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Generated: October 21, 2018

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CLINICAL TRIALS PROFILE FOR APIDRA SOLOSTAR

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Clinical Trials for APIDRA SOLOSTAR

Trial ID Title Status Sponsor Phase Summary
NCT01203111 Intensive Insulin Glulisine Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Basal Insulin and Oral Glucose-lowering Drugs Completed Sanofi Phase 4 Primary Objective: To evaluate the efficacy of an intensive insulin regimen with insulin glargine and insulin glulisine in terms of change in Hemoglobin A1c (HbA1c) level from week 12 (visit 7) to week 24 (visit 10). Secondary Objectives: 1. Percentage of patients with HbA1c < 7% at week 24. 2. Percentage of patients with HbA1c < 7% and no symptomatic nocturnal hypoglycemia event at week 24. 3. Fasting Plasma Glucose (FPG) and 7-point Self Monitoring of Blood Glucose (SMBG) at week 0, week 12 and week 24. 4. Doses of insulin glargine and insulin glulisine: the daily dose (U) and the daily dose / kg (U/kg) will be calculated at week 24. 5. Systolic and diastolic blood pressure, heart rate, weight change will be measured at week 0, week 12 and week 24. 6. Number of patients suffering hypoglycemias (asymptomatic, symptomatic, nocturnal symptomatic, severe and nocturnal severe) will be evaluated during the treatment period. 7-Adverse events.
NCT01204593 baSal BoluS Therapy in patIenTs With TypE 1 Diabetes Mellitus Completed Sanofi Phase 4 Primary Objective: To evaluate the efficacy of the association Lantus (once-a-day, od) Apidra (thrice-a-day, tid) in terms of change HbA1c from baseline to end of study (week 24), in patients with Type 1 Diabetes Mellitus (T1DM). Secondary Objectives: To evaluate: - The change of hemoglobin A1c (HbA1c) from baseline to week 12 - The percentage of patients with HbA1c < 7% at week 12 and week 24 - The FBG and the 7-point self monitoring of blood glucose (SMBG) at baseline, week 12 and week 24 - The daily dose for both insulin glulisine insulin glargine at baseline, week 12 and week 24 - The incidence of symptomatic hypoglycemias - Adverse events
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for APIDRA SOLOSTAR

Condition Name

Condition Name for APIDRA SOLOSTAR
Intervention Trials
Diabetes Mellitus, Type 2 1
Diabetes Mellitus, Type 1 1
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Condition MeSH

Condition MeSH for APIDRA SOLOSTAR
Intervention Trials
Diabetes Mellitus 2
Diabetes Mellitus, Type 1 1
Diabetes Mellitus, Type 2 1
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Clinical Trial Locations for APIDRA SOLOSTAR

Trials by Country

Trials by Country for APIDRA SOLOSTAR
Location Trials
Brazil 2
Mexico 2
Saudi Arabia 2
Algeria 2
United Arab Emirates 1
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Clinical Trial Progress for APIDRA SOLOSTAR

Clinical Trial Phase

Clinical Trial Phase for APIDRA SOLOSTAR
Clinical Trial Phase Trials
Phase 4 2
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Clinical Trial Status

Clinical Trial Status for APIDRA SOLOSTAR
Clinical Trial Phase Trials
Completed 2
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Clinical Trial Sponsors for APIDRA SOLOSTAR

Sponsor Name

Sponsor Name for APIDRA SOLOSTAR
Sponsor Trials
Sanofi 2
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Sponsor Type

Sponsor Type for APIDRA SOLOSTAR
Sponsor Trials
Industry 2
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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Express Scripts
Deloitte
Fish and Richardson
Harvard Business School
Healthtrust
Medtronic
UBS
Covington

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