Study of the Safety and Efficacy of MK-8521 Compared to Placebo and a Diabetes Drug in Participants With Type 2 Diabetes Mellitus (MK-8521-003)

What Was Tested

This registered phase 1 trial tested Liraglutide.

An additional cohort of T2DM participants and a cohort of non-diabetic obese participants has been added.

It had eight arms (groups): one (experimental), one (experimental), one (active comparator), Part 1: Placebo for MK-8521 (placebo comparator) and one (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 87 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Male, or female of non-childbearing potential with Type 2 diabetes mellitus (Parts 1 and 2) or non-diabetic (Part 2). Body mass index (BMI) between: ≥27 and ≤40 kg/m\^2. A1C value \<5.7 at the time of screening (non-diabetic subjects in Part 2 only).

The full record lists 5 inclusion and 20 exclusion criteria; among the exclusions: mentally or legally incapacitated; history of type 1 diabetes mellitus or a history of ketoacidosis; history of cardiovascular disease or cardiac conduction disorder.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

The participants were allocated by chance, so the Liraglutide group and the comparison group should start out alike.

The Liraglutide group and the comparison group ran side by side rather than switching.

As a double-blind Liraglutide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2013-11-07 with completion listed for 2014-10-03.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Number of Participants Experiencing Adverse Events (AEs) in Part 1 (time frame: Up to approximately 42 days). Number of Participants Experiencing Adverse Events (AEs) in Part 2 (time frame: Up to approximately 57 days). Number of Participants Discontinuing Study Drug Due to Adverse Events (AEs) in Part 1 (time frame: Up to approximately 14 days).

It also tracked 17 secondary outcomes, for example Change From Baseline in Fasting Plasma Glucose (FPG) at Day 7 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 1, Change From Baseline in Fasting Plasma Glucose (FPG) at Day 14 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 1, Change From Baseline in 24-hour Weighted Mean Glucose (WMG) at Day 7 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 1, Change From Baseline in 24-hour Weighted Mean Glucose (WMG) at Day 14 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 1, Change From Baseline in Fasting Plasma Glucose (FPG) at Day 14 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 2 and Change From Baseline in Fasting Plasma Glucose (FPG) at Day 19 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 2.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Liraglutide in 87 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Liraglutide compound page, all human trials.