Clinical trial NCT01472809 (phase 1, status: suspended)
Conditions: diabetes
ICD codes: E23.2, N25.1, P70.2, O24.92, Z83.3, Z86.32, E10.65
Drugs: zygk1, placebo
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Reason stopped: 
    not achieved the objective till 4 mg single dose
  
Eligibility criteria:

        Inclusion Criteria:

          1. Age: 18-45 years

          2. Mentally, physically, and legally eligible to give informed consent

          3. Male and female volunteers weighing between 50-75 kg and 45-75 kg (4) respectively.

          4. Ability to communicate effectively with the study personnel

          5. Willingness to adhere to the protocol requirements

          6. For gender effect study, only females with history of sterility or at least one year
             menopause or use of long acting nonhormonal contraceptive measures (e.g., intrauterine
             device) will be recruited.

          7. At least one panel, in single ascending dose and multiple ascending dose will include
             subjects with type 2 diabetes as defined by American Diabetes Association

        Exclusion Criteria:

          1. Presence or history of hypersensitivity to any of the active or inactive ingredients
             of ZYGK1 formulation

          2. Presence or history of pancreatitis at any time (Serum Amylase/Serum Lipase more than
             upper normal limit (UNL))

          3. Presence or history of severe gastrointestinal disease in the last 6 months

          4. Presence or history of renal insufficiency at any time (serum creatinine >UNL)

          5. Active liver disease and/or liver transaminases greater than 1.5 X UNL

          6. History or presence of other systemic disorders or diseases (e.g., respiratory,
             gastrointestinal, endocrine, immunological, dermatological, neurological, psychiatric
             disease or any other body system involvement)

          7. Abnormal bleeding time (BT), clotting time (CT), prothrombin time (PT), and activated
             partial prothrombin time (APTT)

          8. History or presence of any medication in the last 14 days

          9. History or presence of significant alcoholism or drug abuse within the past 1 year

         10. History or presence of significant smoking (more than 10 cigarettes per day) or
             consumption of tobacco products (more than 10 times per day)

         11. Difficulty with donating blood

         12. Systolic blood pressure more than 140 mmHg and less than 100 mmHg and diastolic blood
             pressure more than 90 mmHg and less than 60 mmHg

         13. Pulse rate less than 60 minute and more than 100/minute

         14. Any clinically significant laboratory findings during screening

         15. History or presence of any clinically significant electrocardiogram (ECG)
             abnormalities during screening

         16. Major illness and/or major surgery in last 3 months

         17. Volunteers who have participated in any drug research study other than the present
             trial within past 3 months

         18. Volunteers who have donated one unit (350 ml) of blood in the past 3 months