A Study to Evaluate the Effect of Ranolazine on Postprandial Glucagon in Subjects With Type 2 Diabetes.
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A Phase 1, Randomized, Single-blind, Placebo-controlled, Multiple-dose, Two-sequence, Cross-over Study to Evaluate the Effect of Ranolazine on Glucagon Secretion in Subjects With Type 2 Diabetes Mellitus, Followed by An Open-label, Single Dose, Exenatide Active-control Period
Study Start Date :
Actual Primary Completion Date :
Actual Study Completion Date :
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Ages Eligible for Study:
18 Years to 65 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Males and females, 18 to 65 years old, inclusive
Documented history of T2DM for ≥5 years
Body mass index (BMI) 20.0 to 40.0 kg/m2, inclusive, at Screening
Stable treatment (≥ 12 weeks) with metformin alone, a sulfonylurea alone, a meglitinide alone, or a combination of metformin with either a sulfonylurea or a meglitinide
HbA1c ≥ 7.0% and ≤ 10.5%, inclusive, at Screening
Fasting glucose within specific ranges, at Screening and after 14 +/-2 days of wash-out from prior oral anti-diabetic agents
Ability and willingness to comply with all study procedures during the course of the study, including washout from oral anti-diabetic (OAD) agents approximately 2 weeks prior to Day -2 admission
Females of childbearing potential must have a negative pregnancy test at Screening and on Day -2 admission and must agree to use highly effective contraception methods from Screening throughout study participation and for 14 days following the last dose of study drug.
History of type 1 diabetes mellitus or secondary forms of diabetes
History of acute diabetes complications
Recent or significant heart conditions
QTc interval > 500 msec by ECG at Screening or on Day -2 admission, a personal or family history of QTc prolongation, congenital long QT syndrome, or use of drugs that prolong the QTc interval, such as Class Ia or Class III antiarrhythmic agents, erythromycin, and certain antipsychotics (eg, ziprasidone)
History of severe GI disease (e.g., gastroparesis)
History of pancreatitis (acute or chronic)
Current consumption of > 14 alcoholic drinks per week, or more than 4 alcoholic drinks on any one day
Current regular use of tobacco- or nicotine-containing products in excess of 10 cigarettes per day or equivalent
History of substance abuse within 12 months prior to Screening
Significant hepatic disease, including, but not limited to, chronic active hepatitis and liver cirrhosis (Child-Pugh Class A, B, or C)
History of malignancy within 5 years prior to Screening
Significant thyroid disease
Treatment with selected medications, as indicated in the protocol
Prior treatment with open-label ranolazine or known hypersensitivity or intolerance to ranolazine or its excipients
Known hypersensitivity or intolerance to GLP-1 mimetics
Known hypersensitivity or intolerance to acetaminophen
Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 2.5 X upper limit of normal (ULN)
Positive for human immunodeficiency virus-1 (HIV-1) antibody
Positive urine drug screen
Positive alcohol test
Donation of blood or blood products to a blood bank, blood transfusion, or participation in a clinical study requiring withdrawal of > 500 mL of blood during the 6 weeks prior to Screening
Females who are pregnant or breastfeeding
Other condition(s) that, in the opinion of the investigator, would compromise the safety of the subject, would prevent compliance with the study protocol, or would compromise the quality of the clinical study.