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Generated: September 18, 2019

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CLINICAL TRIALS PROFILE FOR LANTUS SOLOSTAR

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Clinical Trials for Lantus Solostar

Trial ID Title Status Sponsor Phase Summary
NCT00862875 Levemir-Body Composition and Energy Metabolism Completed McMaster University Phase 4 The objectives is to compare the changes in body composition (primary objective), diabetes parameters, energy expenditure and energy intake between Insulin detemir (Levemir® - Novolin® 4 pen) and insulin glargine (Lantus® - Solostar®) both in combination with Metformin and insulin secretagogues (SU) between baseline and after 6 months of insulin therapy in 80 type 2 diabetic patients failing on oral diabetic agents .
NCT00862875 Levemir-Body Composition and Energy Metabolism Completed Novo Nordisk A/S Phase 4 The objectives is to compare the changes in body composition (primary objective), diabetes parameters, energy expenditure and energy intake between Insulin detemir (Levemir® - Novolin® 4 pen) and insulin glargine (Lantus® - Solostar®) both in combination with Metformin and insulin secretagogues (SU) between baseline and after 6 months of insulin therapy in 80 type 2 diabetic patients failing on oral diabetic agents .
NCT00862875 Levemir-Body Composition and Energy Metabolism Completed Institut de Recherches Cliniques de Montreal Phase 4 The objectives is to compare the changes in body composition (primary objective), diabetes parameters, energy expenditure and energy intake between Insulin detemir (Levemir® - Novolin® 4 pen) and insulin glargine (Lantus® - Solostar®) both in combination with Metformin and insulin secretagogues (SU) between baseline and after 6 months of insulin therapy in 80 type 2 diabetic patients failing on oral diabetic agents .
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
NCT01226043 Patient Preference and Satisfaction With Insulin Glargine (Lantus) Solostar Pen vs Conventional Vial-Syringe Method of Lantus Injection Therapy in Patients With Type 2 Diabetes Mellitus Completed Sanofi Phase 4 Primary Objective: To assess patient preference for Lantus SoloSTAR pen versus Lantus vial and syringe at the end of Crossover Phase (Week 4) in patients with type 2 diabetes mellitus (T2DM) Secondary Objectives: To compare Lantus SoloSTAR pen versus Lantus vial and syringe with regard to the following parameters: Randomization/Crossover phase: - Healthcare professional's (HCP) recommendation for Lantus SoloSTAR pen versus Lantus vial and syringe Re-randomization phase: - Change in Fasting Plasma Glucose (FPG) from week 4 to week 10 - Percentage of patients achieving FPG<110 mg/dL at week 10 - Change in Lantus dose injected per day (U) from week 4 to week 10 Observational phase: - Percentage of patients achieving glycosylated hemoglobin (HbA1c) goal (<7%) at week 40 - Time to first observation of HbA1c<7% during the observational phase - Percentage of patients who discontinue Investigational Product (IP) during the observational phase due to dissatisfaction with their current device All phases: - Percentage of patients who discontinue IP during each phase of the study - Safety assessment such as occurrence of hypoglycemic events (HE) and adverse events (AE)
NCT01768559 Efficacy and Safety of Lixisenatide Versus Insulin Glulisine on Top of Insulin Glargine With or Without Metformin in Type 2 Diabetic Patients Completed Sanofi Phase 3 Primary Objective: - To compare lixisenatide versus insulin glulisine in terms of HbA1c reduction and body weight change at week 26 in type 2 diabetic patients not adequately controlled on insulin glargine ± metformin. Secondary Objectives: - To compare the treatments/regimens on: - The percentage of patients reaching the target of HbA1c <7% or ≤6.5% - Body weight - Self-Monitored Glucose profiles - Fasting Plasma Glucose (FPG) - Post-prandial plasma glucose /glucose excursions during a standardized meal test (subset of patients) - Daily doses of insulins - Safety and tolerability
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Clinical Trial Conditions for Lantus Solostar

Condition Name

Condition Name for Lantus Solostar
Intervention Trials
Diabetes Mellitus, Type 1 2
Type 2 Diabetes 2
Diabetes Mellitus, Type 2 2
Diabetes Mellitus 1
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Condition MeSH

Condition MeSH for Lantus Solostar
Intervention Trials
Diabetes Mellitus 4
Diabetes Mellitus, Type 2 3
Diabetes Mellitus, Type 1 2
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Clinical Trial Locations for Lantus Solostar

Trials by Country

Trials by Country for Lantus Solostar
Location Trials
United States 27
Mexico 3
Canada 2
Russian Federation 2
Brazil 2
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Trials by US State

Trials by US State for Lantus Solostar
Location Trials
Arizona 1
Maryland 1
California 1
Colorado 1
Florida 1
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Clinical Trial Progress for Lantus Solostar

Clinical Trial Phase

Clinical Trial Phase for Lantus Solostar
Clinical Trial Phase Trials
Phase 4 4
Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Lantus Solostar
Clinical Trial Phase Trials
Completed 6
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Clinical Trial Sponsors for Lantus Solostar

Sponsor Name

Sponsor Name for Lantus Solostar
Sponsor Trials
Sanofi 4
McMaster University 1
Geropharm 1
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Sponsor Type

Sponsor Type for Lantus Solostar
Sponsor Trials
Industry 6
Other 2
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