Type II Diabetes Mellitus
Conditions
Brief summary
This is a multicenter randomized, double-blind, placebo- and active-controlled (liraglutide; Victoza®), parallel-group, clinical trial of MK-8521 in participants with type 2 diabetes mellitus (T2DM) with inadequate glycemic control while on a stable dose of metformin (≥1000 mg/day). The trial will include a 1-week screening period; at least an 8-week antihyperglycemic agent (AHA) washout period, if required; a 14-week blinded therapy period (which includes single-blind run-in and double-blind therapy); and a 14-day post-treatment visit, 2 weeks after the last dose of investigational product. The primary hypothesis of the trial is that MK-8521 provides greater reduction in hemoglobin A1C relative to placebo after 12 weeks of once-daily administration in participants with T2DM with inadequate glycemic control on metformin monotherapy.
Interventions
DRUGMK-8521
Dose strengths: 180 μg QD administered subcutaneously. A 2-step dose escalation regimen \[60 μg, 120 μg\] over the first 2 weeks is used to achieve the final dose up to 180 μg.); 300 μg QD administered subcutaneously (A 3-step dose escalation regimen \[60 μg, 120 μg, 180 μg\] over the first 3 weeks is used to achieve the final dose up to 300 μg.
DRUGPlacebo
Double dummy matching placebo for the MK-8521 and placebo arms: matching placebo for MK-8521 300 μg QD administered subcutaneously; matching placebo for MK-8521 180 μg QD administered subcutaneously. A dose escalation regimen consistent with that of the MK-8521 300 μg and 180 μg arms of the study; mock escalation will be performed over the first 2 to 3 weeks.
DRUGLiraglutide
Dose strength: 1.8 mg QD administered subcutaneously. A 2-step dose escalation regimen (0.6 mg, 1.2 mg) over the first 2 weeks is used to achieve the final dose up to 1.8 mg.
DRUGMetformin
Metformin immediate release (IR) or metformin extended release (XR) administered ≥1000 mg QD as background therapy
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Have T2DM in accordance with American Diabetes Association guidelines * Be on metformin monotherapy (\>-1000 mg/day: metformin IR or metformin XR) for at least 12 weeks prior to study start with a hemoglobin A1C (A1C) \>-7.5 and \<-10.5% OR Be on dual therapy with metformin (\>-1000 mg/day: dose stable for at least 4 weeks prior to study start) with an A1C of \>-7.0% and \<-10.0% and a second AHA and be willing to washout the second AHA. Allowable AHAs are dipeptidyl peptidase 4 (DPP-4 inhibitors), alpha-glucosidase inhibitors, sulfonylureas, and glinides. * Have a body mass index (BMI) ≥23 kg/m\^2 and ≤40 kg/m\^2 * Is a female who is not of reproductive potential, or is a female of reproductive potential who agrees to avoid becoming pregnant: while receiving study drug and for 14 days after the last dose of study drug
Exclusion criteria
* Have a history of type 1 diabetes or a history of diabetic ketoacidosis * Has a history of other specific types of diabetes (e.g., genetic syndromes, secondary pancreatic diabetes, diabetes due to endocrinopathies, drug- or chemical-induced, and post-organ transplant) * Has been treated with any gut-derived incretin hormone glucagon-like peptide 1 (GLP-1) receptor agonist (e.g. Byetta™, Victoza™ or investigational agents) within the last 6 months or has had GLP-1 receptor agonist discontinued due to gastrointestinal intolerance or lack of efficacy. Note: treatment with a GLP-1 receptor agonist that was discontinued \>6 months prior to study start is not an exclusion if the GLP-1 receptor agonist was discontinued for reasons other than gastrointestinal intolerance or lack of efficacy. * Has a history of clinically significant gastrointestinal disorder (including diabetic gastroparesis; irritable bowel disease; recurrent episodes of nausea, vomiting, diarrhea and abdominal pain) * Has a history of clinically significant and active, immunological, respiratory, genitourinary or major neurological (including stroke, transient ischemic attack and chronic seizures) abnormalities or diseases * Has a history of cardiovascular disease (including diabetic cardiomyopathy) or significant cardiac condition (including a history of myocardial infarction, stable or unstable angina, arterial revascularization, pathologic, symptomatic or sustained tachyarrhythmia \[e.g. atrial fibrillation, sustained supraventricular tachycardia, symptomatic non-sustained supraventricular tachycardia, ventricular tachycardia, ventricular fibrillation, Wolf-Parkinson-White syndrome, congenital long QT syndrome, etc.\]) or heart failure * Has a family history of medullary carcinoma of the thyroid or multiple endocrine neoplasm type-2 syndrome * Has active diabetic proliferative retinopathy or a history of maculopathy * Has human immunodeficiency virus (HIV) * Has a medical history of active liver disease (other than non-alcoholic hepatic steatosis), including chronic hepatitis B or C (assessed by medical history), primary biliary cirrhosis, or active symptomatic gallbladder disease * Is on a weight loss medication or has undergone bariatric surgery * Has a history of acute or chronic pancreatitis of any etiology * Had an event of severe hypoglycemia with neuroglycopenia in the past 12 months * Has a positive urine pregnancy test * Is pregnant or breast-feeding, or is planning to conceive during the trial, including 14 days following the last dose of investigational product * Routinely consumes \>1 alcoholic drinks per day or \>7 alcoholic drinks per week or engages in binge drinking * Routinely consumes ≥480mg /day caffeine in caffeinated beverages (1 cup of coffee contains approximately 120 mg of caffeine * Is taking a beta blocker or medications with sympathomimetic activity (e.g. pseudoephedrine, phenylpropanolamine, etc.) * Is currently a user of nicotine or nicotine containing products or does not agree to refrain from using nicotine during the trial, including 14 days following the last dose of investigational product * Is currently a user of any illicit drugs (including any marijuana use) or has a history of drug (including alcohol) abuse within approximately 5 years * has other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or blinded investigational product administration
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Hemoglobin A1C (A1C) at Week 12 | Baseline and Week 12 | A1C is the percentage of hemoglobin that has glucose bound to it and is a blood marker used to report average blood glucose levels over prolonged periods of time. A1C is reported as a percentage (%). This change from baseline reflects the Week 12 A1C minus the Week 0 A1C. |
| Number of Participants With an Adverse Event (AE) | Up to Week 14 | An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. |
| Number of Participants Who Discontinued Study Treatment Due to an AE | Up to Week 12 | An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. |
| Number of Participants With an AE of Symptomatic Hypoglycemia | Up to Week 14 | An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Hypoglycemia episodes are those with glucose values ≤70 mg/dL (3.9 mmol/L). Symptomatic hypoglycemia episodes were episodes with clinical symptoms reported by the investigator as hypoglycemia and classified as adverse events. |
| Change From Baseline in Heart Rate at Week 12 | Baseline and Week 12 | This change from baseline reflects the Week 12 heart rate minus the Week 0 heart rate. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Systolic Blood Pressure (SBP) at Week 12 | Baseline and Week 12 | This change from baseline reflects the Week 12 SBP minus the Week 0 SBP. |
| Change From Baseline in Body Weight at Week 12 | Baseline and Week 12 | This change from baseline reflects the Week 12 body weight minus the Week 0 body weight. |
| Change From Baseline in Diastolic Blood Pressure (DBP) at Week 12 | Baseline and Week 12 | This change from baseline reflects the Week 12 DBP minus the Week 0 DBP. |
| Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12 | Baseline and Week 12 | This change from baseline reflects the Week 12 FPG minus the Week 0 FPG. |
| Change From Baseline in Fasting Low Density Lipoprotein (LDL) Cholesterol at Week 12 | Baseline and Week 12 | This change from baseline reflects the Week 12 fasting LDL cholesterol minus the Week 0 fasting LDL cholesterol. |
| Change From Baseline in Fasting High Density Lipoprotein (HDL) Cholesterol at Week 12 | Baseline and Week 12 | This change from baseline reflects the Week 12 fasting HDL cholesterol minus the Week 0 fasting HDL cholesterol. |
| Change From Baseline in Fasting Triglycerides at Week 12 | Baseline and Week 12 | This change from baseline reflects the Week 12 fasting triglycerides minus the Week 0 fasting triglycerides. |
Participant flow
Recruitment details
This study was conducted at 84 clinical trial sites in Australia, Colombia, Guatemala, Israel, Spain, New Zealand, and in the United States. Five hundred participants were screened and 176 randomized.
Participants by arm
| Arm | Count |
|---|---|
| MK-8521 180 μg Participants receive double-blind MK-8521 180 μg daily (QD), subcutaneously, over 12 weeks. | 46 |
| MK-8521 300 μg Participants receive double-blind MK-8521 300 μg, QD, subcutaneously, over 12 weeks. | 44 |
| Placebo Participants receive matching double-blind placebo QD over 12 weeks. | 43 |
| Liraglutide 1.8 mg Participants receive open-label liraglutide, 1.8 mg QD, subcutaneously, over 12 weeks. | 43 |
| Total | 176 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 3 | 1 | 1 | 2 |
| Overall Study | Death | 0 | 0 | 1 | 0 |
| Overall Study | Hyperglycemia Discontinuation Criteria | 0 | 1 | 0 | 0 |
| Overall Study | Lost to Follow-up | 0 | 0 | 1 | 0 |
| Overall Study | Non-Compliance With Study Drug | 0 | 1 | 0 | 0 |
| Overall Study | Screen Failure | 0 | 0 | 0 | 1 |
| Overall Study | Study Terminated by Sponsor | 13 | 10 | 6 | 10 |
| Overall Study | Withdrawal by Subject | 0 | 2 | 1 | 0 |
Baseline characteristics
| Characteristic | Total | MK-8521 180 μg | MK-8521 300 μg | Placebo | Liraglutide 1.8 mg |
|---|---|---|---|---|---|
| Age, Continuous | 53.2 Years STANDARD_DEVIATION 8.8 | 54.0 Years STANDARD_DEVIATION 7.6 | 54.2 Years STANDARD_DEVIATION 7.9 | 51.5 Years STANDARD_DEVIATION 10.1 | 52.9 Years STANDARD_DEVIATION 9.4 |
| Antihyperglycemic agent (AHA) Washout Status No | 156 Participants | 41 Participants | 39 Participants | 38 Participants | 38 Participants |
| Antihyperglycemic agent (AHA) Washout Status Yes | 20 Participants | 5 Participants | 5 Participants | 5 Participants | 5 Participants |
| Body Mass Index (BMI) <30 kg/m^2 | 62 Participants | 18 Participants | 14 Participants | 15 Participants | 15 Participants |
| Body Mass Index (BMI) >=30 kg/m^2 | 114 Participants | 28 Participants | 30 Participants | 28 Participants | 28 Participants |
| Body Weight | 89.3 Kilograms STANDARD_DEVIATION 18.5 | 85.4 Kilograms STANDARD_DEVIATION 18.1 | 89.4 Kilograms STANDARD_DEVIATION 20 | 90.2 Kilograms STANDARD_DEVIATION 19 | 92.4 Kilograms STANDARD_DEVIATION 16.5 |
| Diastolic Blood Pressure (DBP) | 77.7 mm Hg STANDARD_DEVIATION 7 | 76.6 mm Hg STANDARD_DEVIATION 6.3 | 77.9 mm Hg STANDARD_DEVIATION 7.4 | 77.6 mm Hg STANDARD_DEVIATION 8.3 | 78.9 mm Hg STANDARD_DEVIATION 5.7 |
| Fasting High Density Lipoprotein (HDL) Cholesterol | 44.8 mg/dL STANDARD_DEVIATION 12.1 | 47.4 mg/dL STANDARD_DEVIATION 12.3 | 41.7 mg/dL STANDARD_DEVIATION 9.5 | 43.1 mg/dL STANDARD_DEVIATION 12 | 46.8 mg/dL STANDARD_DEVIATION 13.8 |
| Fasting Low Density Lipoprotein (LDL) Cholesterol | 98.2 mg/dL STANDARD_DEVIATION 33.9 | 103.3 mg/dL STANDARD_DEVIATION 28.1 | 95.6 mg/dL STANDARD_DEVIATION 33.8 | 100.5 mg/dL STANDARD_DEVIATION 42.8 | 93.0 mg/dL STANDARD_DEVIATION 29.5 |
| Fasting Plasma Glucose (FPG) | 176.4 mg/dL STANDARD_DEVIATION 43.9 | 171.4 mg/dL STANDARD_DEVIATION 41 | 175.0 mg/dL STANDARD_DEVIATION 49.5 | 172.0 mg/dL STANDARD_DEVIATION 39.2 | 187.5 mg/dL STANDARD_DEVIATION 44.9 |
| Fasting Triglycerides | 165.5 mg/dL STANDARD_DEVIATION 92.5 | 171.5 mg/dL STANDARD_DEVIATION 104.6 | 167.1 mg/dL STANDARD_DEVIATION 79.5 | 168.7 mg/dL STANDARD_DEVIATION 96.1 | 154.0 mg/dL STANDARD_DEVIATION 89.5 |
| Heart Rate | 73.3 Beats/minute STANDARD_DEVIATION 8.8 | 72.5 Beats/minute STANDARD_DEVIATION 7.7 | 72.2 Beats/minute STANDARD_DEVIATION 9.9 | 73.8 Beats/minute STANDARD_DEVIATION 8.6 | 74.7 Beats/minute STANDARD_DEVIATION 8.9 |
| Hemoglobin A1C | 8.54 Percent STANDARD_DEVIATION 0.87 | 8.54 Percent STANDARD_DEVIATION 0.82 | 8.43 Percent STANDARD_DEVIATION 0.78 | 8.46 Percent STANDARD_DEVIATION 0.83 | 8.72 Percent STANDARD_DEVIATION 1.03 |
| Hemoglobin A1C Classification by Levels <8.5% | 91 Participants | 22 Participants | 24 Participants | 24 Participants | 21 Participants |
| Hemoglobin A1C Classification by Levels >=8.5% | 85 Participants | 24 Participants | 20 Participants | 19 Participants | 22 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 13 Participants | 4 Participants | 3 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) Asian | 9 Participants | 2 Participants | 3 Participants | 4 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 36 Participants | 8 Participants | 9 Participants | 12 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 12 Participants | 5 Participants | 4 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 106 Participants | 27 Participants | 25 Participants | 23 Participants | 31 Participants |
| Sex: Female, Male Female | 88 Participants | 26 Participants | 18 Participants | 24 Participants | 20 Participants |
| Sex: Female, Male Male | 88 Participants | 20 Participants | 26 Participants | 19 Participants | 23 Participants |
| Systolic Blood Pressure (SBP) | 125.5 mm Hg STANDARD_DEVIATION 12 | 125.1 mm Hg STANDARD_DEVIATION 10.8 | 126.0 mm Hg STANDARD_DEVIATION 12 | 124.6 mm Hg STANDARD_DEVIATION 14.3 | 126.3 mm Hg STANDARD_DEVIATION 11 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 46 | 0 / 44 | 1 / 43 | 0 / 42 |
| other Total, other adverse events | 18 / 46 | 21 / 44 | 15 / 43 | 13 / 42 |
| serious Total, serious adverse events | 0 / 46 | 1 / 44 | 1 / 43 | 0 / 42 |
Outcome results
Primary
Change From Baseline in Heart Rate at Week 12
This change from baseline reflects the Week 12 heart rate minus the Week 0 heart rate.
Time frame: Baseline and Week 12
Population: All randomized, treated participants with at least one heart rate measurement (baseline or post-baseline).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| MK-8521 180 μg | Change From Baseline in Heart Rate at Week 12 | 5.47 Beats/minute |
| MK-8521 300 μg | Change From Baseline in Heart Rate at Week 12 | 6.28 Beats/minute |
| Placebo | Change From Baseline in Heart Rate at Week 12 | -1.42 Beats/minute |
| Liraglutide 1.8 mg | Change From Baseline in Heart Rate at Week 12 | 1.63 Beats/minute |
95% CI: [3.42, 10.37]
95% CI: [0.35, 7.33]
95% CI: [4.17, 11.23]
95% CI: [1.11, 8.19]
Primary
Change From Baseline in Hemoglobin A1C (A1C) at Week 12
A1C is the percentage of hemoglobin that has glucose bound to it and is a blood marker used to report average blood glucose levels over prolonged periods of time. A1C is reported as a percentage (%). This change from baseline reflects the Week 12 A1C minus the Week 0 A1C.
Time frame: Baseline and Week 12
Population: All randomized, treated participants with at least one A1C measurement (baseline or post-baseline).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| MK-8521 180 μg | Change From Baseline in Hemoglobin A1C (A1C) at Week 12 | -0.82 Percent |
| MK-8521 300 μg | Change From Baseline in Hemoglobin A1C (A1C) at Week 12 | -1.05 Percent |
| Placebo | Change From Baseline in Hemoglobin A1C (A1C) at Week 12 | -0.44 Percent |
| Liraglutide 1.8 mg | Change From Baseline in Hemoglobin A1C (A1C) at Week 12 | -1.42 Percent |
p-value: 0.12695% CI: [-0.88, 0.11]Longitudinal data analysis
p-value: 0.01795% CI: [0.11, 1.08]Longitudinal data analysis
p-value: 0.01895% CI: [-1.12, -0.1]Longitudinal data analysis
p-value: 0.14695% CI: [-0.13, 0.87]Longitudinal data analysis
p-value: <0.00195% CI: [-1.49, -0.48]Longitudinal data analysis
Primary
Number of Participants Who Discontinued Study Treatment Due to an AE
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Time frame: Up to Week 12
Population: All randomized participants who received at least 1 dose of study treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MK-8521 180 μg | Number of Participants Who Discontinued Study Treatment Due to an AE | 3 Participants |
| MK-8521 300 μg | Number of Participants Who Discontinued Study Treatment Due to an AE | 1 Participants |
| Placebo | Number of Participants Who Discontinued Study Treatment Due to an AE | 2 Participants |
| Liraglutide 1.8 mg | Number of Participants Who Discontinued Study Treatment Due to an AE | 2 Participants |
Primary
Number of Participants With an Adverse Event (AE)
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Time frame: Up to Week 14
Population: All randomized participants who received at least 1 dose of study treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MK-8521 180 μg | Number of Participants With an Adverse Event (AE) | 24 Participants |
| MK-8521 300 μg | Number of Participants With an Adverse Event (AE) | 29 Participants |
| Placebo | Number of Participants With an Adverse Event (AE) | 25 Participants |
| Liraglutide 1.8 mg | Number of Participants With an Adverse Event (AE) | 22 Participants |
Primary
Number of Participants With an AE of Symptomatic Hypoglycemia
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Hypoglycemia episodes are those with glucose values ≤70 mg/dL (3.9 mmol/L). Symptomatic hypoglycemia episodes were episodes with clinical symptoms reported by the investigator as hypoglycemia and classified as adverse events.
Time frame: Up to Week 14
Population: All randomized participants who received at least 1 dose of study treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MK-8521 180 μg | Number of Participants With an AE of Symptomatic Hypoglycemia | 0 Participants |
| MK-8521 300 μg | Number of Participants With an AE of Symptomatic Hypoglycemia | 2 Participants |
| Placebo | Number of Participants With an AE of Symptomatic Hypoglycemia | 1 Participants |
| Liraglutide 1.8 mg | Number of Participants With an AE of Symptomatic Hypoglycemia | 1 Participants |
p-value: 0.30195% CI: [-12.1, 5.6]Miettinen & Nurminen method
p-value: 0.57395% CI: [-8.1, 13.2]Miettinen & Nurminen method
p-value: 0.29595% CI: [-12.4, 5.5]Miettinen & Nurminen method
p-value: 0.58795% CI: [-8.4, 13.2]Miettinen & Nurminen method
Secondary
Change From Baseline in Body Weight at Week 12
This change from baseline reflects the Week 12 body weight minus the Week 0 body weight.
Time frame: Baseline and Week 12
Population: All randomized, treated participants with at least one body weight measurement (baseline or post-baseline).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| MK-8521 180 μg | Change From Baseline in Body Weight at Week 12 | -2.0 Kilograms |
| MK-8521 300 μg | Change From Baseline in Body Weight at Week 12 | -3.0 Kilograms |
| Placebo | Change From Baseline in Body Weight at Week 12 | -1.3 Kilograms |
| Liraglutide 1.8 mg | Change From Baseline in Body Weight at Week 12 | -2.9 Kilograms |
p-value: 0.18395% CI: [-0.4, 2.2]Longitudinal data analysis
p-value: 0.0195% CI: [-3.1, -0.4]Longitudinal data analysis
p-value: 0.81195% CI: [-1.5, 1.2]Longitudinal data analysis
p-value: 0.28595% CI: [-2, 0.6]Longitudinal data analysis
p-value: 0.01895% CI: [-2.9, -0.3]Longitudinal data analysis
Secondary
Change From Baseline in Diastolic Blood Pressure (DBP) at Week 12
This change from baseline reflects the Week 12 DBP minus the Week 0 DBP.
Time frame: Baseline and Week 12
Population: All randomized, treated participants with at least one DBP measurement (baseline or post-baseline).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| MK-8521 180 μg | Change From Baseline in Diastolic Blood Pressure (DBP) at Week 12 | 0.5 mmHg |
| MK-8521 300 μg | Change From Baseline in Diastolic Blood Pressure (DBP) at Week 12 | 0.4 mmHg |
| Placebo | Change From Baseline in Diastolic Blood Pressure (DBP) at Week 12 | -1.0 mmHg |
| Liraglutide 1.8 mg | Change From Baseline in Diastolic Blood Pressure (DBP) at Week 12 | 0.6 mmHg |
p-value: 0.34795% CI: [-1.7, 4.8]Longitudinal data analysis
p-value: 0.96395% CI: [-3.3, 3.2]Longitudinal data analysis
p-value: 0.39495% CI: [-1.9, 4.7]Longitudinal data analysis
p-value: 0.90595% CI: [-3.5, 3.1]Longitudinal data analysis
p-value: 0.32595% CI: [-1.6, 4.9]Longitudinal data analysis
Secondary
Change From Baseline in Fasting High Density Lipoprotein (HDL) Cholesterol at Week 12
This change from baseline reflects the Week 12 fasting HDL cholesterol minus the Week 0 fasting HDL cholesterol.
Time frame: Baseline and Week 12
Population: All randomized, treated participants with at least one fasting HDL cholesterol measurement (baseline or post-baseline).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MK-8521 180 μg | Change From Baseline in Fasting High Density Lipoprotein (HDL) Cholesterol at Week 12 | -0.4 mg/dL | Standard Deviation 12.3 |
| MK-8521 300 μg | Change From Baseline in Fasting High Density Lipoprotein (HDL) Cholesterol at Week 12 | -0.5 mg/dL | Standard Deviation 6 |
| Placebo | Change From Baseline in Fasting High Density Lipoprotein (HDL) Cholesterol at Week 12 | 3.8 mg/dL | Standard Deviation 6.6 |
| Liraglutide 1.8 mg | Change From Baseline in Fasting High Density Lipoprotein (HDL) Cholesterol at Week 12 | 0.4 mg/dL | Standard Deviation 5.7 |
Secondary
Change From Baseline in Fasting Low Density Lipoprotein (LDL) Cholesterol at Week 12
This change from baseline reflects the Week 12 fasting LDL cholesterol minus the Week 0 fasting LDL cholesterol.
Time frame: Baseline and Week 12
Population: All randomized, treated participants with at least one fasting LDL cholesterol measurement (baseline or post-baseline).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MK-8521 180 μg | Change From Baseline in Fasting Low Density Lipoprotein (LDL) Cholesterol at Week 12 | -9.3 mg/dL | Standard Deviation 23.5 |
| MK-8521 300 μg | Change From Baseline in Fasting Low Density Lipoprotein (LDL) Cholesterol at Week 12 | 8.8 mg/dL | Standard Deviation 41.8 |
| Placebo | Change From Baseline in Fasting Low Density Lipoprotein (LDL) Cholesterol at Week 12 | 4.5 mg/dL | Standard Deviation 33.5 |
| Liraglutide 1.8 mg | Change From Baseline in Fasting Low Density Lipoprotein (LDL) Cholesterol at Week 12 | 0.3 mg/dL | Standard Deviation 18 |
Secondary
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12
This change from baseline reflects the Week 12 FPG minus the Week 0 FPG.
Time frame: Baseline and Week 12
Population: All randomized, treated participants with at least one FPG measurement (baseline or post-baseline).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| MK-8521 180 μg | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12 | -13.7 mg/dL |
| MK-8521 300 μg | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12 | -34.6 mg/dL |
| Placebo | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12 | -5.1 mg/dL |
| Liraglutide 1.8 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12 | -42.9 mg/dL |
p-value: 0.38595% CI: [-28.2, 10.9]Longitudinal data analysis
p-value: 0.00495% CI: [9.7, 48.6]Longitudinal data analysis
p-value: 0.00495% CI: [-49.6, -9.4]Longitudinal data analysis
p-value: 0.41695% CI: [-11.7, 28.2]Longitudinal data analysis
p-value: <0.00195% CI: [-57.5, -18]Longitudinal data analysis
Secondary
Change From Baseline in Fasting Triglycerides at Week 12
This change from baseline reflects the Week 12 fasting triglycerides minus the Week 0 fasting triglycerides.
Time frame: Baseline and Week 12
Population: All randomized, treated participants with at least one fasting triglycerides measurement (baseline or post-baseline).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MK-8521 180 μg | Change From Baseline in Fasting Triglycerides at Week 12 | -2.9 mg/dL | Standard Deviation 91.9 |
| MK-8521 300 μg | Change From Baseline in Fasting Triglycerides at Week 12 | -26.6 mg/dL | Standard Deviation 71.2 |
| Placebo | Change From Baseline in Fasting Triglycerides at Week 12 | -15.6 mg/dL | Standard Deviation 68.9 |
| Liraglutide 1.8 mg | Change From Baseline in Fasting Triglycerides at Week 12 | -20.5 mg/dL | Standard Deviation 48.6 |
Secondary
Change From Baseline in Systolic Blood Pressure (SBP) at Week 12
This change from baseline reflects the Week 12 SBP minus the Week 0 SBP.
Time frame: Baseline and Week 12
Population: All randomized, treated participants with at least one SBP measurement (baseline or post-baseline).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| MK-8521 180 μg | Change From Baseline in Systolic Blood Pressure (SBP) at Week 12 | -2.7 mmHg |
| MK-8521 300 μg | Change From Baseline in Systolic Blood Pressure (SBP) at Week 12 | -1.5 mmHg |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) at Week 12 | 1.0 mmHg |
| Liraglutide 1.8 mg | Change From Baseline in Systolic Blood Pressure (SBP) at Week 12 | -1.7 mmHg |
p-value: 0.15195% CI: [-8.8, 1.4]Longitudinal data analysis
p-value: 0.68295% CI: [-6.2, 4.1]Longitudinal data analysis
p-value: 0.34495% CI: [-7.7, 2.7]Longitudinal data analysis
p-value: 0.94895% CI: [-5, 5.4]Longitudinal data analysis
p-value: 0.30695% CI: [-7.8, 2.5]Longitudinal data analysis