← Human Trials & Peer-Reviewed Studies
Diabetes in the Elderly: Prospective Study
Plain-language guide to NCT01131052: phase 4 randomized trial of Insulin (regular human) and Insulin Glargine, 150 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01131052
- Phase
- phase 4
- Status
- completed
- Start
- 2011-03
- Completion (planned or actual)
- 2013-12
- Participants
- 150 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Diabetes; Hyperglycemia
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
The trial (phase 4) is built around Insulin (regular human) and Insulin Glargine.
Nursing home residents with diabetes have higher rates of serious comorbidities and have greater activity of daily living dependencies than other residents without diabetes.
It had two arms (groups): BASAL PLUS (active comparator) and sliding scale regular insulin (SSRI) (active comparator).
Diabetic subjects receive sliding scale regular insulin (SSRI) before meals and at bedtime as needed.
The registry classes the interventions as drug.
Who Took Part
Enrollment: 150 actual participants took part.
It was open to people of any sex aged from 60 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Males or females \> 60 years of age. A known history of T2DM, receiving either diet alone, oral monotherapy, or with any combination of oral antidiabetic agents (metformin, sulfonylureas, repaglinide, nateglinide, pioglitazone, rosiglitazone, sitagliptin). Patients admitted for non-cardiac elective or emergency surgery or trauma.
The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: subjects with a history of diabetic ketoacidosis and hyperosmolar hyperglycemic state (26).
How the Study Was Run
It was run as a randomized, parallel-group and open-label study.
Random assignment meant chance, not the researchers, decided who got Insulin (regular human) and who got the comparison, which limits bias.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Nothing was hidden in this open-label Insulin (regular human) study: the participants and staff both knew the treatment.
It started in 2011-03 with completion listed for 2013-12.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Mean of Weekly Fasting Blood Glucose Concentration (time frame: 3 months).
It also tracked 5 secondary outcomes, for example Mean Blood Glucose Concentration, Mean of Glycosylated Hemoglobin (hbA1c), Mean of Daily Blood Glucose Concentration, Mean of Glycosylated Hemoglobin (hbA1c) and Mean of Glycosylated Hemoglobin (hbA1c).
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Insulin (regular human) and Insulin Glargine in 150 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 and the Insulin Glargine compound page, all human trials.
Our Notes on the Compounds
Insulin (regular human): The 51-amino-acid pancreatic hormone that lowers blood glucose; this page covers regular (short-acting) insulin studied in human trials.
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.