Efficacy and Safety of Basal Insulin Glargine Combination With Exenatide Bid vs Aspart30 in T2DM
NCT ID: NCT02467920
Last Updated: 2018-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
349 participants
INTERVENTIONAL
2015-08-31
2017-12-31
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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glargine + exenatide
Type 2 diabetic patients with inadequate glycaemic control on premixed human insulin and metformin previously. After a 12-week run-in period , switching premix human insulin to glargine ( once-daily subcutaneous injection at bedtime) combination with exenatide (subcutaneous injection, twice-daily).
glargine + exenatide
glargine ( once-daily subcutaneous injection at bedtime) combination with exenatide (subcutaneous injection, twice-daily)
aspart 30
Type 2 diabetic patients with inadequate glycaemic control on premixed human insulin and metformin previously. After a 12-week run-in period , switching premix human insulin to aspart 30 ( subcutaneous injection, twice daily).
aspart 30
aspart 30 ( subcutaneous injection, twice daily)
Interventions
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glargine + exenatide
glargine ( once-daily subcutaneous injection at bedtime) combination with exenatide (subcutaneous injection, twice-daily)
aspart 30
aspart 30 ( subcutaneous injection, twice daily)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Huazhong University of Science and Technology
OTHER
Responsible Party
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Xuefeng Yu
Director of Department of Endocrinology
Locations
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Tongji Hospital, Tongji Medical College, Huazhong University of Science and technology
Wuhan, Hubei, China
Countries
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Other Identifiers
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ESR-14-10352
Identifier Type: -
Identifier Source: org_study_id
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