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Ertugliflozin and Sitagliptin Co-administration Factorial Study (VERTIS FACTORAL, MK-8835-005)

NCT02099110 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1233

Last updated 2018-09-12

Study results available
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Summary

This is a study of co-administration of ertugliflozin (MK-8835/PF-04971729) and sitagliptin given together or alone along with metformin in participants with Type 2 diabetes mellitus (T2DM) and inadequate glycemic control on metformin monotherapy. The primary hypothesis of this study is that ertugliflozin 15 mg daily plus sitagliptin 100 mg daily provides greater hemoglobin A1C (A1C)-lowering compared with sitagliptin 100 mg daily alone.

Conditions

Interventions

DRUG

Matching Placebo to Ertugliflozin 5 mg

Placebo to ertugliflozin 5 mg tablet, oral, once daily for 52 weeks during the double-blind treatment period

DRUG

Matching Placebo to Ertugliflozin 10 mg

Placebo to ertugliflozin 10 mg tablet, oral, once daily for 52 weeks during the double-blind treatment period

DRUG

Matching Placebo to sitagliptin 100 mg

Placebo to sitagliptin 100 mg tablet, oral, once daily for 52 weeks during the double-blind treatment period

DRUG

Ertugliflozin 5 mg

Ertugliflozin 5 mg tablet, oral, once daily for 52 weeks during the double-blind treatment period

DRUG

Ertugliflozin 10 mg

Ertugliflozin 10 mg tablet, oral, once daily for 52 weeks during the double-blind treatment period

DRUG

Sitagliptin 100 mg

Sitagliptin 100 mg tablet, oral, once daily for 52 weeks during the double-blind treatment period

DRUG

Metformin >= 1500 mg/day

Metformin \>= 1500 mg/day, tablets, oral, for 52 weeks while receiving blinded investigational product during the double-blind treatment period

BIOLOGICAL

Insulin Glargine Rescue Medication

Open-label insulin glargine, subcutaneous injection, as required as a rescue medication; dose determined per the investigator's discretion

DRUG

Glimepiride Rescue Medication

Open-label glimepiride tablets, oral, as required as a rescue medication, dose determined per the investigator's discretion

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-22
Primary Completion
2016-05-26
Completion
2016-05-26
FDA Drug
Yes

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02099110 on ClinicalTrials.gov