Clinical trial NCT02955888 (phase 2, status: terminated)
Conditions: cystic fibrosis
ICD codes: E84.9, Z14.1, E84.0, E84.11, E84.8, E84.19, P09.4
Drugs: pbi4050, placebo
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Reason stopped: 
    unsatisfactory rate of recruitment
  
Eligibility criteria:

        Inclusion Criteria:

          1. Patient is 18 years of age or older at screening.

          2. Patient has a documented and confirmed CF diagnosis.

          3. Patient has performed an OGTT for diagnosis of INDENT, IGT and de novo CFRD within 12
             months prior to screening visit.

          4. Patient has a Body Mass Index (BMI) of at least 17 kg/m2.

          5. Patient has signed written informed consent.

          6. Patient is able and willing to self-monitor blood glucose level at home.

          7. Female patients of childbearing potential must have a negative pregnancy test (serum
             or urine) and agree to use adequate birth control from screening throughout the study
             and for the 30 days after the last study drug administration.

          8. If a male patient has not been vasectomized at least 6 months before screening and
             partners with a woman of childbearing potential, he must be willing to use an
             acceptable contraceptive method throughout the study and for the 30 days after the
             last study drug administration.

        Exclusion Criteria:

          1. Patient has recent or ongoing infection requiring intravenous treatment with an
             anti-infective agent within 30 days before screening.

          2. Patient is concurrently taking high dose of ibuprofen (>30 mg/kg) or is using
             corticosteroids (except inhaled and topical corticosteroids).

          3. Patient is currently using weight-loss medications.

          4. 4. Patient has used any moderate/potent inhibitor of cytochrome P450 (CYP) 2C9 isozyme
             or strong inhibitor of CYP3A isozyme within 30 days prior to the first study drug
             administration.

          5. Patient has significantly elevated liver enzyme levels, defined as alanine
             aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2.5 Upper Limit of Normal
             (ULN) or total bilirubin above ULN at screening.

          6. Patient has a history of chronic alcohol or other substance abuse as determined at
             screening that may prevent study compliance based on Investigator judgment.

          7. History of malignancy of any organ system, treated or untreated, within the past 5
             years other than basal or squamous cell skin cancer.

          8. Patient has unstable chronic heart failure that has required change in therapy within
             2 months prior to screening.

          9. Patient with known non-controlled history of infection with Human Immunodeficiency
             Virus (HIV) and/or active Hepatitis.

         10. Woman who is pregnant, breast-feeding or planning a pregnancy during the course of the
             study.

         11. Woman of childbearing potential who is unwilling to use adequate birth control
             throughout the duration of the study.

         12. Patient has any condition that, in the Investigator's opinion, is likely to interfere
             with study conduct and compliance.

         13. Patient has participated in an investigational clinical trial within 30 days (or 5
             half-lives, whichever is longer) prior to screening visit.

         14. Patient is under insulin and/or repaglinide treatment at screening/baseline