A Phase 3 interventional study of insulin degludec/insulin aspart and insulin glargine in Diabetes and Diabetes Mellitus, Type 2, sponsored by Novo Nordisk A/S. Completed at 50 sites in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2017-03-17.
Sponsored by Novo Nordisk A/S · Phase 3, Interventional, and Treatment
This trial is conducted in Japan. The aim of this trial is to investigate the efficacy and safety of NN5401 (insulin degludec/insulin aspart) with insulin glargine in subjects with type 2 diabetes in Japan. Depending on pre-trial oral anti-diabetic drugs (OADs), subjects continued at the same dose and dosing frequency.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 296 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: insulin degludec/insulin aspart · Drug: insulin glargine
Drug: insulin glargine
Injected subcutaneously (under the skin) once daily prior to the largest meal of the day as monotherapy or combined with no more than 2 oral anti-diabetic drugs (OADs).
Administered according to approved labelling either as monotherapy or combined with no more than 2 OADs.
Change in Glycosylated Haemoglobin (HbA1c)
Observed change from baseline in HbA1c after 26 weeks of treatment
Time frame: Week 0, Week 26
Mean Increment of 9-point Self Measured Plasma Glucose Profile (SMPG) at the Main Evening Meal
Observed mean increment of the 9-point self-measured plasma glucose profile (SMPG) at the main evening meal
Time frame: Week 26
Rate of Treatment Emergent Adverse Events (AEs)
Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.
Time frame: Week 0 to Week 26 + 7 days follow up
Rate of Confirmed Hypoglycaemic Episodes
Observed rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.
Time frame: Week 0 to Week 26 + 7 days follow up
Rate of Nocturnal Confirmed Hypoglycaemic Episodes
Observed rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes were defined as occurring between 00:01 and 05:59 a.m.
Time frame: Week 0 to Week 26 + 7 days follow up
Change in Body Weight
Observed change from baseline in body weight after 26 weeks of treatment
Time frame: Week 0, Week 26
The trial was conducted at 48 sites in Japan.
| Milestone | IDegAsp OD | IGlar OD |
|---|---|---|
| Started | 147 | 149 |
| Completed | 137 | 137 |
| Not completed | 10 | 12 |
| Withdrew: Adverse event | 1 | 1 |
| Withdrew: Lack of efficacy | 0 | 3 |
| Withdrew: Withdrawal criteria | 1 | 1 |
| Withdrew: Unclassified | 8 | 7 |
Observed change from baseline in HbA1c after 26 weeks of treatment
| percentage of glycosylated haemoglobin | IDegAsp OD | IGlar OD |
|---|---|---|
| Change in Glycosylated Haemoglobin (HbA1c) | -1.35 ± 0.86 | -1.22 ± 0.98 |
Observed mean increment of the 9-point self-measured plasma glucose profile (SMPG) at the main evening meal
| mmol/L | IDegAsp OD | IGlar OD |
|---|---|---|
| Mean Increment of 9-point Self Measured Plasma Glucose Profile (SMPG) at the Main Evening Meal | 1.4 ± 4.2 | 4.7 ± 3.6 |
Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.
| Events/100 years of patient exposure | IDegAsp OD | IGlar OD |
|---|---|---|
| Adverse events (AEs) | 334 | 368 |
| Serious AEs | 7 | 4 |
| Severe AEs | 1 | 0 |
| Moderate AEs | 17 | 14 |
| Mild AEs | 316 | 353 |
| Fatal AEs | 0 | 0 |
Observed rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.
| Episodes/100 years of patient exposure | IDegAsp OD | IGlar OD |
|---|---|---|
| Rate of Confirmed Hypoglycaemic Episodes | 191 | 271 |
Observed rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes were defined as occurring between 00:01 and 05:59 a.m.
| Episodes/100 years of patient exposure | IDegAsp OD | IGlar OD |
|---|---|---|
| Rate of Nocturnal Confirmed Hypoglycaemic Episodes | 39 | 53 |
Observed change from baseline in body weight after 26 weeks of treatment
| kg | IDegAsp OD | IGlar OD |
|---|---|---|
| Change in Body Weight | 0.7 ± 2.8 | 0.7 ± 2.2 |
Collected over The adverse events were collected in a time frame of 26 weeks + 7 days follow up.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| IDegAsp OD | — | 5/147 (3.4%) | 37/147 (25.2%) |
| IGlar OD | — | 3/149 (2%) | 47/149 (31.5%) |
| Event | IDegAsp OD | IGlar OD |
|---|---|---|
| Cardiac failureCardiac disorders | 1/147 | 0/149 |
| Inguinal herniaGastrointestinal disorders | 1/147 | 0/149 |
| Pulmonary tuberculosisInfections and infestations | 1/147 | 0/149 |
| Bladder cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/147 | 0/149 |
| Cerebral infarctionNervous system disorders | 1/147 | 1/149 |
| Osteitis condensansMusculoskeletal and connective tissue disorders | 0/147 | 1/149 |
| DizzinessNervous system disorders | 0/147 | 1/149 |
| Event | IDegAsp OD | IGlar OD |
|---|---|---|
| NasopharyngitisInfections and infestations | 33/147 | 38/149 |
| Diabetic retinopathyEye disorders | 8/147 | 10/149 |
| Age, Continuous(years) | IDegAsp OD | IGlar OD | Total |
|---|---|---|---|
| Mean | 60.0 ± 10.0 | 61.0 ± 9.6 | 60.5 ± 9.8 |
| Sex: Female, Male(Participants) | IDegAsp OD | IGlar OD | Total |
|---|---|---|---|
| Female | 57 | 50 | 107 |
| Male | 90 | 99 | 189 |
| Glycosylated haemoglobin (HbA1c)(percentage of glycosylated haemoglobin) | IDegAsp OD | IGlar OD | Total |
|---|---|---|---|
| Mean | 8.3 ± 0.8 | 8.5 ± 0.8 | 8.4 ± 0.8 |
| Fasting plasma glucose (FPG)(mmol/L) | IDegAsp OD | IGlar OD | Total |
|---|---|---|---|
| Mean | 9.0 ± 1.6 | 9.1 ± 1.9 | 9.0 ± 1.7 |
| Body weight(kg) | IDegAsp OD | IGlar OD | Total |
|---|---|---|---|
| Mean | 66.2 ± 13.4 | 66.4 ± 13.3 | 66.3 ± 13.4 |
This study is completed, as verified in Feb 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