Effect of Chronic Exposure to Nextida GC-B on Glycemic Control in Adults With Normoglycemia or Prediabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRousselot BVBA
About this trial
The goal of this clinical trial is to investigate the safety and efficacy of Nextida GC-B on glycemic control in adults with normoglycemia and prediabetes. The main question it aims to answer is:
What is the difference in change in postprandial glycemic control from baseline at Day 90 between Nextida GC-B and placebo as assessed by glucose incremental AUC (iAUC 0-180 min).
Eligibility criteria
Qualifiers
Males and females 18 years and older
BMI of 25 to 34.9 kg/m2, inclusive
Females not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening
Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
Disqualifiers
Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
Allergy, sensitivity, intolerance, or dietary restriction preventing consumption of investigational product, placebo or standardized meal ingredients
Metal implants or other physical characteristics/limitations that may affect DEXA scan results as assessed by the QI
Poor venous access as assessed by the QI
Trial design
Treatments tested in this trial
- Nextida GC-B
- Placebo
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Rousselot BVBA
Lead sponsor
KGK Science Inc.
Collaborator
Source ClinicalTrials.gov