Subjects with a pathological Oral Glucose Tolerance Test (OGTT) MedDRA version: 24.0 Level: LLT Classification code 10065542 Term: Prediabetes System Organ Class: 100000004861
Conditions
Interventions
Product Name: APHD-012
Product Code: APHD-012
Pharmaceutical Form: Coated granules in sachet
INN or Proposed INN: Dextrose Monohydrate
CAS Number: 77938-63-7
Other descriptive name: DEXTROSE MONOHYDRA
Sponsors
Aphaia Pharma US LLC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female subjects 18 – 70 years of age 2. Fully vaccinated against SARS-CoV-2. Full Vaccination means having received all recommended doses of a COVID-19 vaccine listed by either of WHO-Emergency Use Listing (WHO-EUL), FDA or EMA or a mix and match series composed of any heterologous combination of WHO-EUL/FDA/EMA-approved or authorized COVID-19 vaccines. Alternatively, a proven recovery from a COVID-19 infection in combination with at least one vaccination with a WHO, FDA, EMA listed vaccine qualifies as a full vaccination. The vaccination program must have been completed at least two weeks prior Informed Consent Form (ICF) signed. For the avoidance of doubt, the vaccination scheme received shall bein compliance with the current rules defined by the relevant health authorities in the US or Europe. 3. Body mass index 25-35 kg/m2 4. Subjects with an impaired glucose tolerance defined as: HbA1c values =5.7% and = 6.4% and/or Impaired glucose tolerance (glucose between 140 and 199 mg/dL at the 2 hours of the Oral Glucose Tolerance Test (OGTT)) with or without impaired fasting glucose (fasting glucose between 100 and 125 mg/dL) 5. Stable body weight: gain or loss in body weight = 5% body weight over last 3 months 6. History of at least one unsuccessful effort of lifestyle modification (e.g. behavioural intervention, dieting, physical activity) to loose >5% of body weight, completed at least 3 months prior to screening. Subject may have been treated with either diet or exercise alone. 7. Female subjects are not pregnant or lactating, are surgically sterilized, postmenopausal (no menses for the previous 12 months). Female subjects of childbearing potential agree to undergo pregnancy tests and to use an appropriate method of contraception (i.e. surgical sterilization, intrauterine contraceptive device, oral contraceptive, diaphragm, or condom in combination with contraceptive cream, jelly, or foam or abstinence). 8. Male subjects agree to apply proper birth control and to not donate sperm. 9. Male and female subjects agree to continue to use birth control for at least 28 days after the last dose. 10. Willingness to undergo screening and all study procedures and examinations (i.e., physical examinations and laboratory investigations before and after the treatment periods) and to wear a continuous glucose monitoring device. 11. Ability to comprehend subject information and willingness to sign the informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: 1. Evidence of type 2 diabetes defined by fasting plasma glucose = 126 mg/dL; 2-hour OGTT glucose = 200 mg/dL 2. Type I diabetes mellitus 3. HbA1c = 6.5% 4. History of proliferative retinopathy or maculopathy 5. Active COVID-19 infection proven by antigen positive Covid Test 6. Treatment with any medication for weight loss within the past 3 months before screening. Examples include: Orlistat (Xenical®, Alli®), Bupropion-naltrexone (Contrave®), Liraglutide (Saxenda®), semaglutide (Wegovy®), Phentermine-topiramate (Qsymia®). 7. Prior or planned weight loss surgery for obesity 8. Recent (within past 12 months) or planned endoscopic treatment for obesity. Examples include: Intragastric balloon (e.g. OrberaTM, ReShapeTM, ObalonTM), Natural Orifice Transluminal Endoscopic Surgery, endoscopic oral-assisted bariatric surgery procedures, including but not limited to: restorative obesity surgery, endoluminal (ROSE), StomaphyXTM, duodenojejunal bypass liner (e.g. EndobarrierTM), transoral gastroplasty (e.g., TOGA), endoscopic closure devices (e.g., Apollo OverStitchTM). 9. Proven history of bulimia or anorexia nervosa 10. Eating habits consisting of eating relevant amounts of food throughout the night (after 10 p.m.; except if working on night shifts) 11. Treatment with injectable anti-diabetic medications in the last 3 months (e.g., GLP-1 receptor agonists, insulin) 12. Treatment with dipeptidyl peptidase-4 inhibitors in the last 3 months 13. Confirmed medical history of liver cirrhosis 14. Positive test on Viral hepatitis (HbsAG, HCV) 15. Positive test on Human immunodeficiency virus (HIV) 16. Cholestatic disease 17. Alcohol-related liver disease including alcoholic fatty liver, alcoholic hepatitis and alcoholic cirrhosis evidenced by confirmed history of alcohol use, abnormal liver function tests defined below, and complete blood count (CBC), and/or liver biopsy. 18. Abnormal liver function tests: Transaminases: Alanine aminotransferase (ALT) = 3x upper limit of normal (ULN); or Aspartate aminotransferase (AST) = 3x ULN; or Alkaline phosphatase (ALP) = 2.5x ULN; or total bilirubin = 2x ULN 19. Stage 4 hypertension (systolic blood pressure (SBP) = 180, diastolic BP (DBP) = 110) 20. History or presence of any uncontrolled cardiovascular, pulmonary, hepatobiliary, renal, hematological, gastrointestinal, endocrinologic, immunologic, dermatologic, neurological, psychiatric, metabolic, musculoskeletal, or malignant disease (except conditions accepted for inclusion) which the clinical investigator considers a disqualification for participation in the study. 21. Prior or current treatment with drugs aimed to treat abnormal glucose homeostasis including oral antidiabetics, incretin analogues and/or insulin. 22. History of uncontrolled illness (e.g. depression, psychosis) or behaviour that at the discretion of the investigator might confound the study results or pose additional risk in administering the study procedures. 23. Illicit drug abuse (marijuana, amphetamines, barbiturates, cocaine, opiates, phencyclidine and benzodiazepines) 24. Alcohol abuse, defined by regular consumption of alcohol within 6 months before screening defined by intake of ? 7 drinks/week for females, ? 14 drinks/week for males where 1 drink equals to 150 mL of wine or 360 mL of beer or 45 mL of hard liquor 25. Participation in another investigational drug/biologic or medical device study within 30 days of screening or will be enrolled in another investigational drug or medical
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assess change from baseline in AUC0-2h values of Oral Glucose Tolerance Test (OGTT) as measured in blood samples. ;Secondary Objective: - Evaluate changes in prespecified biomarkers and clinical outcome measures (e.g. fasting plasma glucose, HOMA IR). - Assess safety and tolerability in population with a pathologic Oral Glucose Tolerance Test (OGGT). ;Primary end point(s): Change from baseline in AUC0-2h values of Oral Glucose Tolerance Test (OGTT) as measured in blood samples ;Timepoint(s) of evaluation of this end point: Day 113 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Fasting plasma glucose concentrations - HOMA-IR Exploratory outcome measures - Systolic blood pressure (SBP) - Diastolic blood pressure (DBP) - Heart rate (HR) - Triglycerides - Cholesterol Total LDL HDL - Fasting plasma insulin - HbA1c - Alanine transaminase (ALT) - Aspartate transaminase (AST) - Gamma Glutamyl Transferase (GGT) - Continuous Glucose Monitoring (CGM) metrics (e.g. Daily average glucose, time in range, time below/above range, daily glucose variability, AUC0-2h of OGTT as measured with CGM) ;Timepoint(s) of evaluation of this end point: Day 113 | — |
Countries
Slovakia
Contacts
Public ContactKai Deusch
Aphaia Pharma US LLC
Outcome results
None listed