Nutritional, Metabolic, Endocrine
Conditions
Interventions
Placebo
PhAM T1D
Sponsors
Imo State University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adults aged 18-45 years. Clinical diagnosis of Type 1 Diabetes (per ADA criteria). Duration of T1D = 24 months OR established T1D with residual fasting C-peptide = 0.2 nmol/L. HbA1c between 6.5% and 10.0% at screening. On a stable basal–bolus insulin regimen (including insulin glargine) for = 8 weeks prior to randomization. Willing and able to use continuous glucose monitoring (CGM) devices provided by the study. Able to attend clinic visits and comply with supervised dosing/compliance checks. Provided written informed consent.
Exclusion criteria
Exclusion criteria: Episode of diabetic ketoacidosis (DKA) or hospitalization for severe hypoglycemia within the past 8 weeks. Recurrent severe hypoglycemia (= 2 episodes requiring third-party assistance in the past 6 months) or hypoglycemia unawareness (Clarke or Gold score = 4). eGFR 3 × ULN). Active infection with HBV, HCV, HIV, or tuberculosis. Autoimmune comorbidity requiring systemic immunosuppressive therapy. Pregnancy, lactation, or planning pregnancy during the study period. Use of herbal antidiabetic agents within 2 months prior to randomization. Participation in another clinical trial or use of any investigational drug within 3 months prior to randomization. Known allergy, hypersensitivity, or intolerance to PhAM constituents or capsule excipients. Chronic gastrointestinal disorders (e.g., inflammatory bowel disease, chronic diarrhea) that could increase risk of severe GI adverse events. Any other condition judged by the investigator to compromise participant safety, study compliance, or interpretation of study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Name: Change in daily insulin glargine dose (U/kg body weight) Definition: Difference between baseline and Week 24 in the mean total daily dose of insulin glargine, adjusted for body weight, required to maintain target fasting glucose 4–7 mmol/L. Timepoint(s): Baseline, Week 12, Week 24 Type of Measure: Continuous (U/kg/day), obtained from patient insulin diaries and verified at study visits. | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion achieving =20% reduction in daily insulin glargine dose without HbA1c worsening (=0.3% absolute increase) at Week 24. Change in total daily insulin (basal+bolus, U/kg/day) from baseline ? Week 24 (also summarized at Week 12). Change in HbA1c (%) from baseline ? Week 12 and Week 24. Change in fasting plasma glucose (mmol/L) from baseline ? Week 12 and Week 24. Continuous glucose monitoring (CGM) Time-in-Range (70–180 mg/dL, %) over 14-day windows at baseline, Week 12, Week 24. CGM Time-Below-Range (180 mg/dL, %) and >250 mg/dL (%) over 14-day windows at Week 12 and Week 24. Hypoglycemia event rates: Level 1 (<70 mg/dL) and Level 2 (<54 mg/dL), events per participant-month from baseline ? Week 24. MMTT-stimulated C-peptide AUC (2-h) change from baseline ? Week 24 (samples at -10, 0, 15, 30, 60, 90, 120 min). Fasting C-peptide (nmol/L) change from baseline ? Week 12 and Week 24. IDAA1c (HbA1c [%] + 4 × total daily insulin [U/kg/day]) change from baseline ? Week 24. Islet autoantibodies (GAD65, IA-2, ZnT8) titer change from baseline ? Week 24. BMI (kg/m²) change from baseline ? Week 24; and patient-reported outcomes (GI symptom score; Diabetes Distress Scale) change from baseline ? Week 24. Safety/tolerability endpoints: incidence of AEs/SAEs, GI intolerance (diarrhea, nausea, appetite loss), DKA events, study drug discontinuation due to AEs, and adherence (% doses taken), all baseline ? Week 24. | — |
Countries
Nigeria
Contacts
Public ContactEmmanuel Agomuo
Professor
Outcome results
None listed