Efficacy and Safety of Basal Insulin Glargine Combination With Exenatide Bid vs Aspart30 in T2DM

Condition(s) targeted: Type 2 Diabetes Mellitus

Intervention: glargine + exenatide (Drug); aspart 30 (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: Huazhong University of Science and Technology

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.

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: the absolute change in HbA1c from baseline to 24-week endpoint of basal insulin glargine combination with exenatide bid vs. switching to aspart30 in type 2 diabetic patients inadequately controlled on premixed human insulin and metformin.

Secondary outcome:

Change in HbA1c from baseline to 12 weeks endpoint

The percentage of participants who achieved HbA1c ≤ 6.5% and < 7%

Fasting blood glucose

Daily insulin use

Change in body weight

The incidence and rate of hypoglycaemic events during the study

Detailed description: 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).

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

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 < 11. 0 % (HbA1c > 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

Starting date: June 2015
Last updated: June 5, 2015