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Research Study Comparing a New Medicine "Fast-acting Insulin Aspart" to Another Already Available Medicine "NovoRapid"/"NovoLog" in People With Type 2 Diabetes (onset 9)

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.
 
ClinicalTrials.gov Identifier: NCT03268005
Recruitment Status : Completed
First Posted : August 31, 2017
Last Update Posted : May 15, 2019
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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Brief Summary:
The study compares 2 medicines for type 2 diabetes: fast-acting insulin aspart (a new medicine) and NovoRapid®/NovoLog® (a medicine doctors can already prescribe). Fast-acting insulin aspart will be tested to see how well it works and if it is safe. Participants will get either fast-acting insulin aspart or NovoRapid®/ NovoLog® - which treatment you get is decided by chance. Both medicines will be taken together with insulin degludec. Participants will need to take 1 injection 4 times every day (all insulins will be provided in pens). The study will last for about 8 months (34 weeks).

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 2 Drug: Faster-acting insulin aspart Drug: Insulin aspart Drug: Insulin degludec Drug: Metformin Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1264 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Fast-acting Insulin Aspart Compared to NovoRapid® Both in Combination With Insulin Degludec With or Without Metformin in Adults With Type 2 Diabetes (Onset® 9)
Actual Study Start Date : September 19, 2017
Actual Primary Completion Date : January 7, 2019
Actual Study Completion Date : January 29, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Faster aspart + insulin degludec with or without metformin Drug: Faster-acting insulin aspart
Faster aspart given subcutaneously (s.c., under the skin) once a day for 16 weeks. Dose individually adjusted.

Drug: Insulin degludec
Insulin degludec given subcutaneously (s.c., under the skin) once a day for 16 weeks. Dose individually adjusted.

Drug: Metformin
Only participants who took metformin before the study should take metformin tablets, same dose as before the study
Active Comparator: NovoRapid/NovoLog + insulin degludec with or without metformin Drug: Insulin aspart
Insulin aspart given subcutaneously (s.c., under the skin) once a day for 16 weeks. Dose individually adjusted.

Drug: Insulin degludec
Insulin degludec given subcutaneously (s.c., under the skin) once a day for 16 weeks. Dose individually adjusted.

Drug: Metformin
Only participants who took metformin before the study should take metformin tablets, same dose as before the study


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline in HbA1c [ Time Frame: Week 0, week 16 ]
    Measured in %


Secondary Outcome Measures :
  1. Change from baseline in 1-hour postprandial glucose (PPG) increment (meal test) [ Time Frame: Week 0, week 16 ]
    Mean glucose values

  2. Change from baseline in 1,5-anhydroglucitol [ Time Frame: Week 0, week 16 ]
    Measured in appropriate SI unit

  3. Change from baseline in fasting plasma glucose (FPG) [ Time Frame: Week 0, week 16 ]
    Measured in mg/dl or other equivalent SI units

  4. If a subject achieves HbA1c below 7% [ Time Frame: 16 weeks after randomisation ]
    Number of subjects

  5. If a subject achieves HbA1c below 7% without severe hypoglycaemia [ Time Frame: 16 weeks after randomisation ]
    Number of subjects

  6. Change from baseline in 30 minute PPG (meal test) [ Time Frame: Week 0, week 16 ]
    Mean glucose values

  7. Change from baseline in 1 hour PPG (meal test) [ Time Frame: Week 0, week 16 ]
    Mean glucose values

  8. Change from baseline in 2 hour PPG (meal test) [ Time Frame: Week 0, week 16 ]
    Mean glucose values

  9. Change from baseline in 3 hour PPG (meal test) [ Time Frame: Week 0, week 16 ]
    Mean glucose values

  10. Change from baseline in 4 hour PPG (meal test) [ Time Frame: Week 0, week 16 ]
    Mean glucose values

  11. Change from baseline in 30 minute PPG increment (meal test) [ Time Frame: Week 0, week 16 ]
    Mean glucose values

  12. Change from baseline in 2 hour PPG increment (meal test) [ Time Frame: Week 0, week 16 ]
    Mean glucose values

  13. Change from baseline in 3 hour PPG increment (meal test) [ Time Frame: Week 0, week 16 ]
    Mean glucose values

  14. Change from baseline in 4 hour PPG increment (meal test) [ Time Frame: Week 0, week 16 ]
    Mean glucose values

  15. Change from baseline in mean of the 7-9-7-point profile [ Time Frame: Week 0, week 16 ]
    Mean glucose values

  16. Change from baseline in PPG (mean, breakfast, lunch, main evening meal) [ Time Frame: Week 0, week 16 ]
    Mean glucose values

  17. Change from baseline in PPG increment (mean, breakfast, lunch, main evening meal) [ Time Frame: Week 0, week 16 ]
    Mean glucose values

  18. Change from baseline in fluctuation in 7-9-7-point profile [ Time Frame: Week 0, week 16 ]
    Mean glucose values

  19. Change from baseline in the nocturnal self-measured plasma glucose (SMPG) measurements [ Time Frame: Week 0, week 16 ]
    Mean glucose values

  20. If a subject achieves overall PPG (1 hour) equal to or below 7.8 mmol/L [140 mg/dL] [ Time Frame: 16 weeks after randomisation ]
    Number of subjects

  21. If a subject achieves overall PPG (1 hour) equal to or below 7.8 mmol/L [140 mg/dL] without severe hypoglycaemia [ Time Frame: 16 weeks after randomisation ]
    Number of subjects

  22. Insulin dose: units/day [ Time Frame: 16 weeks after randomisation ]
    Count of units

  23. Insulin dose: units/kg/day [ Time Frame: 16 weeks after randomisation ]
    Count of units

  24. Insulin dose: total basal dose [ Time Frame: 16 weeks after randomisation ]
    Count of units

  25. Insulin dose: total bolus dose [ Time Frame: 16 weeks after randomisation ]
    Count of units

  26. Insulin dose: individual meal insulin dose [ Time Frame: 16 weeks after randomisation ]
    Count of units

  27. Change from baseline in total cholesterol [ Time Frame: Week 0, week 16 ]
    Measured in mg/dl or other equivalent SI units

  28. Change from baseline in high density lipoproteins (HDL) cholesterol [ Time Frame: Week 0, week 16 ]
    Measured in mg/dl or other equivalent SI units

  29. Change from baseline in low density lipoproteins (LDL) cholesterol [ Time Frame: Week 0, week 16 ]
    Measured in mg/dl or other equivalent SI units

  30. Number of treatment emergent adverse events (AEs) [ Time Frame: Weeks 0-16 ]
    Count of events

  31. Number of treatment emergent injection site reactions [ Time Frame: Weeks 0-16 ]
    Count of reactions

  32. Number of treatment emergent hypoglycaemic episodes classified both according to the American Diabetes Association (ADA) definition and Novo Nordisk definition: Overall [ Time Frame: Weeks 0-16 ]
    Count of episodes

  33. Number of treatment emergent hypoglycaemic episodes classified both according to the American Diabetes Association (ADA) definition and Novo Nordisk definition: Daytime hypoglycaemic episodes [ Time Frame: Weeks 0-16 ]
    Count of episodes

  34. No. of treatment emergent hypoglycaemic episodes classified both according to the American Diabetes Association (ADA) definition and Novo Nordisk (NN) definition: Nocturnal hypoglycaemic episodes (00:01-05:59 - inclusive) [ Time Frame: Weeks 0-16 ]
    Count of episodes

  35. No. of treatment emergent hypoglycaemic episodes classified both according to the ADA definition and NN definition: Hypoglycaemic episodes from start of meal until 1, 2, 4 hours and from 2 hours (exclusive) to 4 hours (inclusive) after start of meal [ Time Frame: Weeks 0-16 ]
    Count of episodes

  36. Change from baseline in diastolic blood pressure [ Time Frame: Week 0, week 16 ]
    Measured in mmHg

  37. Change from baseline in systolic blood pressure [ Time Frame: Week 0, week 16 ]
    Measured in mmHg

  38. Change from baseline in pulse [ Time Frame: Week 0, week 16 ]
    Count of beats

  39. Change from baseline in erythrocytes [ Time Frame: Week 0, week 16 ]
    Measured in appropriate SI unit

  40. Change from baseline in haematocrit [ Time Frame: Week 0, week 16 ]
    Measured in appropriate SI unit

  41. Change from baseline in haemoglobin [ Time Frame: Week 0, week 16 ]
    Measured in appropriate SI unit

  42. Change from baseline in leucocytes [ Time Frame: Week 0, week 16 ]
    Measured in appropriate SI unit

  43. Change from baseline in thrombocytes [ Time Frame: Week 0, week 16 ]
    Measured in appropriate SI unit

  44. Change from baseline in alanine aminotransferase (ALT) [ Time Frame: Week 0, week 16 ]
    Measured in appropriate SI unit

  45. Change from baseline in aspartate aminotransferase (AST) [ Time Frame: Week 0, week 16 ]
    Measured in appropriate SI unit

  46. Change from baseline in albumin [ Time Frame: Week 0, week 16 ]
    Measured in appropriate SI unit

  47. Change from baseline in alkaline phosphatase [ Time Frame: Week 0, week 16 ]
    Measured in appropriate SI unit

  48. Change from baseline in creatinine [ Time Frame: Week 0, week 16 ]
    Measured in appropriate SI unit

  49. Change from baseline in potassium [ Time Frame: Week 0, week 16 ]
    Measured in appropriate SI unit

  50. Change from baseline in sodium [ Time Frame: Week 0, week 16 ]
    Measured in appropriate SI unit

  51. Change from baseline in total bilirubin [ Time Frame: Week 0, week 16 ]
    Measured in appropriate SI unit

  52. Change from baseline in body weight [ Time Frame: Week 0, week 16 ]
    Measured in kg

  53. Change from baseline in body mass index [ Time Frame: Week 0, week 16 ]
    Measured in kg/sqm


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
Inclusion Criteria: - Male or female, age equal to or above 18 years at the time of signing informed consent. - Diagnosed with type 2 diabetes mellitus for 10 years or longer prior to screening (Visit 1). - Treated with a basal-bolus insulin regimen for 1 year or longer prior to the day of screening (Visit 1). A basal-bolus insulin regimen is defined as basal insulin once or twice daily and bolus insulin analogue taken with meals at least 3 times daily. Treatment with premixed insulin or soluble insulin combination is not considered a basal-bolus regimen. - Treated with or without oral antidiabetic drugs including extended release formulations. - HbA1c 7.0-10.0% (both inclusive) as assessed by central laboratory at screening (Visit 1). Exclusion Criteria: - Any of the following: myocardial infarction, stroke, hospitalization for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening (Visit 1). - Subjects presently classified as being in New York Heart Association (NYHA) Class IV. - Planned coronary, carotid or peripheral artery revascularisation known on the day of screening (Visit 1). - Treatment with injectable GLP-1 receptor agonists in a period of 90 days prior to screening (Visit 1). - Anticipated initiation or change in concomitant medications (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g. treatment with orlistat, thyroid hormones, or corticosteroids).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03268005


Locations
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Sponsors and Collaborators
Novo Nordisk A/S
More Information
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT03268005    
Other Study ID Numbers: NN1218-4113
U1111-1180-0636 ( Other Identifier: World Health Organization (WHO) )
2016-000878-38 ( Registry Identifier: European Medicines Agency (EudraCT) )
First Posted: August 31, 2017    Key Record Dates
Last Update Posted: May 15, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin, Globin Zinc
 Metformin
Insulin Aspart
Insulin, Long-Acting
Insulin degludec, insulin aspart drug combination
Hypoglycemic Agents
Physiological Effects of Drugs