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Efficacy and Safety of Insulin Glargine in Patients With Type 2 Diabetes With Inadequate Control on DPP-4 Inhibitor Therapy
Plain-language guide to NCT02027753: phase 4 interventional trial of Insulin Glargine, 109 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02027753
- Phase
- phase 4
- Status
- completed
- Start
- 2013-12
- Completion (planned or actual)
- 2015-04
- Participants
- 109 (actual)
- Design
- na, 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
The trial (phase 4) is built around Insulin Glargine.
It had 1 arm (groups): Insulin glargine and Oral anti diabetic treatment(s) (experimental).
The registry classes the interventions as drug.
More on the Plan
28 weeks (Screening: About 2 weeks/Treatment: 24 weeks (6 months)/Follow-up: 2 weeks).
Who Took Part
109 actual participants took part.
It was open to people of any sex aged from 20 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Patients with type 2 Diabetes mellitus ≥ 20 aged. Be able and voluntarily agree to participate in this study by signing a written informed consent.
The full record lists 3 inclusion and 23 exclusion criteria; among the exclusions: diabetes patients other than type 2 (eg. type 1 diabetes mellitus, pancreatic disease, secondary diabetes); history of continuous basal insulin treatment within 1 year before screening; history of diabetic acidosis (including keto-acidosis) within 1 year before screening.
How the Study Was Run
It was run as a single-group and open-label study.
Being open-label, the Insulin Glargine study did not mask who received what.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2013-12 with completion listed for 2015-04.
It ran at 1 site in South Korea.
Its stated primary purpose is treatment.
What Was Measured
It also tracked 10 secondary outcomes, for example Change from baseline in HbA1c, Change from baseline in Fasting Plasma glucose (FPG), 2hr-Postprandial Plasma Glucose, Fasting blood glucose (FBG) values, 7-point Self Monitoring of Blood Glucose, Weight change from baseline and Number of Patients with Hypoglycemic Events.
What This Means in Plain Language
Put simply, this is a phase 4 trial of Insulin Glargine in 109 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.