A Phase 4 interventional study of biphasic insulin aspart 30 in Diabetes and Diabetes Mellitus, Type 2, sponsored by Novo Nordisk A/S. Completed at 22 sites in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-02-24.
Sponsored by Novo Nordisk A/S · Phase 4, Interventional, and Treatment
This trial is conducted in Asia. The aim of this trial is to compare BIAsp 30 twice daily individually adjusted by the subject versus BIAsp 30 twice daily individually adjusted by the investigator both combined with oral antidiabetic drugs (OADs) in subjects with type 2 diabetes inadequately controlled with premixed human insulin. Subjects to continue their OAD background treatment: Metformin plus/minus alpha-glucosidase inhibitor.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 344 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.
Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: biphasic insulin aspart 30
Drug: biphasic insulin aspart 30
Dose individually adjusted, administered subcutaneously (s.c., under the skin) twice daily.
Change From Baseline in HbA1c (Glycosylated Haemoglobin)
Estimated mean change from baseline in HbA1c after 20 Weeks of treatment in full analysis set (FAS).
Time frame: Week 0, week 20
Percentage of Subjects Achieving HbA1c Below 7.0%
Time frame: After 20 weeks of treatment
Percentage of Subjects Achieving HbA1c Below or Equal to 6.5%
Time frame: After 20 weeks of treatment
Change From Baseline in FPG (Fasting Plasma Glucose)
Time frame: Week 0, week 20
Incidence of Hypoglycaemic Episodes (All, Major, Minor and Symptoms Only)
Definition of a treatment emergent hypoglycemic episode: an episode occurred after the first administration of insulin or oral anti-diabetic drug, and no later than the last day on trial product. Severe hypoglycemic episode was that requiring assistance to administer carbohydrate, glucagon, or other resusciative actions. Minor hypoglycemic episode was the one with plasma glucose value \< 3.1 mmol/L, either with symptoms that could be handled by subject, or without symptoms.
Time frame: Week 0 to week 20 (inclusive).
Subjects were recruited from 23 sites in 1 country.
| Milestone | Subject-driven Titration | Investigator-driven Titration |
|---|---|---|
| Started | 172 | 172 |
| Exposed | 172 | 172 |
| Completed | 162 | 159 |
| Not completed | 10 | 13 |
| Withdrew: Adverse event | 3 | 1 |
| Withdrew: Lack of efficacy | 1 | 1 |
| Withdrew: Protocol violation | 1 | 4 |
| Withdrew: Withdrawal criteria | 1 | 2 |
| Withdrew: Unclassified | 4 | 5 |
Estimated mean change from baseline in HbA1c after 20 Weeks of treatment in full analysis set (FAS).
| percentage of glycosylated haemoglobin | Subject-driven Titration | Investigator-driven Titration |
|---|---|---|
| Change From Baseline in HbA1c (Glycosylated Haemoglobin) | -1.32 ± 0.86 | -1.31 ± 0.96 |
| percentage (%) of subjects | Subject-driven Titration | Investigator-driven Titration |
|---|---|---|
| Percentage of Subjects Achieving HbA1c Below 7.0% | 64.5 | 58.1 |
| percentage (%) of subjects | Subject-driven Titration | Investigator-driven Titration |
|---|---|---|
| Percentage of Subjects Achieving HbA1c Below or Equal to 6.5% | 35.5 | 37.2 |
| mmol/L | Subject-driven Titration | Investigator-driven Titration |
|---|---|---|
| Change From Baseline in FPG (Fasting Plasma Glucose) | -1.26 ± 2.59 | -1.48 ± 3.01 |
Definition of a treatment emergent hypoglycemic episode: an episode occurred after the first administration of insulin or oral anti-diabetic drug, and no later than the last day on trial product. Severe hypoglycemic episode was that requiring assistance to administer carbohydrate, glucagon, or other resusciative actions. Minor hypoglycemic episode was the one with plasma glucose value \< 3.1 mmol/L, either with symptoms that could be handled by subject, or without symptoms.
| events per patient per year | Subject-driven Titration | Investigator-driven Titration |
|---|---|---|
| All hypoglycemic events | 10.04 | 10.90 |
| Severe hypoglycemic events | 0.02 | 0.02 |
| Minor hypoglycemic events | 1.70 | 1.66 |
| Probable symptomatic hypoglycemia | 0.45 | 0.56 |
Collected over The reported treatment emergent adverse event was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment, up to 20 weeks.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Subject-driven Titration | — | 4/172 (2.3%) | 1/172 (0.6%) |
| Investigator-driven Titration | — | 7/172 (4.1%) | 13/172 (7.6%) |
| Event | Subject-driven Titration | Investigator-driven Titration |
|---|---|---|
| Coronary artery diseaseCardiac disorders | 1/172 | 0/172 |
| MeniereEar and labyrinth disorders | 0/172 | 1/172 |
| GastritisGastrointestinal disorders | 0/172 | 1/172 |
| Brain contusionInjury, poisoning and procedural complications | 1/172 | 0/172 |
| Heat StrokeInjury, poisoning and procedural complications | 0/172 | 1/172 |
| Patella fractureInjury, poisoning and procedural complications | 1/172 | 0/172 |
| Thermal burnInjury, poisoning and procedural complications | 0/172 | 1/172 |
| Intervertebral disc protrusionMusculoskeletal and connective tissue disorders | 0/172 | 1/172 |
| Spinal osteoarthritisMusculoskeletal and connective tissue disorders | 0/172 | 1/172 |
| Adenosquamous cell lung cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/172 | 0/172 |
| Event | Subject-driven Titration | Investigator-driven Titration |
|---|---|---|
| InfluenzaInfections and infestations | 1/172 | 13/172 |
| Age, Continuous(years) | Subject-driven Titration | Investigator-driven Titration | Total |
|---|---|---|---|
| Mean | 54.8 ± 7.3 | 53.4 ± 7.5 | 54.1 ± 7.4 |
| Gender(Participants) | Subject-driven Titration | Investigator-driven Titration | Total |
|---|---|---|---|
| Female | 79 | 101 | 180 |
| Male | 93 | 71 | 164 |
| Race (NIH/OMB)(Participants) | Subject-driven Titration | Investigator-driven Titration | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 172 | 172 | 344 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Weight(kg) | Subject-driven Titration | Investigator-driven Titration | Total |
|---|---|---|---|
| Mean | 70.3 ± 11.3 | 69.5 ± 11.6 | 69.9 ± 11.5 |
| Body mass index (BMI)(kg/m^2) | Subject-driven Titration | Investigator-driven Titration | Total |
|---|---|---|---|
| Mean | 25.76 ± 3.26 | 25.47 ± 3.01 | 25.62 ± 3.14 |
| Glycosylated Haemoglobin (HbA1c)(percentage of glycosylated haemoglobin) | Subject-driven Titration | Investigator-driven Titration | Total |
|---|---|---|---|
| Mean | 8.10 ± 0.64 | 8.14 ± 0.67 | 8.12 ± 0.65 |
| Fasting Plasma Glucose(mmol/L) | Subject-driven Titration | Investigator-driven Titration | Total |
|---|---|---|---|
| Mean | 8.83 ± 2.36 | 9.07 ± 2.43 | 8.95 ± 2.40 |
This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Novo Nordisk A/S