Study Stopped
Upon interim analysis, sufficient data was accrued to assess study hypotheses.
A Study of the Safety and Efficacy of MK-3577 in Participants With Type 2 Diabetes Mellitus (MK-3577-009)
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
3 other identifiers
interventional
118
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 type-2-diabetes-mellitus
Started Mar 2009
Typical duration for phase_2 type-2-diabetes-mellitus
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 24, 2009
CompletedStudy Start
First participant enrolled
March 24, 2009
CompletedFirst Posted
Study publicly available on registry
March 25, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 12, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 13, 2010
CompletedResults Posted
Study results publicly available
January 11, 2017
CompletedSeptember 10, 2018
August 1, 2018
1.3 years
March 24, 2009
November 14, 2016
August 9, 2018
Conditions
Outcome Measures
Primary Outcomes (3)
Change From Baseline (BL) After 4-Week Treatment in Weighted Mean Glucose (WMG)
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.
Week 0 Visit (Baseline), Week 4 Visit, Week 8 Visit
Number of Participants With At Least One Adverse Event (AE) in the Treatment or Post-Treatment Periods
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.
From first dose of study treatment (Week 0 Visit) to Week 18 Post-study Visit (up to 18 weeks).
Number of Participants Who Discontinued Study Treatment Due to an AE
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.
From first dose of study treatment (Week 0 Visit) to Week 16 Visit (up to 16 weeks).
Secondary Outcomes (3)
Change From Baseline (BL) After 4-Week Treatment in Fasting Plasma Glucose (FPG)
Week 0 Visit (Baseline), Week 4 Visit, Week 8 Visit, Week 12 Visit, Week 16 Visit
Change From BL After 4-Week Treatment in 2-hour Post-Meal Glucose (PMG) Levels
Week 0 Visit (Baseline), Week 4 Visit, Week 8 visit
Percentage Change From Baseline (BL) After 4-Week Treatment in Low-Density Lipoprotein C (LDL-C) Levels
Week 0 Visit (Baseline), Week 4 Visit, Week 8 Visit, Week 12 Visit, and Week 16 Visit
Study Arms (14)
PLA→MK-3577 QD AM→MK-3577 QD PM→MK-3577 BID (Arm 1)
EXPERIMENTALParticipants were to receive oral treatment with dose-matched placebo to MK-3577 for 4 weeks during Period 1, followed by MK-3577 10 mg QD AM for 4 weeks during Period 2, followed by MK-3577 6 mg QD PM for 4 weeks during Period 3, followed by MK-3577 25 mg BID for 4 weeks during Period 4. Domiciled participants were also to receive placebo to metformin during Period 1 and Period 2.
MK-3577 QD AM→PLA→MK-3577 BID→MK-3577 QD PM (Arm 2)
EXPERIMENTALParticipants were to receive oral treatment with MK-3577 10 mg QD AM for 4 weeks during Period 1, followed by dose-matched placebo to MK-3577 for 4 weeks during Period 2, followed by MK-3577 25 mg BID for 4 weeks during Period 3, followed by MK-3577 6 mg QD PM for 4 weeks during Period 4. Domiciled participants were also to receive placebo to metformin during Period 1 and Period 2.
MK-3577 QD PM→MK-3577 BID→PLA→MK-3577 QD AM (Arm 3)
EXPERIMENTALParticipants were to receive oral treatment with MK-3577 6 mg QD PM for 4 weeks during Period 1, followed MK- 3577 25 mg BID for 4 weeks during Period 2, followed by dose-matched placebo to MK-3577 for 4 weeks during Period 3, followed by MK-3577 10 mg QD AM for 4 weeks during Period 4.
MK-3577 BID→MK-3577 QD PM→MK-3577 QD AM→PLA (Arm 4)
EXPERIMENTALParticipants were to receive oral treatment with MK-3577 25 mg BID for 4 weeks during Period 1, followed by MK-3577 6 mg QD PM for 4 weeks during Period 2, followed by MK-3577 10 mg QD AM for 4 weeks during Period 3, followed by dose-matched placebo to MK-3577 for 4 weeks during Period 4.
PLA→MK-3577 BID→MK-3577 QD AM→MK-3577 QD PM (Arm 5)
EXPERIMENTALParticipants were to receive oral treatment with dose-matched placebo to MK-3577 for 4 weeks during Period 1, followed by MK-3577 25 mg BID for 4 weeks during Period 2, followed by MK-3577 10 mg QD AM for 4 weeks during Period 3, followed by MK-3577 6 mg QD PM for 4 weeks during Period 4.
MK-3577 QD AM→MK-3577 QD PM→PLA→MK-3577 BID (Arm 6)
EXPERIMENTALParticipants were to receive oral treatment with MK-3577 10 mg QD AM for 4 weeks during Period 1, followed by MK-3577 6 mg QD PM for 4 weeks during Period 2, followed by dose-matched placebo to MK-3577 for 4 weeks during Period 3, followed by MK-3577 25 mg BID for 4 weeks during Period 4.
MK-3577 QD PM→MK-3577 QD AM→MK-3577 BID→PLA (Arm 7)
EXPERIMENTALParticipants were to receive oral treatment with MK-3577 6 mg QD PM for 4 weeks during Period 1, followed by MK-3577 10 mg QD AM for 4 weeks during Period 2, followed by MK-3577 25 mg BID for 4 weeks during Period 3, followed by dose-matched placebo to MK-3577 for 4 weeks during Period 4.
MK-3577 BID→PLA→MK-3577 QD PM→MK-3577 QD AM (Arm 8)
EXPERIMENTALParticipants were to receive oral treatment with MK-3577 25 mg BID for 4 weeks during Period 1, followed by dose-matched placebo to MK-3577 for 4 weeks during Period 2, followed by MK-3577 6 mg QD PM for 4 weeks during Period 3, followed by MK-3577 10 mg QD AM for 4 weeks during Period 4.
PLA→MK-3577 QD PM→MK-3577 BID→MK-3577 QD AM (Arm 9)
EXPERIMENTALParticipants were to receive oral treatment with dose-matched placebo to MK-3577 for 4 weeks during Period 1, followed by MK-3577 6 mg QD PM for 4 weeks during Period 2, followed by MK-3577 25 mg BID for 4 weeks during Period 3, followed by MK-3577 10 mg QD AM for 4 weeks during period 4. Domiciled participants were also to receive placebo to metformin during Period 1 and Period 2.
MK-3577 QD AM→MK-3577 BID→MK-3577 QD PM→PLA (Arm 10)
EXPERIMENTALParticipants were to receive oral treatment with MK-3577 10 mg QD AM for 4 weeks during Period 1, followed by MK-3577 25 mg BID for 4 weeks during Period 2, followed by MK-3577 6 mg QD PM for 4 weeks during Period 3, followed by dose-matched placebo to MK-3577 for 4 weeks during Period 4.
MK-3577 QD PM→PLA→MK-3577 QD AM→MK-3577 BID (Arm 11)
EXPERIMENTALParticipants were to receive oral treatment with MK-3577 6 mg QD PM for 4 weeks during Period 1, followed by dose-matched placebo to MK-3577 for 4 weeks during Period 2, followed by MK-3577 10 mg QD AM for 4 weeks during Period 3, followed by MK-3577 25 mg BID for 4 weeks during Period 4. Domiciled participants were also to receive placebo to metformin during Period 1 and Period 2.
MK-3577 BID→MK-3577 QD AM→PLA→MK-3577 QD PM (Arm 12)
EXPERIMENTALParticipants were to receive oral treatment with MK-3577 25 mg BID for 4 weeks during Period 1, followed by MK-3577 10 mg QD AM for 4 weeks during Period 2, followed by dose-matched placebo to MK-3577 for 4 weeks during Period 3, followed by MK-3577 6 mg QD PM for 4 weeks during Period 4.
PLA→METF→MK-3577 QD AM→MK-3577 QD PM (Arm 13)
EXPERIMENTALDomiciled participants were to receive oral treatment with dose-matched placebo to metformin (METF) for 4 weeks during Period 1, followed by metformin 1000 mg BID for 4 weeks during Period 2, followed by MK-3577 10 mg QD AM for 4 weeks during Period 3, followed by MK-3577 6 mg QD PM for 4 weeks during Period 4. Participants in this arm were administered metformin placebo during Period 1 and active metformin during Period 2.
METF→PLA→MK-3577 QD PM→MK-3577 QD AM (Arm 14)
EXPERIMENTALDomiciled participants were to receive oral treatment with metformin 1000 mg BID for 4 weeks during Period 1, followed by dose-matched placebo to metformin for 4 weeks during Period 2, followed by MK-3577 6 mg QD PM for 4 weeks during Period 3, followed by MK-3577 10 mg QD AM for 4 weeks during Period 4. Participants in this arm were administered active metformin during Period 1 and metformin placebo during Period 2.
Interventions
MK-3577 oral tablets totaling 6 mg in the evening (PM), 10 mg in the morning (AM), or 25 mg twice daily (BID) depending upon randomization, administered during a 4 week treatment period.
Dose-matched placebo tablets to MK-3577 administered during a 4 week treatment period
Two 500 mg tablets of metformin were administered twice daily (2000 mg total daily dose) to domiciled participants during a 4 week treatment period.
Two placebo tablets to metformin were administered twice daily (2000 mg total daily dose) to domiciled participants during a 4 week treatment period.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
A pre-specified interim analysis of the efficacy and safety data for the initial cohort of participants in this study (Cohort 1) determined that sufficient data had been accrued to assess the study hypotheses, thus the study was discontinued.
Results Point of Contact
- Title
- Vice President, Late Stage Development Group Leader
- Organization
- Merck Sharp & Dohme Corp
Study Officials
- STUDY DIRECTOR
Medical Director
Merck Sharp & Dohme LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 24, 2009
First Posted
March 25, 2009
Study Start
March 24, 2009
Primary Completion
July 12, 2010
Study Completion
July 13, 2010
Last Updated
September 10, 2018
Results First Posted
January 11, 2017
Record last verified: 2018-08
Data Sharing
- IPD Sharing
- Will share
https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf