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Efficacy/Safety Study of Glimepiride to Type 2 Diabetes Patients Based on Metformin And Basal Insulin Treatment
Plain-language guide to NCT02026310: not phased randomized trial of Insulin Glargine, 40 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02026310
- Phase
- not phased
- Status
- completed
- Start
- 2014-01
- Completion (planned or actual)
- 2015-11
- Participants
- 40 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Diabetes Mellitus, Type 2
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this not phased trial, researchers set out to test Insulin Glargine.
It had two arms (groups): glimepiride (experimental) and Metformin and glargine (active comparator).
The registry classes the interventions as drug.
Who Took Part
The registry lists 40 actual participants took part.
It was open to people of any sex aged from 35 years up to 70 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Understand the whole test process, voluntary and signed informed consent form. Men and women aged 35 to 70 years old. Diagnosed with type 2 diabetes. Patients should be able to self blood glucose monitoring.
The full record lists 7 inclusion and 12 exclusion criteria; among the exclusions: sulfonylureas,glinides,tzds use within 3 months before the study; pregnant or lactating women; A history of ketoacidosis.
How the Study Was Run
Design: randomized, parallel-group and open-label.
Because people in this Insulin Glargine 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.
Nothing was hidden in this open-label Insulin Glargine study: the participants and staff both knew the treatment.
It started in 2014-01 with completion listed for 2015-11.
It ran at 1 site in China.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): 24 weeks after treatment, HbA1c values' change compared with baseline (time frame: 24 weeks after treatment).
It also tracked 1 secondary outcome, for example hypoglycemia events.
What This Means in Plain Language
Put simply, this is a not phased, randomized trial of Insulin Glargine in 40 people.
The trial is marked completed; 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.