Health Condition 1: null- Type II Diabetes Mellitus
Conditions
Interventions
Intervention1: Ranolazine: Each ranolazine ER tablet, 500 mg, contains the following inactive ingredients: microcrystalline cellulose, methacrylic acid copolymer (Type C), hypromellose, magnesium ste
Sponsors
Gilead Sciences Inc
Klinera Corporation India
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria Subjects must meet all of the following inclusion criteria to be eligible for participation in this study. 1. Written informed consent 2. Males and females, 18 to 75 years old, inclusive 3. Documented history of T2DM 4. Metformin therapy at a stable total daily dose >=ï? 1500 mg and =8 weeks prior to Screening 5. Body mass index (BMI) 25 to 45 kg/m2, inclusive, at Screening 6. HbA1c within the following ranges, based on current metformin dose 7. C-peptide >=ï? 0.8 ng/mL at Screening 8. FSG >=ï? 130 mg/dL (7.2 mmol/L) and 125 mg/dL and 129 mg/dL who are otherwise eligible as determined by the Investigator. 10. Females of child-bearing potential must have a negative serum pregnancy test at Screening and must agree to use highly effective contraception methods from Screening throughout the duration of the Treatment Period and for 14 days following the last dose of study drug 11. At least 80% compliance in dosing during the Qualifying Period
Exclusion criteria
Exclusion criteria: Exclusion Criteria Subjects who meet any of the following exclusion criteria are not to be enrolled in this study. Disease-specific: 1. History or current diagnosis of type 1 diabetes mellitus 2. History of diabetic ketoacidosis, ketosis-prone diabetes, or hyperosmolar hyperglycemic coma 3. History of severe hypoglycemia (>=ï? 1 episode within 3 months prior to Screening or >=ï? 2 episodes within 6 months prior to Screening), defined as hypoglycemia requiring third party assistance to actively administer carbohydrate, glucagon, or other resuscitative actions due to severe impairment in consciousness or behavior 4. Clinically significant complications of diabetes that in the judgment of the investigator would make the subject unsuitable to participate in this study Medical: 5. Any clinically significant cardiovascular (CV) or cerebrovascular event, eg, myocardial infarction (MI), acute coronary syndrome (ACS), recent revascularization (including coronary artery bypass graft procedures [CABG] or percutaneous coronary intervention [PCI]), transient ischemic attack (TIA), or ischemic stroke 6. History of congestive heart failure defined as New York Heart Association (NYHA) stage III or IV and/or known left ventricular ejection fraction 7. Inadequately controlled or unstable hypertension as defined by a systolic blood pressure (SBP) 160 mmHg or diastolic blood pressure (DBP) 100 mmHg at Screening and/or Randomization 8.QTc interval 500 msec by ECG at Screening, a personal or family history of QTc prolongation, congenital long QT syndrome, or subjects who are receiving drugs that prolong the QTc interval, such as Class Ia or Class III antiarrhythmic agents, erythromycin, and certain antipsychotics (eg, ziprasidone) 9. History of bariatric surgery at any time in the past or any other surgery within 2 months prior to Screening; or planning to undergo surgery during the study (planned minor surgery maybe acceptable upon approval of the Medical Monitor) 10.Any other hospitalization in the 14 days prior to Screening or planned hospitalization at any time during the study 11. Significant weight change (ï??ï?½ï? 5%) 2 months prior to Screening, or enrollment in a weight loss program which is not in the maintenance phase at Screening 12. Undergoing any type of dialysis at Screening or planning to undergo any type of dialysis during the course of the study 13. Serum creatinine concentration >= 1.5 mg/dL for males or >= 1.4 mg/dL for females at Screening 14. History of liver cirrhosis (Child-Pugh Class A, B, or C) 15. Active liver disease and/or significant abnormal liver function defined as aspartate aminotransferase (AST) 3x upper limit of the normal range (ULN) and/or alanine aminotransferase (ALT) 3x ULN and/or serum total bilirubin 2.0 mg/dL 16. Positive blood screen for hepatitis C antibody or hepatitis B surface antigen 17. Hemoglobin 12 g/dL for males or 11g/dL for females at Screening 18. History of alcohol or drug abuse (in the Investigatorâ??s opinion) within 1 year prior to Screening 19. Clinical hypothyroidism (subjects that have an abnormal thyroid stimulating hormone [TSH] value at Screening will be further evaluated by free T4 [fT4]; subjects
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of the study is to: ï?? Determine the effect of ranolazine on hemoglobin A1c (HbA1c) after 24 weeks of treatment when added to metformin in subjects who have inadequately controlled type 2 diabetes mellitus (T2DM) despite current treatment with stable metformin therapy in addition to diet and exercise.Timepoint: 24 Weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| ï?? Determine the effect of IP on postprandial serum glucose ï?? Determine the effect of IP on fasting serum glucose ï?? Evaluate the effect of IP on each of the following parameters: serum C-peptide, serum insulin, and plasma glucagon ï?? Evaluate the pharmacokinetics of ranolazine in subjects with T2DM ï?? Evaluate the safety and tolerability of IP in subjects who have inadequately controlled T2DM despite current treatment with stable metformin therapy in addition to diet and exercise.Timepoint: 24 Weeks | — |
Countries
Argentina, Canada, Czech Republic, Hungary, India, Israel, Mexico, Poland, Republic of Korea, Romania, Russian Federation, South Africa, Ukraine, United States of America
Contacts
Public ContactDr Rohit Shete
Klinera Corporation India
Outcome results
None listed