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Generated: December 14, 2018

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CLINICAL TRIALS PROFILE FOR PIOGLITAZONE HYDROCHLORIDE

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Clinical Trials for Pioglitazone Hydrochloride

Trial ID Title Status Sponsor Phase Summary
NCT00013598 Treatment of Nonalcoholic Steatohepatitis With Pioglitazone Completed National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Phase 2 This study will evaluate the effectiveness of pioglitazone, a new diabetes medicine, on decreasing insulin resistance and improving liver disease in patients with nonalcoholic steatohepatitis (NASH). NASH is a chronic liver disease with unknown cause that involves fat accumulation and inflammation in the liver, leading to liver cirrhosis in 10 to 15 percent of patients and significant liver scarring in another 30 percent. Although similar to a condition that affects people who drink excessive amounts of alcohol, NASH occurs in people who drink only minimal or no alcohol. It is most often seen in patients with insulin resistance. Pioglitazone decreases insulin resistance and improves blood lipid (fat) levels, so that it may improve liver disease in NASH. Patients with NASH 18 years of age or older may be eligible for this study. Candidates will be screened with a medical history and physical examination and routine blood tests. They will see a dietitian for counseling on diet and weight reduction, if needed. They will stop taking any medications for liver disease and take a daily multivitamin pill. After 2 months, those eligible for participation will be enrolled in the study. Participants will be admitted to the Clinical Center for 2 to 3 days for a complete medical history, physical examination, blood tests, urinalysis, chest X-ray, electrocardiogram, abdominal ultrasound and a liver biopsy. After the diagnosis of NASH is confirmed, the following procedures will be performed: - Echocardiography - imaging test using sound waves shows the heart structure and function - Resting metabolic rate - measures amount of oxygen (and calories) used to maintain body functions at rest. While lying down, the patient wears a clear plastic hood over the head for 20 minutes while the amount of oxygen used is measured. - Magnetic resonance imaging (MRI) scans - shows the size of the liver and other organs. The patient lies on a table in a metal cylinder that contains a magnetic field (the scanner) for no more than 30 minutes while the organs are imaged. - Dual energy X-ray absorptiometry (DEXA) scan measures whole body composition, including amount of fat. The patient lies under an X-ray scanning machine for about 2 minutes. - Oral glucose tolerance test (OGTT) - measures blood sugar and insulin levels. The patient drinks a very sweet drink containing glucose (sugar), after which blood samples are collected at various intervals during the 3-hour test. The blood is drawn through a catheter (thin plastic tube) placed in the arm before the test begins. - Intravenous glucose tolerance test (IVGTT) - determines how the tissues respond to insulin and glucose. Glucose is injected into a vein, followed by a short infusion of insulin. Blood samples are collected through a catheter at various intervals during the 3-hour test. When the above procedures are completed, patients start taking pioglitazone by mouth once a day for 48 weeks, keeping track of the medication and any side effects. They will be seen at the clinic every 2 weeks for the first month and then every 4 weeks for the rest of the treatment period. The visits will include an interview and examination by a physician and blood draw for laboratory tests. Female patients will have a pregnancy test at each clinic visit. At the end of the treatment period patients will be admitted to the Clinical Center for a repeat medical evaluation that will include the procedures described above.
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.
NCT00063622 Pioglitazone vs Vitamin E vs Placebo for Treatment of Non-Diabetic Patients With Nonalcoholic Steatohepatitis (PIVENS) Completed National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Phase 3 The purpose of this study is to determine if therapy with pioglitazone or vitamin E will lead to an improvement in liver histology in non-diabetic adult patients with non-alcoholic steatohepatitis (NASH).
NCT00086502 Pioglitazone Add-on Study in Patients With Type 2 Diabetes Mellitus Completed Merck Sharp & Dohme Corp. Phase 3 The purpose of this study is to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus.
NCT00091949 Insulin Resistance Intervention After Stroke Trial Completed National Institute of Neurological Disorders and Stroke (NINDS) Phase 3 The purpose of this study is to determine if pioglitazone is effective in preventing future strokes or heart attacks among non-diabetic persons who have had a recent ischemic stroke.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Pioglitazone Hydrochloride

Condition Name

Condition Name for Pioglitazone Hydrochloride
Intervention Trials
Type 2 Diabetes Mellitus 59
Diabetes Mellitus, Type 2 53
Type 2 Diabetes 41
Diabetes Mellitus 31
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Condition MeSH

Condition MeSH for Pioglitazone Hydrochloride
Intervention Trials
Diabetes Mellitus 183
Diabetes Mellitus, Type 2 169
Insulin Resistance 33
Fatty Liver 24
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Clinical Trial Locations for Pioglitazone Hydrochloride

Trials by Country

Trials by Country for Pioglitazone Hydrochloride
Location Trials
Germany 117
Canada 78
Mexico 63
India 58
United Kingdom 57
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Trials by US State

Trials by US State for Pioglitazone Hydrochloride
Location Trials
Texas 78
California 65
Ohio 57
New York 55
Florida 53
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Clinical Trial Progress for Pioglitazone Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Pioglitazone Hydrochloride
Clinical Trial Phase Trials
Phase 4 112
Phase 3 87
Phase 2/Phase 3 9
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Clinical Trial Status

Clinical Trial Status for Pioglitazone Hydrochloride
Clinical Trial Phase Trials
Completed 269
Recruiting 40
Terminated 35
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Clinical Trial Sponsors for Pioglitazone Hydrochloride

Sponsor Name

Sponsor Name for Pioglitazone Hydrochloride
Sponsor Trials
Takeda 59
Merck Sharp & Dohme Corp. 20
Takeda Pharmaceuticals North America, Inc. 16
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Sponsor Type

Sponsor Type for Pioglitazone Hydrochloride
Sponsor Trials
Other 287
Industry 218
NIH 48
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