Effects of Tianqi Capsule on Glucose Variability in Patients With Type 2 Diabetes.

• Status: Unknown status
• Trial end date: 2018-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effects and safety of Tianqi Capsule on glucose variability in patients with type 2 diabetes by continuous blood glucose monitoring system.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking Union Medical College Hospital

Criteria

Inclusion Criteria

• 18.5kg/m2≤BMI≤35.0 kg/m2;

• meet type 2 diabetes mellitus diagnostic criteria published by 1999 WHO;

• with blood variability, defined as standard deviation of blood glucose more than 3.5mmol／L within 2 days by self-monitoring of blood glucose（SMBG）(more than 5 times per day)

• diabetic duration more than 1 year; in stable condition for more than 4 weeks with unchanged lifestyle and other drugs intervention; （permit taking metformin or sulphonylureas which dosage is unchanged during study period ）

• HbA1c≤10％;

• signed the informed consent form.

Exclusion Criteria:

• have acute diabetes complications （e.g. diabetic ketoacidosis，diabetic hyperosmolar coma,diabetic lactic acidosis,Hypoglycemic coma）

• have severe chronic diabetes complications(e.g. diabetic retinopathy stage 4~6,severe diabetic nephropathy needs dialysis and so on）

• have gastrointestinal disease which have serious influence on digestive function and disorder of absorption

• have other endocrine disease (hyperthyroidism,acromegaly,Cushing's syndrome and so on.)

• have severe heart disease(such as acute myocardium infarction, unstable angina,heart failure NYHA functional classification III or IV）

• have moderate or severe liver function abnormality(ALT,TBil or AST> double upper limit )

• have moderate and severe renal function abnormality(eGFR < 50ml／min)

• blood leukocyte <4.0×10^9/L; blood thrombocyte<90×10^9/L

• taking drugs affecting glucose metabolism,such as glucocorticoid

• have other serious illness which considered to exacerbate and be life-threaten during fellow up period;

• have evidence of mental disorders;

• alcoholics and drug abuse

• females who were pregnant, lactating, planning for pregnancy, or sexually active but with no contraceptive measures;

• have participated in clinical trials within 3 months before;

• other conditions researchers thought to unable to evaluate the curative effect and finish the study.

• allergic to the ingredients of herbs contained in Tianqi capsule