efficacy and safety of basal insulin glargine combination with exenatide bid vs aspart30 in t2dm

Conditions: Type 2 Diabetes Mellitus

Summary: efficacy and safety of basal insulin glargine combination with exenatide bid vs switching premix human insulin to aspart30 in t2dm with inadequate glycaemic control on premixed human insulin and metformin: a randomized, open, parallel trial.

this is a multicentre, open-label, randomized and parallel trial that will compare the efficacy and safety of basal insulin glargine combination with exenatide bid vs. switching premix human insulin to aspart30 in type 2 diabetic patients with inadequate glycaemic control on premixed human insulin and metformin. approximately 248 patients will be enrolled in the study from china and randomized in a 1:1 ratio to one of the 2 treatment arms: once-daily insulin glargine + twice-daily exenatide + metformin; or twice-daily aspart 30 + metformin. study treatment will continue for 24 weeks. the primary efficacy measure is the change in hba1c at 24 weeks. the study consists of 3 periods: a 1-week screening (period a), a 12-week run-in period (period b) and a 24-week treatment period (period c).

Eligibility criteria:
inclusion criteria: * provision of informed consent * type 2 diabetic patients receiving twice-daily premixed human insulin 30 therapy ≥ 30 u/d and metformin with maximum tolerated dosage (≤ 1500mg/d) * hba1c \> 8.0 % and \ 7.0 % and \< 10.0% at randomization) * men and women (non-pregnant and using a medically approved birth-control method) aged ≥ 18 and ≤ 70 years * bmi ≥ 23 and ≤ 35 kg/m2 exclusion criteria: * type 1 diabetes or other specific types of diabetes * pregnancy, preparation for pregnancy, lactation and women of child-bearing age incapable of effective contraception methods * uncooperative subject because of various reasons * abnormal liver function, glutamic-pyruvic transaminase (alt) and glutamic-oxaloacetic transaminase (ast) \> twice the upper limits of normal * impairment of renal function, serum creatinine: ≥ 133mmol/l for female，≥ 135mmol/l for male * serious chronic gastrointestinal diseases * edema * serious heart diseases, such as cardiac insufficiency (level iii or more according to nyha), acute coronary syndrome and old myocardial infraction * blood pressure: systolic blood pressure (sbp) ≥ 180mmhg and/or diastolic blood pressure (dbp) ≥ 110mmhg * white blood count (wbc) \< 4.0×109/l or platelet count (plt) \< 90×109/l，or definite anemia (hb：\< 120g/l for male, \< 110g/l for female), or other hematological diseases * endocrine system diseases, such as hyperthyroidism and hypercortisolism * experimental drug allergy or frequent hypoglycemia * psychiatric disorders, drug or other substance abuse * diabetic ketoacidosis and hyperosmolar nonketotic coma requiring insulin therapy * stressful situations such as surgery, serious trauma and so on * chronic hypoxic diseases such as pulmonary emphysema and pulmonary heart disease * combined use of drugs effecting glucose metabolism such as glucocorticoid * tumor, especially bladder tumor and/or family history of bladder tumor and/or long-term hematuria

Keywords: exenatide glargine aspart 30