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Comparison of NN1250 With Insulin Glargine Plus Insulin Aspart With/Without Metformin and With/Without Pioglitazone in Type 2 Diabetes
Phase 3 trial testing insulin degludec in Diabetes in 1,006 participants. Completed in 28 October 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 | 1,006 |
| Start date | 1 September 2009 |
| Primary completion | 28 October 2010 |
| Estimated completion | 28 October 2010 |
| Sites | 136 locations across Hong Kong, Italy, Slovakia, Russia, South Africa, Ireland, Germany, Romania |
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 52 weeks of treatment
| Group | Value | 95% CI |
|---|---|---|
| IDeg OD | -1.17 | ± 1.03 |
| IGlar OD | -1.29 | ± 0.98 |
Change from baseline in HbA1c after 78 weeks of treatment
| Group | Value | 95% CI |
|---|---|---|
| IDeg OD | -0.95 | ± 1.13 |
| IGlar OD | -1.15 | ± 0.99 |
Mean of 9-point SMPG at 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 | 7.3 | ± 1.8 |
| IGlar OD | 6.9 | ± 1.5 |
Mean of the SMPG at 78 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, before breakfast.
| Group | Value | 95% CI |
|---|---|---|
| IDeg OD | 7.2 | ± 1.9 |
| IGlar OD | 6.8 | ± 1.4 |
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 | 1039 | |
| IGlar OD | 1271 |
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 occurring between 00:01 and 05:59 a.m.
| Group | Value | 95% CI |
|---|---|---|
| IDeg OD | 134 | |
| IGlar OD | 176 |
Corresponds to rate of AEs per 100 patient years of exposure. Mild AEs: no or transient symptoms, no interference with subject's daily activities. Moderate AEs: marked symptoms, moderate interference with subject's daily activities. Severe AEs: considerable interference with subject's daily activities, unacceptable. Serious adverse event (SAE): 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 | 411 | |
| IGlar OD | 403 |
| Group | Value | 95% CI |
|---|---|---|
| IDeg OD | 20 | |
| IGlar OD | 20 |
| Group | Value | 95% CI |
|---|---|---|
| IDeg OD | 24 | |
| IGlar OD | 20 |
| Group | Value | 95% CI |
|---|---|---|
| IDeg OD | 113 | |
| IGlar OD | 118 |
| Group | Value | 95% CI |
|---|---|---|
| IDeg OD | 274 | |
| IGlar OD | 266 |
| 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 | 1109 | |
| IGlar OD | 1363 |
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 occurring between 00:01 and 05:59 a.m.
| Group | Value | 95% CI |
|---|---|---|
| IDeg OD | 139 | |
| IGlar OD | 184 |
Time frame: Adverse events were collected in a time frame of 78 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 | IDeg OD | IGlar OD |
|---|---|---|---|
| Hypoglycaemia | Metabolism and nutrition disorders | — | — |
| Coronary artery disease | Cardiac disorders | — | — |
| Hypoglycaemic unconsciousness | Metabolism and nutrition disorders | — | — |
| Acute myocardial infarction | Cardiac disorders | — | — |
| Non-cardiac chest pain | General disorders | — | — |
| Angina pectoris | Cardiac disorders | — | — |
| Angina unstable | Cardiac disorders | — | — |
| Cardiac failure congestive | Cardiac disorders | — | — |
| Myocardial ischaemia | Cardiac disorders | — | — |
| Cerebrovascular accident | Nervous system disorders | — | — |
| Transient ischaemic attack | Nervous system disorders | — | — |
| Asthma | Respiratory, thoracic and mediastinal disorders | — | — |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | — | — |
| Hypertension | Vascular disorders | — | — |
| Atrial fibrillation | Cardiac disorders | — | — |
| Cardiac failure | Cardiac disorders | — | — |
| Coronary artery stenosis | Cardiac disorders | — | — |
| Myocardial infarction | Cardiac disorders | — | — |
| Chest discomfort | General disorders | — | — |
| Cholelithiasis | Hepatobiliary disorders | — | — |
| Bronchitis | Infections and infestations | — | — |
| Cellulitis | Infections and infestations | — | — |
| Gastroenteritis viral | Infections and infestations | — | — |
| Pneumonia | Infections and infestations | — | — |
| Wrong drug administered | 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 | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — |
| Influenza | Infections and infestations | — | — |
| Wrong drug administered | Injury, poisoning and procedural complications | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — |
| Oedema peripheral | General disorders | — | — |
| Hypertension | Vascular disorders | — | — |
| Bronchitis | Respiratory, thoracic and mediastinal disorders | — | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — | — |
| Sinusitis | Infections and infestations | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
Most-reported serious reactions: Hypoglycaemia, Coronary artery disease, Hypoglycaemic unconsciousness, Acute myocardial infarction, Non-cardiac chest pain, Angina pectoris, Angina unstable, Cardiac failure congestive.
Data from ClinicalTrials.gov NCT00972283 adverse events section.
This trial is conducted in Africa, Asia, Europe, and the United States of America (USA). The aim of this clinical trial is to compare NN1250 (insulin degludec (IDeg)) with insulin glargine (IGlar) plus insulin aspart (IAsp) with/without metformin and with/without pioglitazone in subjects with type 2 diabetes (main period) followed by investigating the long-term safety in terms of comparing NN1250 with insulin glargine plus insulin aspart with or without metformin and with or without pioglitazone in subjects with type 2 diabetes. All oral anti-diabetic drug (OAD) treatment will be discontinued, if applicable, when trial participant enters the trial (NN1250-3582) with the exception of metformin and pioglitazone. Subjects who consent to participate in the extension trial (NN1250-3667) will continue to receive the treatment to which they were randomly allocated in the 52 week trial NN1250-3582. The main period is registered internally at Novo Nordisk as NN1250-3582 while the extension period is registered as NN1250-3667.
7 peer-reviewed publications reference this trial (live from Europe PMC):
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