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This study evaluated the efficacy and safety of Semaglutide injection in patients with type 2 diabetes mellitus. It enrolled patients aged 18-75 who were taking metformin and had an HbA1c above 7%. It was conducted in Phase 3 and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion criteria: * Healthy male or female of Caucasian descent * If female, postmenopausal * Age: 18-65 years old * BMI: 18-25 kg/m2 * Subjects should be able to give informed consent Exclusion Criteria: * Use of any systemic medication (except for paracetamol), including proton pump inhibitors, antibiotics and pro-/prebiotics in the past three months or during the study period. * Use of the EcN probiotic strain (Mutaflor®) in the past 12 months. * (Expected) prolonged comprised immunity (e.g. due to recent cytotoxic chemotherapy or human immunodeficiency viruses (HIV) infection with a CD4-T cell count \< 240/mm3). * History of moderate to severe disease of the digestive tract, such as celiac disease, chronic diarrhoea (≥3 stools/day for \>4 weeks), chronic obstipation (\<2 defecations/week for \>3 months), Irritable Bowel Syndrome (IBS) (according to Rome IV criteria) or Inflammatory Bowel Disease (IBD). * Any gastro-intestinal disorder within the past 6 months * Smoking or illicit drug use (e.g. amphetamine/cocaine/heroin/GHB) in the past three months or use during the study period. * Use of \>21 units of alcohol per week on average in the past three months or use of \>2 units of alcohol during the study period. * Simultaneous participation in other studies