Type 2 Diabetes Mellitus MedDRA version: 9.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus
Conditions
Interventions
Product Name: CANAGLIFLOZIN
Product Code: JNJ-28431754
Pharmaceutical Form: Over encapsulated tablet
Current Sponsor code: JNJ-28431754
Concentration unit: mg milligram(s)
Concentration type: equal
Co
Sponsors
Janssen Cilag International NV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Potential subjects must satisfy all of the following criteria to be eligible to participate in the study: Inclusion Criteria for Prescreening and Screening • Man or woman with T2DM between 18 and 80 years of age, inclusive, – On metformin monotherapy at a stable protocol specified dose* for at least 12 weeks before screening and has an HbA1c of > or =7.0% and or =7.5% and or =7.0% and or =6.5% and or =7.0% and , or =9.5%, after discontinuing the AHA and on a stable protocol-specified dose* of metformin at least 10 weeks; or – On metformin at a dose or =6.5% and o r=9.0% at screening and has a Week -2 visit HbA1c of > or =7.0% and or =2,000 mg/day [or > or =1,500 mg/day, if unable to tolerate a higher dose].) • Body mass index (BMI) > or =22 to 45 years of age with amenorrhea for at least 18 months, or ? >45 years of age with amenorrhea for 6 to 40 IU/mL. – surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy), or – abstinent (at the discretion of the investigator/per local regulations), or – if sexually active, be practicing a highly effective method of birth control such as hormonal prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double-barrier method (eg, condoms, diaphragm, or cervical cap with spermicidal foam, cream, or gel), male partner sterilization before subject randomization and must agree to continue to use a highly effective method of birth control throughout the study, as local regulations permit. • Women of childbearing potential must have a negative urine Beta human chorionic gonadotropin (Beta hCG) pregnancy test at screening and baseline (predose, Day 1). • Willing/able to adhere to the prohibitions and restrictions specified in this protocol • Subjects must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study. • To participate in the optional pharmacogenomic component of this study, subjects must have signed the informed consent form for pharmacogenomic research indicating willingness to participate in the pharmacogenomic component of the study (where local regulations permit). Refusal to give consent for this component does not exclude a subject from participation in the clinical study. Inclusion Criteria for Randomization • Subjects must have a HbA1c between (> or =7.0% and (< or =9.5% at Week 2 • Subjects must have a FPG < or =270 mg/dL (15 mmol/L) at Week-2 (At the investigator’s discret
Exclusion criteria
Exclusion criteria: Potential subjects who meet any of the following criteria will be excluded from participating in the study: Metabolic • History of diabetic ketoacidosis, type 1 diabetes mellitus, pancreas or beta cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy • History of proliferative diabetic retinopathy for which further evaluation or treatment is planned during the course of the study • History of >1 severe hypoglycemic episodes, defined as an episode that requires the help of another person, within 6 months before screening. Refer to Attachment 2, Hypoglycemia: Definitions, Symptoms, and Treatment for a definition of severe hypoglycemia. • History of hereditary glucose-galactose malabsorption or primary renal glucosuria • Ongoing, uncontrolled, untreated thyroid disorder (ie, the subject has a known thyroid stimulating hormone [TSH] value that is undetectable or >10 mIU/L). Subjects taking a thyroxine supplementation for thyroid disorder should be on a stable dose for (> or =3 months • History of an ongoing eating disorder or significant weight loss or weight gain, defined as an increase or decrease of 5% in body weight (based on subject report) within 3 months before screening Renal/Cardiovascular • Renal disease requiring treatment with immunosuppressive therapy within the past 12 months before screening or a history of dialysis or renal transplant • History of myocardial infarction, unstable angina, or cerebrovascular accident within 3 months before screening, or history of New York Heart Association (NYHA) Class III-IV cardiac disease; Refer to Attachment 3, New York Heart Association Classification of Cardiac Disease, for a description of the classes Gastrointestinal • Ongoing clinically relevant liver disease (eg, hepatitis B or hepatitis C) • History of prior bariatric surgical procedures Laboratory • Serum creatinine (> or =1.4 mg/dL (124 micromol/L) for men and (> or =1.3 mg/dL (115 micromol/L) for women; or estimated glomerular filtration rate (eGFR) or =600 mg/dL (6.74 mmol/L) at screening. A one-time repeat of the serum triglycerides is allowed, at the discretion of the investigator. • Alanine aminotransferase (ALT) >2.0 times the upper limit of normal (ULN) or total bilirubin >1.5 xULN, at screening, unless in the opinion of the investigator and as agreed upon by the sponsor’s medical officer, the findings are consistent with Gilbert’s disease. A one-time repeat is allowed, at the discretion of the investigator. Other conditions • History of malignancy within 5 years before screening (except squamous and basal cell carcinomas and cervical carcinomas in situ) • History of human immunodeficiency virus (HIV) infection • Any condition that in the opinion of the investigator would compromise the well-being of the subject or the study or prevent the subject from meeting or performing study requirements (eg., planned inpatient surgery or procedures) Medications/Therapies • Current use of a disallowed therapy (refer to Attachment 4, List of Disallowed Therapies for a complete listing of excluded medications and therapies). Known allergies, hypersensitivity, or intolerance to JNJ-28431754 or its excipients (refer to Section 14.1, Physical Description of Study Drug(s) • Contraindication to the use of glimepiride or metformin, as per the local prescribing information, o
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective in this study is to compare the HbA1c-lowering efficacy of JNJ-28431754 100 mg and JNJ-28431754 300 mg with glimepiride after 52 weeks of treatment. ;Secondary Objective: The secondary objectives in this study are: From Baseline to Week 52 • To compare the change in body weight from baseline in each JNJ-28431754 group with the glimepiride group • To compare the incidence of hypoglycemia in each JNJ-28431754 group with the glimepiride group • To compare the change in systolic and diastolic blood pressure from baseline in each JNJ-28431754 group with the glimepiride group • To compare the change in fasting plasma glucose (FPG) from baseline in each JNJ-28431754 group with the glimepiride group • To assess the overall safety and tolerability of JNJ-28431754 compared with glimepiride At Week 104: • To compare the durability of HbA1c-lowering efficacy in each JNJ-28431754 group with the glimepiride group from Week 26 to Week 104 • To assess the overall safety and tolerability from baseline of JNJ-28431754 compared with glimepiride in subjects with T2DM throughout the study ;Primary end point(s): The primary efficacy endpoint will be the change in HbA1c from baseline through Week 52. | — |
Countries
Bulgaria, Denmark, Finland, Germany, Norway, Slovakia
Outcome results
None listed