Clinical trial NCT02477865 (phase 3, status: unknown status)
Conditions: type 2 diabetes mellitus
ICD codes: E11.65, E11.9, E11.21, E11.36, E11.41, E11.42, E11.44
Drugs: pex168(100µg), pex168(200µg), placebo
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria (all of the 8 must be met)：

          1. Type 2 diabetes mellitus confirmed by the 1999 WHO criteria；

          2. Men or women；

          3. Age at signing the ICF≥18 years and ≤78 years；

          4. Body mass index (BMI) 20-40 Kg/m2；

          5. At least 8 weeks of treatment with diet control and exercise received prior to
             screening；

          6. No glucose-lowering agents received within the 8 weeks prior to screening；

          7. 7.5%≤HbA1c≤11.0% at screening（local or centralized test）； 7.0%≤HbA1c≤10.5% at
             randomization（centralized test），and FBG< 13.9 mmol/L（local test）；

          8. Ability to understand the procedures and approach of this study, willingness to
             complete the study in strict compliance with the protocol and to voluntarily sign the
             ICF.

        Exclusion criteria：

          1. Investigator suspecting the subject of allergy to the study drug；

          2. Use of any of the following medications or therapies prior to screening：

               1. GLP-1 receptor agonists, GLP-1 analogues, DPP-4 inhibitors or any other incretin
                  analogues.

               2. Growth hormone therapy within the 6 months prior to screening；

               3. History of drug abuse or alcohol abuse；

               4. Participation in any clinical trial within the 3 months prior to screening；

               5. Prolonged intravenous, oral or intraarticular treatment with corticosteroids
                  within the 2 months prior to screening;

               6. Use of any weight control agents or surgeries within the 2 months prior to
                  screening;

               7. Any medications used prior to screening that at the investigator's discretion may
                  confound the interpretation of the efficacy or safety data；

          3. History or evidence of any of the following conditions prior to screening：

               1. Type 1 diabetes mellitus, single gene mutation DM, DM associated with pancreatic
                  injury，or secondary DM；

               2. History of hypertension with SBP>160 mmHg and/or DBP>100 mmHg；

               3. History of acute/chronic pancreatitis, history of symptomatic cholecystopathy;

               4. History of myeloid C-cell carcinoma, history of multiple endocrine neoplasm （MEN）
                  2A or 2B syndrome, or related familiar history；

               5. Gastric emptying disorders, severe chronic gastrointestinal disorders;

               6. History of severe hypoglycemia, unconsciousness or severe hypoglycemia history；

               7. Significant hematological disorders, or any diseases；

               8. Severe diabetic complications that in the opinion of the investigator make the
                  subject not suitable to participate in this study；

               9. Tumors of any organ or system that not been treated within the 5 years prior to
                  screening；

              10. Coronary angioplasty, coronary stenting, coronary artery bypass, uncompensated
                  heart failure （NYHA Class III or IV）, within the 6 months prior to screening；

              11. Acute metabolic complications within the 6 months prior to screening；

              12. Thyroid dysfunction within the 6 months prior to screening；

              13. Blood lipid disorders within the 6 months prior to screening；

              14. Any severe trauma or severe infection within the 1 month prior to screening；

          4. Laboratory indicators meeting any of the following criteria prior to screening：

               1. ALT>2.5×ULN and/or AST>2.5×ULN and/or total bilirubin>2.5×ULN；

               2. Hemoglobin≤100 g/L；

               3. Serum creatinine>1.5×UNL and eGFR < 45 ml/min/1.73 m2； eGFR is calculated
                  as：186.3 ×[（Serum Creatinine（mmol/L）/88.4）]-1.154 × [Age (years)]- 0.203 × 1.223
                  × 0.742 （Females） or ×1（Males）

               4. Serum thyroid-stimulating hormone（TSH） out of the reference range that is
                  assessed as clinically significant by the investigator;

               5. Fasting TGL>5.64 mmol/L（500 mg/dl）；

               6. Blood amylase and urine amylase>ULN that is assessed as clinically significant by
                  the investigator；

               7. Any clinically significant laboratory abnormalities；

          5. Clinically significant 12-lead ECG abnormalities；

          6. Blood donation or loss≥400 mL，or receipt of blood donation within the 4 weeks prior to
             screening；

          7. Pregnant or lactating women, or men or women of child-bearing potential not willing to
             take contraceptive measures during the study；

          8. Any other conditions of the subject that at the investigator's discretion may compound
             the interpretation of the efficacy or safety data.