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Pharmacist Intervention for Glycemic Control in The Community
Plain-language guide to NCT01335763: not phased interventional trial of Insulin Glargine, 100 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01335763
- Phase
- not phased
- Status
- completed
- Start
- 2011-04
- Completion (planned or actual)
- 2012-10
- Participants
- 100 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Type 2 Diabetes
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (not phased) is built around Insulin Glargine.
It had 1 arm (groups): Insulin glargine (other).
The registry classes the interventions as drug.
More on the Plan
As type 2 diabetes is a progressive disease, most patients with type 2 diabetes will eventually require insulin.
However, physicians are often reluctant to initiate insulin in these patients.
This approach has been used successfully by their group in the past with dyslipidemia and hypertension management involving patients with diabetes.
Who Took Part
The registry lists 100 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: Male or Female over 18 years of age. Type 2 diabetes for at least 6 months. Taking 1 or more oral hypoglycemic agents. Signed informed consent.
The full record lists 6 inclusion and 8 exclusion criteria; among the exclusions: have used, or currently using, insulin; history of ketoacidosis; works night shift.
How the Study Was Run
It was run as a single-group and open-label study.
Everyone knew when Insulin Glargine 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 2011-04 with completion listed for 2012-10.
It ran at 1 site in Canada.
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: The change in HbA1c from baseline to week 26 (time frame: 6 months).
It also tracked 6 secondary outcomes, for example Quality of life and patient satisfaction, Proportion of patients achieving the target HbA1c, Persistence on insulin glargine, Safety and Health economic evaluation.
What This Means in Plain Language
Put simply, this is a not phased trial of Insulin Glargine in 100 people.
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.