A Pooled Analysis of the Safety and Efficacy of MK-0431A and MK-0431A XR in Pediatric Participants With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Therapy (Alone or in Combination With Insulin) (MK-0431A-170/MK-0431A-289)

What Was Tested

In this phase 3 trial, researchers set out to test Insulin (regular human).

The purpose of this study is to assess the effect of the addition of sitagliptin (administered as MK-0431A or MK-0431A XR) relative to the addition of placebo on glycated hemoglobin (A1C), and the safety and tolerability of the addition of sitagliptin, in pediatric participants (ages 10-17 years) with type 2 diabetes mellitus with inadequate glycemic control on metformin therapy (alone or in combination with insulin).

It had four arms (groups): Sitagliptin/Metformin (experimental), Metformin (placebo comparator), Sitagliptin/Metformin XR (experimental) and Metformin XR (placebo comparator).

Participants received one tablet of sitagliptin/metformin and one tablet of metformin-placebo, administered twice daily prior to the morning and evening meals, for up to 20 weeks in the base study alone, or for up to 54 weeks if the participant also entered the extension study. Participants in this arm were enrolled in protocol MK-0431A-170.

Participants received one tablet of metformin and one tablet of placebo to sitagliptin/metformin, administered twice daily prior to the morning and evening meals, for up to 20 weeks in the base study alone, or for up to 54 weeks if the participant also entered the extension study. Participants in this arm were enrolled in protocol MK-0431A-170.

Participants received two tablets of sitagliptin/metformin XR and two tablets of metformin XR placebo, administered once daily with a meal, for up to 54 weeks. Participants in this arm were enrolled in protocol MK-0431A-289.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 223 actual participants took part.

It was open to people of any sex aged from 10 years up to 17 years.

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

Examples of who could join: For MK-0431A-170 base study and MK-0431A-289:. Has type 2 diabetes mellitus (T2DM). For MK-0431A-170 extension protocol:. Has completed the P170 base study.

The full record lists 9 inclusion and 24 exclusion criteria; among the exclusions: for mk-0431a-170 base study and mk-0431a-289:; has type 1 diabetes mellitus; has monogenic diabetes or secondary diabetes.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-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.

As a double-blind Insulin (regular human) study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2011-12-07 with completion listed for 2019-09-17.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change From Baseline in A1C at Week 20 (time frame: Baseline and Week 20). Number of Participants Who Experienced ≥1 Adverse Event During Weeks 0-20 (time frame: Up to Week 20). Number of Participants Who Discontinued Study Drug Due to Experiencing an Adverse Event During Weeks 0-20 (time frame: Up to Week 20).

It also tracked 9 secondary outcomes, for example Change From Baseline in A1C at Week 54, Change From Baseline in Fasting Plasma Glucose (FPG) at Week 20, Change From Baseline in FPG at Week 54, Percentage of Participants Initiating Glycemic Rescue Therapy by Week 20 and Percentage of Participants Initiating Insulin Glargine During Weeks 20-54.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin (regular human) in 223 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.