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Generated: December 10, 2018

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CLINICAL TRIALS PROFILE FOR INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT

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Clinical Trials for Insulin Aspart Protamine Recombinant; Insulin Aspart Recombinant

Trial ID Title Status Sponsor Phase Summary
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 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 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 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.
NCT00965549 Comparison of a Basal Plus One Insulin Regimen With a Biphasic Insulin Regimen in Type 2 Diabetes Patients Completed Sanofi Phase 4 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
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 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.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Insulin Aspart Protamine Recombinant; Insulin Aspart Recombinant

Condition Name

Condition Name for Insulin Aspart Protamine Recombinant; Insulin Aspart Recombinant
Intervention Trials
Diabetes Mellitus, Type 2 4
Diabetes 2
Type 2 Diabetes Mellitus 1
Post-Transplant Glucocorticoid Induced Diabetes 1
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Condition MeSH

Condition MeSH for Insulin Aspart Protamine Recombinant; Insulin Aspart Recombinant
Intervention Trials
Diabetes Mellitus, Type 2 5
Diabetes Mellitus 5
Hyperglycemia 1
Overweight 1
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Clinical Trial Locations for Insulin Aspart Protamine Recombinant; Insulin Aspart Recombinant

Trials by Country

Trials by Country for Insulin Aspart Protamine Recombinant; Insulin Aspart Recombinant
Location Trials
Japan 1
Australia 1
Canada 1
United States 1
Korea, Republic of 1
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Trials by US State

Trials by US State for Insulin Aspart Protamine Recombinant; Insulin Aspart Recombinant
Location Trials
Kentucky 1
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Clinical Trial Progress for Insulin Aspart Protamine Recombinant; Insulin Aspart Recombinant

Clinical Trial Phase

Clinical Trial Phase for Insulin Aspart Protamine Recombinant; Insulin Aspart Recombinant
Clinical Trial Phase Trials
Phase 4 6
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Clinical Trial Status

Clinical Trial Status for Insulin Aspart Protamine Recombinant; Insulin Aspart Recombinant
Clinical Trial Phase Trials
Completed 5
Terminated 1
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Clinical Trial Sponsors for Insulin Aspart Protamine Recombinant; Insulin Aspart Recombinant

Sponsor Name

Sponsor Name for Insulin Aspart Protamine Recombinant; Insulin Aspart Recombinant
Sponsor Trials
Novo Nordisk A/S 3
Sanofi 2
Vancouver General Hospital 1
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Sponsor Type

Sponsor Type for Insulin Aspart Protamine Recombinant; Insulin Aspart Recombinant
Sponsor Trials
Industry 5
Other 1
U.S. Fed 1
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Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
US Army
AstraZeneca
Julphar
Cipla
Citi
Farmers Insurance
Cerilliant
Teva

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