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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)

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ClinicalTrials.gov Identifier: NCT01819129
Recruitment Status : Completed
First Posted : March 27, 2013
Results First Posted : December 5, 2017
Last Update Posted : January 30, 2019
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

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
Enrollment 881
Recruitment Details 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 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.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 345 344
Exposed 341 341
Completed 301 305
Not Completed 44 39
Reason Not Completed
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
Arm/Group Title Faster Aspart NovoRapid Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 345 344 689
Hide Baseline Analysis Population Description
Full analysis set included all randomized subjects.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 345 participants 344 participants 689 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, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 345 participants 344 participants 689 participants
59.6  (9.3) 59.4  (9.6) 59.5  (9.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 345 participants 344 participants 689 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)  
Mean (Standard Deviation)
Unit of measure:  Percentage of glycosylated haemoglobin
Number Analyzed 345 participants 344 participants 689 participants
7.96  (0.68) 7.89  (0.71) 7.92  (0.70)
Body Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 345 participants 344 participants 689 participants
89.0  (16.9) 88.3  (16.7) 88.7  (16.8)
1.Primary Outcome
Title Change From Baseline in HbA1c
Hide Description The primary endpoint was change from baseline in HbA1c after 26 weeks of randomized treatment. For this endpoint baseline (week 0) and week 26 have been presented, where week 26 data is end of trial containing last available measurement.
Time Frame Week 0, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis of this efficacy endpoint was based on the full analysis set (FAS). FAS included all randomized subjects. The statistical evaluation of the FAS was to follow the intention-to-treat (ITT) principle and subjects contributed to the evaluation ‘as randomized’.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 345 344
Mean (Standard Deviation)
Unit of Measure: Percentage of glycosylated haemoglobin
Baseline (week 0) 7.96  (0.68) 7.89  (0.71)
Week 26 6.63  (0.88) 6.59  (0.84)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Faster Aspart, NovoRapid
Comments Change from baseline in HbA1c is analysed using a mixed-effect model for repeated measurements including changes from baseline in HbA1c at visit 14, 18, 22, 26, 30 and 36. The model includes treatment, region and continuous glucose monitoring (CGM) strata as fixed effects, subject as random effect, HbA1c at baseline as covariate and interaction between all fixed effects and visit, and between the covariate and visit.
Type of Statistical Test Non-Inferiority or Equivalence
Comments The assessment was done by comparing the difference of faster aspart vs. NovoRapid®/NovoLog® in change from baseline in HbA1c after 26 weeks of randomized treatment to a non-inferiority limit of 0.4%.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.02
Confidence Interval (2-Sided) 95%
-0.15 to 0.10
Estimation Comments The estimated parameter i.e mean difference is the estimated treatment difference for Faster aspart vs. NovoRapid (Faster aspart - NovoRapid).
2.Secondary Outcome
Title Change From Baseline in 2-hour PPG Increment (Meal Test)
Hide Description For this endpoint baseline (week 0) and week 26 have been presented, where week 26 data is end of trial containing last available measurement.
Time Frame Week 0, week 26
Hide Outcome Measure Data
Hide Analysis Population Description
This endpoint was summarized using the Full Analysis Set (FAS). FAS included all randomized subjects.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 345 344
Mean (Standard Deviation)
Unit of Measure: mmol/L
Baseline (week 0) Number Analyzed 338 participants 331 participants
7.57  (3.19) 7.34  (3.12)
Week 26 Number Analyzed 342 participants 342 participants
4.55  (3.13) 4.9  (3.36)
3.Secondary Outcome
Title Number of Treatment Emergent Confirmed Hypoglycaemic Episodes
Hide Description A hypoglycaemic episode was defined as treatment-emergent if the onset of the episode was on or after the first day of exposure to randomized treatment and no later than 1 day after the last day of randomized treatment. A severe or blood glucose (BG) confirmed hypoglycaemic episode was an episode that was severe according to the American Diabetes Association (ADA) classification (an episode that required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with or without symptoms consistent with hypoglycaemia.
Time Frame From Week 0 to Week 26.
Hide Outcome Measure Data
Hide Analysis Population Description
This endpoint was summarized using the safety analysis set. Safety analysis set included all subjects receiving at least one dose of the test product or comparator. Subjects in the safety analysis set contributed to the evaluation ‘as treated’.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 341 341
Measure Type: Number
Unit of Measure: Number of episodes
2857 2692
4.Secondary Outcome
Title Change From Baseline in Body Weight
Hide Description For this endpoint baseline (week 0) and week 26 have been presented, where week 26 data is end of trial containing last available measurement.
Time Frame Week 0, week 26
Hide Outcome Measure Data
Hide Analysis Population Description
This endpoint was summarized using the FAS. FAS included all randomized subjects.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 345 344
Mean (Standard Deviation)
Unit of Measure: Kg
Baseline (week 0) 89.0  (16.9) 88.3  (16.7)
Week 26 91.6  (18.2) 90.8  (17.7)
Time Frame All treatment-emergent adverse events (AEs) were collected from the date on or after the first day of exposure to randomized treatment until no later than 7 days after the last day of randomised treatment
Adverse Event Reporting Description Safety analysis set was used for the assessment of safety including AEs. The safety analysis set included all subjects who received at least one dose of test product (faster aspart) or comparator(NovoRapid).
 
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Faster Aspart NovoRapid
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Faster Aspart NovoRapid
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   15/341 (4.40%)      24/341 (7.04%)    
Cardiac disorders     
Acute myocardial infarction  1  1/341 (0.29%)  1 1/341 (0.29%)  1
Angina unstable  1  0/341 (0.00%)  0 1/341 (0.29%)  1
Cardiomyopathy  1  1/341 (0.29%)  1 0/341 (0.00%)  0
Coronary artery occlusion  1  0/341 (0.00%)  0 1/341 (0.29%)  1
Myocardial ischaemia  1  1/341 (0.29%)  1 0/341 (0.00%)  0
Ear and labyrinth disorders     
Aural polyp  1  1/341 (0.29%)  1 0/341 (0.00%)  0
Gastrointestinal disorders     
Colitis ischaemic  1  0/341 (0.00%)  0 1/341 (0.29%)  1
Gastric polyps  1  0/341 (0.00%)  0 1/341 (0.29%)  1
Inguinal hernia  1  0/341 (0.00%)  0 1/341 (0.29%)  1
Infections and infestations     
Bacteraemia  1  1/341 (0.29%)  1 0/341 (0.00%)  0
Cellulitis  1  0/341 (0.00%)  0 1/341 (0.29%)  1
Cholecystitis infective  1  1/341 (0.29%)  1 0/341 (0.00%)  0
Lobar pneumonia  1  1/341 (0.29%)  1 0/341 (0.00%)  0
Osteomyelitis  1  0/341 (0.00%)  0 1/341 (0.29%)  1
Otitis externa  1  1/341 (0.29%)  1 0/341 (0.00%)  0
Pneumonia  1  1/341 (0.29%)  1 0/341 (0.00%)  0
Injury, poisoning and procedural complications     
Fall  1  0/341 (0.00%)  0 2/341 (0.59%)  2
Wrong drug administered  1  0/341 (0.00%)  0 1/341 (0.29%)  1
Investigations     
Arteriogram coronary  1  0/341 (0.00%)  0 1/341 (0.29%)  1
Metabolism and nutrition disorders     
Hypoglycaemia  1  2/341 (0.59%)  4 3/341 (0.88%)  5
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Cardiac myxoma  1  1/341 (0.29%)  1 0/341 (0.00%)  0
Refractory anaemia with an excess of blasts  1  0/341 (0.00%)  0 1/341 (0.29%)  1
Renal cancer stage II  1  0/341 (0.00%)  0 1/341 (0.29%)  1
Transitional cell carcinoma  1  2/341 (0.59%)  2 0/341 (0.00%)  0
Nervous system disorders     
Carotid artery occlusion  1  0/341 (0.00%)  0 1/341 (0.29%)  1
Carotid artery stenosis  1  0/341 (0.00%)  0 2/341 (0.59%)  2
Ischaemic stroke  1  0/341 (0.00%)  0 1/341 (0.29%)  1
Transient ischaemic attack  1  0/341 (0.00%)  0 2/341 (0.59%)  2
VIIth nerve paralysis  1  1/341 (0.29%)  1 0/341 (0.00%)  0
Renal and urinary disorders     
Renal failure acute  1  0/341 (0.00%)  0 1/341 (0.29%)  1
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease  1  0/341 (0.00%)  0 1/341 (0.29%)  1
Pulmonary embolism  1  1/341 (0.29%)  1 1/341 (0.29%)  1
Skin and subcutaneous tissue disorders     
Diabetic foot  1  0/341 (0.00%)  0 1/341 (0.29%)  1
Stasis dermatitis  1  0/341 (0.00%)  0 1/341 (0.29%)  1
Surgical and medical procedures     
Cholecystectomy  1  1/341 (0.29%)  1 0/341 (0.00%)  0
Coronary artery bypass  1  0/341 (0.00%)  0 1/341 (0.29%)  1
Vascular disorders     
Hypertension  1  1/341 (0.29%)  1 0/341 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Faster Aspart NovoRapid
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   49/341 (14.37%)      53/341 (15.54%)    
Infections and infestations     
Nasopharyngitis  1  17/341 (4.99%)  20 24/341 (7.04%)  27
Upper respiratory tract infection  1  16/341 (4.69%)  19 22/341 (6.45%)  27
Urinary tract infection  1  20/341 (5.87%)  27 13/341 (3.81%)  16
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
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.
At the end of the trial, one or more public disclosures may be prepared collaboratively by the Investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Reporting Anchor and Disclosure (1452)
Organization: Novo Nordisk A/S
EMail: clinicaltrials@novonordisk.com
Layout table for additonal information
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: January 30, 2019