A Phase 3 interventional study of insulin degludec/insulin aspart and insulin degludec in Diabetes and Diabetes Mellitus, Type 2, sponsored by Novo Nordisk A/S. Completed at 51 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-04-02.
Sponsored by Novo Nordisk A/S · Phase 3, Interventional, and Treatment
This trial is conducted in Africa, Europe and the United States of America (USA).
The aim of the trial is to compare the difference in change in glycosylated haemoglobin (HbA1c) between insulin degludec/insulin aspart (IDegAsp) and/or oral anti-diabetic drugs (OADs) and insulin degludec (IDeg) plus insulin aspart (IAsp)and/or OADs.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 274 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.
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Exclusion Criteria:
Drug: insulin degludec/insulin aspart
Drug: insulin degludec · Drug: insulin aspart
Dose individually adjusted. For subcutaneous (s.c, under the skin) administration twice a day.
Dose individually adjusted. For subcutaneous (s.c, under the skin) administration once daily.
Dose individually adjusted. For subcutaneous (s.c, under the skin) administration with the main meals 2-4 times daily in accordance with local labelling.
Change From Baseline in HbA1c (%)
Change from baseline in HbA1c (%) after 26 weeks of treatment
Time frame: Week 0, week 26
Change From Baseline in Fasting Plasma Glucose (FPG)
Change from baseline in FPG after 26 weeks of treatment
Time frame: Week 0, week 26
Number of Treatment Emergent Hypoglycaemic Episodes
According to the Novo Nordisk definition for confirmed hypoglycaemic episodes (severe hypoglycaemia and/or a measured Plasma Glucose (PG) \<3.1 mmol/L(56 mg/dL))
Time frame: During Weeks 0-26
Number of Treatment Emergent Hypoglycaemic Episodes
According to the American Diabetes Association (ADA) definition following are the categories of hypoglycaemic episodes: Severe hypoglycaemia, Documented symptomatic hypoglycaemia, Asymptomatic hypoglycaemia, Probable symptomatic hypoglycaemia and Relative hypoglycaemia
Time frame: During Weeks 0-26
Number of Treatment Emergent Nocturnal (00:01-05:59 am) Confirmed Hypoglycaemic Episodes
Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.
Time frame: Weeks 0-26
Incidence of Treatment Emergent Adverse Events (TEAE)
A TEAE was defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment
Time frame: Weeks 0-26
The trial was conducted in 5 countries (48 sites): Algeria (4), Austria (6), France (8), Norway (6) and United States (24).
| Milestone | IDegAsp BID | IDeg OD+IAsp |
|---|---|---|
| Started | 138 | 136 |
| Exposed | 136 | 135 |
| Completed | 113 | 117 |
| Not completed | 25 | 19 |
| Withdrew: Adverse event | 0 | 5 |
| Withdrew: Withdrawal criteria | 21 | 12 |
| Withdrew: Unclassified | 4 | 2 |
Change from baseline in HbA1c (%) after 26 weeks of treatment
| percentage change in HbA1c | IDegAsp BID | IDeg OD+IAsp |
|---|---|---|
| Change From Baseline in HbA1c (%) | -1.23 ± 0.13 | -1.42 ± 0.12 |
Change from baseline in FPG after 26 weeks of treatment
| mmol/L | IDegAsp BID | IDeg OD+IAsp |
|---|---|---|
| Change From Baseline in Fasting Plasma Glucose (FPG) | -2.22 ± 0.38 | -1.90 ± 0.36 |
According to the Novo Nordisk definition for confirmed hypoglycaemic episodes (severe hypoglycaemia and/or a measured Plasma Glucose (PG) \<3.1 mmol/L(56 mg/dL))
| episodes | IDegAsp BID | IDeg OD+IAsp |
|---|---|---|
| Number of Treatment Emergent Hypoglycaemic Episodes | 706 | 841 |
According to the American Diabetes Association (ADA) definition following are the categories of hypoglycaemic episodes: Severe hypoglycaemia, Documented symptomatic hypoglycaemia, Asymptomatic hypoglycaemia, Probable symptomatic hypoglycaemia and Relative hypoglycaemia
| episodes | IDegAsp BID | IDeg OD+IAsp |
|---|---|---|
| ADA (American Diabetes Association) | 2894 | 2685 |
| Severe | 29 | 15 |
| Documented symptomatic | 1818 | 1843 |
| Asymptomatic | 930 | 728 |
| Probable symptomatic | 26 | 33 |
| Relative | 91 | 66 |
Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.
| episodes | IDegAsp BID | IDeg OD+IAsp |
|---|---|---|
| Number of Treatment Emergent Nocturnal (00:01-05:59 am) Confirmed Hypoglycaemic Episodes | 75 | 96 |
A TEAE was defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment
| number of events | IDegAsp BID | IDeg OD+IAsp |
|---|---|---|
| Incidence of Treatment Emergent Adverse Events (TEAE) | 330 | 298 |
Collected over The adverse events (AEs) were collected for a duration of 28 weeks ie. from the first trial-related activity after the subject had signed the informed consent until the end of the post-treatment follow-up period (visit 29).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| IDegAsp BID | — | 7/136 (5.1%) | 46/136 (33.8%) |
| IDeg OD+IAsp | — | 13/135 (9.6%) | 38/135 (28.1%) |
| Event | IDegAsp BID | IDeg OD+IAsp |
|---|---|---|
| Road traffic accidentInjury, poisoning and procedural complications | 0/136 | 2/135 |
| Wrong drug administeredInjury, poisoning and procedural complications | 0/136 | 2/135 |
| HypoglycaemiaMetabolism and nutrition disorders | 1/136 | 2/135 |
| Ocular hypertensionEye disorders | 0/136 | 1/135 |
| Rib fractureInjury, poisoning and procedural complications | 0/136 | 1/135 |
| Pituitary tumour benignNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/136 | 1/135 |
| Prostate cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/136 | 1/135 |
| Hypoglycaemic unconsciousnessNervous system disorders | 1/136 | 1/135 |
| DepressionPsychiatric disorders | 0/136 | 1/135 |
| Suicidal ideationPsychiatric disorders | 0/136 | 1/135 |
| Event | IDegAsp BID | IDeg OD+IAsp |
|---|---|---|
| NasopharyngitisInfections and infestations | 11/136 | 12/135 |
| AstheniaGeneral disorders | 10/136 | 2/135 |
| HeadacheNervous system disorders | 10/136 | 8/135 |
| DiarrhoeaGastrointestinal disorders | 9/136 | 9/135 |
| InfluenzaInfections and infestations | 9/136 | 5/135 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 8/136 | 3/135 |
| Back painMusculoskeletal and connective tissue disorders | 5/136 | 7/135 |
| FatigueGeneral disorders | 7/136 | 1/135 |
The full analysis set (FAS) included all randomised subjects. The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation "as randomised".
| Age, Continuous(years) | IDegAsp BID | IDeg OD+IAsp | Total |
|---|---|---|---|
| Age | 59.6 ± 8.3 | 59.6 ± 9.2 | 59.6 ± 8.7 |
| Sex: Female, Male(Participants) | IDegAsp BID | IDeg OD+IAsp | Total |
|---|---|---|---|
| Female | 65 | 50 | 115 |
| Male | 73 | 86 | 159 |
| Glycosylated haemoglobin (HbA1c)(percentage of glycosylated haemoglobin) | IDegAsp BID | IDeg OD+IAsp | Total |
|---|---|---|---|
| Mean | 8.3 ± 0.9 | 8.3 ± 0.7 | 8.3 ± 0.8 |
| Fasting plasma glucose(mmol/L) | IDegAsp BID | IDeg OD+IAsp | Total |
|---|---|---|---|
| Mean | 9.0 ± 3.0 | 8.8 ± 2.9 | 8.9 ± 3.0 |
This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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Novo Nordisk A/S