Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
This trial is conducted in Europe. This is a clinical trial investigating the effectiveness and the safety of using biphasic insulin aspart 30 both for initiation and intensification of insulin treatment in type 2 diabetes.
Interventions
DRUGbiphasic insulin aspart
Treat-to-target dose titration scheme (dose individually adjusted), injected s.c. (under the skin)
Sponsors
Novo Nordisk A/S
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Type 2 Diabetes Mellitus for more than 12 months * HbA1c: 7.5 - 11.0% * An antidiabetic regimen that has been stable for at least 3 months prior to screening * An antidiabetic regimen that includes a minimum of 2 oral anti-diabetic drugs (OADs) or 1 OAD plus evening or bedtime basal insulin * OADs dosed at 50% or more of the maximum recommended dose
Exclusion criteria
* Use of any insulin preparations other than NPH or glargine within the past 6 months * Use of more than 60 units of insulin per day * Morning time insulin administration * Use of more than one insulin dose daily
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Subjects Achieving the Treatment Target of Glycosylated Haemoglobin (HbA1c) Below 7.0% | week 48 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Trial Completers Achieving the Treatment Target of Glycosylated Haemoglobin (HbA1c) Below 7.0% | week 48 | — |
| Number of Hypoglycaemic Episodes | weeks 0-48 | Total number of hypoglycaemic episodes experienced from baseline (week 0) to end of trial (week 48). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose (PG) below 3.1 mmol/L or 56 mg/dL. Symptoms only if subject was able to treat her/himself and with either no PG or blood glucose measurement or PG higher than or equal to 3.1 mmol/L or 56 mg/dL. |
| Number of Diurnal Hypoglycaemic Episodes | weeks 0-48 | Total number of hypoglycaemic episodes during the day (diurnal) experienced in the trial from baseline (week 0) to end of trial (week 48). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose (PG) below 3.1 mmol/L or 56 mg/dL. Symptoms only if subject was able to treat her/himself and with either no PG or blood glucose measurement or PG higher than or equal to 3.1 mmol/L or 56 mg/dL. |
| Number of Nocturnal Hypoglycaemic Episodes | weeks 0-48 | Total number of hypoglycaemic episodes during the night (nocturnal) experienced in the trial from baseline (week 0) to end of trial (week 48). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose (PG) below 3.1 mmol/L or 56 mg/dL. Symptoms only if subject was able to treat her/himself and with either no PG or blood glucose measurement or PG higher than or equal to 3.1 mmol/L or 56 mg/dL. |
| Number of Treatment Emergent Serious Adverse Events (SAEs) | weeks 0-48 | Total number of treatment emergent SAEs experienced from baseline (week 0) to end of trial (week 48). A treatment emergent SAE were defined as an adverse event which occurred in the trial treatment period. |
Countries
Turkey (Türkiye)
Participant flow
Recruitment details
One single site in Turkey
Pre-assignment details
Eligible subjects were those with type 2 diabetes inadequately controlled with oral anti-diabetic drugs (OADs) with or without basal insulin therapy.
Participants by arm
| Arm | Count |
|---|---|
| BIAsp 30 Subjects received individually adjusted dose of biphasic insulin aspart 30 (BIAsp 30) once daily for 16 weeks. If the treatment target of HbA1c below 7% was reached after 16 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 16, then BIAsp 30 treatment was increased to twice daily for additional 16 weeks. If the treatment target of HbA1c below 7% was reached after 32 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 32, then BIAsp 30 treatment was increased to three times daily for additional 16 weeks until week 48 (end of trial). | 160 |
| Total | 160 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Inability to tolerate trial medication | 4 |
| Overall Study | Lack of Efficacy | 2 |
| Overall Study | Lost to Follow-up | 12 |
| Overall Study | Non-compliance with trial procedures | 15 |
| Overall Study | Protocol Violation | 11 |
| Overall Study | Unclassified | 4 |
Baseline characteristics
| Characteristic | BIAsp 30 |
|---|---|
| Age, Continuous | 54.4 years STANDARD_DEVIATION 10 |
| BMI | 31.1 kg/m^2 STANDARD_DEVIATION 5.7 |
| Diabetes Duration | 9.5 years STANDARD_DEVIATION 5.1 |
| Height | 161 cm STANDARD_DEVIATION 9 |
| Sex: Female, Male Female | 98 Participants |
| Sex: Female, Male Male | 62 Participants |
| Weight | 80.2 kg STANDARD_DEVIATION 15.1 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 44 / 160 |
| serious Total, serious adverse events | 5 / 160 |
Outcome results
Primary
Percentage of Subjects Achieving the Treatment Target of Glycosylated Haemoglobin (HbA1c) Below 7.0%
Time frame: week 48
Population: Full Analysis Set (FAS) was all subjects who have been exposed to at least one dose of trial drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BIAsp 30 | Percentage of Subjects Achieving the Treatment Target of Glycosylated Haemoglobin (HbA1c) Below 7.0% | Achieving treatment target HbA1c < 7.0% | 34.4 percentage of subjects |
| BIAsp 30 | Percentage of Subjects Achieving the Treatment Target of Glycosylated Haemoglobin (HbA1c) Below 7.0% | Not achieving treatment target HbA1c < 7.0% | 46.9 percentage of subjects |
Secondary
Number of Diurnal Hypoglycaemic Episodes
Total number of hypoglycaemic episodes during the day (diurnal) experienced in the trial from baseline (week 0) to end of trial (week 48). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose (PG) below 3.1 mmol/L or 56 mg/dL. Symptoms only if subject was able to treat her/himself and with either no PG or blood glucose measurement or PG higher than or equal to 3.1 mmol/L or 56 mg/dL.
Time frame: weeks 0-48
Population: Safety analysis set was all subjects who have been exposed to at least one dose of trial drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BIAsp 30 | Number of Diurnal Hypoglycaemic Episodes | Major | 2 episodes |
| BIAsp 30 | Number of Diurnal Hypoglycaemic Episodes | Minor | 33 episodes |
| BIAsp 30 | Number of Diurnal Hypoglycaemic Episodes | Symptom only | 13 episodes |
Secondary
Number of Hypoglycaemic Episodes
Total number of hypoglycaemic episodes experienced from baseline (week 0) to end of trial (week 48). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose (PG) below 3.1 mmol/L or 56 mg/dL. Symptoms only if subject was able to treat her/himself and with either no PG or blood glucose measurement or PG higher than or equal to 3.1 mmol/L or 56 mg/dL.
Time frame: weeks 0-48
Population: Safety analysis set was all subjects who have been exposed to at least one dose of trial drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BIAsp 30 | Number of Hypoglycaemic Episodes | Major | 4 episodes |
| BIAsp 30 | Number of Hypoglycaemic Episodes | Minor | 43 episodes |
| BIAsp 30 | Number of Hypoglycaemic Episodes | Symptom only | 15 episodes |
Secondary
Number of Nocturnal Hypoglycaemic Episodes
Total number of hypoglycaemic episodes during the night (nocturnal) experienced in the trial from baseline (week 0) to end of trial (week 48). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose (PG) below 3.1 mmol/L or 56 mg/dL. Symptoms only if subject was able to treat her/himself and with either no PG or blood glucose measurement or PG higher than or equal to 3.1 mmol/L or 56 mg/dL.
Time frame: weeks 0-48
Population: Safety analysis set was all subjects who have been exposed to at least one dose of trial drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BIAsp 30 | Number of Nocturnal Hypoglycaemic Episodes | Major | 2 episodes |
| BIAsp 30 | Number of Nocturnal Hypoglycaemic Episodes | Minor | 10 episodes |
| BIAsp 30 | Number of Nocturnal Hypoglycaemic Episodes | Symptom only | 2 episodes |
Secondary
Number of Treatment Emergent Serious Adverse Events (SAEs)
Total number of treatment emergent SAEs experienced from baseline (week 0) to end of trial (week 48). A treatment emergent SAE were defined as an adverse event which occurred in the trial treatment period.
Time frame: weeks 0-48
Population: Safety analysis set was all subjects who have been exposed to at least one dose of trial drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BIAsp 30 | Number of Treatment Emergent Serious Adverse Events (SAEs) | 7 events |
Secondary
Percentage of Trial Completers Achieving the Treatment Target of Glycosylated Haemoglobin (HbA1c) Below 7.0%
Time frame: week 48
Population: Full Analysis Set (FAS) was all subjects who have been exposed to at least one dose of trial drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BIAsp 30 | Percentage of Trial Completers Achieving the Treatment Target of Glycosylated Haemoglobin (HbA1c) Below 7.0% | Achieving treatment target HbA1c < 7.0% | 48.2 percentage of trial completers |
| BIAsp 30 | Percentage of Trial Completers Achieving the Treatment Target of Glycosylated Haemoglobin (HbA1c) Below 7.0% | Not achieving treatment target HbA1c < 7.0% | 51.8 percentage of trial completers |