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Last Updated: March 29, 2024

CLINICAL TRIALS PROFILE FOR INSULIN GLARGINE


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Biosimilar Clinical Trials for insulin glargine

This table shows clinical trials for biosimilars. See the next table for all clinical trials
Trial ID Title Status Sponsor Phase Start Date Summary
NCT03819790 ↗ The Effect of Soliqua on Glucose Variability in Type 2 Patients Among South Asians Completed Sanofi Phase 4 2018-10-02 The overall objective of this study is to compare the effects of Soliqua, a titratable combination of insulin and GLP-1 receptor agonist in a single pen versus Glargine U100 insulin (Basaglar or Lantus) and gliclazide MR, both added to metformin, on measures of glucose variability using masked CGM data among people of South Asian origin living in Canada with type 2 diabetes (T2DM).
NCT03819790 ↗ The Effect of Soliqua on Glucose Variability in Type 2 Patients Among South Asians Completed LMC Diabetes & Endocrinology Ltd. Phase 4 2018-10-02 The overall objective of this study is to compare the effects of Soliqua, a titratable combination of insulin and GLP-1 receptor agonist in a single pen versus Glargine U100 insulin (Basaglar or Lantus) and gliclazide MR, both added to metformin, on measures of glucose variability using masked CGM data among people of South Asian origin living in Canada with type 2 diabetes (T2DM).
NCT04591457 ↗ The Efficacy, Safety, and Immunogenicity Study Comparing an Insulin Glargine Biosimilar Sansulin Log-G to Lantus Not yet recruiting Indonesia University Phase 2 2020-10-01 This is an open-label randomised multicenter clinical study to investigate efficacy, safety, and immunogenicity of the drug products: Insulin Glargine biosimilar ® Log-G and its reference Lantus® in type 2 diabetes mellitus patients
>Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for insulin glargine

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00046462 ↗ Determine Whether Glycemic Control is Different Between Lantus & a 3rd Oral Agent When Failure With Other Treatment Completed Sanofi Phase 3 2001-11-01 The purposes of the study is to determine whether blood sugar control is different between Lantus and a third oral anti-diabetic agent when added to patients who fail a thiazolidinedione and sulfonylurea or metformin combination.
NCT00064714 ↗ Effect of AC2993 With or Without Immunosuppression on Beta Cell Function in Patients With Type I Diabetes Completed National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Phase 2 2003-07-01 This study will determine 1) the safety of AC2993 in patients with type I diabetes; 2) the ability of AC2993 to improve beta cell function; and 3) the effects of immunosuppression on beta cell function. Type I diabetes is an autoimmune disease, in which the immune system attacks the beta cells of the pancreas. These cells produce insulin, which regulates blood sugar. AC2993 may improve the pancreas's ability to produce insulin and help control blood sugar, but it may also activate the original immune response that caused the diabetes. Thus, this study will examine the effects of AC2993 alone as well as in combination with immunosuppressive drugs. Patients between 18 and 60 years of age who have type I diabetes mellitus may be eligible for this 20-month study. They must have had diabetes for at least 5 years and require insulin treatment. Candidates will be screened with a questionnaire, followed by medical history and physical examination, blood and urine tests, a chest x-ray and skin test for tuberculosis, electrocardiogram (EKG), and arginine stimulated C-peptide test (see description below). Participants will undergo the following tests and procedures: Advanced screening phase: Participants undergo a diabetes education program, including instruction on frequent blood glucose monitoring, dietary education on counting carbohydrates, intensive insulin therapy, review of signs and symptoms of low blood sugar (hypoglycemia), and potential treatment with glucagon shots. Patients must administer insulin via an insulin pump or take at least four injections per day including glargine (Lantus) insulin. 4-month run-in phase - Arginine-stimulated C-peptide test: This test measures the body's insulin production. The patient is injected with a liquid containing arginine, a normal constituent of food that increases insulin release from beta cells into the blood stream. After the injection, seven blood samples are collected over 10 minutes. - Mixed meal stimulated C-peptide test with acetaminophen: This test assesses the response of the beta cells to an ordinary meal and the time it takes for food to pass through the stomach. The patient drinks a food supplement and takes acetaminophen (Tylenol). Blood samples are then drawn through a catheter (plastic tube placed in a vein) every 30 minutes for 4 hours to measure levels of various hormones and the concentration of acetaminophen. - Euglycemic clamp: This test measures the body's level of insulin resistance by measuring the amount of glucose necessary to compensate for an increased insulin level while maintaining a prespecified blood glucose level.
NCT00064714 ↗ Effect of AC2993 With or Without Immunosuppression on Beta Cell Function in Patients With Type I Diabetes Completed AstraZeneca Phase 2 2003-07-01 This study will determine 1) the safety of AC2993 in patients with type I diabetes; 2) the ability of AC2993 to improve beta cell function; and 3) the effects of immunosuppression on beta cell function. Type I diabetes is an autoimmune disease, in which the immune system attacks the beta cells of the pancreas. These cells produce insulin, which regulates blood sugar. AC2993 may improve the pancreas's ability to produce insulin and help control blood sugar, but it may also activate the original immune response that caused the diabetes. Thus, this study will examine the effects of AC2993 alone as well as in combination with immunosuppressive drugs. Patients between 18 and 60 years of age who have type I diabetes mellitus may be eligible for this 20-month study. They must have had diabetes for at least 5 years and require insulin treatment. Candidates will be screened with a questionnaire, followed by medical history and physical examination, blood and urine tests, a chest x-ray and skin test for tuberculosis, electrocardiogram (EKG), and arginine stimulated C-peptide test (see description below). Participants will undergo the following tests and procedures: Advanced screening phase: Participants undergo a diabetes education program, including instruction on frequent blood glucose monitoring, dietary education on counting carbohydrates, intensive insulin therapy, review of signs and symptoms of low blood sugar (hypoglycemia), and potential treatment with glucagon shots. Patients must administer insulin via an insulin pump or take at least four injections per day including glargine (Lantus) insulin. 4-month run-in phase - Arginine-stimulated C-peptide test: This test measures the body's insulin production. The patient is injected with a liquid containing arginine, a normal constituent of food that increases insulin release from beta cells into the blood stream. After the injection, seven blood samples are collected over 10 minutes. - Mixed meal stimulated C-peptide test with acetaminophen: This test assesses the response of the beta cells to an ordinary meal and the time it takes for food to pass through the stomach. The patient drinks a food supplement and takes acetaminophen (Tylenol). Blood samples are then drawn through a catheter (plastic tube placed in a vein) every 30 minutes for 4 hours to measure levels of various hormones and the concentration of acetaminophen. - Euglycemic clamp: This test measures the body's level of insulin resistance by measuring the amount of glucose necessary to compensate for an increased insulin level while maintaining a prespecified blood glucose level.
NCT00069784 ↗ The ORIGIN Trial (Outcome Reduction With Initial Glargine Intervention) Completed Population Health Research Institute Phase 3 2003-08-01 The primary objectives of the ORIGIN study were: - To determine whether insulin glargine-mediated normoglycemia can reduce cardiovascular morbidity and/or mortality in people at high risk for vascular disease with either Impaired Fasting Glucose (IFG), Impaired Glucose Tolerance (IGT) or early type 2 diabetes; - To determine whether omega-3 fatty acids can reduce cardiovascular mortality in people with IFG, IGT or early type 2 diabetes. The secondary objectives of the insulin glargine study were to determine if insulin glargine-mediated normoglycemia can reduce: - total mortality (all causes); - the risk of diabetic microvascular outcomes; - the rate of progression of IGT or IFG to type 2 diabetes.
NCT00069784 ↗ The ORIGIN Trial (Outcome Reduction With Initial Glargine Intervention) Completed Sanofi Phase 3 2003-08-01 The primary objectives of the ORIGIN study were: - To determine whether insulin glargine-mediated normoglycemia can reduce cardiovascular morbidity and/or mortality in people at high risk for vascular disease with either Impaired Fasting Glucose (IFG), Impaired Glucose Tolerance (IGT) or early type 2 diabetes; - To determine whether omega-3 fatty acids can reduce cardiovascular mortality in people with IFG, IGT or early type 2 diabetes. The secondary objectives of the insulin glargine study were to determine if insulin glargine-mediated normoglycemia can reduce: - total mortality (all causes); - the risk of diabetic microvascular outcomes; - the rate of progression of IGT or IFG to type 2 diabetes.
NCT00082381 ↗ Effect of AC2993 Compared With Insulin Glargine in Patients With Type 2 Diabetes Also Using Combination Therapy With Sulfonylurea and Metformin Completed Eli Lilly and Company Phase 3 2003-06-01 This is a multicenter, comparator-controlled, open-label, randomized, two-arm, parallel trial to compare the effect of exenatide twice daily and insulin glargine on glycemic control, as measured by hemoglobin A1c (HbA1c).
NCT00082381 ↗ Effect of AC2993 Compared With Insulin Glargine in Patients With Type 2 Diabetes Also Using Combination Therapy With Sulfonylurea and Metformin Completed AstraZeneca Phase 3 2003-06-01 This is a multicenter, comparator-controlled, open-label, randomized, two-arm, parallel trial to compare the effect of exenatide twice daily and insulin glargine on glycemic control, as measured by hemoglobin A1c (HbA1c).
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for insulin glargine

Condition Name

Condition Name for insulin glargine
Intervention Trials
Diabetes Mellitus, Type 2 159
Type 2 Diabetes Mellitus 93
Diabetes 86
Type 2 Diabetes 66
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Condition MeSH

Condition MeSH for insulin glargine
Intervention Trials
Diabetes Mellitus 453
Diabetes Mellitus, Type 2 326
Diabetes Mellitus, Type 1 119
Hyperglycemia 26
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Clinical Trial Locations for insulin glargine

Trials by Country

Trials by Country for insulin glargine
Location Trials
United Kingdom 94
South Africa 93
Romania 87
Brazil 85
Australia 79
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Trials by US State

Trials by US State for insulin glargine
Location Trials
California 127
Texas 126
Florida 113
Georgia 102
Washington 96
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Clinical Trial Progress for insulin glargine

Clinical Trial Phase

Clinical Trial Phase for insulin glargine
Clinical Trial Phase Trials
Phase 4 213
Phase 3 186
Phase 2/Phase 3 4
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Clinical Trial Status

Clinical Trial Status for insulin glargine
Clinical Trial Phase Trials
Completed 427
Terminated 33
Not yet recruiting 22
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Clinical Trial Sponsors for insulin glargine

Sponsor Name

Sponsor Name for insulin glargine
Sponsor Trials
Sanofi 173
Novo Nordisk A/S 98
Eli Lilly and Company 81
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Sponsor Type

Sponsor Type for insulin glargine
Sponsor Trials
Industry 464
Other 278
NIH 10
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