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Effect of Exenatide on 24h-UAER in Patients With Diabetic Nephropathy
Plain-language guide to NCT02690883: phase 4 randomized trial of Exenatide and Insulin Lispro, 92 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02690883
- Phase
- phase 4
- Status
- completed
- Start
- 2016-04-08
- Completion (planned or actual)
- 2019-12-13
- Participants
- 92 (actual)
- Design
- randomized, open label (everyone knows who gets what), prevention
- Conditions studied
- Diabetic Nephropathies
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 4 trial, researchers set out to test Exenatide and Insulin Lispro.
This is a multi-center, randomized, parallel study to evaluate effect of exenatide on 24h-UAER in patients with diabetic nephropathy.
Screening will be made to select eligible participants before intervention.
It had two arms (groups): Lispro (active comparator) and Exenatide (experimental).
The registry classes the interventions as drug.
Who Took Part
92 actual participants took part.
It was open to people of any sex aged from 18 years up to 80 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Provision of informed consent prior to any study specific procedures. Body mass index (BMI) ≥18 and ≤35 kg/m2. Blood Pressure (BP) ≥ 90/60mmHg and ≤160/100mmHg.
The full record lists 7 inclusion and 2 exclusion criteria; among the exclusions: type 1 diabetes mellitus, diabetes resulting from pancreatic injury or secondary forms of diabetes, eg, acromegaly or cushing's syndrome; acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma within the past 6 months.
How the Study Was Run
The set-up was randomized, parallel-group and open-label.
The participants were allocated by chance, so the Exenatide group and the comparison group should start out alike.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Nothing was hidden in this open-label Exenatide study: the participants and staff both knew the treatment.
It started in 2016-04-08 with completion listed for 2019-12-13.
Its stated primary purpose is prevention.
What Was Measured
The main thing measured (primary outcome): the percentage change of 24h-UAER(urinary albumin excretion rates) from baseline at Week 24 (time frame: from baseline at Week 24).
It also tracked 6 secondary outcomes, for example the percentage change of ACR, Change in 24h-UAER, Change in HbA1c, Change in FPG, Change in Weight and Change in Blood pressure.
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Exenatide and Insulin Lispro in 92 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 and the Insulin Lispro compound page, all human trials.
Our Notes on the Compounds
Exenatide: A 39-amino-acid GLP-1 receptor agonist first identified in Gila monster venom; sold as Byetta and Bydureon for type 2 diabetes.
Insulin Lispro: A rapid-acting mealtime insulin analog; brands include Humalog, Admelog and Lyumjev.
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.