Type 2 Diabetes MedDRA version: 9.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus
Conditions
Interventions
Trade Name: BYETTA 5 Mikrogramm Injektionslösung, Fertigpen
Product Name: Exenatide
Product Code: LY2148568
Pharmaceutical Form: Solution for injection
INN or Proposed INN: exenatide
CAS Number: 14173
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 Present with type 2 diabetes as defined by the World Health Organization (WHO) criteria. 2 Aged between 18 and 75 years of age, inclusive. 3 Patients have been treated with a stable dose of the following for at least 3 months prior to screening: • 100 mg/day sitagliptin and • =1500 mg/day metformin, or maximum tolerated dose (extended-release or immediate-release). 4 Have inadequate glycemic control as evidenced by an HbA1c between 7.1% and 9%, inclusive. 5 Have a body mass index (BMI) =20kg/m2 and 10% for at least 3 months prior to screening). 6 This inclusion criterion applies to females of childbearing potential (not surgically sterilized and between menarche and 1-year postmenopause) only: • Are not breastfeeding. • Test negative for pregnancy at the time of screening based on a blood serum pregnancy test. • Intend not to become pregnant during the study. • Have practiced a reliable method of birth control (e.g., use of oral contraceptives or approved hormonal implant; diaphragms with contraceptive jelly; cervical caps with contraceptive jelly; condoms with contraceptive foam; contraceptive patch; injectable contraception; intrauterine devices; partner with vasectomy; or abstinence) for at least 6 weeks prior to screening. • Agree to continue to use a reliable method of birth control (see above) during the study, as determined by the investigator. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 7 Are investigator site personnel directly affiliated with this study and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted. 8 Are Lilly or Amylin employees. 9 Are currently enrolled in, or discontinued within the last 30 days (or longer, if local guidelines require) from, a clinical trial involving an off-label use of an investigational drug or device (other than the study drug/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. 10 Have previously completed or withdrawn from this study or any other study investigating exenatide. 11 Have had poorly controlled blood pressure (=160 mm Hg, systolic value; =110 mm Hg, diastolic value) within the last 4 weeks. 12 Have a known allergy or hypersensitivity to exenatide, sitagliptin or excipients contained in exenatide or sitagliptin. 13 Have characteristics contraindicating metformin, exenatide or sitagliptin use, according to product-specific label. 14 Have had a clinically significant history of cardiac disease or presence of active cardiac disease within the year prior to inclusion in the study, including myocardial infarction, clinically significant arrhythmia, unstable angina, moderate to severe congestive heart failure (New York Heart Association Class III or IV [CCNYHA 1994]), coronary artery bypass surgery, or angioplasty; or is expected to require coronary artery bypass surgery or angioplasty during the course of the study. Refer to Protocol Attachment GWDK.4 for descriptions of the cardiac disease classifications. 15 Have a history of renal transplantation; or are currently receiving renal dialysis; or have serum creatinine =1.5 mg/dL (132 µmol/L) for males and =1.2 mg/dL (110 µmol/L) for females; or have an estimated creatinine clearance of <60 mL/min (Bergman et al. 2007) based on the standard Cockcroft-Gault formula 16 Have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, alanine aminotransaminase (ALT), or serum glutamic pyruvic transaminase (SGPT) greater than 2.5 times the upper limit of the reference range. 17 Are known to have active proliferative retinopathy. 18 Patients with a history of, or current, acute or chronic pancreatitis. 19 Used drugs for weight loss (for example, orlistat, sibutramine, phenylpropanolamine, or similar over-the-counter medications) within 1 month of screening. 20 Are currently treated with any of the following excluded medications: o Thiazolidinediones (TZD) within 3 months of screening. o Sulfonylurea (SU) within 3 months of screening. o Dipeptidyl peptidase-4 [DPP-4] inhibitors, with the exception of sitagliptin, within 3 months of screening. o Meglitinide derivatives (for example, repaglinide or nateglinide) within 3 months of screening. o Alpha-glucosidase inhibitors (for example, miglitol or acarbose) within 3 months of screening. o Exogenous insulin within the 3 months prior to screening. o Drugs that directly affect gastrointestinal motility, including, but not limited to: metoclopramide, cisapride, and chronic macrolide antibiotics. o Systemic corticosteroids (excluding topical and inhaled preparations) by oral, intravenous (IV), or intramuscular (IM) route used regularly (for longer than 1 month) or used within 1 month immediately prior to screening. o Any other oral antidiabetic (OAD) agent, other than
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to test the hypothesis that switching to exenatide and metformin is non-inferior to adding exenatide to sitagliptin and metformin, as measured by a change in HbA1c from baseline to endpoint (Week 20), in patients with type 2 diabetes experiencing inadequate glycemic control with sitagliptin plus metformin.;Secondary Objective: • proportion of patients achieving HbA1c =7.0%, <7.0% and =6.5% at endpoint (Week 20) • change from baseline to endpoint (Week 20) in fasting serum glucose (FSG) • change from baseline to endpoint (Week 20) in body weight • change from baseline to endpoint (Week 20) in waist circumference and waist-to-hip ratio • 7-point self-monitored blood glucose (SMBG) profiles and mean blood glucose (BG) measurement based on 7-point SMBG • change from baseline to endpoint (Week 20) in serum lipids (total cholesterol [TC], high-density lipoprotein cholesterol [HDL-C], fasting triglycerides, calculated low-density lipoprotein cholesterol [LDL-C]) • safety and tolerability (including incidence of hypoglycemic events);Primary end point(s): | — |
Countries
Germany, Greece
Outcome results
None listed