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Effectiveness and Safety of Treatment of Insulin Glargine in Type 2 Diabetes Mellitus Following Glucagon-like Peptide-1 (GLP-1) Failure
Plain-language guide to NCT01461577: phase 4 interventional trial of Insulin Glargine, 89 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01461577
- Phase
- phase 4
- Status
- completed
- Start
- 2011-11
- Completion (planned or actual)
- 2012-12
- Participants
- 89 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Type 2 Diabetes Mellitus
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 4 trial tested Insulin Glargine.
Secondary Objective: * To determine the change in glycemic control, safety, and treatment satisfaction in insulin glargine use in patients following GLP-1 failure.
It had 1 arm (groups): insulin glargine (experimental).
The registry classes the interventions as drug.
More on the Plan
1-2 weeks screening period, 24 weeks treatment period, 1 week follow-up period.
Who Took Part
The registry lists 89 actual participants took part.
It was open to people of any sex aged from 30 years up to 75 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Patients of aged ≥30 and ≤75 years with type 2 diabetes mellitus (T2DM).
The full record lists 3 inclusion and 27 exclusion criteria; among the exclusions: inpatient with t2dm; diabetes other than t2dm (e.g. secondary to pancreatic disorders, drug or chemical agent intake); body mass index (bmi) \>28 kg/m2.
How the Study Was Run
The set-up was 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 2011-11 with completion listed for 2012-12.
It ran at 1 site in Japan.
Its stated primary purpose is treatment.
What Was Measured
It also tracked 10 secondary outcomes, for example Changes of fasting plasma glucose (FPG) levels from baseline, Changes of beta cell marker: C-peptide from baseline, Changes of Lipid profile: Lipid profile from baseline, Weight change from baseline, Evaluation of patient's treatment satisfaction and Number of patients with hypoglycemia.
What This Means in Plain Language
Put simply, this is a phase 4 trial of Insulin Glargine in 89 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.