CLINICAL TRIALS PROFILE FOR LEVEMIR
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All Clinical Trials for Levemir
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00264901 ↗ | Comparison of Self Adjustment Versus Standard of Care Treatment in Subjects With Type 2 Diabetes | Completed | Novo Nordisk A/S | Phase 4 | 2005-10-01 | This trial is conducted in the United States of America (USA). This trial aims for a comparison of the safety and efficacy in subjects with type 2 diabetes using either self titration or physician guided titration according to the local standard of care. |
| NCT00331604 ↗ | Safety and Efficacy of Inhaled Insulin in Type 2 Diabetes | Terminated | Novo Nordisk A/S | Phase 3 | 2006-08-31 | This trial is conducted in Asia, Europe and South America. The aim of this research is to compare the efficacy (reduction in HbA1c and blood glucose) and pulmonary safety (pulmonary function tests, chest x-rays) of mealtime inhaled insulin with subcutaneous insulin aspart both in combination with insulin detemir in Type 2 Diabetes. |
| NCT00405418 ↗ | Lantus Versus Levemir Treat-To-Target | Completed | Sanofi | Phase 4 | 2006-11-01 | Primary objective: To demonstrate the non-inferiority of insulin glargine in comparison to insulin detemir in term of percentage of patients who reach the target of HbA1c < 7% at the end of the treatment period and do not experience symptomatic hypoglycemia, confirmed by plasma glucose (PG) ≤ 56 mg/dL (3.1 mmol/L) Secondary objectives: - To compare between the 2 treatment groups, the percentage of patients who reach the target of HbA1c < 7% and < 6.5% at the end of the treatment period - To compare the changes in HbA1c and fasting plasma glucose (FPG) - To compare the evolution of blood glucose profiles - To compare the day to day FPG variability, the insulin doses - To determine in each treatment group the biochemical and patient-related determinants of failure to reach HbA1c targets - To compare the overall incidence and rate of symptomatic hypoglycemia and nocturnal symptomatic hypoglycemia confirmed by PG ≤ 56 mg/dL (3.1 mmol/L) - To compare over the treatment period, the overall incidence and rate of symptomatic hypoglycemia and symptomatic nocturnal hypoglycemia (with PG ≤ 70 mg/dL [3.9 mmol/L]), of symptomatic day-time hypoglycemia (with PG ≤ 70 mg/dL and with PG ≤ 56 mg/dL), of severe hypoglycemia, of asymptomatic hypoglycemia with PG ≤ 56 mg/dL - To compare the overall safety: incidence of adverse events (including serious hypoglycemia and local tolerance at injection site), change in body weight, in waist circumference and in waist / hip ratio - To assess the quality of life and treatment satisfaction |
| NCT00467246 ↗ | Sub-Cutaneous Insulin in Hyperglycaemic Emergencies | Withdrawn | The Royal Bournemouth Hospital | N/A | 1969-12-31 | Hyperglycaemic emergencies are associated with significant mortality (mortality in Diabetic Ketoacidosis 0.65 - 3.3% and in HyperOsmolar Non-Ketotic Coma 12 -17%). To reduce morbidity and mortality, prompt intervention and coma and close monitoring are essential. The study is designed to investigate whether a simple intervention with a long acting insulin can improve resolution of acidosis and hyperglycaemia, prevent recurrence of ketoacidosis and shorten hospital stay. |
| NCT00474045 ↗ | Efficacy and Safety of Insulin Detemir Versus Neutral Protamine Hagedorn (NPH) Insulin in Pregnant Women With Type 1 Diabetes | Completed | Novo Nordisk A/S | Phase 3 | 2007-05-01 | This trial is conducted in Africa, Europe, North and South America and Oceania. The aim of this trial is to compare the effect and safety on blood glucose control in pregnant women with type 1 diabetes of a modern insulin analogue (insulin detemir) and human insulin (NPH insulin) given as long-acting insulin in combination with a short-acting insulin (insulin aspart). |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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