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Impact of Combined of Lantus(Insulin Glargine) and Lyxumia (Lixisenatide) on Insulin Secretion and Gastric Emptying
Plain-language guide to NCT01910194: phase 2 randomized trial of Insulin Glargine, 39 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01910194
- Phase
- phase 2
- Status
- completed
- Start
- 2013-12
- Completion (planned or actual)
- 2014-10
- Participants
- 39 (actual)
- Design
- randomized, open label (everyone knows who gets what)
- Conditions studied
- Diabetes Mellitus
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 2) is built around Insulin Glargine.
Impact of combined Lantus (insulin glargine) and Lyxumia(lixisenatide) on insulin secretion and gastric emptying.
It had two arms (groups): Lyxumia (other) and Lantus (other).
4 weeks Luxumia plus another 4 weeks combination.
4 weeks Lantus plus another 4 weeks combination.
The registry classes the interventions as drug.
Who Took Part
39 actual participants took part.
It was open to people of any sex aged from 18 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 diagnosed at least one year before the screening visit not previously treated with glitazones, insulin or GLP-1 agonists. Inadequately controlled diabetes mellitus.
The full record lists 2 inclusion and 1 exclusion criteria; among the exclusions: subjects with type 1 diabetes, maturity onset diabetes of the young (mody) or secondary forms of diabetes such as due to pancreatitis.
How the Study Was Run
The set-up was randomized, parallel-group and open-label.
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.
Nothing was hidden in this open-label Insulin Glargine study: the participants and staff both knew the treatment.
It started in 2013-12 with completion listed for 2014-10.
It ran at 2 sites in Germany (2).
What Was Measured
Primary outcome: AUCISEC(0-10min) (time frame: Within 0 to 10 min after iv glucose challenge).
What This Means in Plain Language
Put simply, this is a phase 2, randomized trial of Insulin Glargine in 39 people.
Its size is small, so on its own it can only give an early look.
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.