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Comparison of Exenatide and Metformin Monotherapy in Overweight/Obese Patients With Newly Diagnosed Type 2 Diabetes
Plain-language guide to NCT03297879: phase 4 non-randomized trial of Exenatide, 230 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT03297879
- Phase
- phase 4
- Status
- completed
- Start
- 2013-01-01
- Completion (planned or actual)
- 2016-02-28
- Participants
- 230 (actual)
- Design
- non-randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Type2 Diabetes
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 4) is built around Exenatide.
The present study assessed the therapeutic effect of exenatide and metformin as the initial therapy in overweight/obese patients with newly diagnosed Type 2 diabetes (T2D).
It had two arms (groups): exenatide group (experimental) and metformin group (active comparator).
The drug-naïve, overweight or obese patients with newly diagnosed T2D.
The drug-naïve, overweight or obese patients with newly diagnosed T2D.
The registry classes the interventions as drug.
More on the Plan
The present study was a prospective, nonrandomized, interventional study.The drug-naïve, overweight or obese patients with newly diagnosed T2D were consecutively enrolled.
An oral glucose tolerance test was performed during the screenings.
All of the patients have no diabetes antibodies and were diagnosed with T2D within the previous 3 months, according to the ADA diagnostic criteria.
None of the patients had administered anti-diabetic drugs or diet therapy before participation.
Who Took Part
The registry lists 230 actual participants took part.
It was open to people of any sex aged from 20 years up to 65 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Age 20 - \<65 years,. Body mass index (BMI) ≥ 24 kg/m2,. Diabetes antibodies (-). Diagnosed with T2D within the previous 3 months.
The full record lists 5 inclusion and 13 exclusion criteria; among the exclusions: anti-diabetic drugs or diet therapy before participation; coronary artery disease; liver function impairment.
How the Study Was Run
It was run as a non-randomized, parallel-group and open-label study.
The Exenatide group and the comparison group ran side by side rather than switching.
Being open-label, the Exenatide study did not mask who received what.
It started in 2013-01-01 with completion listed for 2016-02-28.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): The change of HbA1c (time frame: baseline and 12 weeks).
What This Means in Plain Language
Put simply, this is a phase 4, non-randomized trial of Exenatide in 230 people.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Exenatide compound page, all human trials.
Our Notes on the Compound
Exenatide: A 39-amino-acid GLP-1 receptor agonist first identified in Gila monster venom; sold as Byetta and Bydureon for type 2 diabetes.
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.