Suspended

Sitagliptin/Simvastatin Fixed-Dose Combination for Type 2 Diabetes Mellitus with Inadequate Glycemic Control

Study Aim

This phase 3 study aims to evaluate the effectiveness and safety of a fixed-dose combination of Sitagliptin and Simvastatin, compared to Sitagliptin alone, in improving glycemic control in individuals with Type 2 Diabetes Mellitus who have inadequate glycemic control.

What is being tested

Sitagliptin/Simvastatin FDC

+ Placebo to sitagliptin

+ Placebo to simvastatin

Drug

Who is being recruted

Diabetes Mellitus+3

+ Endocrine System Diseases

+ Metabolic Diseases

From 18 to 79 Years

+23 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 3

Interventional

Study Start: October 2012

See protocol details

Summary

Principal SponsorMerck Sharp & Dohme LLC

Last updated: August 24, 2018

Sourced from a government-validated database.Claim as a partner

Study start date: October 10, 2012

Actual date on which the first participant was enrolled.

The purpose of this study is to assess the efficacy and safety of sitagliptin/simvastatin fixed-dose combination (FDC) in participants with T2DM who have inadequate glycemic control while on metformin monotherapy. The primary hypothesis of this study is that after 16 weeks of therapy, the mean change from baseline in hemoglobin A1C (A1C) in participants treated with sitagliptin/simvastatin FDC is non-inferior compared to sitagliptin alone.

NCT01678820

Principal SponsorMerck Sharp & Dohme LLC

Last updated: August 24, 2018

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

299 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 79 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Diabetes MellitusEndocrine System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism DisordersDiabetes Mellitus, Type 2

Criteria

4 inclusion criteria required to participate

1) Male; (2) female not of reproductive potential; or (3) female of reproductive potential who agrees to remain abstinent or use alone or in conjunction with their partner 2 methods of contraception to prevent pregnancy during the study and for 14 days after the last dose of study drug

has T2DM

is currently on metformin monotherapy at a daily dose of at least 1500 mg for at least 10 weeks

is not on a lipid-lowering agent for at least 6 weeks prior to entering the study

19 exclusion criteria prevent from participating

consumes > 2 alcoholic drinks per day or > 14 alcoholic drinks per week, or engages in binge drinking

currently participating in or has participated in another clinical study within the past 12 weeks

has a history of active liver disease

has a history of malignancy in the previous 5 years (excluding adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer)

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening for 16 weeks. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.

Group II

Active Comparator

Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening for 16 weeks. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.

Group III

Active Comparator

Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening for 16 weeks. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

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SuspendedNo study centers