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Insulin Glargine in Type 2 Diabetes Mellitus
Plain-language guide to NCT00272077: phase 4 randomized trial of Insulin Glargine. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00272077
- Phase
- phase 4
- Status
- completed
- Start
- 2005-04
- Completion (planned or actual)
- 2006-05
- Participants
- n/a
- Design
- randomized, 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
In this phase 4 trial, researchers set out to test Insulin Glargine.
Primary objective: To evaluate in explorative manner the fasting blood glucose (FBG) coefficient of variability (CV)calculated on SMBG values (SMBG : Self-Monitoring of Blood Glucose).
The registry classes the interventions as drug.
Who Took Part
It was open to people of any sex aged from 45 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Diagnosis of type 2 diabetes mellitus for at least 5 years;. Body mass index (BMI) \> 27 and \< 35 kg/m2;.
The full record lists 6 inclusion and 15 exclusion criteria; among the exclusions: patients diagnosed with type 1 insulin dependent diabetes;; patients with latent autoimmune diabetes of adults (lada), defined as fasting c-peptide levels \< 1 ng/ml;; cardiac status nyha iii-iv;.
How the Study Was Run
Design: randomized, crossover and open-label.
Random assignment meant chance, not the researchers, decided who got Insulin Glargine and who got the comparison, which limits bias.
Each person switched between Insulin Glargine and the comparison at some point, usually with a gap in between.
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.
It started in 2005-04 with completion listed for 2006-05.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: SMBG values (time frame: during the last 4 weeks before visit 3 (end of cycle 1) and visit 4).
It also tracked 8 secondary outcomes, for example glycaemic control (HbA1c, fasting blood glucose, insulin and C-peptide),, frequency of hypoglycaemias, body weight, lipid profile (serum total cholesterol, LDL-cholesterol, HDL-cholesterol and triglycerides), urinary albumin-to-creatinine ratio and standard meal test.
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Insulin Glargine in 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.