A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel group Study to Evaluate the Efficacy and Safety of Ranolazine When Added to Metformin in Subjects with Type 2 Diabetes Mellitus.
- Conditions
- Health Condition 1: null- Type II Diabetes Mellitus
- Registration Number
- CTRI/2012/11/003110
- Lead Sponsor
- Gilead Sciences Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 400
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 <=ï? 2550 mg in addition to diet and exercise for >=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 <=ï? 240 mg/dL (13.3 mmol/L) at Screening and at the end of the Qualifying Period (+ 2 days). A one-time central laboratory re-test of FSG is allowed for subjects with an initial central laboratory FSG between
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
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 <= 3 months prior to Screening
6. History of congestive heart failure defined as New York Heart
Association (NYHA) stage III or IV and/or known left ventricular ejection fraction <= 40%
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method