Randomized Sitagliptin Withdrawal Study (MK-0431-845)

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.

Timeline

Start

2016-05-09

Primary completion

2018-01-22

Completion

2018-01-30

Outcome

Met primary endpoint

registry analysis (superiority test); Sitagliptin vs Placebo; p < 0.001; Between Group Difference in the LSM -0.46 (95% CI -0.58 to -0.34); LDA NCT02738879 ↗

registry analysis (superiority test); Sitagliptin vs Placebo; p = 0.039; Event Rate Ratio 0.73 (95% CI 0.54 to 0.98); Negative Binomial Model NCT02738879 ↗

Publications

• Roussel R, Duran-Garcia S, Zhang Y, Shah S, Darmiento C, Shankar RR, Golm GT, Lam RLH, O'Neill EA, Gantz I, Kaufman KD, Engel SS. Double-blind, randomized clinical trial comparing the efficacy and safety of continuing or discontinuing the dipeptidyl peptidase-4 inhibitor sitagliptin when initiating insulin glargine therapy in patients with type 2 diabetes: The CompoSIT-I Study. Diabetes Obes Metab. 2019 Apr;21(4):781-790. doi: 10.1111/dom.13574. Epub 2018 Dec 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sitagliptin	Small molecule	100 mg	Oral
Background	Metformin	Small molecule	1500 mg	Oral
Background	Metformin XR	Small molecule	1500 mg	Oral
Background	insulin glargine	Protein / enzyme biologic	10 iu	Subcutaneous

Indications