diabetes mellitus
Conditions
Interventions
new stepwise arm:Saxagliptin-Met-basal insulin
traditional stepwise arm:Met-DiaMicron MR-basal insulin
Sponsors
Fuwai Hospital
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Provision of informed consent prior to any study specific procedures; 2. Newly diagnosed T2DM(WHO diagnostic criteria 1999); 3. Treatment naive; 4. Men and women (non-pregnant and using a medically approved birth-control method) aged at least 60 years at screening; 5. HbA1c 7.5%~10.0% at screening by local laboratory; 6. BMI 18~40 kg/m2.
Exclusion criteria
Exclusion criteria: 1. Women who are pregnant, intending to become pregnant during the study period,currently lactating females, or women of child-bearing potential not using highly effective, medically approved birth control methods; 2. Diagnosis or history of: a. Type 1 diabetes mellitus, diabetes resulting from pancreatic injury or secondary forms of diabetes, eg, acromegaly or Cushing's syndrome; b. Acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma within the past 6 months. 3. Treatment with any anti-diabetic medication for more than 7 consecutive days prior to screening in the last 8 weeks. Especially the one whose previous treatment with any dipeptidyl peptidase-4 (DPP4) inhibitor or GLP-1 receptor agonists within the past one year; 4. History of hypersensitivity reaction (e.g., anaphylaxis, angioedema, exfoliative skin conditions) to dipeptidyl peptidase-4 inhibitor (DPP4) or Gliclazide; 5. Treatment with systemic glucocorticoids (oral, intravenous) for more than consecutive 7 days within the past 6 months; 6. Treatment with strong cytochrome P450 3A4/5 (CYP450 3A4/5) inhibitors, e.g., ketoconazole, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, and telithromycin. 7. Triglycerides (fasting) >4.5 mmol/L (>400 mg/dL) at screening or within 4 weeks prior to screening (by local laboratory); 8. Patients with clinically apparent liver disease characterized by either one of the following: a. ALT or AST >3* upper limit of normal confirmed on two consecutive measurements (by local laboratory) within 4 weeks prior to screening period; b. Impaired excretory (eg, hyperbilirubinemia) and/or synthetic function, or other conditions of decompensated liver disease such as coagulopathy, hepatic encephalopathy, hypoalbuminemia, ascites and bleeding from oesophageal varices; c. Acute viral or active autoimmune, alcoholic, or other types of hepatitis. 9. Patients with moderate /severe renal impairment or end-stage renal disease (Creatinine>194.5 mmol/L or K+>5.5 mmol/L) at screening or within 4 weeks prior to screening (by local laboratory); 10. Congestive heart failure defined as New York Heart Association (NYHA) class III or IV; 11. Significant cardiovascular history within the past 3 months prior to screening defined as: myocardial infarction, coronary angioplasty or bypass graft(s), valvular disease or repair, unstable angina pectoris, transient ischemic attack, or cerebrovascular accident; 12. History of chronic pancreatitis or idiopathic acute pancreatitis; 13. History of gastrointestinal disease including gastroenterostomy, enterectomy, severe hernia, intestinal obstruction, intestinal ulcer; 14. History of genetic galactose lntolerance, Lapp lactase deficiency and glucose-galactose malabsorption; 15. History of medullary thyroid carcinoma; 16. Diagnosed and/or treated malignancy (except for basal cell skin cancer, in situ carcinoma of the cervix, or in situ prostate cancer) within the past 5 years; 17. History of organ transplant or acquired immunodeficiency syndrome (AIDS); 18. History of alcohol abuse or illegal drug abuse within the past 12 months; 19. Potentially unreliable patients and those judged by the Investigator to be unsuitable for the study; 20. SBP higher than 180mmHg or DBP higher than 110mmHg; 21. Patients were likely to undergo coronary artery bypass graft surgery during the following 4 weeks; 22. Other contradictions for metformin.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c;plasma glucose;plasma insulin;glucagon; | — |
Secondary
| Measure | Time frame |
|---|---|
| Body weight;height;Lipids(Triglycerides and total cholesterol); | — |
Countries
China
Contacts
Public ContactGuangwei Li
Outcome results
None listed