Phase 3
N=331
Research Study to Compare a New Medicine "Fast-acting Insulin Aspart" to Another Medicine "Insulin Aspart" in Chinese People With Diabetes
Diabetes Mellitus, Type 1 · Diabetes Mellitus, Type 2
Bottom Line
View on ClinicalTrials.gov: NCT04588259 ↗Enrolled (actual)
331
Serious AEs
4.1%
Results posted
Mar 2024
Primary outcome: Primary: Change From Baseline in Glycosylated Haemoglobin (HbA1c) (Percentage [%]) — -0.57; -0.54 Percentage of HbA1c — p=0.5102
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Faster aspart (Drug); Insulin aspart (Drug); Insulin degludec (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Novo Nordisk A/S
- Primary completion
- Jul 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Glycosylated Haemoglobin (HbA1c) (Percentage [%]) |
-0.57; -0.54 | 0.5102 |
| PRIMARY Change From Baseline in HbA1c (Millimoles Per Mole [mmol/Mol]) |
-6.18; -5.89 | 0.5102 |
| SECONDARY Change From Baseline in 30-minutes, 1-hour, 2-hour and 3-hour Post Prandial Glucose (PPG) Increment (Meal Test) |
-1.01; 0.18; -0.94; 0.46; 0.21; 0.64 | — |
| SECONDARY Change From Baseline in 30-minutes, 1-hour, 2-hour and 3-hour PPG (Meal Test) |
-0.64; 0.37; -0.55; 0.64; 0.60; 0.81 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) |
0.39; 0.20 | — |
| SECONDARY Change From Baseline in 7-9-7-point Self-measured Plasma Glucose (SMPG) for Mean of the 7-9-7-point Profile |
-0.73; -0.76 | — |
| SECONDARY Change From Baseline in 7-9-7-point SMPG for 1-hour PPG (Mean, Breakfast, Lunch, Main Evening Meal) |
-1.01; -0.37; -1.16; -1.07; -1.34; -0.68 | — |
| SECONDARY Change From Baseline in 7-9-7-point SMPG for PPG Increment (Mean, Breakfast, Lunch, Main Evening Meal) |
-1.37; -0.49; -1.09; -0.19; -0.34; 0.15 | — |
| SECONDARY Change From Baseline in 7-9-7-point SMPG for Fluctuation in 7-9-7-point Profile: Ratio to Baseline |
0.77; 0.73 | — |
| SECONDARY Number of Participants Who Achieved HbA1c Less Than (<) 7.0 (Percent [%]) (Yes/No) |
59; 55; 91; 95 | — |
| SECONDARY Number of Participants Who Achieved HbA1c <7.0% Without Severe Hypoglycaemia Episodes (Yes/No) |
59; 55; 91; 95 | — |
| SECONDARY Number of Participants Who Achieved PPG Target (Overall Mean of Daily PPG Measurements in SMPG) for Overall PPG (1-hour) Less Than or Equal (≤) to 7.8 mmol/L (Yes/No) |
61; 51; 89; 99 | — |
| SECONDARY Number of Participants Who Achieved PPG Target (Overall Mean of Daily PPG Measurements in SMPG) for Overall PPG (1-hour) Less Than or Equal (≤) to 7.8 mmol/L Without Severe Hypoglycaemia (Yes/No) |
61; 51; 89; 99 | — |
| SECONDARY Insulin Dose (Units/Day): Total Basal |
27.01; 27.21 | — |
| SECONDARY Insulin Dose (Units/Day): Total Bolus |
39.49; 39.16 | — |
| SECONDARY Insulin Dose (Units/Day): Individual Meal Insulin Dose |
12.00; 11.54; 13.67; 13.84; 13.82; 13.78 | — |
| SECONDARY Insulin Dose (Units/kg/Day): Total Basal |
0.37; 0.39 | — |
| SECONDARY Insulin Dose (Units/kg/Day): Total Bolus |
0.56; 0.57 | — |
| SECONDARY Insulin Dose (Units/kg/Day): Individual Meal Insulin Dose |
0.17; 0.17; 0.19; 0.20; 0.20; 0.20 | — |
| SECONDARY Number of Treatment Emergent Adverse Events (TEAEs) |
285; 263 | — |
| SECONDARY Number of Treatment Emergent Injection Site Reactions |
0; 0 | — |
| SECONDARY Number of Treatment Emergent Hypoglycaemic Episodes Classified Both According to the American Diabetes Association (ADA) Definition and Novo Nordisk (NN) Definition: Overall |
1; 0; 915; 971; 453; 402 | — |
| SECONDARY Number of Treatment Emergent Hypoglycaemic Episodes Classified Both According to the ADA Definition and NN Definition: Day Time Hypoglycaemic Episodes (00:01-05:59 - Both Inclusive) |
0; 0; 863; 927; 440; 390 | — |
| SECONDARY Number of Treatment Emergent Hypoglycaemic Episodes Classified Both According to the ADA Definition and NN Definition: Nocturnal Hypoglycaemic Episodes (00:01-05:59 - Both Inclusive) |
0; 0; 49; 43; 10; 10 | — |
| SECONDARY Number of Treatment Emergent Hypoglycaemic Episodes Classified Both According to the ADA Definition and NN Definition: Hypoglycaemic Episodes From Start of Meal Until 30 Minutes |
0; 0; 6; 8; 1; 1 | — |
| SECONDARY Number of Treatment Emergent Hypoglycaemic Episodes Classified Both According to the ADA Definition and NN Definition: Hypoglycaemic Episodes From Start of Meal Until 1 Hour |
0; 0; 43; 41; 17; 17 | — |
| SECONDARY Number of Treatment Emergent Hypoglycaemic Episodes Classified Both According to the ADA Definition and NN Definition: Hypoglycaemic Episodes From Start of Meal Until 2 Hours |
0; 0; 126; 147; 33; 39 | — |
| SECONDARY Number of Treatment Emergent Hypoglycaemic Episodes Classified Both According to the ADA Definition and NN Definition: Hypoglycaemic Episodes From Start of Meal Until 4 Hours |
0; 0; 391; 433; 142; 133 | — |
| SECONDARY Number of Treatment Emergent Hypoglycaemic Episodes Classified Both According to the ADA Definition and NN Definition: Hypoglycaemic Episodes From 2 Hours (Exclusive) to 4 Hours (Inclusive) After Start of Meal |
0; 0; 265; 286; 109; 94 | — |
Summary
Fast-acting insulin aspart (faster aspart) will be tested to see how well it works and if it is safe. The study compares 2 medicines for type 1 and type 2 diabetes - faster aspart (a new medicine) and insulin aspart (a medicine doctors can already prescribe). Participants will either get faster aspart or insulin aspart (NovoRapid®) - which treatment is decided by chance. Both medicines will be taken together with insulin degludec. Participants will need to take 1 injection 4 times every day: 3 injections 0-2 minutes before breakfast, lunch and dinner and 1 injection at the same time every day. All study medicines are provided in pens. A pen is a tool to inject insulin under the skin.The study will last for about 7 months (30 weeks). Participants will have 11 clinic visits and 17 phone contacts with the study doctor. At 8 clinic visits participants will have blood samples taken. At 3 clinic visits participants cannot eat or drink (water is allowed) 8 hours before the visits - at 2 of these visits participants will be asked to drink a liquid meal and to stay at the clinic for about 5 hours. Participants will fill in a diary the last 3 days before the visits/phone contacts. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.
Eligibility Criteria
Inclusion Criteria
- Male or female, age above or equal to 18 years at the time of signing informed consent
- Diagnosed with Diabetes Mellitus, Type 1 (T1DM) at least or equal to 1 year prior to screening or diagnosed with Diabetes Mellitus, Type 2 (T2DM) at least or equal to 5 years prior to screening
- Treated with a basal-bolus insulin regimen or a premix insulin regimen at least or equal to 1 year prior to screening. Insulin regimen must be unchanged within 60 days prior to screening. A basal-bolus insulin regimen is defined as basal insulin once or twice daily and bolus insulin taken with meals at least thrice daily. A premix insulin regimen is defined as premix insulin twice or thrice daily
- For subjects with T1DM: not treated with any oral anti-diabetes drugs (OADs) for at least 90 days prior to screening. For subjects with T2DM: not treated with any OADs or treated with 1-2 OADs within 90 days prior to screening. Allowed OADs are metformin, alpha-glucosidase inhibitor, sodium-glucose co-transporter-2 inhibitors (SGLT2i) and dipeptidyl peptidase-4 inhibitors (DPP4i). Change in OAD and dose prior to screening is allowed.
- HbA1c 7.5-9.5% (both inclusive) as assessed by central laboratory at screening
Exclusion Criteria
- Any of the following: myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within the past 180 days prior to the day of screening
- 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
- Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within the past 90 days prior to the day of screening
- 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)
Data sourced from ClinicalTrials.gov (NCT04588259). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.