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Effects of Modulators of Gluconeogenesis, Glycogenolysis and Glucokinase Activity

Plain-language guide to NCT05098470: phase 3 randomized trial of Insulin Glargine, 100 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT05098470
Phase
phase 3
Status
active, not recruiting
Start
2022-03-07
Completion (planned or actual)
2025-07-29
Participants
100 (estimated)
Design
randomized, open label (everyone knows who gets what), other
Conditions studied
Type 2 Diabetes
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered phase 3 trial tested Insulin Glargine.

However, it is still unknown if this rise in blood sugar can be controlled using medications.

It had three arms (groups): Metformin (active comparator), Insulin Glargine (active comparator) and Dorzagliatin (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 100 planned participants were the target.

It was open to people of any sex aged from 25 years up to 80 years.

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

The full record lists 2 inclusion and 10 exclusion criteria; among the exclusions: insulin therapy; SGLT2 inhibitors; long acting glp-1 analogues.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Random assignment meant chance, not the researchers, decided who got Insulin Glargine and who got the comparison, which limits bias.

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

Everyone knew when Insulin Glargine was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2022-03-07 with completion listed for 2025-07-29.

It ran at 2 sites in United States (2).

Its stated primary purpose is other.

What Was Measured

Researchers chose this as the main measure: Contribution of gluconeogenesis (GNG) to endogenous glucose production (EGP) (time frame: 8 weeks).

It also tracked 2 secondary outcomes, for example Contribution of glycogenolysis (GLY) to EGP and Glucokinase activity.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine in 100 people.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin Glargine compound page, all human trials.

Our Notes on the Compound

Insulin Glargine: A long-acting insulin analog given once daily; brands include Lantus, Toujeo, Basaglar and Semglee.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.