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Clinical Trials/NCT02825251
NCT02825251CompletedPhase 3

Efficacy and Safety of Continuous Subcutaneous Insulin Infusion of Faster-acting Insulin Aspart Compared to NovoRapid® in Adults With Type 1 Diabetes

Novo Nordisk A/S1 site in 1 country472 target enrollmentStarted: July 6, 2016Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
472
Locations
1
Primary Endpoint
Change in Glycosylated Haemoglobin (HbA1c)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to investigate efficacy and safety of Continuous Subcutaneous Insulin Infusion of Faster-acting Insulin Aspart compared to NovoRapid® in Adults with Type 1 Diabetes.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Male or female, age at least 18 years at the time of signing the informed consent
  • •Diagnosed with T1DM (Type 1 Diabetes Mellitus) (based on clinical judgement and/or supported by laboratory analysis as per local guidelines) equal or above 1 year prior to the day of screening
  • •Using the same Medtronic pump (Minimed 530G (551/751), Paradigm Veo (554/754), Paradigm Revel (523/723), Paradigm (522/722)) for CSII in a basal-bolus regimen with a rapid acting insulin analogue for at least six months prior to screening and willing to stay on the same pump model throughout the trial (if the model is changed the change should not exceed 7 consecutive days.)
  • •HbA1c (glycosylated haemoglobin) 7.0-9.0% (53-75 mmol/mol) as assessed by central laboratory at screening
  • •Body mass index (BMI) below or equal to 35.0 kg/m^2 at screening
  • •Ability and willingness to take at least 3 daily meal-time insulin bolus infusions every day throughout the trial

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
  • •Planned coronary, carotid or peripheral artery revascularisation known on the day of screening
  • •History of hospitalization for ketoacidosis below or equal to 180 days prior to the day of screening
  • •Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before screening
  • •Any condition which, in the opinion of the Investigator, might jeopardise a Subject's safety or compliance with the protocol

Arms & Interventions

Faster-acting insulin aspart CSII

Experimental

Intervention: Faster-acting insulin aspart (Drug)

NovoRapid® CSII

Active Comparator

Intervention: insulin aspart (Drug)

Outcomes

Primary Outcomes

Change in Glycosylated Haemoglobin (HbA1c)

Time Frame: Week 0, week 16

Change from baseline (week 0) in HbA1c was evaluated after 16 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 Outcomes

  • Percentage of Subjects Reaching Overall PPG (1 Hour) ≤7.8 mmol/L [140 mg/dL](Week 16)
  • Insulin Dose in Units/kg/Day: Total Bolus(Week 16)
  • Change From Baseline in 1-hour PPG Increment(Week 0, Week 16)
  • Change From Baseline in Time Spent in Low IG (≤3.9 mmol/L [70 mg/dL]) During CGM(Week 0, week 16)
  • Change From Baseline of the 7-7-9 Point SMPG Profile: in Nocturnal SMPG Measurements(Week 0, week 16)
  • Insulin Dose in Units/Day: Total Basal(Week 16)
  • Insulin Dose in Units/Day: Total Bolus(Week 16)
  • Insulin Dose in Units/Day: Individual Meal Insulin Dose(Week 16)
  • Insulin Dose in Units/kg/Day: Individual Meal Insulin Dose(Week 16)
  • Percentage of Time Spent With IG ≤2.5, 3.0, 3.5, 3.9 mmol/L [45, 54, 63, 70 mg/dL]) and IG >10.0, 12.0, 13.9 mmol/L [180, 216, 250 mg/dL])(Week 16)
  • Change From Baseline in 1,5-anhydroglucitol(Week 0, Week 16)
  • Change From Baseline in Fasting Plasma Glucose (FPG)(Week 0, week 16)
  • Percentage of Subjects Reaching HbA1c <7.0% (53 mmol/Mol)(Week 16)
  • Change From Baseline of the 7-7-9 Point SMPG Profile: PPG (Mean, Breakfast, Lunch and Main Evening Meal)(Week 0, week 16)
  • Change From Baseline in Lipids-lipoproteins Profile (Total Cholesterol, High Density Lipoproteins, Low Density Lipoproteins)(Week 0, week 16)
  • Insulin Dose in Units/Day: Total Daily Insulin Dose(Week 16)
  • Insulin Dose in Units/kg/Day: Total Basal(Week 16)
  • Insulin Dose in Units/kg/Day: Total Daily Insulin Dose(Week 16)
  • Change From Baseline in 30-min, 1-hour, 2-hour, 3-hour and 4-hour PPG (Meal Test)(Week 0, week 16)
  • Change From Baseline in 30-min, 2-hour, 3-hour and 4-hour PPG Increment (Meal Test)(Week 0, week 16)
  • Change From Baseline of the 7-7-9 Point SMPG Profile: Pre-prandial Plasma Glucose (PG) (Mean, Pre-breakfast, Pre-lunch, Pre-main Evening Meal)(Week 0, week 16)
  • Change From Baseline of the 7-7-9 Point SMPG Profile: Fluctuation in 7-7-9 Point Profile(Week 0, week 16)
  • Percentage of Subjects Reaching Overall PPG (1 Hour) ≤7.8 mmol/L [140 mg/dL] Without Severe Hypoglycaemia(Week 16)
  • Percentage of Subjects Reaching HbA1c <7.0% (53 mmol/Mol) Without Severe Hypoglycaemic Episodes(Week 16)
  • Change From Baseline in Mean of the 7-7-9 Point Self-measured Plasma Glucose (SMPG) Profile(Week 0, week 16)
  • Change From Baseline of the 7-7-9 Point SMPG Profile: PPG Increment (Mean, Breakfast, Lunch and Main Evening Meal)(Week 0, week 16)
  • Insulin Delivery Pump Parameter: Insulin Carbohydrate Ratio(Week 16)
  • Insulin Delivery Pump Parameter: Glucose Sensitivity Factor(Week 16)
  • Incidence of Episodes With IG ≤2.5, 3.0, 3.5, 3.9 mmol/L [45, 54, 63, 70 mg/dL]) and IG >10.0, 12.0, 13.9 mmol/L [180, 216, 250 mg/dL])(Week 16)
  • Insulin Delivery Pump Parameter: Active Insulin Time(Week 16)
  • Change From Baseline in Mean IG Increment (0-30 Min, 0-1 Hour and 0-2 Hours After Start of Meal) (Mean, Breakfast, Lunch and Main Evening Meal)(Week 0, week 16)
  • Change From Baseline in Mean Time to the IG Peak After Start of Meal (Mean, Breakfast, Lunch and Main Evening Meal)(Week 0, week 16)
  • Change From Baseline in Mean IG Peak After Start of Meal (Mean, Breakfast, Lunch and Main Evening Meal)(Week 0, week 16)
  • Change From Baseline in Mean of the IG Profile(Week 0, week 16)
  • Percentage of Time Spent Within IG Target Range 4.0-7.8 mmol/L (71-140 mg/dL) and 4.0-10 mmol/L (71-180 mg/dL)(Week 16)
  • Variation in the IG Profile(Week 16)
  • Area Under the Curve (AUC3.9-IG) for IG ≤3.9 mmol/L [70 mg/dL](Week 16)
  • Change From Baseline in AUCIG,0-2h(Week 0, week 16)
  • Change From Baseline in AUCIG,0-4h(Week 0, week 16)
  • Number of Treatment Emergent Infusion Site Reactions(Weeks 0-16)
  • Change From Baseline in AUCIG,0-15min(Week 0, week 16)
  • Change From Baseline in AUCIG,0-30min(Week 0, week 16)
  • Change From Baseline in AUCIG,0-1h(Week 0, week 16)
  • Change From Baseline in IG Peak After Start of Meal(Week 0, week 16)
  • Number of Treatment Emergent Adverse Events (AEs)(Weeks 0-16)
  • Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) and Novo Nordisk (NN) Definition: Overall(Weeks 0-16)
  • Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Nocturnal Hypoglycaemic Episodes (00:01-05:59 - Inclusive)(Weeks 0-16)
  • Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes During First 1 Hour After Start of the Meal(Weeks 0-16)
  • Change From Baseline in Time to the IG Peak After Start of Meal(Week 0, week 16)
  • Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Daytime Hypoglycaemic Episodes (06:00-00:00 - Inclusive)(Weeks 0-16)
  • Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes During First 2 Hours After Start of the Meal(Weeks 0-16)
  • Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes During First 4 Hours After Start of the Meal(Weeks 0-16)
  • Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes Occurring Between 1 Hour to 2 Hours After Start of the Meal(Weeks 0-16)
  • Number of Unexplained Episodes of Hyperglycaemia (Confirmed by SMPG)(Weeks 0-16)
  • Change From Baseline in Physical Examination: Cardiovascular System(Week 0, week 16)
  • Change From Baseline in Physical Examination: Central and Peripheral Nervous System(Week 0, week 16)
  • Change From Baseline in Physical Examination: Gastrointestinal System, Including the Mouth(Week 0, week 16)
  • Change From Baseline in Physical Examination: Musculoskeletal System(Week 0, week 16)
  • Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes Occurring Between 2 to 4 Hours After Start of the Meal(Weeks 0-16)
  • Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes Occurring Between 2 to 3 Hours After Start of the Meal(Weeks 0-16)
  • Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes Occurring Between 3 to 4 Hours After Start of the Meal(Weeks 0-16)
  • Change From Baseline in Physical Examination: Respiratory System(Week 0, week 16)
  • Change From Baseline in Physical Examination: Skin(Week 0, week 16)
  • Change From Baseline in Physical Examination: Head, Ears, Eyes, Nose, Throat and Neck(Week 0, week 16)
  • Change From Baseline in Vital Sign: Blood Pressure(Week 0, week 16)
  • Change From Baseline in Vital Sign: Pulse(Week 0, week 16)
  • Change From Screening in Electrocardiogram (ECG)(Week 0, week 16)
  • Change From Screening in Fundus Photography/Fundoscopy(Week 0, week 16)
  • Change From Baseline in Haematology: Haemoglobin(Week 0, week 16)
  • Change From Baseline in Haematology: Haematocrit(Week 0, week 16)
  • Change From Baseline in Haematology: Erythrocytes(Week 0, week 16)
  • Change From Baseline in Haematology: Thrombocytes(Week 0, week 16)
  • Change From Baseline in Haematology: Leucocytes(Week 0, week 16)
  • Change From Baseline in Biochemistry: Total Protein(Week 0, week 16)
  • Change From Baseline in Biochemistry: Creatinine(Week 0, week 16)
  • Change From Baseline in Biochemistry: Alanine Aminotransferase (ALT)(Week 0, week 16)
  • Change From Baseline in Biochemistry: Alkaline Phosphatase (ALP)(Week 0, week 16)
  • Change From Baseline in Urinalysis: Protein(Week 0, week 16)
  • Change From Baseline in Urinalysis: Albumin/Creatine Ratio(Week 0, week 16)
  • Change From Baseline in Urinalysis: Erythrocytes(Week 0, week 16)
  • Change From Baseline in Biochemistry: Aspartate Aminotransferase (AST)(Week 0, week 16)
  • Change From Baseline in Biochemistry: Total Bilirubin(Week 0, week 16)
  • Change From Baseline in Body Mass Index (BMI)(Week 0, week 16)
  • Change From Baseline in Biochemistry: Albumin(Week 0, week 16)
  • Change From Baseline in Biochemistry: Sodium(Week 0, week 16)
  • Change From Baseline in Biochemistry: Potassium(Week 0, week 16)
  • Change From Baseline in Body Weight(Week 0, week 16)
  • Number of Subjects With at Least One Non-routine Change-of-infusion-sets Categorised by Reasons for Change-of-infusion-sets(Week 0-16)
  • Change From Baseline in Urinalysis: Ketones(Week 0, week 16)
  • Number of Change-of-infusion-sets Per Week(Week 0-16)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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