A double-blind, randomized, placebo-controlled, parallel group study of rimonabant 20 mg daily for the treatment of Type 2 diabetic patients with nonalcoholic steatohepatitis (NASH) - STRONG2
- Conditions
- MedDRA version: 9.1Level: LLTClassification code 10053219Term: Non-alcoholic steatohepatitisDiabetic patients with Non-Alcoholic Steato-Hepatitis (NASH)
- Registration Number
- EUCTR2007-003013-14-IT
- Lead Sponsor
- sanofi-aventis recherche & development
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 720
1. Patients who are at least 18 years of age and with a diagnosis of NASH by liver biopsy performed within last 6 months (based on pre-defined histological criteria as confirmed by a central pathologist) 2. Confirmed Type 2 DM diagnosed by fasting plasma glucose ≥ 126 mg/dl or 2-hour post load glucose ≥ 200 mg/dl during an OGTT (equivalent of 75 g anhydrous glucose in water) of at least 6 months duration
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
;
1. Patients who are at least 18 years of age and with a diagnosis of NASH by liver biopsy performed within last 6 months (based on pre-defined histological criteria as confirmed by a central pathologist) 2. Confirmed Type 2 DM diagnosed by fasting plasma glucose ≥ 126 mg/dl or 2-hour post load glucose ≥ 200 mg/dl during an OGTT (equivalent of 75 g anhydrous glucose in water) of at least 6 months duration
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria related to study methodology -Refusal or inability to give informed consent to participate in the study -Average alcohol ingestion > 21 units/wk (males) or > 14 units/wk (females) -History of or presence of Type 1 diabetes mellitus - Hemoglobin A1C > 8.5. -Other cause of chronic liver disease and/or hepatic steatosis: - Wilson?s Disease - Alpha-1-Antitrypsin deficiency - Viral hepatitis - Primary Biliary Cirrhosis - Autoimmune hepatitis - Genetic iron overload - History of sleep apnea (unless on Constant Positive Airway Pressure therapy) - History of or current HIV infection - Hypo- or hyper-thyroidism -Any contraindication to liver biopsy based on local standard for pre-liver biopsy risk assessment -History of or planned gastrointestinal bypass surgery/intervention -Hepatic Cirrhosis with a Child-Pugh classification of B or C -Concomitant Hepatocellular Carcinoma (HCC) 10. Previous hepatic transplantation -Recent significant weight loss (> 5% TBW within previous 6 months) -ALT or AST > 10 x ULN at screening or within 3 months of screening -Recent (within 6 months of baseline liver biopsy and screening visit) or concomitant use of agent known to cause hepatic steatosis: - corticosteroids - amiodarone - methotrexate - tamoxifen - tetracycline - high dose estrogens - valproic acid -Recent (within 3 months of baseline liver biopsy and screening visit) change in anti-diabetes treatment, such as a change in dose-regimen of anti-diabetes agent or introduction of new- antidiabetes agent (a specific diabetes medication /treatment page will be included in the CRF). -Recent change in dose/ regimen or introduction of: - Vitamin E, Vitamin C - betaine, s-adenosyl methionine (SAM), ursodeoxycholate (UDCA) - silymarin (silybin) - fibrate - statin - pentoxyfilline - angiotensin II inhibitor -Recent change in dose/ regimen or introduction of weight loss agent such as: - orlistat - sibutramine - rimonabant - Any situation that in the Investigator?s opinion, may interfere with optimal study participation -Participation in any clinical study of an investigational agent within 30 days or five half-lives of the investigational agent, whichever is longer -Presence of clinically relevant cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, hematological, neurological, psychiatric, systemic, ocular, gynecologic (if female), or any acute infectious disease or signs of acute illness -Presence or history of multiple allergic reactions to drugs 21. Presence or history of cancer within past 5 yrs with exception of adequately treated localized basal cell carcinoma of the skin, in situ cervical cancer or solid malignancy surgically excised in toto without recurrence for five years -Women of childbearing potential not protected by effective contraceptive method of birth control or surgical sterilization and/or who are unwilling or unable to be tested for pregnancy. -Be pregnant or breastfeeding -Hypersensitivity to rimonabant or to any of the excipients.
;
Exclusion criteria related to study methodology -Refusal or inability to give informed consent to participate in the study -Average alcohol ingestion > 21 units/wk (males) or > 14 units/wk (females) -History of or presence of Type 1 diabetes mellitus - Hemoglobin A1C > 8.5. -Other cause of chronic liver disease and/or hepatic steatosis: - Wilson?s Disease - Alpha-1-Antitrypsin deficiency - Viral hepatitis - Primary Biliary Cirrhosis - Autoimmune hepatitis - Genetic iron overload - History of sleep apnea (unless on Constant Positive Airway Pressure therapy) - History of or current HIV infection - Hypo- or hyper-thyroidism -Any contraindication to liver biopsy based on local standard for pre-liver biopsy risk assessment -History of or planned gastrointestinal bypass surgery/intervention -Hepatic Cirrhosis with a Child-Pugh classification of B or C -Concomitant Hepatocellular Carcinoma (HCC) 10. Previous hepatic transplantation -Recent significant weight loss (> 5% TBW within previous 6 months) -ALT or AST > 10 x ULN at screening or within 3 months of screening -Recent (within 6 months of baseline liver biopsy and screening visit) or concomitant use of agent known to cause hepatic steatosis: - corticosteroids - amiodarone - methotrexate - tamoxifen - tetracycline - high dose estrogens - valproic acid -Recent (within 3 months of baseline liver biopsy and screening visit) change in anti-diabetes treatment, such as a change in dose-regimen of anti-diabetes agent or introduction of new- antidiabetes agent (a specific diabetes medication /treatment page will be included in the CRF). -Recent change in dose/ regimen or introduction of: - Vitamin E, Vitamin C - betaine, s-adenosyl methionine (SAM), ursodeoxycholate (UDCA) - silymarin (silybin) - fibrate - statin - pentoxyfilline - angiotensin II inhibitor -Recent change in dose/ regimen or introduction of weight loss agent such as: - orlistat - sibutramine - rimonabant - Any situation that in the Investigator?s opinion, may interfere with optimal study participation -Participation in any clinical study of an investigational agent within 30 days or five half-lives of the investigational agent, whichever is longer -Presence of clinically relevant cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, hematological, neurological, psychiatric, systemic, ocular, gynecologic (if female), or any acute infectious disease or signs of acute illness -Presence or history of multiple allergic reactions to drugs 21. Presence or history of cancer within past 5 yrs with exception of adequately treated localized basal cell carcinoma of the skin, in situ cervical cancer or solid malignancy surgically excised in toto without recurrence for five years -Women of childbearing potential not protected by effective contraceptive method of birth control or surgical sterilization and/or who are unwilling or unable to be tested for pregnancy. -Be pregnant or breastfeeding -Hypersensitivity to rimonabant or to any of the excipients.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method