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

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ClinicalTrials.gov Identifier: NCT02467920
Recruitment Status : Completed
First Posted : June 10, 2015
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
Xuefeng Yu, Huazhong University of Science and Technology

Brief 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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: glargine + exenatide Drug: aspart 30 Phase 4

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).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 349 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : August 2015
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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).
Drug: glargine + exenatide
glargine ( once-daily subcutaneous injection at bedtime) combination with exenatide (subcutaneous injection, twice-daily)

Active Comparator: 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).
Drug: aspart 30
aspart 30 ( subcutaneous injection, twice daily)




Primary Outcome Measures :
  1. 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. [ Time Frame: from baseline to 24-week endpoint ]

Secondary Outcome Measures :
  1. Change in HbA1c from baseline to 12 weeks endpoint [ Time Frame: from baseline to 12 weeks endpoint ]
  2. The percentage of participants who achieved HbA1c ≤ 6.5% and < 7% [ Time Frame: 12 weeks and 24 weeks ]
  3. Fasting blood glucose [ Time Frame: 12 weeks and 24 weeks ]
  4. Daily insulin use [ Time Frame: baseline, 12 weeks and 24 weeks ]
  5. Change in body weight [ Time Frame: from baseline to 12 and 24 weeks ]
  6. The incidence and rate of hypoglycaemic events during the study [ Time Frame: baseline, 12 weeks and 24 weeks ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02467920


Locations
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China, Hubei
Tongji Hospital, Tongji Medical College, Huazhong University of Science and technology
Wuhan, Hubei, China, 430000
Sponsors and Collaborators
Huazhong University of Science and Technology

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Responsible Party: Xuefeng Yu, Director of Department of Endocrinology, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier: NCT02467920     History of Changes
Other Study ID Numbers: ESR-14-10352
First Posted: June 10, 2015    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018
Keywords provided by Xuefeng Yu, Huazhong University of Science and Technology:
exenatide
glargine
aspart 30
Additional relevant MeSH terms:
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Insulin
Insulin, Globin Zinc
Insulin Glargine
Insulin Aspart
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Obesity Agents
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists