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

November 12, 2018 updated by: Xuefeng Yu, 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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

349

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430000
        • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
from baseline to 24-week endpoint

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in HbA1c from baseline to 12 weeks endpoint
Time Frame: from baseline to 12 weeks endpoint
from baseline to 12 weeks endpoint
The percentage of participants who achieved HbA1c ≤ 6.5% and < 7%
Time Frame: 12 weeks and 24 weeks
12 weeks and 24 weeks
Fasting blood glucose
Time Frame: 12 weeks and 24 weeks
12 weeks and 24 weeks
Daily insulin use
Time Frame: baseline, 12 weeks and 24 weeks
baseline, 12 weeks and 24 weeks
Change in body weight
Time Frame: from baseline to 12 and 24 weeks
from baseline to 12 and 24 weeks
The incidence and rate of hypoglycaemic events during the study
Time Frame: baseline, 12 weeks and 24 weeks
baseline, 12 weeks and 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huazhong University of Science and Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2015

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

June 2, 2015

First Submitted That Met QC Criteria

June 5, 2015

First Posted (Estimate)

June 10, 2015

Study Record Updates

Last Update Posted (Actual)

November 14, 2018

Last Update Submitted That Met QC Criteria

November 12, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESR-14-10352

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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