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Insulin Glargine (Lantus) vs Sulfonylurea (SU) for BETA Cell Function (BETA Study)
Plain-language guide to NCT00562172: phase 4 randomized trial of Insulin Glargine, 75 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00562172
- Phase
- phase 4
- Status
- completed
- Start
- 2007-09
- Completion (planned or actual)
- 2010-10
- Participants
- 75 (actual)
- Design
- randomized, 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.
Primary objective: To compare long-term glycemic control and preservation of beta cell function when basal insulin or sulfonylurea is added on metformin in the early Type 2 Diabetes Mellitus patients Secondary objective: To assess the change of insulin resistance, microvascular complication incidence, patient satisfaction with treatment.
It had two arms (groups): 1 (experimental) and 2 (active comparator).
The registry classes the interventions as drug.
Who Took Part
75 actual participants took part.
It was open to people of any sex aged from 18 years up to 70 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
The full record lists 0 inclusion and 12 exclusion criteria; among the exclusions: type 2 diabetes mellitus patients on metformin monotherapy; 20 kg/m² ≤bmi ≤ 35 kg/m²; diabetes duration: at least 6 months.
How the Study Was Run
The set-up was randomized, parallel-group and open-label.
Because people in this Insulin Glargine study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.
The Insulin Glargine group and the comparison group ran side by side rather than switching.
Nothing was hidden in this open-label Insulin Glargine study: the participants and staff both knew the treatment.
It started in 2007-09 with completion listed for 2010-10.
It ran at 1 site in South Korea.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: ß-cell Function parameter (time frame: From the signature of the Informed Consent Form (ICF) up to the end of study). Glucose Homeostasis and glycemic control status (time frame: From the signature of the Informed Consent Form (ICF) up to the end of study).
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Insulin Glargine in 75 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.