← Human Trials & Peer-Reviewed Studies
Efficacy and Safety of Vildagliptin Added to Continuous Subcutaneous Insulin Infusion in Uncontrolled Type 2 Diabetes
Plain-language guide to NCT03563794: phase 4 randomized trial of Insulin Lispro, 400 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT03563794
- Phase
- phase 4
- Status
- status unknown
- Start
- 2018-06-10
- Completion (planned or actual)
- 2019-06-10
- Participants
- 400 (estimated)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- T2DM
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 4 trial, researchers set out to test Insulin Lispro.
It had two arms (groups): CSII(insulin Lispro)+Vildagliptin (experimental) and CSII(insulin Lispro) (active comparator).
The registry classes the interventions as drug.
Who Took Part
The registry lists 400 planned participants were the target.
It was open to people of any sex aged from 30 years up to 70 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: 30≤ age≤70 years old. BMI 18.0-28.0 Kg/m2. Patients do not use antihyperglycemia drugs. Patients use antihyperglycemia drugs for ≥8 weeks(exclusion of DPP-4 inhibitors and GLP-1 receptor agonist).
The full record lists 7 inclusion and 9 exclusion criteria; among the exclusions: congestive heart failure (new york heart association functional classification iii-iv); severe infection in the previous 3 months; severely acute or chronic diabetic complications.
How the Study Was Run
It was run as a randomized, parallel-group and open-label study.
The participants were allocated by chance, so the Insulin Lispro group and the comparison group should start out alike.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Nothing was hidden in this open-label Insulin Lispro study: the participants and staff both knew the treatment.
It started in 2018-06-10 with completion listed for 2019-06-10.
It ran at 1 site in China.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): blood glucose (time frame: 7 days).
It also tracked 1 secondary outcome, for example hypoglycemia.
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Insulin Lispro in 400 people.
Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Insulin Lispro compound page, all human trials.
Our Notes on the Compound
Insulin Lispro: A rapid-acting mealtime insulin analog; brands include Humalog, Admelog and Lyumjev.
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.