  (16.9)   88.3  (16.7)   88.7  (16.8) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in HbA1c   [ Time Frame: Week 0, Week 26 ]

2.  Secondary:   Change From Baseline in 2-hour PPG Increment (Meal Test)   [ Time Frame: Week 0, week 26 ]

3.  Secondary:   Number of Treatment Emergent Confirmed Hypoglycaemic Episodes   [ Time Frame: From Week 0 to Week 26. ]

4.  Secondary:   Change From Baseline in Body Weight   [ Time Frame: Week 0, week 26 ]


  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: Clinical Reporting Anchor and Disclosure (1452)
Organization: Novo Nordisk A/S
e-mail: clinicaltrials@novonordisk.com


Publications of Results:

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01819129     History of Changes
Other Study ID Numbers: NN1218-3853
2010-024051-93 ( EudraCT Number )
U1111-1118-2509 ( Other Identifier: WHO )
CTRI/2014/01/004285 ( Registry Identifier: Clinical Trials Registry - India (CTRI) )
First Submitted: March 21, 2013
First Posted: March 27, 2013
Results First Submitted: October 2, 2017
Results First Posted: December 5, 2017
Last Update Posted: December 5, 2017