Comparison of Two Treatment Regimens (Sitagliptin Versus Liraglutide) on Participants Who Failed to Achieve Good Glucose Control on Metformin Alone (MK-0431-403)

What this study is testing ClinicalTrials.gov NCT01296412 ↗

Description as written by the study sponsor.

This study is being done to compare the effectiveness and safety of two treatment paradigms (oral sitagliptin with or without glimepiride versus liraglutide with or without increased dosing) for the treatment of participants with Type 2 Diabetes that is not adequately controlled with metformin alone. The primary hypothesis postulated that the mean change from baseline in hemoglobin A1c (A1C) in participants treated with a sitagliptin-based treatment is non-inferior to that of participants treated with a liraglutide-based treatment.

Treatments tested

• sitagliptin also known as MK-0431, Januvia®, Tesavel®, Xelevia®, Ristaben® Drug

  100 mg tablet, orally, once daily.

• liraglutide also known as Victoza® Drug

  0.6 mg by subcutaneous (pen) injection, once daily, on Days 1-7; up-titrated on Day 8 to 1.2 mg daily. At Week 12, dose may be increased to 1.8 mg once daily for participants who did not meet protocol-specified glycemic goals.

• glimepiride also known as Amaryl® Drug

  starting dose of 1 mg tablet (up-titrated as needed), once daily, as needed, after Week 12.

• metformin also known as Fortamet®, Glucophage®, Glucophage® XR, Glumetza®, Riomet®, Metgluco®, Glycoran® Drug

  metformin tablets at a dose of ≥1500 mg per day