A Study of the Safety and Efficacy of Sitagliptin Addition During Metformin Up-titration (MK-0431-848)

Summary

This trial is designed to evaluate, in adult participants with Type 2 diabetes mellitus (T2DM) and inadequate glycemic control on sub-maximal metformin mono-therapy (1000 mg/day), the effect of up-titration of metformin plus the addition of sitagliptin compared to up-titration of metformin alone on glycemic control. The primary hypothesis of this study is that up-titration of metformin to 2000 mg/day (1000 mg/twice a day) plus the addition of sitagliptin 100 mg/day provides greater reduction in hemoglobin A1C (A1C) compared to metformin up-titration alone. Another primary objective of this study is to evaluate the safety and tolerability of this treatment.

Timeline

Start

2016-06-16

Primary completion

2018-02-01

Completion

2018-02-01

Outcome

Met primary endpoint

registry analysis (superiority test); Sitagliptin vs Placebo; p <0.001; Difference in Least Squares Means -0.41 (95% CI -0.59 to -0.23); Longitudinal Data Analysis NCT02791490 ↗

paper with sitagliptin and placebo, respectively; the between-group difference in LS mean changes from baseline HbA1c was -4.5 mmol/mol (-6.5, -2.5) (-0.41% [-0.59, -0.23]); P < 0.001. PMID 30609212 ↗

Publications

• Frias JP, Zimmer Z, Lam RLH, Amorin G, Ntabadde C, Iredale C, O'Neill EA, Engel SS, Kaufman KD, Makimura H, Crutchlow MF. Double-blind, randomized clinical trial assessing the efficacy and safety of early initiation of sitagliptin during metformin uptitration in the treatment of patients with type 2 diabetes: The CompoSIT-M study. Diabetes Obes Metab. 2019 May;21(5):1128-1135. doi: 10.1111/dom.13626. Epub 2019 Feb 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sitagliptin	Small molecule	100 mg	Oral
Background	Metformin	Small molecule	1000 mg	—

Indications