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

What Was Tested

In this phase 2 trial, researchers set out to test Liraglutide.

It had four arms (groups): one (experimental), one (experimental), Placebo (placebo comparator) and one (active comparator).

Participants receive matching double-blind placebo, QD over 12 weeks.

The registry classes the interventions as drug.

Who Took Part

The registry lists 176 actual participants took part.

It was open to people of any sex aged from 21 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Have T2DM in accordance with American Diabetes Association guidelines. Have a body mass index (BMI) ≥23 kg/m\^2 and ≤40 kg/m\^2.

The full record lists 4 inclusion and 21 exclusion criteria; among the exclusions: 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 a family history of medullary carcinoma of the thyroid or multiple endocrine neoplasm type-2 syndrome.

How the Study Was Run

The set-up was 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.

Neither the participants nor the staff measuring them knew who was on Liraglutide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2015-07-27 with completion listed for 2017-04-18.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change From Baseline in Hemoglobin A1C (A1C) at Week 12 (time frame: Baseline and Week 12). Number of Participants With an Adverse Event (AE) (time frame: Up to Week 14). Number of Participants Who Discontinued Study Treatment Due to an AE (time frame: Up to Week 12).

It also tracked 7 secondary outcomes, for example Change From Baseline in Body Weight at Week 12, Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12, Change From Baseline in Fasting Low Density Lipoprotein (LDL) Cholesterol at Week 12, Change From Baseline in Fasting High Density Lipoprotein (HDL) Cholesterol at Week 12, Change From Baseline in Fasting Triglycerides at Week 12 and Change From Baseline in Systolic Blood Pressure (SBP) at Week 12.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Liraglutide in 176 people.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

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