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Efficacy and Safety of Faster-acting Insulin Aspart Compared to NovoRapid® Both in Combination With Insulin Degludec in Adults With Type 1 Diabetes (onset®8)

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ClinicalTrials.gov Identifier: NCT02500706
Recruitment Status : Completed
First Posted : July 16, 2015
Results First Posted : August 10, 2018
Last Update Posted : June 12, 2019
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
This trial is conducted in Asia, Europe and North America. The purpose is to confirm efficacy in terms of glycaemic control of treatment with mealtime faster-acting insulin aspart in combination with insulin degludec in adults with Type 1 Diabetes Mellitus.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 1 Drug: Faster-acting insulin aspart Drug: insulin aspart Drug: insulin degludec Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Faster-acting Insulin Aspart Compared to NovoRapid® Both in Combination With Insulin Degludec in Adults With Type 1 Diabetes
Actual Study Start Date : May 4, 2016
Actual Primary Completion Date : July 17, 2017
Actual Study Completion Date : August 16, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: Mealtime faster-acting insulin aspart and insulin degludec Drug: Faster-acting insulin aspart
Injected subcutaneously (under the skin) three times daily for 26 weeks. Dose individually adjusted. Mealtime dosing is defined as injecting 0-2 minutes before the meal. Postmeal dosing is defined as injecting 20 minutes after the start of the meal.

Drug: insulin degludec
Injected subcutaneously (under the skin) once daily for 26 weeks. Dose individually adjusted

Active Comparator: Mealtime NovoRapid® and insulin degludec Drug: insulin aspart
Injected subcutaneously (under the skin) three times daily for 26 weeks. Dose individually adjusted. Mealtime dosing is defined as injecting 0-2 minutes before the meal.

Drug: insulin degludec
Injected subcutaneously (under the skin) once daily for 26 weeks. Dose individually adjusted

Experimental: Postmeal faster-acting insulin aspart and insulin degludec Drug: Faster-acting insulin aspart
Injected subcutaneously (under the skin) three times daily for 26 weeks. Dose individually adjusted. Mealtime dosing is defined as injecting 0-2 minutes before the meal. Postmeal dosing is defined as injecting 20 minutes after the start of the meal.

Drug: insulin degludec
Injected subcutaneously (under the skin) once daily for 26 weeks. Dose individually adjusted




Primary Outcome Measures :
  1. Change From Baseline in HbA1c 26 Weeks After Randomisation [ Time Frame: Week 0, week 26 ]
    Change from baseline (week 0) in HbA1c was evaluated after 26 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In-trial period: the observation period from date of randomisation until last trial-related subject-site contact.


Secondary Outcome Measures :
  1. Change From Baseline in 1-hour Post Prandial Glucose (PPG) Increment 26 Weeks After Randomisation (Meal Test) [ Time Frame: Week 0, week 26 ]
    The 1-hour PPG increment was analysed based on the laboratory-measured values in the meal test, and was derived using the 1-hour PPG measurement minus the pre-prandial plasma glucose (PG). The results are based on the last in-trial value, which included the last available measurement in the in-trial period.

  2. Change From Baseline in 1,5-anhydroglucitol 26 Weeks After Randomisation [ Time Frame: Week 0, week 26 ]
    The results are based on the last in-trial value, which included the last available measurement in the in-trial period.

  3. Change From Baseline in Fasting Plasma Glucose (FPG) 26 Weeks After Randomisation [ Time Frame: Week 0, week 26 ]
    The results are based on the last in-trial value, which included the last available measurement in the in-trial period.

  4. Percentage of Subjects Reaching HbA1c Targets (HbA1c < 7.0%) 26 Weeks After Randomisation [ Time Frame: 26 weeks after randomisation ]
    The percentage of subjects who achieved the HbA1c target of <7.0% 26 weeks after randomisation. Subjects without an HbA1c measurement at week 26 were treated as non-responders.

  5. Percentage of Subjects Reaching HbA1c Targets (HbA1c < 7.0% Without Severe Hypoglycaemia) 26 Weeks After Randomisation [ Time Frame: 26 weeks after randomisation ]
    The percentage of subjects who achieved the HbA1c target of <7.0% without severe hypoglycaemia 26 weeks after randomisation. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration. Subjects without an HbA1c measurement at week 26 were treated as non-responders.

  6. Percentage of Subjects Reaching HbA1c Targets (HbA1c < 7.0% Without Severe Hypoglycaemia and Minimal Weight Gain [<3.0%]) 26 Weeks After Randomisation [ Time Frame: 26 weeks after randomisation ]
    The percentage of subjects who achieved the HbA1c target of <7.0% without severe hypoglycaemia and with minimal weight gain (defined as less than a 3% increase) 26 weeks after randomisation. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration. Subjects without an HbA1c measurement at week 26 or without body weight measurement at week 26 were treated as non-responders.

  7. Change From Baseline in 30- Min, 1- Hour, 2- Hour, 3- Hour and 4- Hour PPG 26 Weeks After Randomisation [ Time Frame: Week 0, week 26 ]
    Laboratory measured PG from the meal test was analysed for 30, 60, 120, 180, and 240 minutes PPG separately. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.

  8. Change From Baseline in 30- Min, 1- Hour, 2- Hour, 3- Hour and 4- Hour PPG Increment 26 Weeks After Randomisation [ Time Frame: Week 0, week 26 ]
    Laboratory measured PG from the meal test was analysed for 30, 60, 120, 180, and 240 minutes PPG separately. The corresponding PPG increments were derived separately using each PPG measurement minus the pre-prandial PG. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.

  9. Change From Baseline in 7-9-7-point Self-measured Plasma Glucose (SMPG) 26 Weeks After Randomisation: Mean of the 7-9-7-point Profile [ Time Frame: Week 0, week 26 ]
    The subject was instructed to perform a 7-9-7 SMPG point profile on the 3 consecutive days just before selected visit. 7-point profile (day 3 and day 1 before selected visit): before breakfast, 60 minutes after the start of breakfast, before lunch, 60 minutes after the start of lunch, before main evening meal, 60 minutes after the start of main evening meal, and at bedtime. 9-point profile (day 2 before selected visit) included all timepoints of 7-points profile with addition of SMPG measurement at 4 a.m. and before breakfast on the following day. The mean of the 7-9-7-point profile was defined as the area under the curve profile divided by the measurement time, and was calculated using the linear trapezoidal technique. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.

  10. Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: PPG (Mean, Breakfast, Lunch, Main Evening Meal) [ Time Frame: Week 0, week 26 ]
    The subject was instructed to perform a 7-9-7 SMPG point profile on the 3 consecutive days just before selected visit. 7-point profile (day 3 and day 1 before selected visit): before breakfast, 60 minutes after the start of breakfast, before lunch, 60 minutes after the start of lunch, before main evening meal, 60 minutes after the start of main evening meal, and at bedtime. 9-point profile (day 2 before selected visit) included all timepoints of 7-points profile with addition of SMPG measurement at 4 a.m. and before breakfast on the following day. Results were derived from the three profiles: post-breakfast, post-lunch, post-main evening meal. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.

  11. Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: PPG Increment (Mean, Breakfast, Lunch, Main Evening Meal) [ Time Frame: Week 0, week 26 ]
    The subject was instructed to perform a 7-9-7 SMPG point profile on the 3 consecutive days just before selected visit. 7-point profile (day 3 and day 1 before selected visit): before breakfast, 60 minutes after the start of breakfast, before lunch, 60 minutes after the start of lunch, before main evening meal, 60 minutes after the start of main evening meal, and at bedtime. 9-point profile (day 2 before selected visit) included all timepoints of 7-points profile with addition of SMPG measurement at 4 a.m. and before breakfast on the following day. PPG increment for each meal (breakfast, lunch, main evening meal) was derived from the 7-point and 9-point profile as the difference between PPG values and the PG value before the meal in each separate profile. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.

  12. Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: Fluctuation in 7-9-7-point Profile [ Time Frame: Week 0, week 26 ]
    The subject was instructed to perform a 7-9-7 SMPG point profile on the 3 consecutive days just before selected visit. 7-point profile (day 3 and day 1 before selected visit): before breakfast, 60 minutes after the start of breakfast, before lunch, 60 minutes after the start of lunch, before main evening meal, 60 minutes after the start of main evening meal, and at bedtime. 9-point profile (day 2 before selected visit) included all timepoints of 7-points profile with addition of SMPG measurement at 4 a.m. and before breakfast on the following day. Fluctuation in SMPG profile was the average absolute difference from the mean of the SMPG profile. Change from baseline is represented as ratio to baseline value. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.

  13. Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: Change in the Nocturnal Self-measured Plasma Glucose Measurements [ Time Frame: Week 0, week 26 ]
    The subject was instructed to perform 7-9-7 SMPG point profile on 3 consecutive days just before selected visit. 7-point profile (day 3 and day 1 before selected visit): before breakfast,60 minutes after the start of breakfast,before lunch,60 minutes after the start of lunch, before main evening meal,60 minutes after the start of main evening meal,and at bedtime. 9-point profile (day 2 before selected visit) included all timepoints of 7-points profile with addition of SMPG measurement at 4 a.m. and before breakfast on following day. Change from baseline in nocturnal PG values (nocturnal increments) was assessed by considering differences between PG values available at bedtime, at 4 a.m and the before breakfast value the following day: (04:00 PG value minus at bedtime PG value), (before breakfast PG value minus at bedtime PG value) and (before breakfast PG value minus 04:00 PG value). Results are based on the last in-trial value (the last available measurement in the in-trial period).

  14. Percentage of Subjects Reaching PPG Target (Overall Mean of Daily PPG Measurements in SMPG) 26 Weeks After Randomisation: Overall PPG (1 Hour) ≤7.8 mmol/L [ Time Frame: 26 weeks after randomisation ]
    Percentage of subjects achieving an overall mean 1-hour PPG ≤7.8 mmol/L [140 mg/dL] 26 weeks after randomisation. Subjects without an overall mean 1-hour PPG at week 26 were treated as non-responders.

  15. Percentage of Subjects Reaching PPG Target (Overall Mean of Daily PPG Measurements in SMPG) 26 Weeks After Randomisation: Overall PPG (1 Hour) ≤7.8 mmol/L Without Severe Hypoglycaemia [ Time Frame: 26 weeks after randomisation ]
    Percentage of subjects achieving an overall mean 1-hour PPG ≤7.8 mmol/L [140 mg/dL] 26 weeks after randomisation without severe hypoglycaemia. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration. Subjects without an overall mean 1-hour PPG at week 26 were treated as non-responders.

  16. Percentage of Subjects Reaching PPG Target (Overall Mean of Daily PPG Measurements in SMPG) 26 Weeks After Randomisation: Overall PPG (1 Hour) ≤7.8 mmol/L and HbA1c <7.0% and Minimal Weight Gain (<3.0%) Without Severe Hypoglycaemia [ Time Frame: 26 weeks after randomisation ]
    The percentage of subjects who achieved overall mean 1 hour PPG ≤7.8 mmol/L [140 mg/dL], had HbA1c < 7.0% and had minimal weight gain (increase in body weight from baseline <3.0%) 26 weeks after randomisation, and without severe hypoglycaemic episodes. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration. Subjects without an overall mean 1-hour PPG or an HbA1c value or a body weight at week 26 were treated as non-responders.

  17. Change From Baseline in Lipids-lipoproteins Profile 26 Weeks After Randomisation (Total Cholesterol, High Density Lipoproteins [HDL] Cholesterol, Low Density Lipoproteins [LDL] Cholesterol) [ Time Frame: Week 0, week 26 ]
    Change from baseline in HDL cholesterol, LDL cholesterol and total cholesterol 26 weeks after randomization are represented as ratio to baseline values. The results are based on the last in-trial value (the last available measurement in the in-trial period).

  18. Insulin Dose (Basal Insulin Dose, Total and Individual Meal Insulin Dose) [ Time Frame: Week 0, week 26 ]
    The insulin doses were summarised descriptively at week 0 and week 26 both by meal type and as total daily dose (total daily and separately for each mealtime dose). Week 26 results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.

  19. Number of Treatment Emergent Adverse Events During 26 Weeks After Randomisation [ Time Frame: Week 0 to week 26 (+7 days) ]
    A treatment emergent adverse event (TEAE) was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.

  20. Number of Treatment-emergent Injection Site Reactions During the 26 Weeks After Randomisation [ Time Frame: Week 0 to week 26 (+7 days) ]
    A treatment emergent event was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.

  21. Number of Hypoglycaemic Episodes Classified Both According to the American Diabetes Association (ADA) Definition and Novo Nordisk (NN) Definition During 26 Weeks After Randomisation: Overall [ Time Frame: Week 0 to week 26 (+1 day) ]

    ADA classification includes following criteria: Severe,Documented symptomatic,Asymptomatic,Probable symptomatic,Pseudo-hypoglycaemia.

    NN Classification:

    • Severe:same as per ADA classification
    • Symptomatic blood glucose (BG) confirmed: PG<3.1 mmol/L with symptoms consistent with hypoglycaemia
    • Asymptomatic BG confirmed:PG<3.1 mmol/L without symptoms consistent with hypoglycaemia
    • Severe or BG confirmed symptomatic:severe according to ADA classification or BG confirmed by PG<3.1 mmol/L with symptoms consistent with hypoglycaemia
    • BG confirmed:PG<3.1 mmol/L with or without symptoms consistent with hypoglycaemia
    • Severe or BG confirmed:severe according to ADA classification or BG confirmed by PG<3.1 mmol/L with or without symptoms consistent with hypoglycaemia
    • Unclassifiable Results represent total number of hypoglycaemic episodes. Treatment emergent episode: an event that has onset up to 1 day after last day of randomised treatment and excluding events occurring in run-in period.

  22. Number of Hypoglycaemic Episodes Classified Both According to the ADA Definition and Novo Nordisk Definition During 26 Weeks After Randomisation: Daytime and Nocturnal Hypoglycaemic Episodes (00:01-05:59 - Inclusive) [ Time Frame: Week 0 to week 26 (+1 day) ]

    ADA classification includes following criteria: Severe, Documented symptomatic, Asymptomatic, Probable symptomatic, Pseudo-hypoglycaemia.

    NN Classification:

    • Severe: same as per ADA classification
    • Symptomatic BG confirmed: PG<3.1 mmol/L with symptoms consistent with hypoglycaemia
    • Asymptomatic BG confirmed: PG<3.1 mmol/L without symptoms consistent with hypoglycaemia
    • Severe or BG confirmed symptomatic: severe according to the ADA classification or BG confirmed by PG<3.1 mmol/Lwith symptoms consistent with hypoglycaemia
    • BG confirmed: PG<3.1 mmol/L with or without symptoms consistent with hypoglycaemia
    • Severe or BG confirmed: severe according to the ADA classification or BG confirmed by PG<3.1 mmol/L with or without symptoms consistent with hypoglycaemia
    • Unclassifiable Results represent total number of hypoglycaemic episodes. Nocturnal hypoglycaemic episodes were episodes occurring between 00:01 and 05:59 both inclusive.

  23. Number of Hypoglycaemic Episodes Classified Both According to the ADA Definition and Novo Nordisk Definition During 26 Weeks After Randomisation: From Start of Meal Until 1,2, 4 Hours and From 2 Hours (Exclusive) to 4 Hours (Inclusive) After Start of Meal [ Time Frame: Week 0 to week 26 (+1 day) ]

    ADA classification includes following criteria: Severe, Documented symptomatic, Asymptomatic, Probable symptomatic, Pseudo-hypoglycaemia.

    NN Classification:

    • Severe: same as per ADA classification
    • Symptomatic BG confirmed: PG<3.1 mmol/L with symptoms consistent with hypoglycaemia
    • Asymptomatic BG confirmed: PG<3.1 mmol/L without symptoms consistent with hypoglycaemia
    • Severe or BG confirmed symptomatic: severe according to the ADA classification or BG confirmed by PG<3.1 mmol/Lwith symptoms consistent with hypoglycaemia
    • BG confirmed: PG<3.1 mmol/L with or without symptoms consistent with hypoglycaemia
    • Severe or BG confirmed: severe according to the ADA classification or BG confirmed by PG<3.1 mmol/L with or without symptoms consistent with hypoglycaemia
    • Unclassifiable Results represent total number of hypoglycaemic episodes related to meals.

  24. Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) [ Time Frame: Week 0, week 26 ]
    The physical examination parameters included head, ears, eyes, nose, throat, neck; respiratory system; cardiovascular system; gastrointestinal system including mouth; musculoskeletal system; central and peripheral nervous system; and skin. The examinations were measured as 'normal', 'abnormal, not clinically significant' (Abn, NCS) or 'abnormal, clinically significant' (Abn, CS). Reported results are percentage of subjects with 'normal', 'Abn, NCS' and 'Abn, CS' physical examinations at week 0 and week 26. Week 26 results are based on the last on-treatment value (last value), which included the last available measurement in the on-treatment period.

  25. Change From Baseline in Blood Pressure 26 Weeks After Randomisation [ Time Frame: Week 0, week 26 ]
    Change from baseline in systolic blood pressure and diastolic blood pressure 26 weeks after randomisation. Results are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.

  26. Change From Baseline in Pulse 26 Weeks After Randomisation [ Time Frame: Week 0, week 26 ]
    Results are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.

  27. Change From Baseline in Clinical Evaluation (Electrocardiogram) 26 Weeks After Randomisation [ Time Frame: Week 0, week 26 ]
    The electrocardiogram was interpreted by the investigator into following categories: Normal; Abn, NCS; Abnormal, CS. Reported results are percentage of subjects with 'normal', 'Abn, NCS' and 'Abn, CS' physical examinations at week 0 and week 26. Week 26 data are based on the last on-treatment value which contains the last available measurement in the on-treatment period.

  28. Change From Baseline in Clinical Evaluation (Fundoscopy/Fundus Photography) 26 Weeks After Randomisation [ Time Frame: Week 0, week 26 ]
    The result of the fundus photography/dilated fundoscopy was interpreted by the investigator into following categories: Normal; Abn, NCS; Abnormal, CS. Reported results are percentage of subjects with 'normal', 'Abn, NCS' and 'Abn, CS' fundoscopy/fundus photography results at week 0 and week 26. Week 26 data are based on the last on-treatment value which contains the last available measurement in the on-treatment period.

  29. Change From Baseline in Erythrocytes 26 Weeks After Randomisation [ Time Frame: Week 0, week 26 ]
    Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.

  30. Change From Baseline in Haematocrit 26 Weeks After Randomisation [ Time Frame: Week 0, week 26 ]
    Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.

  31. Change From Baseline in Haemoglobin 26 Weeks After Randomisation [ Time Frame: Week 0, week 26 ]
    Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.

  32. Change From Baseline in Leukocytes 26 Weeks After Randomisation [ Time Frame: Week 0, week 26 ]
    Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.

  33. Change From Baseline in Thrombocytes 26 Weeks After Randomisation [ Time Frame: Week 0, week 26 ]
    Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.

  34. Change From Baseline in Alanine Aminotransferase 26 Weeks After Randomisation [ Time Frame: Week 0, week 26 ]
    Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.

  35. Change From Baseline in Albumin 26 Weeks After Randomisation [ Time Frame: Week 0, week 26 ]
    Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.

  36. Change From Baseline in Alkaline Phosphatase 26 Weeks After Randomisation [ Time Frame: Week 0, week 26 ]
    Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.

  37. Change From Baseline in Aspartate Aminotransferase 26 Weeks After Randomisation [ Time Frame: Week 0, week 26 ]
    Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.

  38. Change From Baseline in Total Bilirubin 26 Weeks After Randomisation [ Time Frame: Week 0, week 26 ]
    Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.

  39. Change From Baseline in Potassium 26 Weeks After Randomisation [ Time Frame: Week 0, week 26 ]
    Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.

  40. Change From Baseline in Creatinine 26 Weeks After Randomisation [ Time Frame: Week 0, week 26 ]
    Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.

  41. Change From Baseline in Total Protein 26 Weeks After Randomisation [ Time Frame: Week 0, week 26 ]
    Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.

  42. Change From Baseline in Urinary Albumin-to-creatinine Ratio 26 Weeks After Randomisation [ Time Frame: Week 0, week 26 ]
    Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.

  43. Change From Baseline in Urinalysis (Ketones) 26 Weeks After Randomisation [ Time Frame: Week 0, week 26 ]
    Presence of ketone in urine was assessed by urine dipstick and categorised as: Negative, Positive, Trace, 1+, 2+, 3+. Change from baseline is represented in terms of percentage of patients with ketone values at week 0 and week 26 (last on-treatment value). Last on-treatment value contains the last available measurement in the on-treatment period.

  44. Change From Baseline in Urinalysis (Protein) 26 Weeks After Randomisation [ Time Frame: Week 0, week 26 ]
    Presence of protein in urine was assessed by urine dipstick and categorised as: Negative, Positive, Trace, 1+, 2+, 3+. Change from baseline is represented in terms of percentage of patients with protein values at week 0 and week 26 (last on-treatment value). Last on-treatment value contains the last available measurement in the on-treatment period.

  45. Change From Baseline in Urinalysis (Erythrocytes) 26 Weeks After Randomisation [ Time Frame: Week 0, week 26 ]
    Presence of erythrocytes in urine was assessed by urine dipstick and categorised as: Negative, Positive, Trace, 1+, 2+, 3+. Change from baseline is represented in terms of percentage of patients with erythrocytes values at week 0 and week 26 (last on-treatment value). Last on-treatment value contains the last available measurement in the on-treatment period.

  46. Change From Baseline in Anti-insulin Aspart (Specific and Cross-reacting With Human Insulin) Antibody Development 26 Weeks After Randomisation [ Time Frame: Week 0, week 26 ]
    Insulin aspart antibody titres (antibodies specific for insulin aspart and those cross-reacting with human insulin) measured at baseline and at 26 weeks. Week 26 data are based on the last on-treatment value which contains the last available measurement in the on-treatment period. Anti-insulin aspart antibody was measured as % bound radioactivity-labelled insulin aspart/Total added radioactivity-labelled insulin aspart (%B/T).

  47. Change From Baseline in Body Weight 26 Weeks After Randomisation [ Time Frame: Week 0, week 26 ]
    The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.

  48. Change From Baseline in Body Mass Index 26 Weeks After Randomisation [ Time Frame: Week 0, week 26 ]
    The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.



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 greater than or equal to 18 years ( for Japan and Taiwan: age greater than or equal to 20 years) at the time of signing informed consent - Type 1 Diabetes Mellitus (based on clinical judgement and/or supported by laboratory analysis as per local guidelines) 12 months or more prior to screening - Currently treated with a basal-bolus insulin regimen for at least 12 months prior to screening (Visit 1) - Currently treated with a basal insulin analogue for at least 4 months prior to screening (Visit 1) - HbA1c 7.0-9.5% (53-80 mmol/mol) (both inclusive) as assessed by central laboratory - Body Mass Index less than or equal to 35.0 kg/m^2 Exclusion Criteria: - Within the past 180 days any of the following: myocardial infarction, stroke or hospitalization for unstable angina and/or transient ischemic attack - Subjects presently classified as being in New York Heart Association (NYHA) Class IV Currently planned coronary, carotid or peripheral artery revascularisation - Diabetic ketoacidosis requiring hospitalisation within the last 180 days prior to screening (Visit 1) - Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of three months before screening (Visit 1)

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): NCT02500706


  Show 152 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
  Study Documents (Full-Text)

Documents provided by Novo Nordisk A/S:
Study Protocol  [PDF] March 13, 2018
Statistical Analysis Plan  [PDF] March 13, 2018


Additional Information:
Publications of Results:
Other Publications:
Layout table for additonal information
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT02500706     History of Changes
Other Study ID Numbers: NN1218-4131
2015-001047-36 ( EudraCT Number )
U1111-1167-9495 ( Other Identifier: WHO )
First Posted: July 16, 2015    Key Record Dates
Results First Posted: August 10, 2018
Last Update Posted: June 12, 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:
Layout table for MeSH terms
Insulin
Insulin, Globin Zinc
Insulin Aspart
Insulin, Long-Acting
Insulin degludec, insulin aspart drug combination
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs