Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
biphasic insulin aspart 30 · 54 trials · 4 indications
Change from baseline in HbA1c after 26 weeks of treatment. The response and change from baseline in response after 26 weeks are analysed using an analysis of covariance model with treatment, anti-diabetic therapy at screening and sex as fixed factors, age and baseline response as covariate. Missing values imputed using last observed value.
Mean change in HbA1c was evaluated from baseline (week 0) to end of Ramadan (day 29 of Ramadan).
Change from baseline in HbA1c after 26 weeks of treatment.
Change from baseline in HbA1c after 26 weeks of treatment.
Change in glycosylated haemoglobin A1c (HbA1c) from week 0 (baseline) to end of treatment (week 16)
HbA1c values offer evidence of the efficacy and durability of the insulin regimens.
HbA1c values offer evidence of the efficacy and durability of the insulin regimens.
Rate of major and minor hypoglycaemic episodes per patient year (1year=365.25days) of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose ≤ 55 mg/dL.
Rate of nocturnal major and minor hypoglycaemic episodes per patient year (1year=365.25days) of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose ≤ 55 mg/dL. Episodes were defined as nocturnal if the time of onset was between 23:00 and 05:59 (both inclusive).
| Arm | Type | Description |
|---|---|---|
| IDegAsp BID | EXPERIMENTAL | - |
| BIAsp 30 BID | ACTIVE_COMPARATOR | - |
| IDegAsp U100 BID | EXPERIMENTAL | - |
| BIAsp U100 BID | ACTIVE_COMPARATOR | - |
| BIAsp 50-50-30 | EXPERIMENTAL | Biphasic insulin aspart 50 administered before breakfast and lunch + biphasic insulin aspart 30 at dinner combined with metformin |
| BIAsp 30-30 | ACTIVE_COMPARATOR | Biphasic insulin aspart 30 administered before breakfast and dinner combined with metformin |
| Insulin detemir (basal insulin) | EXPERIMENTAL | Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a second insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen. |
| Insulin aspart (prandial insulin) | ACTIVE_COMPARATOR | Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. In the second and third years, a second insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen. |
| Biphasic insulin aspart 30 (biphasic insulin) | ACTIVE_COMPARATOR | Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. In the second and third years, a second insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen. |
| BIAsp 30 | EXPERIMENTAL | - |
| A | EXPERIMENTAL | - |
| BIAsp | EXPERIMENTAL | - |
| BHI | EXPERIMENTAL | - |
| BIAsp 50 or 70 | EXPERIMENTAL | - |
| BHI 30 | ACTIVE_COMPARATOR | - |
| BIAsp 70 | EXPERIMENTAL | - |
| BIAsp 70 + BIAsp 50 | EXPERIMENTAL | - |
| B | ACTIVE_COMPARATOR | - |
| Mix30 | ACTIVE_COMPARATOR | - |
| SIAC | EXPERIMENTAL | - |
| SIAC 30 (B) | EXPERIMENTAL | - |
| SIAC 45 (B) | EXPERIMENTAL | - |
| Treatment period 1 | EXPERIMENTAL | - |
| Treatment period 2 | ACTIVE_COMPARATOR | - |
| IDegAsp - BIAsp | EXPERIMENTAL | - |
| BIAsp - IDegAsp | EXPERIMENTAL | - |
| NN5401 - low dose | EXPERIMENTAL | - |
| NN5401 - medium dose | EXPERIMENTAL | - |
| NN5401 - high dose | EXPERIMENTAL | - |
| biphasic insulin aspart 30 - low dose | ACTIVE_COMPARATOR | - |
| biphasic insulin aspart 30 - medium dose | ACTIVE_COMPARATOR | - |
| biphasic insulin aspart 30 - high dose | ACTIVE_COMPARATOR | - |
| IDegAsp | EXPERIMENTAL | - |
| IDegAsp low | EXPERIMENTAL | - |
| IDegAsp middle | EXPERIMENTAL | - |
| IDegAsp high | EXPERIMENTAL | - |
| BIAsp 30 low | EXPERIMENTAL | - |
| BIAsp 30 middle | EXPERIMENTAL | - |
| BIAsp 30 high | EXPERIMENTAL | - |
| IDegAsp 30 + placebo | EXPERIMENTAL | - |
| Insulin aspart + insulin degludec - low concentration 1 | EXPERIMENTAL | - |
| IDegAsp 40 + placebo | EXPERIMENTAL | - |
| Insulin aspart + insulin degludec - high concentration 1 | EXPERIMENTAL | - |
| IDegAsp 45 + placebo | EXPERIMENTAL | - |
| Insulin aspart + insulin degludec | EXPERIMENTAL | - |
| IDegAsp 55 + placebo | EXPERIMENTAL | - |
| Insulin aspart + insulin degludec - high concentration | EXPERIMENTAL | - |
| BIAsp 30 + placebo | ACTIVE_COMPARATOR | - |
| Trial part 1 | EXPERIMENTAL | - |
| Trial part 2 | EXPERIMENTAL | - |
| BIAsp 50 | EXPERIMENTAL | - |
| IAsp | ACTIVE_COMPARATOR | - |
| Formulation 1 | EXPERIMENTAL | - |
| Formulation 2 | ACTIVE_COMPARATOR | - |
| Formulation A | EXPERIMENTAL | - |
| Formulation B | EXPERIMENTAL | - |
| Dosing visit 1 | EXPERIMENTAL | - |
| Dosing visit 2 | EXPERIMENTAL | - |
| BIAsp 70 clinical trial formulation | EXPERIMENTAL | - |
| BIAsp 70 final formulation | EXPERIMENTAL | - |
| BIAsp 50 final formulation | EXPERIMENTAL | - |
| Insulin aspart | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| insulin degludec/insulin aspart | DRUG | Twice daily subcutaneous (sc, under the skin) injection. |
| biphasic insulin aspart | DRUG | Twice daily subcutaneous (sc, under the skin) injection. |
| biphasic insulin aspart 30 | DRUG | Injected subcutaneously twice daily. Dose was individually adjusted. |
| metformin | DRUG | Tablets, 500 - 2000 mg, once, twice or three times daily |
| biphasic insulin aspart 50 | DRUG | Treat-to-target dose titration scheme (dose adjusted individually), s.c. (under the skin) injection before breakfast and lunch |
| biphasic human insulin | DRUG | - |
| exenatide | DRUG | - |
| insulin glargine | DRUG | - |
| insulin detemir | DRUG | Treat-to-target (individually adjusted dose), subcutaneously (under the skin) injection, once or twice daily plus option for insulin aspart |
| insulin aspart | DRUG | Treat-to-target (individually adjusted dose), subcutaneously (under the skin) injection, twice daily plus option for insulin detemir |
| pioglitazone | DRUG | - |
| insulin NPH | DRUG | - |
| biphasic human insulin 50 | DRUG | Administered subcutaneously (s.c., under the skin) twice daily for 24 weeks. Injected 30 minutes before breakfast and dinner |
| biphasic insulin aspart 70 | DRUG | Administered subcutaneously (s.c., under the skin) at breakfast, lunch and dinner. Randomised subjects being lean and overweight with a body mass index (BMI) of maximum 30 kg/m\^2 will receive BIAsp 70 |
| biphasic human insulin 30 | DRUG | Administered subcutaneously (s.c., under the skin), twice a day |
| insulin degludec | DRUG | Administered subcutaneously (s.c., under the skin). |
| insulin degludec/insulin aspart 30 | DRUG | A single dose administered subcutaneously (s.c., under the skin). |
| insulin degludec/insulin aspart 40 | DRUG | A single dose administered subcutaneously (s.c., under the skin). |
| insulin degludec/insulin aspart 45 | DRUG | A single dose administered subcutaneously (s.c., under the skin). |
| insulin degludec/insulin aspart 55 | DRUG | A single dose administered subcutaneously (s.c., under the skin). |
| placebo | DRUG | A single dose administered subcutaneously (s.c., under the skin). |
| insulin glulisine | DRUG | - |
| insulin degludec/insulin aspart 50 | DRUG | Single dose administrated subcutaneously (s.c., under the skin). |
Inclusion Criteria: * Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial * Male or female at least 18 years of age * Type 2 diabetes mellitu...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| FibroBiologics, Inc. | FBLG | 1 | PHASE1 | Undisclosed |
| MiMedx Group, Inc. | MDXG | 2 | N/A | Undisclosed |
| Integra LifeSciences Holdings Corporation | IART | 1 | N/A | Undisclosed |
| Organogenesis Holdings, Inc. Class A | ORGO | 1 | N/A | Undisclosed |
| Healthcare Services Group, Inc. | HCSG | 1 | N/A | Undisclosed |
Biphasic insulin aspart 30 is used for diabetes. It is a premixed insulin formulation containing 30% rapid-acting insulin aspart and 70% intermediate-acting protamine-crystallized insulin aspart. It is being developed by Novo Nordisk A/S and is currently in Phase 3 clinical development for the treatment of diabetes.
Biphasic insulin aspart 30 is developed by Novo Nordisk A/S, a pharmaceutical company listed on the stock exchange under the ticker NVO. The company is conducting clinical trials to evaluate this insulin formulation for the treatment of diabetes.
Biphasic insulin aspart 30 is in Phase 3 clinical development. It is an investigational drug for diabetes and has not been approved by regulatory authorities. The development program includes 54 completed clinical trials with a total enrollment of 8,362 participants.
Biphasic insulin aspart 30 has been studied in 54 completed clinical trials. Notable trials include NCT01174303, a Phase 1 study in young adults and elderly subjects with type 1 diabetes, and NCT01523041, a Phase 1 study comparing two formulations of biphasic insulin aspart 70. Other trials include NCT01527552 and NCT01620437, both Phase 1 bioequivalence studies in healthy subjects.
Biphasic insulin aspart 30 and biphasic insulin aspart 70 are different formulations of the same drug. Biphasic insulin aspart 30 contains 30% rapid-acting insulin aspart and 70% intermediate-acting insulin aspart, while biphasic insulin aspart 70 contains 70% rapid-acting and 30% intermediate-acting components. Both are being developed by Novo Nordisk for diabetes.