← Human Trials & Peer-Reviewed Studies
Study of Efficacy and Safety of Vildagliptin as add-on Insulin Therapy in T2DM Patients
Plain-language guide to NCT02002221: phase 4 randomized trial of Insulin (regular human), 156 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02002221
- Phase
- phase 4
- Status
- completed
- Start
- 2013-12
- Completion (planned or actual)
- 2015-02
- Participants
- 156 (actual)
- Design
- randomized, triple-blind, treatment
- Conditions studied
- Type 2 Diabetes Mellitus (T2DM)
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
The trial (phase 4) is built around Insulin (regular human).
It had two arms (groups): Vildagliptin (LAF237) (experimental) and Placebo (placebo comparator).
The registry classes the interventions as drug.
Who Took Part
156 actual participants took part.
It was open to people of any sex aged from 20 years up to 74 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Confirmed diagnosis of T2DM by standard criteria. Age: ≥ 20 to \< 75 years old at Visit 1. BMI ≥ 20 to ≤ 35 kg/m2 at Visit 1.
The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: type 1 diabetes, monogenic diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes; hepatic disorder.
How the Study Was Run
The set-up was randomized, parallel-group and triple-blind.
The participants were allocated by chance, so the Insulin (regular human) group and the comparison group should start out alike.
Groups ran in parallel: each of the participants stayed in one arm throughout.
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 2013-12 with completion listed for 2015-02.
It ran at 31 sites in Japan (31).
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 12 Weeks Between Treatment Groups (time frame: Baseline, week 12).
It also tracked 4 secondary outcomes, for example Percentage of Patients Meeting Responder Rates in HbA1c, Change From Baseline in Fasting Plasma Glucose (FPG) at 12 Weeks and Number of Participants With Incidence of Hypoglycemia and Severe Hypoglycemia.
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Insulin (regular human) in 156 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.
Our Notes on the Compound
Insulin (regular human): The 51-amino-acid pancreatic hormone that lowers blood glucose; this page covers regular (short-acting) insulin studied in human trials.
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.