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Single Cohort, 2-Period Study to Assess Pharmacokinetics of Metformin Alone and in Combination With Ranolazine 500 mg | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Single Cohort, 2-Period Study to Assess Pharmacokinetics of Metformin Alone and in Combination With Ranolazine 500 mg

A Phase 1, Open-label, Single Cohort, Two-Period Fixed Sequence Study to Assess the Pharmacokinetics of Metformin Alone and in Combination With Ranolazine 500 mg Twice Daily in Subjects With Type 2 Diabetes Mellitus

NCT01546558•Gilead Sciences

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the effect of steady-state ranolazine 500 mg bid on the steady state pharmacokinetics (PK) of metformin in subjects with type 2 diabetes mellitus (T2DM).

Detailed Description

The primary objective of this study is as follows: • To evaluate the effect of steady-state ranolazine 500 mg twice daily (bid) on the steady state pharmacokinetics (PK) of metformin in subjects with T2DM. The secondary objectives of this study are as follows: * To examine the safety and tolerability of metformin when co administered with ranolazine 500 mg bid at steady-state in subjects with T2DM. * To determine the steady-state PK of ranolazine 500 mg bid in subjects with T2DM receiving metformin.

Eligibility

Age

30 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Males and females, 30 to 65 years old, inclusive
•Documented history of T2DM
•HbA1c 6.5%-10%, inclusive
•Fasting serum glucose ≤ 270 mg/dL at Screening
•Fasting C-peptide ≥ 1 ng/mL at Screening
•Stable metformin monotherapy (metformin ≥ 1500 mg total daily dose for at least 4 weeks prior to Screening)
•Body mass index (BMI) 25 to 40 kg/m2, inclusive, at Screening
•Creatinine Clearance \> 80 mL/min at Screening
•Females of child-bearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day -1 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

Exclusion Criteria

•Type 1 Diabetes Mellitus (T1DM)
•Use of insulin therapy \< 3 months prior to Screening
•History of ketoacidosis, ketosis-prone diabetes, or lactic acidosis
•Clinically significant complications of diabetes
•History of hypoglycemia
•Any non-insulin antidiabetic therapy (other than metformin) \< 2 months prior to Screening
•Any clinically significant cardiovascular event \< 2 months prior to Screening
•Clinically significant, inadequately controlled, or unstable hypertension
•Hospitalization \< 2 months prior to Screening or major surgery \< 3 months prior to Screening
•History of gastrointestinal disease or surgery that could impact drug absorption
+11 more criteria

Locations (1)

SeaView Research Inc.

Miami, Florida, United States

Key Dates

Start Date

February 1, 2012

Primary Completion Date

March 1, 2012

Completion Date

March 1, 2012

Last Updated

July 11, 2012

Enrollment

ACTUAL participants

Conditions

Type 2 Diabetes Mellitus

Interventions

Metformin

DRUG

Ranolazine

DRUG

Feasibility of a Tailored Online Self-compassion Intervention

NCT07051005

Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

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RECRUITINGNA

Achieving Routine Intervention and Screening for Emotional Health

NCT06887049

Type 2 Diabetes Mellitus (T2DM)Diabetes Distress

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 11, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Single Cohort, 2-Period Study to Assess Pharmacokinetics of Metformin Alone and in Combination With Ranolazine 500 mg

Inclusion Criteria

Exclusion Criteria

Feasibility of a Tailored Online Self-compassion Intervention

Achieving Routine Intervention and Screening for Emotional Health

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