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A Pan Asian Trial Comparing Efficacy and Safety of NN5401 and Biphasic Insulin Aspart 30 in Type 2 Diabetes
Phase 3 trial testing insulin degludec/insulin aspart in Diabetes in 424 participants. Completed in 23 December 2010.
| Lead sponsor | Novo Nordisk A/S |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 424 |
| Start date | 1 February 2010 |
| Primary completion | 23 December 2010 |
| Estimated completion | 23 December 2010 |
| Sites | 46 locations across Hong Kong, Japan, Malaysia, Taiwan, South Korea |
Novo Nordisk A/S — full company profile →
18 and older, any sex, with Diabetes or Diabetes Mellitus, Type 2. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change from baseline in HbA1c after 26 weeks of treatment.
| Group | Value | 95% CI |
|---|---|---|
| IDegAsp BID | -1.38 | ± 0.88 |
| BIAsp 30 BID | -1.42 | ± 0.97 |
Mean of SMPG at 26 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime, at 4 am and before breakfast.
| Group | Value | 95% CI |
|---|---|---|
| IDegAsp BID | 7.6 | ± 1.7 |
| BIAsp 30 BID | 7.9 | ± 1.8 |
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 are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol.
| Group | Value | 95% CI |
|---|---|---|
| IDegAsp BID | 956 | |
| BIAsp 30 BID | 952 |
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 are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occuring between 00:01 and 05:59 a.m.
| Group | Value | 95% CI |
|---|---|---|
| IDegAsp BID | 111 | |
| BIAsp 30 BID | 155 |
Change from baseline in body weight after 26 weeks of treatment.
| Group | Value | 95% CI |
|---|---|---|
| IDegAsp BID | 1.1 | ± 2.9 |
| BIAsp 30 BID | 1.4 | ± 3.0 |
Time frame: The adverse events were collected in a time frame of 26 weeks + 7 days follow up. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | IDegAsp BID | BIAsp 30 BID |
|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | — | — |
| Gastroenteritis | Infections and infestations | — | — |
| Hypoglycaemic unconsciousness | Metabolism and nutrition disorders | — | — |
| Acute coronary syndrome | Cardiac disorders | — | — |
| Angina pectoris | Cardiac disorders | — | — |
| Cardiac failure | Cardiac disorders | — | — |
| Coronary artery stenosis | Cardiac disorders | — | — |
| Cataract | Eye disorders | — | — |
| Diabetic retinopathy | Eye disorders | — | — |
| Glaucoma | Eye disorders | — | — |
| Intestinal obstruction | Gastrointestinal disorders | — | — |
| Pancreatitis chronic | Gastrointestinal disorders | — | — |
| Chest pain | General disorders | — | — |
| Cholecystitis acute | Hepatobiliary disorders | — | — |
| Cellulitis | Infections and infestations | — | — |
| Pneumonia | Infections and infestations | — | — |
| Subcutaneous abscess | Infections and infestations | — | — |
| Urinary tract infection | Infections and infestations | — | — |
| Clavicle fracture | Injury, poisoning and procedural complications | — | — |
| Drug toxicity | Injury, poisoning and procedural complications | — | — |
| Fall | Injury, poisoning and procedural complications | — | — |
| Femur fracture | Injury, poisoning and procedural complications | — | — |
| Joint sprain | Injury, poisoning and procedural complications | — | — |
| Diabetic foot | Metabolism and nutrition disorders | — | — |
| Hypoglycaemia | Metabolism and nutrition disorders | — | — |
| Reaction | System | IDegAsp BID | BIAsp 30 BID |
|---|---|---|---|
| Nasopharyngitis | Infections and infestations | — | — |
| Upper respiratory tract infection | Infections and infestations | — | — |
| Diabetic retinopathy | Eye disorders | — | — |
Most-reported serious reactions: Acute myocardial infarction, Gastroenteritis, Hypoglycaemic unconsciousness, Acute coronary syndrome, Angina pectoris, Cardiac failure, Coronary artery stenosis, Cataract.
Data from ClinicalTrials.gov NCT01059812 adverse events section.
This trial is conducted in Asia. The aim of this clinical trial is to compare NN5401 (insulin degludec/insulin aspart (IDegAsp)) with biphasic insulin aspart (BIAsp) 30 in patients with type 2 diabetes not optimally controlled on once or twice daily insulin with or without metformin.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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