A randomized double blind, placebo-controlled clinical trial to assess the effects of taspoglutide (RO5073031) on cardiovascular outcomes in subjects with inadequately controlled type 2 diabetes and established cardiovascular disease - EMERGE 8
- Conditions
- Patients with Type 2 diabetesMedDRA version: 12.0Level: LLTClassification code 10067585Term: Type 2 diabetes mellitus
- Registration Number
- EUCTR2009-014986-22-LT
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 2000
1. Men and women > 18 years old at screening. Women of childbearing potential will be required to use two approved birth control methods during the entire course of the study.
2. Known type 2 diabetes (T2D) or newly diagnosed T2D according to the 1997 American Diabetes Association diagnostic criteria*
*Fasting plasma glucose (FPG) values =126 mg/dl, or symptomatic hyperglycemia and a casual glucose =200 mg/dl OR 2-h plasma glucose =200 mg/dl after a 75 g oral glucose load
Diabetes may be managed with diet alone, or with any approved glucose-lowering therapies except for those listed in exclusion criteria 11 and 12. The diabetes reatment will follow the local usual standard of care
3. HbA1C =6.5% and =10% at screening
4. Body mass index (BMI) = 23 kg/m2 at screening
5. Subjects with established cardiovascular (CV) disease with onset =1 month prior to screening and who are stable in the Investigator’s judgment, based on the presence of at least one of the following:
Documented coronary disease:
• Myocardial infarction
• History of coronary revascularization (percutaneous coronary interventions, coronary artery bypass graft surgery - CABG)
• Documented angina pectoris with ischemic ECG changes at rest or with ischemic ECG changes on a graded exercise test, or positive cardiac imaging stress test results documenting ischemia
• Angiographic or CT-imaging (e.g. MDCT/CTA) evidence of = 70% narrowing of one coronary artery or = 50% narrowing of two or more coronary arteries
Documented cerebrovascular disease:
• History of stroke (TIA is not fulfilling this inclusion criterion)
• Angiographic evidence of at least 75% narrowing of one or more carotid arteries
• History of arterial revascularization Documented symptomatic peripheral arterial disease:
• Current intermittent claudication and ankle-brachial index =0.85 and/or documented peripheral artery disease
• History of intermittent claudication and previous intervention (peripheral bypass, angioplasty)
6. Ability and willingness to give written informed consent and to comply with the requirements of the study.
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. Women who are currently pregnant, currently lactating, or intent to become pregnant during the study period.
2. Diagnosis of or history of:
a. Type 1 diabetes mellitus, diabetes resulting from pancreatic injury, or secondary forms of diabetes, e.g., acromegaly and Cushing’s Syndrome
b. Acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma within the past 6 months
c. Severe hypoglycemia (defined as requiring third party assistance) within one month prior to screening
3. Clinically significant gastrointestinal (GI) disease, judged likely to limit tolerability of taspoglutide, such as inflammatory bowel disease, celiac disease, diabetic
gastroparesis, cholelithiasis
4. History of bariatric surgery (e.g. gastric bypass or antrectomy), small or large bowel resection, or laparoscopic gastric banding, or intent to undergo any similar procedure during the study period
5. History of chronic pancreatitis or acute pancreatitis.
6. Family or personal history of medullary thyroid carcinoma.
7. Currently scheduled for cardiac surgery or arterial revascularization (carotid, coronary or peripheral) procedures
8. Current NYHA class IV heart failure or post-transplantation cardiomyopathy
9. Diagnosed and/or treated malignancy (except for basal cell skin cancer, in situ carcinoma of the cervix or in situ prostate cancer) within the past 5 years
10. Any concurrent medical condition/disorder that, in the opinion of the Investigator, is likely to:
- Interfere with the subject’s ability to complete the entire study period or to participate in all aspects of the trial
- Require the administration during the study of a treatment that would affect the interpretation of the efficacy and safety variables
11. Current treatment or known intolerance to exenatide or exendin-4 analogues, GLP-1 or GLP-1 analogues
12. Current treatment with insulin or insulin analogues
13. Treatment with systemic (oral or parenteral) corticosteroids for more than 7 consecutive days within 12 weeks prior to screening
14. Use of any investigational drug within 30 days or 5 half-lives (whichever is longer) prior to screening unless local health authority guidelines mandate a longer period
15. Any of the following laboratory abnormalities at screening:
a. ALT or AST > 3 times the upper limit of the normal range
b. Fasting triglycerides > 5.6 mmol/L (> 500 mg/dL)
16. Glomerular filtration rate (GFR) <30 mL/min/1.73m2 estimated by the Modification of Diet in Renal Disease (MDRD) equation: GFR (mL/min/1.73 m2) = 186 x
(serumcr)-1.154 x (Age)-0.203 x (0.742 if female) x (1.212 if African-American) (Please see the following web-based GFR calculator: http://www.nkdep.nih.gov/professionals/gfr_calculators/orig_con.htm)
17. Systolic blood pressure (SBP) = 180 or diastolic blood pressure (DBP) = 110 mmHg at screening
18. Potentially unreliable subjects and those judged by the Investigator to be unsuitable for the study
19. History of active substance abuse (including alcohol) within the past 2 years
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