Type 2 Diabetes Mellitus MedDRA version: 14.1 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Sponsors
Gilead Sciences, Inc.
Eligibility
Sex/Gender
All
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. Treatment naïve to antihyperglycemic therapy or having received no prior treatment with antihyperglycemic therapy for at least 90 days or TZDs (eg, rosiglitazone or pioglitazone) for at least 24 weeks prior to Screening 5. Body mass index (BMI) 25 kg/m2 to 45 kg/m2 inclusive at Screening 6. HbA1c 7% - 10% inclusive, at Screening and at the end of Qualifying Period (Day 14 +2 days) 7. FSG of = 130 mg/dL (7.2 mmol/L) and = 240 mg/dL (13.3 mmol/L) at Screening and at the end of Qualifying Period (Day 14 +2 days). A one-time central laboratory re-test of FSG is allowed in subjects with an initial central laboratory FSG =125 mg/dL (6.9 mmol/L) and =65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: - Diabetes- Specific Exclusions: 1. History of or current diagnosis of type 1 diabetes mellitus 2. History of diabetic ketoacidosis, ketosis-prone diabetes, or hyperosmolar hyperglycemic coma 3.History of a severe episode of hypoglycemia (=1 episode within 3 months prior to Screening or =2 episodes within 6 months prior to Screening), defined as hypoglycemia requiring 3rd 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 subjects unsuitable to participate in this study - Medical Exclusions: 5. History of any clinically significant cardiovascular or cerebrovascular event = 3 months prior to Screening 6. Inadequately controlled or unstable hypertension as defined by SBP > 160 mmHg or DBP > 100 mmHg at Screening and Randomization. 7. Prolonged 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) 8. History of bariatric surgery at any time in the past or any other surgery 3x ULN and/or ALT> 3x ULN and/or serum total bilirubin > 2.0 mg/dL 14. History of cancer (except non-melanomic skin cancers or cervical in situ) within 5 years prior to Screening. 15. History of alcohol or other drug abuse 20 mg or lovastatin at a daily dose > 40 mg, within 14 days prior to Randomization 22. Weight-loss medication or anti-obesity medication (prescription or non-prescriptio
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to: • Determine the effect of ranolazine monotherapy on HbA1c in subjects with T2DM who are inadequately controlled with diet and exercise alone and who are treatment naïve to antihyperglycemic therapy or have not received antihyperglycemic therapy in the 90 days (or TZDs in the 24 weeks) prior to Screening;Secondary Objective: The secondary objectives of the study are to: • Determine the effect of ranolazine monotherapy on postprandial glucose (PPG) • Determine the effect of ranolazine monotherapy on fasting serum glucose (FSG) The additional objectives of the study are to: • Evaluate the effect of ranolazine monotherapy on each of the following endpoints: serum C-peptide, serum insulin, plasma glucagon • Evaluate the pharmacokinetics (PK) of ranolazine The safety objective of the study is to: • Evaluate the safety and tolerability of ranolazine monotherapy in subjects who are treatment naïve to antihyperglycemic therapy or have not received antihyperglycemic therapy in the 90 days (or TZDs in the 24 weeks) prior to Screening;Primary end point(s): The primary efficacy endpoint of this study is: • Change from Baseline in HbA1c at Week 24;Timepoint(s) of evaluation of this end point: Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary efficacy endpoints of this study are the following: • Change from Baseline in incremental change of 2-hour PPG at Week 24 • Change from Baseline in FSG at Week 24 or change from Baseline in 2-hour PPG at Week 24 ;Timepoint(s) of evaluation of this end point: Week 24 | — |
Countries
Belarus, Czech Republic, Hungary, Israel, Mexico, Poland, Romania, Russian Federation, Serbia, Slovakia, South Africa, Ukraine, United States
Contacts
Public ContactInternational Regulatory Affairs
Gilead Sciences International Ltd
Outcome results
None listed