Diabetes
Conditions
Interventions
Experimental Group:Pioglitazone Hydrochloride and Metformin Hydrochloride Tablets
Sponsors
Beijing Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Aged between 18 and 65 (including 18 and 65); (2) Body mass index 19 <= BMI <= 45; (3) Patients with type 2 diabetes (WHO standard, 1999); (4) Patients taking metformin 750 ~ 1500mg with poor glycemic control (7.5% <= HbAlc <=10.0%, or 7mmol / L <= blood glucose (FPG) <= 13.9mmol / L); (5) Willing to sign informed consent.
Exclusion criteria
Exclusion criteria: (1) Combined use of other oral hypoglycemic drugs; (2) abnormal liver function, ALT, AST are 2.5 times the upper limit of normal; (3) Renal function impairment, serum creatinine: female >= 133 µmol / L, male >= 135 µmol / L; (4) severe chronic gastrointestinal diseases; (5) Patients with severe heart disease, such as cardiac insufficiency (New York heart function classification reaches Grade III or above), acute coronary syndrome, and old myocardial infarction; (6) Blood pressure: SBP >= 180mmHg and / or DBP>= 110mmHg; (7) White blood cell count <= 3.5 x 10^9 / L or platelet count <= 90 x 10^9 / L, or have anemia (hemoglobin: male <120g / L, female <110g / L), or other blood system diseases (8) Diseases of the endocrine system, such as hyperthyroidism and hypercortisolism; (9) Those who are allergic to the test drug or have frequent hypoglycemia; (10) People with mental disorders, drugs or other substance abuse; (11) Insulin is needed to treat patients with diabetic ketoacidosis, hypertonic non-ketogenic coma, etc .; (12) Have chronic hypoxic diseases such as emphysema, pulmonary heart disease; (13) Concomitant use of drugs that affect glucose metabolism, such as glucocorticoids; (14) Cancer patients, especially those with bladder tumors, and / or have a family history of bladder tumors, and / or a long history of hematuria; (15) Those with fragile fractures caused by osteoporosis in the past 6 months; (16) pregnancy or breastfeeding; (17) Participants in other clinical trials of drugs within three months; (18) Patients that the investigator considers unsuitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glycated hemoglobin (HbA1c); | — |
Secondary
| Measure | Time frame |
|---|---|
| Fasting blood glucose, 2h blood glucose reduction after standard meal;Fasting insulin level;Blood lipid levels: triglycerides, cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol;Inflammatory index: IL-6, hs-CRP,TNF-a;Blood pressure level; | — |
Countries
China
Contacts
Public ContactLixin Guo
Beijing Hospital
Outcome results
None listed