Type II Diabetes MellitusPhase 2NCT02492763

A Preliminary Study of the Efficacy and Safety of MK-8521 for Type 2 Diabetes (MK-8521-004)

A Phase 2 study testing MK-8521, Liraglutide and Metformin in people with Type II Diabetes Mellitus, run by Merck Sharp & Dohme LLC.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 21 to 65 years
Conditions the study is for: Type II Diabetes Mellitus
What is being tested?: MK-8521, Liraglutide and Metformin
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 176 participants
Where: No sites listed yet
Study dates: 27 Jul 2015to 18 Apr 2017
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

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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

About this study

Official title: A Phase IIa, Multicenter, Placebo- and Active-controlled, Randomized, Double-Blind, Clinical Trial to Evaluate the Safety and Efficacy of MK-8521 Compared to Placebo in Subjects With Type 2 Diabetes Mellitus

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.

Conditions: Type II Diabetes Mellitus
Being tested: MK-8521, Placebo, Liraglutide, Metformin
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MK-8521Drug
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.
PlaceboDrug
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.
LiraglutideDrug
Also called Victoza®
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.
MetforminDrug
Metformin immediate release (IR) or metformin extended release (XR) administered ≥1000 mg QD as background therapy

Study groups in NCT02492763
Study group	Role	What they receive
MK-8521 300 μg	Experimental	Participants receive double-blind MK-8521 300 μg daily (QD), subcutaneously, over 12 weeks. Receives: Drug: MK-8521; Drug: Placebo; Drug: Metformin
MK-8521 180 μg	Experimental	Participants receive double-blind MK-8521 180 μg QD, subcutaneously, over 12 weeks. Receives: Drug: MK-8521; Drug: Placebo; Drug: Metformin
Placebo	Placebo comparator	Participants receive matching double-blind placebo, QD over 12 weeks. Receives: Drug: Placebo; Drug: Metformin
Liraglutide 1.8 mg	Active comparator	Participants receive open-label 1.8 mg of liraglutide, QD, subcutaneously, over 12 weeks. Receives: Drug: Liraglutide; Drug: Metformin

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline and Week 12
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.
Measured: Up to Week 14
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.
Measured: Up to Week 12
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.
Measured: Up to Week 14
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.
Measured: Baseline and Week 12

Secondary outcomes (7)

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.
Measured: Baseline and Week 12
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.
Measured: Baseline and Week 12
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.
Measured: Baseline and Week 12
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.
Measured: Baseline and Week 12
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.
Measured: Baseline and Week 12
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.
Measured: Baseline and Week 12
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.
Measured: Baseline and Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Jul 201518 Apr 2017

First posted9 Jul 2015 (estimated)
Study start27 Jul 2015
Primary completion18 Apr 2017
Study completion18 Apr 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Type II Diabetes MellitusStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 176 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02492763
Sponsor's protocol ID: 8521-004
Other IDs: MK-8521-004
Status last verified: Aug 2018
First submitted: 6 Jul 2015
Last updated: 10 Sep 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Type II Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase IIa, Multicenter, Placebo- and Active-controlled, Randomized, Double-Blind, Clinical Trial to Evaluate the Safety and Efficacy of MK-8521 Compared to Placebo in Subjects With Type 2 Diabetes Mellitus
ClinicalTrials.gov ID: NCT02492763
Acronym / sponsor ID: 8521-004
Conditions: Type II Diabetes Mellitus
Phase: Phase 2
Study type: Interventional
Recruitment status: Terminated
Enrolment: 176 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 27 Jul 2015 (actual)
Primary completion: 18 Apr 2017 (actual)
Study completion: 18 Apr 2017 (actual)
First posted: 9 Jul 2015 (estimated)
Results: Posted 8 Mar 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
MK-8521 300 μg	Experimental	Drug: MK-8521, Drug: Placebo, Drug: MetforminParticipants receive double-blind MK-8521 300 μg daily (QD), subcutaneously, over 12 weeks.
MK-8521 180 μg	Experimental	Drug: MK-8521, Drug: Placebo, Drug: MetforminParticipants receive double-blind MK-8521 180 μg QD, subcutaneously, over 12 weeks.
Placebo	Placebo comparator	Drug: Placebo, Drug: MetforminParticipants receive matching double-blind placebo, QD over 12 weeks.
Liraglutide 1.8 mg	Active comparator	Drug: Liraglutide, Drug: MetforminParticipants receive open-label 1.8 mg of liraglutide, QD, subcutaneously, over 12 weeks.

Who may qualify

Ages: 21 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (21 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MK-8521Dose 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.	Drug	MK-8521 180 μg, MK-8521 300 μg
PlaceboDouble 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.	Drug	MK-8521 180 μg, MK-8521 300 μg, Placebo
LiraglutideAlso: Victoza®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.	Drug	Liraglutide 1.8 mg
MetforminMetformin immediate release (IR) or metformin extended release (XR) administered ≥1000 mg QD as background therapy	Drug	Liraglutide 1.8 mg, MK-8521 180 μg, MK-8521 300 μg, Placebo

Primary outcome

Change From Baseline in Hemoglobin A1C (A1C) at Week 12
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline and Week 12
This change from baseline reflects the Week 12 heart rate minus the Week 0 heart rate.

7 secondary outcomes

Change From Baseline in Body Weight at Week 12
Time frame: Baseline and Week 12
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12
Time frame: Baseline and Week 12
Change From Baseline in Fasting Low Density Lipoprotein (LDL) Cholesterol at Week 12
Time frame: Baseline and Week 12
Change From Baseline in Fasting High Density Lipoprotein (HDL) Cholesterol at Week 12
Time frame: Baseline and Week 12
Change From Baseline in Fasting Triglycerides at Week 12
Time frame: Baseline and Week 12
Change From Baseline in Systolic Blood Pressure (SBP) at Week 12
Time frame: Baseline and Week 12
Change From Baseline in Diastolic Blood Pressure (DBP) at Week 12
Time frame: Baseline and Week 12

Results and safety

Results posted to the registry on 8 Mar 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MK-8521 180 μg	46	30
MK-8521 300 μg	44	29
Placebo	43	33
Liraglutide 1.8 mg	43	30

Primary outcome: Change From Baseline in Hemoglobin A1C (A1C) at Week 12

Time frame: Baseline and Week 12. Least squares mean (95% Confidence Interval). Unit: Percent

Measure	MK-8521 180 μg n = 46	MK-8521 300 μg n = 44	Placebo n = 43	Liraglutide 1.8 mg n = 42
Value	-0.82 (-1.16 to -0.49)	-1.05 (-1.41 to -0.69)	-0.44 (-0.80 to -0.08)	-1.42 (-1.77 to -1.07)

MK-8521 180 μg vs Placebo: Difference in Least Squares Means: -0.39 (95% CI -0.88 to 0.11), p = 0.126, Longitudinal data analysis
MK-8521 180 μg vs Liraglutide 1.8 mg: Difference in Least Squares Means: 0.60 (95% CI 0.11 to 1.08), p = 0.017, Longitudinal data analysis
MK-8521 300 μg vs Placebo: Difference in Least Squares Means: -0.61 (95% CI -1.12 to -0.10), p = 0.018, Longitudinal data analysis

Population analysed: All randomized, treated participants with at least one A1C measurement (baseline or post-baseline).

Primary outcome: Number of Participants With an Adverse Event (AE)

Time frame: Up to Week 14. Count of participants. Unit: Participants

Measure	MK-8521 180 μg n = 46	MK-8521 300 μg n = 44	Placebo n = 43	Liraglutide 1.8 mg n = 42
Value	24	29	25	22

Population analysed: All randomized participants who received at least 1 dose of study treatment.

Primary outcome: Number of Participants Who Discontinued Study Treatment Due to an AE

Time frame: Up to Week 12. Count of participants. Unit: Participants

Measure	MK-8521 180 μg n = 46	MK-8521 300 μg n = 44	Placebo n = 43	Liraglutide 1.8 mg n = 42
Value	3	1	2	2

Population analysed: All randomized participants who received at least 1 dose of study treatment.

Primary outcome: Number of Participants With an AE of Symptomatic Hypoglycemia

Time frame: Up to Week 14. Count of participants. Unit: Participants

Measure	MK-8521 180 μg n = 46	MK-8521 300 μg n = 44	Placebo n = 43	Liraglutide 1.8 mg n = 42
Value	0	2	1	1

MK-8521 180 μg vs Placebo: Difference in % vs Placebo: -2.3 (95% CI -12.1 to 5.6), p = 0.301, Miettinen & Nurminen method
MK-8521 300 μg vs Placebo: Difference in % vs Placebo: 2.2 (95% CI -8.1 to 13.2), p = 0.573, Miettinen & Nurminen method
MK-8521 180 μg vs Liraglutide 1.8 mg: Difference in % vs Liraglutide: -2.4 (95% CI -12.4 to 5.5), p = 0.295, Miettinen & Nurminen method

Population analysed: All randomized participants who received at least 1 dose of study treatment.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to Week 14. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MK-8521 180 μg	0 of 46 (0%)	18 of 46 (39.1%)	0 of 46
MK-8521 300 μg	1 of 44 (2.3%)	21 of 44 (47.7%)	0 of 44
Placebo	1 of 43 (2.3%)	15 of 43 (34.9%)	1 of 43
Liraglutide 1.8 mg	0 of 42 (0%)	13 of 42 (31%)	0 of 42

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MK-8521, Liraglutide and Metformin in people with Type II Diabetes Mellitus, run by Merck Sharp & Dohme LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 10 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Hemoglobin A1C (A1C) at Week 12 (time frame: Baseline and Week 12). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02492763.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2018.