A double-blind randomized study to determine the effect of empagliflozin versus placebo on brain insulin sensitivity in patients with prediabetes

Phase 1

• Conditions: brain insulin sensitivity in patients with prediabetes; MedDRA version: 20.0Level: LLTClassification code 10065542Term: PrediabetesSystem Organ Class: 100000004861; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2016-003477-18-DE
• Lead Sponsor: niversity Hospital Tuebingen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-01-12
• Last Update Posted: 5 July 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Subjects meeting all of the following criteria will be considered for admission to the trial:
•Must be between 30 and 75 years at the time of signing the informed consent.
•Fasting blood glucose between 100 and 125 mg/dl and/or 2-hour post load glucose between 140 and 199 mg/dl during a 75 g oral glucose tolerance test (ADA criteria for prediabetes).
•Body mass index (BMI) between 25 and 40 kg/m².
•Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures.
•Ability to adhere to the study visit schedule and other protocol requirements.
•Females of childbearing potential (FCBP1) must agree
?to utilize two reliable forms of contraception simultaneously or practice complete abstinence from heterosexual contact for at least 28 days before starting study drug, while participating in the study (including dose interruptions), and for at least 28 days after study treatment discontinuation and must agree to pregnancy testing during this timeframe
?to abstain from breastfeeding during study participation and 28 days after study drug discontinuation.
•Males must agree
?to use a latex condom during any sexual contact with FCBP while participating in the study and for 28 days following discontinuation from this study, even if he has undergone a successful vasectomy
?to refrain from donating semen or sperm while participating in this study and for 28 days after discontinuation from this study treatment.
•All subjects must agree to refrain from donating blood while on study drug and for 28 days after discontinuation from this study treatment.
•All subjects must agree not to share medication.
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 20

Exclusion Criteria

Subjects presenting with any of the following criteria will not be included in the trial:
•Women during pregnancy and lactation.
•History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal products. This includes empagliflozin, placebo and human insulin.
•Participation in other clinical trials or observation period of competing trials up to 30 days prior to this study.
•Diabetes mellitus
•Known malformation of the central nervous system
•Persons working nightshift
•Treatment with glucose lowering drugs, drugs with central nervous actions or systemic steroid therapy
•Any relevant (according to investigator’s judgment) cardiovascular disease, e.g. myocardial infarction, acute coronary syndrome, unstable angina pectoris, PTCA, heart failure (NYHA II-IV), stroke or transient ischemic attack (TIA), within 12 months prior to screening.
•Indication of liver disease, as per medical history or defined by serum levels of either Alanine Aminotransferase (ALT [SGPT]), Aspartate Aminotransferase (AST [SGOT]), or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined during screening.
•Alcohol abuse, defined as more than 20 gr/day
•Impaired renal function, defined as estimated Glomerular Filtration Rate (eGFR) = 60 ml/min (MDRD formula) as determined during screening.
•Known structural and functional urogenital abnormalities, that predispose for urogenital infections.
•Patients with a haemoglobin (Hb) = 11.5 g/dl (for males) and Hb = 10.5 g/dl (for females) at screening.
•Bariatric surgery within the past two years and other gastrointestinal surgeries that induce chronic malabsorption within the last 5 years.
•Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years.
•Treatment with anti-obesity drugs 3 months prior to informed consent or any other treatment at the time of screening (i.e. surgery, aggressive diet regimen, etc.) leading to unstable body weight.
•Known autoimmune disease (except autoimmune disease of the thyroid gland) or chronic inflammatory condition.
•Claustrophobia
•Any other clinically significant major organ system disease at screening such as relevant gastrointestinal, neurologic, psychiatric, endocrine (i.e. pancreatic), hematologic, malignant, infection or other major systemic diseases making implementation of the protocol or interpretation of the study results difficult.
•Presence of any contraindication for the conduct of an MRI investigation, such as cardiac pacemakers, ferromagnetic haemostatic clips in the central nervous system, metallic splinters in the eye, ferromagnetic or electronically operated active devices like automatic cardioverter defibrillators, cochlear implants, insulin pumps and nerve stimulators, prosthetic heart valves etc.
Any other clinical condition that would jeopardize patients’ safety while participating in this clinical trial.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified