A Study of Once-Daily NNC0090-2746 in Participants With Type 2 Diabetes Inadequately Controlled With Metformin

What Was Tested

This registered phase 2 trial tested Liraglutide.

This trial is conducted in the United States of America (USA).

It had three arms (groups): Treatment Period: Placebo QD (placebo comparator), Treatment Period: NNC0090-2746 QD (experimental) and Treatment Period: Liraglutide QD (active comparator).

Participants will receive daily SC placebo injections during the 12-week, double-blind treatment period.

Participants will receive daily 1.8-mg SC injections of NNC0090-2746 during the 12-week, double-blind treatment period.

The registry classes the interventions as drug.

Who Took Part

The registry lists 108 actual participants took part.

It was open to people of any sex.

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

The full record lists 11 inclusion and 19 exclusion criteria; among the exclusions: females who are pregnant or lactating; history of type 1 diabetes (t1d), diabetes resulting from pancreatic injury, or secondary forms of diabetes such as cushing's syndrome or acromegaly; history of acute metabolic complications such as diabetic ketoacidosis or state of hyperosmolar hyperglycemia.

How the Study Was Run

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

Because people in this Liraglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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 2014-08-18 with completion listed for 2015-09-15.

It ran at 20 sites in United States (20).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in HbA1c (time frame: Day 1; Week 8).

It also tracked 9 secondary outcomes, for example Change in body weight, Percent change in body weight, Change in fasting plasma glucose (FPG), Change in post-prandial plasma glucose level, Change in post-prandial insulin level and Change in post-prandial C-peptide level.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Liraglutide in 108 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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