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A Study to Determine the Safety and Efficacy of Albiglutide in Patients With Type 2 Diabetes
Plain-language guide to NCT00838916: phase 3 randomized trial of Insulin Glargine, 779 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00838916
- Phase
- phase 3
- Status
- completed
- Start
- 2009-02
- Completion (planned or actual)
- 2012-01
- Participants
- 779 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Diabetes Mellitus, Type 2
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
In this phase 3 trial, researchers set out to test Insulin Glargine.
It had two arms (groups): albiglutide weekly injection (experimental) and insulin glargine (active comparator).
Albiglutide weekly subcutaneous injection.
Insulin glargine daily injection.
The registry classes the interventions as biological and drug.
Who Took Part
Enrollment: 779 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: Type 2 diabetes. BMI 20-45kg/m2 inclusive.
The full record lists 2 inclusion and 2 exclusion criteria; among the exclusions: females who are pregnant, lactating or within \<6 weeks post-partum; current symptomatic heart failure (nyha class iii-iv).
How the Study Was Run
It was run as a randomized, parallel-group and open-label study.
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.
Being open-label, the Insulin Glargine study did not mask who received what.
It started in 2009-02 with completion listed for 2012-01.
It ran at 337 sites in United States (314), South Africa (11), Russia (6) and United Kingdom (6).
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 52 (time frame: Baseline and Week 52).
It also tracked 10 secondary outcomes, for example Change From Baseline in HbA1c at Week 156, Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52, Change From Baseline in Fasting Plasma Glucose (FPG) at Week 156, Time to Hyperglycemia Rescue, Change From Baseline in Body Weight at Week 52 and Change From Baseline in Body Weight at Week 156.
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Insulin Glargine in 779 people.
With 779 participants it is a large trial for this field.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
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.