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Glucose Control With Multiple Daily Insulin Injections In Diabetic Patients Hospitalized In A General Medicine Ward
Plain-language guide to NCT00464854: not phased non-randomized trial of Insulin Glargine and Insulin Aspart, 100 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00464854
- Phase
- not phased
- Status
- terminated early
- Start
- 2005-07
- Completion (planned or actual)
- 2006-09
- Participants
- 100
- Design
- non-randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Diabetes Mellitus
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered not phased trial tested Insulin Glargine and Insulin Aspart.
The registry classes the interventions as drug.
More on the Plan
Admission Blood tests: * Routine: CBC, Creatinine, Urea, Na, K, GOT, GPT, Alp, Albumin, Glu * HbA1C \& Fructosamine.
Additional measurements were performed according to clinical needs such as suspected hypoglycemia or unexplained deterioration of clinical condition.
Who Took Part
The registry lists 100 planned participants were the target.
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: Adult (\<18 years) Male and female T1 \& T2DM patients who can sign an informed consent. Insulin treatment (at least one injection a day) prior to hospitalization for at least half a year.
The full record lists 2 inclusion and 4 exclusion criteria; among the exclusions: diabetic ketoacidosis; hyperosmolar state due to hyperglycemia; fertile women who do not use oral contraception or iud.
How the Study Was Run
Design: non-randomized, single-group and open-label.
Nothing was hidden in this open-label Insulin Glargine study: the participants and staff both knew the treatment.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2005-07 with completion listed for 2006-09.
It ran at 1 site in Israel.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Achievement of a fasting blood glucose of [amount hidden]/dl and a mean daily glucose level of [amount hidden]/dl during hospitalization.
What This Means in Plain Language
Put simply, this is a not phased, non-randomized trial of Insulin Glargine and Insulin Aspart in 100 people.
It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Insulin Glargine compound page and the Insulin Aspart compound page, all human trials.
Our Notes on the Compounds
Insulin Glargine: A long-acting insulin analog given once daily; brands include Lantus, Toujeo, Basaglar and Semglee.
Insulin Aspart: A rapid-acting mealtime insulin analog; brands include NovoLog, NovoRapid and Fiasp.
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.