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Generated: December 19, 2018

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CLINICAL TRIALS PROFILE FOR PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE

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Clinical Trials for Pioglitazone Hydrochloride And Metformin Hydrochloride

Trial ID Title Status Sponsor Phase Summary
NCT00062764 Treating Nonalcoholic Steatohepatitis With Pioglitazone Completed National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Phase 2 Nonalcoholic steatohepatitis (NASH) is a common liver disease that resembles alcoholic hepatitis but occurs in persons who drink little or no alcohol. The etiology of NASH is unclear, but it is commonly associated with diabetes, obesity, and insulin resistance. Several pilot studies, including a study of pioglitazone at the NIH Clinical Center (01-DK-0130), have shown that the insulin-sensitizing thiazolidinediones lead to decreases in serum alanine aminotransferase (ALT) levels and improved liver histology. Once therapy is stopped, however, ALT levels rapidly return to pre-treatment values. Inaddition we are currently enrolling patients with NASH in a pilot study of metformin therapy for 48-weeks, however our results in 3 patients thus far have not been very encouraging. In the current study, patients who have completed the pilot study of pioglitazone and have been off therapy for 48 weeks will be offered re-treatment for 3 years. We also propose to treat patients who have not had a satisfactory response to metformin with pioglitazone for the same duration. After a repeat medical and metabolic evaluation and liver biopsy, patients with moderate-to-severe NASH (activity score greater than or equal to 4) will restart pioglitazone at a dose of 15 mg daily. If after 48 weeks, ALT levels are not normal or improved to the degree identified during the pilot study, the dose will be increased to 30 mg daily at the end of 3 years, all patients will undergo repeat medical and metabolic evaluation and liver biopsy. The primary end point will be improvement in liver histology. Secondary end points will be improvements in insulin sensitivity, reduction in visceral fat, liver volume, and liver biochemistry. The aim of this study is to evaluate whether long-term pioglitazone therapy can safely achieve and maintain biochemical and histological improvements in NASH.
NCT00063232 Treating Nonalcoholic Steatohepatitis (NASH) With Metformin Completed National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Phase 2 Nonalcoholic Steatohepatitis (NASH) is associated with progressive liver disease, fibrosis, and cirrhosis. Although the cause of NASH is unknown, it is often associated with obesity, type 2 diabetes, and insulin resistance. At present, there are no approved treatments for NASH patients, but an experimental approach has focused on improving their insulin sensitivity. Metformin is one of the most commonly used medications for the treatment of diabetes. The purpose of this study is to determine whether the medical problems of NASH patients, specifically liver damage, improves when their insulin sensitivity is enhanced with metformin. The study will last 3 to 5 years and will enroll up to 30 patients. Participants will undergo a complete medical examination, a series of lab tests, and a liver biopsy. They will then start taking a single 500-mg tablet of metformin once a day for 2 weeks, then the same dosage twice a day for 2 more weeks, if they tolerate the first dosage. The dosage will increase to 1,000 mg twice a day for the remaining 44 weeks of the study. After 1 year, participants will undergo a repeat medical examination and liver biopsy.
NCT00097279 Comparison of Biphasic Insulin Aspart 70/30 With Anti-Diabetic Drugs in Subjects With Type 2 Diabetes Completed Novo Nordisk A/S Phase 3 This trial is conducted in the United States of America (USA). The purpose of this study is to test whether biphasic insulin aspart 70/30 is a safe and at least as effective alternative in combination with two oral anti-diabetics compared to the two oral anti-diabetics alone for the control of blood glucose.
NCT00108615 Effects of Insulin Sensitizers in Subjects With Impaired Glucose Tolerance Completed VA Office of Research and Development Phase 4 Subjects with impaired glucose tolerance will be randomized to receive pioglitazone or metformin for 10 weeks. Measurements of insulin sensitivity, body composition, glucose tolerance, and muscle lipid accumulation will be performed. Adipose tissue and muscle biopsies are performed. The goal of the study is to determine whether the lipotoxiciy of impaired glucose tolerance is ameliorated by pioglitazone.
NCT00159211 Abdominal Adipose Tissue Distribution in Type 2 Diabetic Patients Treated During 6 Months With Pioglitazone or Insulin Terminated Laboratoires Takeda N/A In type 2 diabetic patients with poor glycemic control despite maximum "classic" oral treatment, bed time insulin therapy may lead to a parallel increase in abdominal visceral and subcutaneous fat, whereas pioglitazone treatment should lead to a stability (or even a decrease ) in visceral and an increase in subcutaneous abdominal fat. As visceral fat mass is correlated with insulin-resistance and cardio-vascular risk, the evolution of visceral abdominal fat in type 2 diabetic patients is of great importance. Main objective: To compare visceral and subcutaneous abdominal fat compartment after a six-month bed time insulin or pioglitazone treatment in type 2 diabetic patients with poor glycemic control despite a maximal oral treatment with metformin and sulfonylureas. The study hypothesis is that quantity of visceral and subcutaneous abdominal adipose tissue should differently evolute comparing a 6 month treatment with pioglitazone® (30 or 45mg/j) or NPH " bed-time " insulin (0.2u/kg/
NCT00159211 Abdominal Adipose Tissue Distribution in Type 2 Diabetic Patients Treated During 6 Months With Pioglitazone or Insulin Terminated Assistance Publique - Hôpitaux de Paris N/A In type 2 diabetic patients with poor glycemic control despite maximum "classic" oral treatment, bed time insulin therapy may lead to a parallel increase in abdominal visceral and subcutaneous fat, whereas pioglitazone treatment should lead to a stability (or even a decrease ) in visceral and an increase in subcutaneous abdominal fat. As visceral fat mass is correlated with insulin-resistance and cardio-vascular risk, the evolution of visceral abdominal fat in type 2 diabetic patients is of great importance. Main objective: To compare visceral and subcutaneous abdominal fat compartment after a six-month bed time insulin or pioglitazone treatment in type 2 diabetic patients with poor glycemic control despite a maximal oral treatment with metformin and sulfonylureas. The study hypothesis is that quantity of visceral and subcutaneous abdominal adipose tissue should differently evolute comparing a 6 month treatment with pioglitazone® (30 or 45mg/j) or NPH " bed-time " insulin (0.2u/kg/
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Pioglitazone Hydrochloride And Metformin Hydrochloride

Condition Name

Condition Name for Pioglitazone Hydrochloride And Metformin Hydrochloride
Intervention Trials
Diabetes Mellitus, Type 2 30
Type 2 Diabetes Mellitus 28
Type 2 Diabetes 21
Diabetes Mellitus 16
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Condition MeSH

Condition MeSH for Pioglitazone Hydrochloride And Metformin Hydrochloride
Intervention Trials
Diabetes Mellitus 92
Diabetes Mellitus, Type 2 89
Fatty Liver 10
Polycystic Ovary Syndrome 8
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Clinical Trial Locations for Pioglitazone Hydrochloride And Metformin Hydrochloride

Trials by Country

Trials by Country for Pioglitazone Hydrochloride And Metformin Hydrochloride
Location Trials
United States 771
Germany 43
Canada 33
Mexico 29
China 22
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Trials by US State

Trials by US State for Pioglitazone Hydrochloride And Metformin Hydrochloride
Location Trials
Texas 35
California 30
Florida 29
North Carolina 26
Georgia 25
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Clinical Trial Progress for Pioglitazone Hydrochloride And Metformin Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Pioglitazone Hydrochloride And Metformin Hydrochloride
Clinical Trial Phase Trials
Phase 4 58
Phase 3 38
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Pioglitazone Hydrochloride And Metformin Hydrochloride
Clinical Trial Phase Trials
Completed 86
Recruiting 19
Unknown status 11
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Clinical Trial Sponsors for Pioglitazone Hydrochloride And Metformin Hydrochloride

Sponsor Name

Sponsor Name for Pioglitazone Hydrochloride And Metformin Hydrochloride
Sponsor Trials
Takeda 21
Novo Nordisk A/S 8
Eli Lilly and Company 6
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Sponsor Type

Sponsor Type for Pioglitazone Hydrochloride And Metformin Hydrochloride
Sponsor Trials
Other 95
Industry 79
NIH 6
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Argus Health
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US Army
McKesson
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AstraZeneca
Deloitte
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