A Study in China Evaluating the Safety and Efficacy of Adding Sitagliptin to Stable Therapy With Insulin With or Without Metformin in Participants With Type 2 Diabetes Mellitus (T2DM) (MK-0431-254)

What Was Tested

This registered phase 3 trial tested Insulin (regular human).

It had two arms (groups): Sitagliptin (experimental) and Placebo (placebo comparator).

The registry classes the interventions as biological and drug.

Who Took Part

467 actual participants took part.

It was open to people of any sex aged from 18 years up to 79 years.

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

The full record lists 4 inclusion and 17 exclusion criteria; among the exclusions: has been treated with any antihyperglycemic therapies other than a protocol-required insulin (alone or with metformin) within the prior 12 weeks or has ever; is currently on treatment with daily use (one or more injections per day) of; has a history of 2 or more episodes of hypoglycemia resulting in seizure,.

How the Study Was Run

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

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

The Insulin (regular human) group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Insulin (regular human), so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2012-07-10 with completion listed for 2014-06-11.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change From Baseline in Hemoglobin A1C (HbA1C) Levels at Week 24 in Participants Receiving Insulin Alone or in Combination With Metformin (time frame: Baseline and Week 24). Number of Participants With One or More Adverse Events (time frame: Up to Week 26). Number of Participants Discontinuing Study Medication Due to an AE (time frame: Up to Week 24).

It also tracked 2 secondary outcomes, for example Change From Baseline in HbA1C Levels at Week 24 in Participants Receiving Insulin in Combination With Metformin and Change From Baseline in 2-Hour Post Meal Glucose Levels at Week 24 in Participants Receiving Insulin Alone or in Combination With Metformin.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin (regular human) in 467 people.

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

More context: the Insulin (regular human) compound page, all human trials.