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Safety and Efficacy of Ertugliflozin in the Treatment of Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin and Sitagliptin (MK-8835-006; VERTIS SITA2)

NCT02036515 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 464

Last updated 2018-09-13

Study results available
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Summary

This is a safety and efficacy study of ertugliflozin (MK-8835/PF-04971729) in the treatment of participants with type 2 diabetes mellitus who have inadequate glycemic control on metformin and sitagliptin. The primary objective of the trial is to assess the hemoglobin A1C (A1C)-lowering efficacy of the addition of ertugliflozin compared to the addition of placebo with an underlying hypothesis that addition of treatment with ertugliflozin provides greater reduction in A1C compared with the addition of placebo; the primary objective will be tested for both 5-mg and 15-mg doses of ertugliflozin.

Conditions

Interventions

DRUG

Ertugliflozin 5 mg

Ertugliflozin, oral, 5 mg tablet once daily for 52 weeks

DRUG

Ertugliflozin 15 mg

Ertugliflozin, oral, 5 mg and 10 mg tablet once daily for 52 weeks

DRUG

Placebo for ertugliflozin 5 mg

Matching placebo for ertugliflozin 5 mg, oral, once daily for 52 weeks

DRUG

Metformin

Participants are to remain on their stable doses of metformin (oral, \>=1500 mg/day) while receiving blinded investigational product during the double-blind treatment period.

DRUG

Sitagliptin

Participants are to remain on their stable doses of sitagliptin (oral, 100 mg once daily) while receiving blinded investigational product during the double-blind treatment period.

DRUG

Glimepiride

Glimepiride rescue medication, oral, once daily, open-label glimepiride; dose determined per the investigator's discretion

BIOLOGICAL

Insulin

Insulin glargine rescue medication, injectable, as required. In the event that an investigator considers use of glimepiride to not be appropriate for a participant meeting protocol specified glycemic rescue criteria, insulin glargine can be initiated as the rescue medication, and managed by the investigator according to clinical practice guidelines of the local country.

DRUG

Placebo for ertugliflozin 10 mg

Matching placebo for ertugliflozin 10 mg, oral, once daily for 52 weeks

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
2014-03-12
Primary Completion
2016-06-06
Completion
2016-06-06

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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 NCT02036515 on ClinicalTrials.gov