Status:
COMPLETED
Effect of Empagliflozin Versus Placebo on Brain Insulin Sensitivity in Patients With Prediabetes
Lead Sponsor:
University Hospital Tuebingen
Conditions:
PreDiabetes
Body Weight
Eligibility:
All Genders
30-75 years
Phase:
PHASE2
Brief Summary
Recently, various sodium glucose cotransporter 2 (SGLT2) inhibitors have been approved for the treatment of type 2 diabetes mellitus. Empagliflozin is a preparation of this class of substances. SGLT2 ...
Eligibility Criteria
Inclusion
- 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.
- 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.
Exclusion
- 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, Percutaneous transluminal coronary angioplasty (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.
- Subjects 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.
- Refusal to get informed of unexpected detected pathological MRI findings
- Any other clinical condition that would jeopardize subjects' safety while participating in this clinical trial.
Key Trial Info
Start Date :
June 9 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 18 2019
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT03227484
Start Date
June 9 2017
End Date
November 18 2019
Last Update
April 29 2020
Active Locations (1)
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1
University of Tuebingen, Department of Internal Medicine IV
Tübingen, Germany, 72076