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Efficacy of Insulin Lispro Mix 50/50 Therapy
Plain-language guide to NCT01303042: not phased interventional trial of Insulin Lispro, 80 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01303042
- Phase
- not phased
- Status
- status unknown
- Start
- 2011-02
- Completion (planned or actual)
- 2013-12
- Participants
- 80 (estimated)
- 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
This registered not phased trial tested Insulin Lispro.
Insulin therapy with lispro mix 50/50 t.i.d. is a treatment with a single insulin device.
It had 1 arm (groups): Insulin lispro mix 50/50 (experimental).
The registry classes the interventions as drug.
More on the Plan
Patients will continue existing insulin therapy for three months.
After that, the investigators will change insulin therapy according to the insulin regimen below and continue the therapy for six months.
Patients will terminate from sulfonylurea treatment at the change of insulin therapy.
The investigators will not change other oral hypoglycemic agents during the whole study period.
Who Took Part
80 planned participants were the target.
It was open to people of any sex aged from 20 years up to 75 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
The full record lists 0 inclusion and 8 exclusion criteria; among the exclusions: patients with renal failure with serum creatinine level ≧ 2.0; patients with hepatocirrhosis; patients with proliferative diabetic retinopathy or worse.
How the Study Was Run
It was run as a single-group and open-label study.
Everyone knew when Insulin Lispro was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2011-02 with completion listed for 2013-12.
It ran at 4 sites in Japan (4).
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: pre- and postprandial glucose levels in SMBG (time frame: nine months).
It also tracked 1 secondary outcome, for example Total score of Questionnaire on QOL.
What This Means in Plain Language
Put simply, this is a not phased trial of Insulin Lispro in 80 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.