Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparison of Exenatide vs. Biphasic Insulin Aspart 30 on Glucose Variability in Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02449603
Recruitment Status : Completed
First Posted : May 20, 2015
Last Update Posted : November 14, 2018
Sponsor:
Collaborators:
Fourth Military Medical University
First Affiliated Hospital Xi'an Jiaotong University
Second Affiliated Hospital of Xi'an Jiaotong University
Shaanxi Provincial People's Hospital
Chang'An Hospital
Xi’an Gaoxin Hospital
Xi'an Central Hospital
Shaanxi Aerospace Hospital
Information provided by (Responsible Party):
Xijing Hospital

Brief Summary:
This is a multi-centre, open-label, randomized, parallel trial to compare the effect of Exenatide versus Biphasic insulin Aspart 30 on glucose variability and inflammatory markers in type 2 diabetes mellitus (T2DM) patients inadequately controlled with metformin monotherapy.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Exenatide Drug: Biphasic insulin Aspart 30 Phase 4

Detailed Description:
Studies have showed that fluctuations of glucose seem to have more deleterious effects than sustained hyperglycaemia in the development of diabetic complications. The present randomized controlled trial was designed with primary aim to evaluate glycaemic fluctuation in the comparison between twice-daily Exenatide and other treatment paradigm (e.g. insulin Aspart 30).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Exenatide vs. Biphasic Insulin Aspart 30 on Glucose Variability in Type 2 Diabetes : a Randomised Open Parallel-controlled Study
Actual Study Start Date : November 2015
Actual Primary Completion Date : April 2018
Actual Study Completion Date : April 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exenatide
Exenatide (Colorless transparent liquid, comes in a prefilled pen.5ug/10ug, AstraZeneca) should be initiated, 60 minutes pre-breakfast and pre-supper, at 5ug twice a day for 4 weeks and then titrated up at 10ug twice a day until the completion of the study.
Drug: Exenatide
Other Name: Byetta

Active Comparator: Biphasic insulin Aspart 30
Biphasic insulin Aspart 30 (Colorless transparent liquid, 100u/mL, 3ml each, Novo Nordisk), subcutaneous injection, starting at a dose of 0.2-0.4 IU/kg, or 10~12 IU/d assigned in pre-breakfast and pre-supper in a 1:1 ratio. The adjustment of insulin dose is instructed to achieve an optimal balance between glycaemic control and risk of hypoglycaemia as dictated by best clinical practice, titrated to glucose targets of fasting plasma glucose (FPG) and pre-supper <7 mmol/L.
Drug: Biphasic insulin Aspart 30



Primary Outcome Measures :
  1. Change of mean amplitude of glycemic excursions [ Time Frame: from baseline to Week 16 ]

Secondary Outcome Measures :
  1. HbA1c [ Time Frame: at baseline and Week 16 ]
  2. Hours of hypoglycemia as measured by continuous glucose monitoring system (CGMS) [ Time Frame: at baseline and Week 16 ]
  3. Blood pressure [ Time Frame: at baseline and Week 16 ]
  4. Lipids [ Time Frame: at baseline and Week 16 ]
  5. Body mass index [ Time Frame: at baseline and Week 16 ]
  6. Waist circumference [ Time Frame: at baseline and Week 16 ]
  7. Monocyte chemotactic protein-1 (MCP-1) [ Time Frame: at baseline and Week 16 ]
  8. High-sensitivity C-reactive protein (hs-CRP) [ Time Frame: at baseline and Week 16 ]
  9. Urinary albumin [ Time Frame: at baseline and Week 16 ]
  10. Number of participants with adverse events/severe adverse events [ Time Frame: from baseline to Week 16 ]
  11. Number of participants with clinical hypoglycemia [ Time Frame: from baseline to Week 16 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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 prior to any study specific procedures.
  • Men and women (non-pregnant and using a medically approved birth-control method) aged between 18 and 70 years at screening.
  • Confirmed type 2 diabetes with history of at least half a year.
  • Treatment with stable, maximum tolerated doses of metformin (≧1500mg/d, ≧3 months).
  • HbA1c ≥ 7.5% and ≤ 10.0% at screening or within 4 weeks prior to screening (by local laboratory).
  • Body mass index: 21-35 kg/m^2.

Exclusion Criteria:

  • Women who are pregnant, intending to become pregnant during the study period, currently lactating females, or women of child-bearing potential not using highly effective, medically approved birth control methods.
  • Diagnosis or history of:

    1. Type 1 diabetes mellitus, diabetes resulting from pancreatic injury or secondary forms of diabetes, e.g., acromegaly or Cushing's syndrome.
    2. Acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma within the past 6 months.
  • Previous treatment with any dipeptide peptidase-4 (DPP4) inhibitor or glucagon-like peptide-1 (GLP-1) receptor agonists within the past one year.
  • History of hypersensitivity reaction (e.g., anaphylaxis, angioedema, exfoliative skin conditions) to dipeptide peptidase-4 inhibitor (DPP4) or Acarbose.
  • Treatment with any anti-diabetic medication for more than 7 consecutive days other than metformin in the last 3months prior to screening.
  • Treatment with systemic glucocorticoids (oral, intravenous) for more than consecutive 7 days within the past 6 months.
  • Triglycerides (fasting) > 4.5 mmol/L (> 400 mg/dL) at screening or within 4 weeks prior to screening (by local laboratory).
  • Patients with clinically apparent liver disease characterized by either one of the following:

    1. Alanine transaminase (ALT) or aspartate aminotransferase (AST) > 3x upper limit of normal (ULN) confirmed on two consecutive measurements (by local laboratory) within 4 weeks prior to screening period
    2. Impaired excretory (e.g. hyperbilirubinemia) and/or synthetic function, or other conditions of decompensated liver disease such as coagulopathy, hepatic encephalopathy, hypoalbuminemia, ascites and bleeding from oesophageal varices.
    3. Acute viral or active autoimmune, alcoholic, or other types of hepatitis.
  • Patients with moderate /severe renal impairment or end-stage renal disease (estimated Glomerular Filtration Rate ≤ 60 mL/min calculated by using the abbreviated equation developed by the Modification of Diet in Renal Disease (MDRD) study with modification for the Chinese population) at screening or within 4 weeks prior to screening (by local laboratory)
  • Congestive heart failure defined as New York Heart Association (NYHA) class III or IV.
  • Significant cardiovascular history within the past 3 months prior to screening defined as: myocardial infarction, coronary angioplasty or bypass graft(s), valvular disease or repair, unstable angina pectoris, transient ischemic attack, or cerebrovascular accident.
  • History of chronic pancreatitis or idiopathic acute pancreatitis.
  • History of gastrointestinal disease including gastroenterostomy, enterectomy, Roemheld Syndrome, severe hernia, intestinal obstruction, intestinal ulcer.
  • History of genetic galactose intolerance, Lapp lactase deficiency and glucose-galactose malabsorption.
  • History of medullary thyroid carcinoma.
  • Diagnosed and/or treated malignancy (except for basal cell skin cancer, in situ carcinoma of the cervix, or in situ prostate cancer) within the past 5 years.
  • History of organ transplant or acquired immunodeficiency syndrome (AIDS).
  • History of alcohol abuse or illegal drug abuse within the past 12 months.
  • Potentially unreliable patients and those judged by the Investigator to be unsuitable for the study.

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): NCT02449603


Locations
Layout table for location information
China, Shaanxi
Xijing Hospital, Fourth Military Medical university
Xi'an, Shaanxi, China, 710032
Sponsors and Collaborators
Xijing Hospital
Fourth Military Medical University
First Affiliated Hospital Xi'an Jiaotong University
Second Affiliated Hospital of Xi'an Jiaotong University
Shaanxi Provincial People's Hospital
Chang'An Hospital
Xi’an Gaoxin Hospital
Xi'an Central Hospital
Shaanxi Aerospace Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Xijing Hospital
ClinicalTrials.gov Identifier: NCT02449603     History of Changes
Other Study ID Numbers: ESR-14-10319
First Posted: May 20, 2015    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018
Keywords provided by Xijing Hospital:
Chinese population
Additional relevant MeSH terms:
Layout table for MeSH terms
Insulin
Insulin, Globin Zinc
Insulin Aspart
Insulin, Long-Acting
Insulin degludec, insulin aspart drug combination
Biphasic Insulins
Insulin aspart, insulin aspart protamine drug combination 30:70
Insulin, Isophane
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Obesity Agents
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists