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Generated: February 22, 2019

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CLINICAL TRIALS PROFILE FOR INSULIN GLARGINE RECOMBINANT

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Clinical Trials for Insulin Glargine Recombinant

Trial ID Title Status Sponsor Phase Summary
NCT00046462 Determine Whether Glycemic Control is Different Between Lantus & a 3rd Oral Agent When Failure With Other Treatment Completed Sanofi Phase 3 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 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 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.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Insulin Glargine Recombinant

Condition Name

Condition Name for Insulin Glargine Recombinant
Intervention Trials
Diabetes Mellitus, Type 2 141
Diabetes 85
Type 2 Diabetes Mellitus 77
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Condition MeSH

Condition MeSH for Insulin Glargine Recombinant
Intervention Trials
Diabetes Mellitus 386
Diabetes Mellitus, Type 2 275
Diabetes Mellitus, Type 1 96
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Clinical Trial Locations for Insulin Glargine Recombinant

Trials by Country

Trials by Country for Insulin Glargine Recombinant
Location Trials
United Kingdom 90
India 75
Spain 75
Mexico 72
Australia 66
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Trials by US State

Trials by US State for Insulin Glargine Recombinant
Location Trials
California 107
Texas 102
Florida 92
Georgia 85
Washington 80
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Clinical Trial Progress for Insulin Glargine Recombinant

Clinical Trial Phase

Clinical Trial Phase for Insulin Glargine Recombinant
Clinical Trial Phase Trials
Phase 4 185
Phase 3 160
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Insulin Glargine Recombinant
Clinical Trial Phase Trials
Completed 321
Recruiting 52
Not yet recruiting 28
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Clinical Trial Sponsors for Insulin Glargine Recombinant

Sponsor Name

Sponsor Name for Insulin Glargine Recombinant
Sponsor Trials
Sanofi 165
Novo Nordisk A/S 85
Eli Lilly and Company 65
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Sponsor Type

Sponsor Type for Insulin Glargine Recombinant
Sponsor Trials
Industry 409
Other 189
NIH 8
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Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
Covington
Johnson and Johnson
Chinese Patent Office
McKinsey
Fish and Richardson
Healthtrust
Medtronic
Fuji

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