Clinical trial • Phase II • Endocrinology
Nicotinic acid for Prediabetes
Phase II trial of Nicotinic acid for Prediabetes. Randomised, placebo cir-na (no dose or schedule specified in source)-controlled. 390 participants.
Overview
- Trial Therapeutic Area
- Endocrinology
- Trial Disease
- Prediabetes
- Trial Stage
- Phase II
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 12-06-2025
- First CTIS Authorization Date
- 19-08-2025
Trial design
Randomised, placebo cir-na (no dose or schedule specified in source)-controlled Phase II trial across 2 sites in Germany.
- Randomised
- Yes
- Comparator
- Placebo CIR-NA (no dose or schedule specified in source)
- Target Sample Size
- 390
- Trial Duration For Participant
- 182
Eligibility
Recruits 390 No vulnerable population selected (isVulnerablePopulationSelected = false). Informed consent documents for adults are provided (L1_SIS_and_ICF_adult; L1_SIS_and_ICF_adult_subgroup)..
- Pregnancy Exclusion
- Pregnant or breastfeeding women
- Vulnerable Population
- No vulnerable population selected (isVulnerablePopulationSelected = false). Informed consent documents for adults are provided (L1_SIS_and_ICF_adult; L1_SIS_and_ICF_adult_subgroup).
Inclusion criteria
- {"criterion_text":"- Male and female participants ≥ 18 to < 80 years of age"}
- {"criterion_text":"- Body mass index ≥ 20 kg/m²"}
- {"criterion_text":"- Diagnosed prediabetes according to the current EASD/DDG guidelines"}
Exclusion criteria
- {"criterion_text":"- Presence or a history of type 2 diabetes mellitus according to the current EASD/DDG guidelines"}
- {"criterion_text":"- Renal impairment (glomerular filtration rate <60 ml/min/1.73)"}
- {"criterion_text":"- Impairment of hepatic function (one or more of liver enzymes alanine transaminase, aspartate transaminase and gamma glutamyl transferase [> 3-fold compared to normal range])"}
- {"criterion_text":"- Current infection with hepatitis B or C"}
- {"criterion_text":"- Current or history of malignancy except for completely resected basal cell carcinoma and squamous cell carcinoma of the skin"}
- {"criterion_text":"- Use of antibiotics (systemic or gut-acting [non-absorbed]) within 8 weeks prior to the first dose of IMP"}
- {"criterion_text":"- Pregnant or breastfeeding women"}
- {"criterion_text":"- Long term use of higher doses of proton pump inhibitors, targeted H2-receptor antagonists or antacid formulations (i.e., doses equivalent to > 40 mg pantoprazole per day)"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Remission of prediabetes at week 26","definition_or_measurement_approach":""}
Secondary endpoints
- {"endpoint_text":"- Progression of prediabetes to type 2 diabetes mellitus at week 26","definition_or_measurement_approach":"As stated in trial objectives: assessment of progression to T2DM at week 26 (no further measurement definition provided in source)"}
- {"endpoint_text":"- Fasting plasma glucose levels at week 26","definition_or_measurement_approach":"Fasting plasma glucose (FPG) measured at week 26"}
- {"endpoint_text":"- Glycated haemoglobin (HbA1c) levels at week 26","definition_or_measurement_approach":"HbA1c measured at week 26"}
- {"endpoint_text":"- 2-h oral Glucose Tolerance Test levels at week 26","definition_or_measurement_approach":"2-hour oral glucose tolerance test (oGTT) measured at week 26"}
Recruitment
- Planned Sample Size
- 390
- Recruitment Window Months
- 30
- Consent Approach
- Informed consent obtained from adult participants using provided adult subject information and informed consent forms (documents: L1_SIS_and_ICF_adult; L1_SIS_and_ICF_adult_subgroup). No assent process described; participants are aged ≥18.
Methods
- Site-based recruitment at participating clinical sites (Universitaet Leipzig; Universitaetsklinikum Schleswig-Holstein AöR)
- Use of recruitment materials described in documents: A5 flyers and fold flyers (documents: K2_Recruitment_material_description_... A5_Flyer; Faltflyer) and recruitment arrangements document (K1_Recruitment arrangements)
Geography
- Total Number Of Sites
- 2
- Total Number Of Participants
- 390
Germany
- Earliest CTIS Part Ii Submission Date
- 01-08-2025
- Latest Decision Or Authorization Date
- 24-10-2025
- Processing Time Days
- 84
- Number Of Sites
- 2
- Number Of Participants
- 390
Sites
- Site Name
- Universitaet Leipzig
- Department Name
- Department of Endocrinology, Nephrology and Rheumatology
- Principal Investigator Name
- Matthias Blueher
- Principal Investigator Email
- Matthias.blueher@medizin.uni-leipzig.de
- Contact Person Name
- Matthias Blueher
- Contact Person Email
- Matthias.blueher@medizin.uni-leipzig.de
- Site Name
- Universitaetsklinikum Schleswig-Holstein AöR
- Department Name
- Department of Internal Medicine I
- Principal Investigator Name
- Matthias Laudes
- Principal Investigator Email
- matthias.laudes@uksh.de
- Contact Person Name
- Matthias Laudes
- Contact Person Email
- matthias.laudes@uksh.de
Sponsor
Primary sponsor
- Full Name
- Universitaetsklinikum Schleswig-Holstein AöR
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Germany
Investigational products
- Investigational Product Name
- CIR-NA (controlled-ileal-release nicotinic acid)
- Active Substance
- Nicotinic acid
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Maximum Dose
- 200 mg per day
- Investigational Product Name
- Placebo CIR-NA
- Modality
- Other
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