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Randomized Sitagliptin Withdrawal Study (MK-0431-845)

NCT02738879 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 746

Last updated 2019-02-25

Study results available
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Summary

This is a trial of continuing sitagliptin versus withdrawing sitagliptin in participants with Type 2 diabetes mellitus (T2DM) and inadequate glycemic control who initiate and titrate insulin glargine (LANTUS®) based on a treat-to-target algorithm to achieve fasting glucose levels of 72-100 mg/dL (4-5.6 mmol/L). A primary hypothesis of this trial is that after 30 weeks, continuing sitagliptin results in a greater reduction of hemoglobin A1C (A1C) relative to withdrawing sitagliptin.

Conditions

Interventions

DRUG

Sitagliptin

Sitagliptin 100 mg, oral, once daily for 30 weeks

DRUG

Placebo to sitagliptin

Placebo to sitagliptin, 100 mg, oral, once daily for 30 weeks

DRUG

Metformin

At least 1500 mg/day, oral, twice daily for participants entering the study on immediate-release metformin + sitagliptin or a fixed dose combination (FDC).

DRUG

Metformin XR

At least 1500 mg/day, oral, once daily for participants entering the study on extended-release metformin + sitagliptin or a FDC.

DRUG

Insulin glargine

Insulin glargine (LANTUS®) initiated at 10 units and titrated based on a treat-to-target algorithm to achieve fasting glucose levels of 72-100 mg/dL (4-5.6 mmol/L); administered once daily subcutaneously.

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
2016-05-09
Primary Completion
2018-01-22
Completion
2018-01-30

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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 NCT02738879 on ClinicalTrials.gov