A Study of the Safety and Efficacy of MK-3577 in Participants With Type 2 Diabetes Mellitus (MK-3577-009)

The primary efficacy outcome in this study was the assessment of 24-hour weighted mean glucose (WMG) levels for domiciled participants after 4-week treatment (Periods 1 and 2 only). At selected study sites, a subset of participants domiciled (stayed) overnight and underwent 24-hour blood sampling at the Week 0 Visit (Baseline), Week 4 Visit (end of Period 1), and Week 8 Visit (end of Period 2). Domiciled participants were not expected to follow a weight-maintaining diet while receiving standard meals from a dietician or licensed healthcare professional. WMG was calculated as the weighted average value of the glucose from the 24-hour blood sample (for Baseline, Week 4, and Week 8) and analyzed using a Longitudinal Data Analysis (LDA) model. Results were expressed as the change from baseline after 4-week treatment in 24-hour WMG.

Time frame: Week 0 Visit (Baseline), Week 4 Visit, Week 8 Visit

Population: All randomized domiciled participants receiving ≥1 dose of therapy and having 24-hour WMG measurement either at BL or end of Treatment Period 1 or 2. Number of Participants Analyzed=number of participants included in LDA model. Participants in MK-3577 25 mg BID group did not undergo 24-hour glucose sampling and were not analyzed.

An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of the SPONSOR's product, is also an AE.

Time frame: From first dose of study treatment (Week 0 Visit) to Week 16 Visit (up to 16 weeks).

Population: All randomized participants who took ≥1 dose of study treatment (N=118). Because this was a cross-over study, participants were counted in more than one treatment group. AEs were reported by the treatment that participants were receiving at the time of the event. Not all participants received all treatments.

An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of the SPONSOR's product, is also an AE.

Time frame: From first dose of study treatment (Week 0 Visit) to Week 18 Post-study Visit (up to 18 weeks).

Population: All randomized participants who took ≥1 dose of study treatment (N=118). Because this was a cross-over study, participants were counted in more than one treatment group. AEs were reported by the treatment that participants were receiving at the time of the event. Not all participants received all treatments.

Fasting blood samples were obtained during study site visits at Baseline (Week 0 Visit) and Week 4 of each treatment period (Week 4 Visit, Week 8 Visit, Week 12 Visit, Week 16 Visit). Participants were counseled to fast (no food or drink except water and non-study medications, as directed) for at least 12 hours prior to all study visits. FPG was analyzed using an LDA model, and change from baseline (Week 0) after 4-week treatment in FPG was reported.

Time frame: Week 0 Visit (Baseline), Week 4 Visit, Week 8 Visit, Week 12 Visit, Week 16 Visit

Population: All randomized participants receiving ≥1 dose of therapy and having FPG measurement either at BL or end of Treatment Period. Number of Participants Analyzed=number of participants included in the LDA model.

Two-hour PMG was analyzed in both non-domiciled and domiciled participants. Non-domiciled participants completed a 3-point meal tolerance test (MTT) at Week 0 (Baseline) and Week 4 Visits of Treatment Period 1. Participants completed 12-hr fasting prior to the Week 0 (Baseline) and Week-4 clinic visits. Fasting blood samples were obtained at the beginning of these clinic visits, after which participants consumed a standardized meal (1 nutrition bar and 1 can of nutrition drink), and then completed the MTT, in which plasma glucose was measured at 30 min and 120 min (2 hr) post-meal. The 2-hr PMG data also include data from domiciled participants, based on 2-hr post-morning meal glucose levels in the 24-hr blood glucose sample at the Week 4 and Week 8 Visits. The 2-hour PMG was analyzed using an LDA model, and change from baseline (Week 0) after 4-week treatment in 2-hour PMG was reported.

Time frame: Week 0 Visit (Baseline), Week 4 Visit, Week 8 visit

Population: All randomized participants receiving ≥1 dose of therapy and having MTT measurement either at Week 0 (BL) or end of Treatment Period 1. N=number of participants included in the Longitudinal Data Analysis (LDA) model

Blood samples were obtained from all participants to measure LDL-C levels at Week 0 (Baseline) and Week 4 of each treatment period (Week 4 Visit, Week 8 Visit, Week 12 Visit, and Week 16 Visit). For each visit, LDL-C was measured over 2 days. The average of duplicate measurements (when available) was used in the analysis.

Time frame: Week 0 Visit (Baseline), Week 4 Visit, Week 8 Visit, Week 12 Visit, and Week 16 Visit

Population: All randomized participants who took at least 1 dose of study treatment and had a valid reading at timepoint.