Clinical trial NCT00868790: A Study of the Safety and Efficacy of MK-3577 in Participants With Type 2 Diabetes Mellitus (MK-3577-009)
Official title: A Phase IIa, Multicenter, Randomized, Placebo- and Active-Comparator Controlled, Cross-Over Clinical Trial to Study the Safety and Efficacy of MK-3577 in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-03-25
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study assessed the safety and efficacy of MK-3577. The primary efficacy hypothesis was that, after 4 weeks of treatment, either the morning (AM) administration or the evening (PM) administration of MK-3577 provides superior reduction of 24-hour weighted mean glucose (WMG) levels compared to placebo (PLA). The primary safety hypothesis was that MK-3577 is well tolerated compared to placebo.

Detailed description: This was a 4-period/5-treatment crossover study. Each period was 4 weeks. The 5 treatments consisted of MK-3577 10 mg once daily (QD) in the AM, MK-3577 6 mg QD in the evening (PM), MK-3577 25 mg twice daily (BID), metformin 1000 mg BID, and placebo to MK-3577/placebo to metformin. Participants were to be randomized to one of 14 treatment sequence arms. A subset of participants in each group was to domicile (stay overnight) at selected clinical sites at Baseline, Week 4 (end of Period 1), and Week 8 (end of Period 2) to undergo 24-hr blood sample.

Eligibility criteria: Inclusion Criteria:

* Participant has type 2 diabetes
* Participant is either not taking antihyperglycemic medications for the last 10 weeks OR is taking a single oral antihyperglycemic medication (but not a Peroxisome Proliferator-Activated Receptor gamma \[PPARg\] agonist) OR is taking a low-dose combination oral antihyperglycemic medication (not a PPARg agonist) at dose less than or equal to 50% of the maximum dose
* Female participant is unable to have children

Exclusion Criteria:

* Participant has a history of type 1 diabetes or ketoacidosis
* Participant has been treated with a PPARg agonist in the last 12 weeks
* Participant has been treated with insulin in the last 12 weeks
* Participant has had prescription lipid-modifying drug therapy in the last 12 weeks
* Participant has a history of coronary artery disease
* Participant has had a stroke or transient ischemic attack
* Participant has congestive heart failure

Primary outcomes:
measure: Change From Baseline (BL) After 4-Week Treatment in Weighted Mean Glucose (WMG)
timeFrame: Week 0 Visit (Baseline), Week 4 Visit, Week 8 Visit
measure: Number of Participants With At Least One Adverse Event (AE) in the Treatment or Post-Treatment Periods
timeFrame: From first dose of study treatment (Week 0 Visit) to Week 18 Post-study Visit (up to 18 weeks).
measure: Number of Participants Who Discontinued Study Treatment Due to an AE
timeFrame: From first dose of study treatment (Week 0 Visit) to Week 16 Visit (up to 16 weeks).
Secondary outcomes:
measure: Change From Baseline (BL) After 4-Week Treatment in Fasting Plasma Glucose (FPG)
timeFrame: Week 0 Visit (Baseline), Week 4 Visit, Week 8 Visit, Week 12 Visit, Week 16 Visit
measure: Change From BL After 4-Week Treatment in 2-hour Post-Meal Glucose (PMG) Levels
timeFrame: Week 0 Visit (Baseline), Week 4 Visit, Week 8 visit
measure: Percentage Change From Baseline (BL) After 4-Week Treatment in Low-Density Lipoprotein C (LDL-C) Levels
timeFrame: Week 0 Visit (Baseline), Week 4 Visit, Week 8 Visit, Week 12 Visit, and Week 16 Visit
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: