Change From Baseline in Hemoglobin A1C (A1C) at Week 12
| Group | Value (Percent) |
|---|---|
| MK-8521 180 μg | -0.82 |
| MK-8521 300 μg | -1.05 |
| Placebo | -0.44 |
| Liraglutide 1.8 mg | -1.42 |
Trial · Interventional
TerminatedPhase 2Results postedRegistry dataThis trial was stopped early.
The registry gives no reason.
Results were posted for this trial.
1 trial · 1 stopped early · 1 with posted results
A Preliminary Study of the Efficacy and Safety of MK-8521 for Type 2 Diabetes (MK-8521-004)
NCT0249276327 Jul 2015 to 18 Apr 2017
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Experimental
MK-8521 300 μg
Participants receive double-blind MK-8521 300 μg daily (QD), subcutaneously, over 12 weeks.
Experimental
MK-8521 180 μg
Participants receive double-blind MK-8521 180 μg QD, subcutaneously, over 12 weeks.
Placebo comparator
Placebo
Participants receive matching double-blind placebo, QD over 12 weeks.
Active comparator
Liraglutide 1.8 mg
Participants receive open-label 1.8 mg of liraglutide, QD, subcutaneously, over 12 weeks.
Outcomes the sponsor listed as primary.
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.
Change From Baseline in Body Weight at Week 12
Time frame · Baseline and Week 12
This change from baseline reflects the Week 12 body weight minus the Week 0 body weight.
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12
Time frame · 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
Time frame · 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
Time frame · 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
Time frame · Baseline and Week 12
This change from baseline reflects the Week 12 fasting triglycerides minus the Week 0 fasting triglycerides.
Change From Baseline in Systolic Blood Pressure (SBP) at Week 12
Time frame · Baseline and Week 12
This change from baseline reflects the Week 12 SBP minus the Week 0 SBP.
Change From Baseline in Diastolic Blood Pressure (DBP) at Week 12
Time frame · Baseline and Week 12
This change from baseline reflects the Week 12 DBP minus the Week 0 DBP.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (Percent) |
|---|---|
| MK-8521 180 μg | -0.82 |
| MK-8521 300 μg | -1.05 |
| Placebo | -0.44 |
| Liraglutide 1.8 mg | -1.42 |
| Group | Value (Participants) |
|---|---|
| MK-8521 180 μg | 24 |
| MK-8521 300 μg | 29 |
| Placebo | 25 |
| Liraglutide 1.8 mg | 22 |
| Group | Value (Participants) |
|---|---|
| MK-8521 180 μg | 3 |
| MK-8521 300 μg | 1 |
| Placebo | 2 |
| Liraglutide 1.8 mg | 2 |
| Group | Value (Participants) |
|---|---|
| MK-8521 180 μg | 0 |
| MK-8521 300 μg | 2 |
| Placebo | 1 |
| Liraglutide 1.8 mg | 1 |
| Group | Value (Beats/minute) |
|---|---|
| MK-8521 180 μg | 5.47 |
| MK-8521 300 μg | 6.28 |
| Placebo | -1.42 |
| Liraglutide 1.8 mg | 1.63 |
| Group | Value (Kilograms) |
|---|---|
| MK-8521 180 μg | -2.0 |
| MK-8521 300 μg | -3.0 |
| Placebo | -1.3 |
| Liraglutide 1.8 mg | -2.9 |
| Group | Value (mg/dL) |
|---|---|
| MK-8521 180 μg | -13.7 |
| MK-8521 300 μg | -34.6 |
| Placebo | -5.1 |
| Liraglutide 1.8 mg | -42.9 |
| Group | Value (mg/dL) | Spread |
|---|---|---|
| MK-8521 180 μg | -9.3 | 23.5 |
| MK-8521 300 μg | 8.8 | 41.8 |
| Placebo | 4.5 | 33.5 |
| Liraglutide 1.8 mg | 0.3 | 18.0 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| MK-8521 180 μgParticipants receive double-blind MK-8521 180 μg daily (QD), subcutaneously, over 12 weeks. | 0 / 46 | 0 / 46 | 18 / 46 |
| MK-8521 300 μgParticipants receive double-blind MK-8521 300 μg, QD, subcutaneously, over 12 weeks. | 0 / 44 | 1 / 44 | 21 / 44 |
| PlaceboParticipants receive matching double-blind placebo QD over 12 weeks. | 1 / 43 | 1 / 43 | 15 / 43 |
| Liraglutide 1.8 mgParticipants receive open-label liraglutide, 1.8 mg QD, subcutaneously, over 12 weeks. | 0 / 42 | 0 / 42 | 13 / 42 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
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