CLINICAL TRIALS PROFILE FOR INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT
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All Clinical Trials for Insulin Aspart Protamine Recombinant; Insulin Aspart Recombinant
Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
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NCT01648218 ↗ | Insulin Therapy for Post-transplant Glucocorticoid Induced Hyperglycemia | Terminated | Vancouver General Hospital | Phase 4 | 2012-08-01 | No consensus guidelines exist for management of post-transplant glucocorticoid induced hyperglycemia, but most published reviews recommend insulin as first line therapy. A variety of insulin regimens have been proposed, including mealtime short-acting regular or analog insulin, once daily neutral protamine hagedorn (NPH) insulin, pre-mixed insulin, or basal insulin alone such as glargine or detemir. However, no randomized trial has ever examined different insulin regimens to determine which most effectively controls post-transplant steroid-induced hyperglycemia. Consequently, the proposed study intends to examine three commonly used insulin regimens used for managing post-transplant once-daily glucocorticoid-induced hyperglycemia to determine which is most effective: - Group 1: Intermediate-acting (NPH) insulin at breakfast - Group 2: Short-acting insulin (regular or aspart) before meals - Group 3: Insulin glargine at breakfast Question/Hypothesis: Among three commonly used insulin regimens, which is most effective for managing post-transplant once-daily glucocorticoid-induced hyperglycemia? |
NCT01212913 ↗ | Comparison of Insulin Glargine/Insulin Glulisine Regimen to Insulin Aspart/Insulin Aspart Protamine 30/70 in Type 2 Diabetes Mellitus Patients (T2DM) | Completed | Sanofi | Phase 4 | 2010-08-01 | Primary Objective: To demonstrate the non-inferiority of hemoglobin A1c (HbA1c) control at six months between the basal plus one and the biphasic insulin regimen. Secondary Objective: To demonstrate favorable outcome for basal plus over biphasic insulin when it comes to comparing when both hemoglobin A1c (HbA1c) target goal achievement and non-hypoglycemic event is taken into account. |
NCT00965549 ↗ | Comparison of a Basal Plus One Insulin Regimen With a Biphasic Insulin Regimen in Type 2 Diabetes Patients | Completed | Sanofi | Phase 4 | 2009-07-01 | The primary objective is to demonstrate the non-inferiority at six months of a basal plus one insulin regimen (Lantus plus one injection of Apidra) compared with a biphasic insulin regimen (NovoMix 30) at controlling glycosylated haemoglobin (HbA1c) in type 2 diabetes. The secondary objective are: - To compare the proportion of patients in each treatment group reaching HbA1c target (< 7%) at the end of the treatment period - To compare the rates of hypoglycaemia (total, severe, nocturnal) - To compare the change in body weight from visit 10 to visit 24 - To compare the change in diabetes specific quality of life and other patient reported outcomes from visit 10 to visit 24 - Diabetes Treatment Satisfaction Questionnaire - status and change (DTSQs+c) - Audit of Diabetes-Dependent Quality of Life (ADDQoL) questionnaire - Insulin Treatment Satisfaction Questionnaire (ITSQ) - EuroQoL 5 Dimensions (EQ5D) questionnaire - To record the change in the daily dose of insulin from visit 2 to visit 10 and visit 10 to visit 24 |
NCT00795600 ↗ | Comparison of the Change in Fat Distribution in Overweight and Obese Subjects With Type 2 Diabetes After Insulin Treatment | Completed | Novo Nordisk A/S | Phase 4 | 2009-04-01 | This trial is conducted in Europe. The aim of this clinical trial is to compare the change in trunk fat mass, assessed by Double Energy X-ray Absorptiometry (DEXA) after 26 weeks of treatment with insulin detemir or insulin NPH (Neutral Protamine Hagedorn) (both combined with insulin aspart at the main meals) in overweight and obese subjects with type 2 diabetes. |
NCT00821795 ↗ | Veterans Inpatient Insulin Study and Transition to Outpatient Therapy | Completed | Novo Nordisk A/S | Phase 4 | 2009-03-11 | Volunteers are being invited to take part in a research study about insulin therapy of diabetes. They are being invited to take part in this research study because they have diabetes and have an illness requiring hospitalization. If they volunteer to take part in this study, they will be one of about 120 people to do so. The investigators hope to answer the following research questions: - To show that insulin aspart protamine 70/30 mix taken twice daily is as good as insulin NPH/Reg 70/30 mix taken twice a day for treatment of diabetes after discharge from the hospital. - To show how safe the two medicines are (insulin aspart 70/30 mix vs. insulin NPH/Reg 70/30 mix) and how well they work for the treatment of diabetes when transitioning from inpatient therapy to outpatient care. |
NCT00821795 ↗ | Veterans Inpatient Insulin Study and Transition to Outpatient Therapy | Completed | Dennis G. Karounos, M.D. | Phase 4 | 2009-03-11 | Volunteers are being invited to take part in a research study about insulin therapy of diabetes. They are being invited to take part in this research study because they have diabetes and have an illness requiring hospitalization. If they volunteer to take part in this study, they will be one of about 120 people to do so. The investigators hope to answer the following research questions: - To show that insulin aspart protamine 70/30 mix taken twice daily is as good as insulin NPH/Reg 70/30 mix taken twice a day for treatment of diabetes after discharge from the hospital. - To show how safe the two medicines are (insulin aspart 70/30 mix vs. insulin NPH/Reg 70/30 mix) and how well they work for the treatment of diabetes when transitioning from inpatient therapy to outpatient care. |
NCT01649570 ↗ | Safety and Efficacy of Insulin Aspart in Type 2 Diabetes | Completed | Novo Nordisk A/S | Phase 4 | 2002-03-01 | This trial is conducted in Japan. The aim of this trial is to investigate the safety and efficacy of NovoRapid® (insulin aspart) as meal time insulin in subjects with type 2 diabetes treated on a basal-bolus regimen with Neutral Protamine Hagedorn (NPH) human insulin. |
>Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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