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Comparison of NN1250 Plus Insulin Aspart With Insulin Glargine Plus Insulin Aspart in Type 1 Diabetes
Phase 3 trial testing insulin degludec in Diabetes in 629 participants. Completed in 8 November 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 | 629 |
| Start date | 1 September 2009 |
| Primary completion | 8 November 2010 |
| Estimated completion | 8 November 2010 |
| Sites | 91 locations across France, South Africa, Russia, United Kingdom, Germany, United States |
Novo Nordisk A/S — full company profile →
18 and older, any sex, with Diabetes or Diabetes Mellitus, Type 1. 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 52 weeks of treatment
| Group | Value | 95% CI |
|---|---|---|
| IDeg OD | -0.40 | ± 0.73 |
| IGlar OD | -0.39 | ± 0.84 |
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.
| Group | Value | 95% CI |
|---|---|---|
| IDeg OD | 383 | |
| IGlar OD | 374 |
| Group | Value | 95% CI |
|---|---|---|
| IDeg OD | 14 | |
| IGlar OD | 17 |
| Group | Value | 95% CI |
|---|---|---|
| IDeg OD | 22 | |
| IGlar OD | 26 |
| Group | Value | 95% CI |
|---|---|---|
| IDeg OD | 105 | |
| IGlar OD | 106 |
| Group | Value | 95% CI |
|---|---|---|
| IDeg OD | 256 | |
| IGlar OD | 242 |
| Group | Value | 95% CI |
|---|---|---|
| IDeg OD | 1 | |
| IGlar OD | 1 |
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.
| Group | Value | 95% CI |
|---|---|---|
| IDeg OD | 3750 | |
| IGlar OD | 3743 |
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 |
|---|---|---|
| IDeg OD | 390 | |
| IGlar OD | 532 |
The unit for measuring antibody levels is amount of tracer bound to the antibodies in the precipitate (B) expressed in percentage of the total amount of tracer (T) added to the mixture (%B/T). Samples were taken before 1st dosing and after a 1-week wash-out period.
| Group | Value | 95% CI |
|---|---|---|
| IDeg OD | 11.3 | ± 15.6 |
| IGlar OD | 11.0 | ± 16.0 |
Change from baseline in HbA1c after 104 weeks of treatment
| Group | Value | 95% CI |
|---|---|---|
| IDeg OD | -0.27 | ± 0.75 |
| IGlar OD | -0.24 | ± 0.86 |
Mean of 9-point self-measured plasma glucose profile (SMPG) after 104 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 |
|---|---|---|
| IDeg OD | 8.0 | ± 2.2 |
| IGlar OD | 8.1 | ± 2.2 |
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.
| Group | Value | 95% CI |
|---|---|---|
| IDeg OD | 4254 | |
| IGlar OD | 4018 |
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 |
|---|---|---|
| IDeg OD | 441 | |
| IGlar OD | 586 |
Mean of 9-point self-measured plasma glucose profile (SMPG) after 52 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 |
|---|---|---|
| IDeg OD | 8.1 | ± 2.3 |
| IGlar OD | 8.3 | ± 2.4 |
Time frame: The adverse events were collected in a time frame of 104 weeks + 1 week after last dose in main trial + 1 more week after last dose in extension trial.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | IDeg OD | IGlar OD |
|---|---|---|---|
| Hypoglycaemia | Metabolism and nutrition disorders | — | — |
| Hypoglycaemic unconsciousness | Metabolism and nutrition disorders | — | — |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | — | — |
| Hypoglycaemic seizure | Metabolism and nutrition disorders | — | — |
| Myocardial infarction | Cardiac disorders | — | — |
| Incorrect dose administered | Injury, poisoning and procedural complications | — | — |
| Coronary artery disease | Cardiac disorders | — | — |
| Acute myocardial infarction | Cardiac disorders | — | — |
| Colitis | Gastrointestinal disorders | — | — |
| Diabetic gastroparesis | Gastrointestinal disorders | — | — |
| Gastritis | Gastrointestinal disorders | — | — |
| Inguinal hernia | Gastrointestinal disorders | — | — |
| Melaena | Gastrointestinal disorders | — | — |
| Salivary gland calculus | Gastrointestinal disorders | — | — |
| Sudden death | General disorders | — | — |
| Cholelithiasis | Hepatobiliary disorders | — | — |
| Cellulitis | Infections and infestations | — | — |
| Cholecystitis infective | Infections and infestations | — | — |
| Gastroenteritis | Infections and infestations | — | — |
| Pneumonia | Infections and infestations | — | — |
| Pulmonary tuberculoma | Infections and infestations | — | — |
| Pulmonary tuberculosis | Infections and infestations | — | — |
| Forearm fracture | Injury, poisoning and procedural complications | — | — |
| Joint injury | Injury, poisoning and procedural complications | — | — |
| Pneumothorax traumatic | Injury, poisoning and procedural complications | — | — |
| Reaction | System | IDeg OD | IGlar OD |
|---|---|---|---|
| Nasopharyngitis | Infections and infestations | — | — |
| Upper respiratory tract infection | Infections and infestations | — | — |
| Headache | Nervous system disorders | — | — |
| Sinusitis | Infections and infestations | — | — |
| Gastroenteritis | Infections and infestations | — | — |
| Influenza | Infections and infestations | — | — |
| Hypoglycaemia | Metabolism and nutrition disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — |
| Bronchitis | Infections and infestations | — | — |
| Urinary tract infection | Infections and infestations | — | — |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — |
| Back Pain | Musculoskeletal and connective tissue disorders | — | — |
| Wrong drug administered | Injury, poisoning and procedural complications | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Gastrointestinal viral | Infections and infestations | — | — |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | — | — |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | — | — |
| Seasonal allergy | Immune system disorders | — | — |
Most-reported serious reactions: Hypoglycaemia, Hypoglycaemic unconsciousness, Diabetic ketoacidosis, Hypoglycaemic seizure, Myocardial infarction, Incorrect dose administered, Coronary artery disease, Acute myocardial infarction.
Data from ClinicalTrials.gov NCT00982228 adverse events section.
This trial is conducted in Africa, Europe and the United States of America (USA). The aim of the trial is to compare NN1250 (insulin degludec, soluble insulin basal analogue (SIBA)) plus insulin aspart with insulin glargine (IGlar) plus insulin aspart in patients with type 1 diabetes. The main period is registered internally at Novo Nordisk as NN1250-3583 while the extension period is registered as NN1250-3644.
7 peer-reviewed publications reference this trial (live from Europe PMC):
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