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

NCT02449603 | Completed Phase 4 DMC

• 1 other identifier: ESR-14-10319
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

Chinese population

Outcome Measures

Primary Outcomes (1)

• Change of mean amplitude of glycemic excursions

  from baseline to Week 16

Secondary Outcomes (11)

• HbA1c

  at baseline and Week 16

• Hours of hypoglycemia as measured by continuous glucose monitoring system (CGMS)

  at baseline and Week 16

• Blood pressure

  at baseline and Week 16

• Lipids

  at baseline and Week 16

• Body mass index

  at baseline and Week 16

Study Arms (2)

Exenatide

EXPERIMENTAL

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

Biphasic insulin Aspart 30

ACTIVE COMPARATOR

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

Interventions

Exenatide DRUG

Also known as: Byetta

Exenatide

Biphasic insulin Aspart 30 DRUG

Biphasic insulin Aspart 30

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• Type 1 diabetes mellitus, diabetes resulting from pancreatic injury or secondary forms of diabetes, e.g., acromegaly or Cushing's syndrome.
• 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:
• 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
• 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.
• 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.

Sponsors & Collaborators

• Xijing Hospital: lead
• Air Force Military Medical University, China: collaborator
• First Affiliated Hospital Xi'an Jiaotong University: collaborator
• Second Affiliated Hospital of Xi'an Jiaotong University: collaborator
• Shaanxi Provincial People's Hospital: collaborator
• Chang'An Hospital: collaborator
• Xi'an Gaoxin Hospital: collaborator
• Xi'an Central Hospital: collaborator
• Shaanxi Aerospace Hospital: collaborator

Study Sites (1)

Xijing Hospital, Fourth Military Medical university

Xi'an, Shaanxi, 710032, China

Location

Related Publications (2)

• Wang L, Liu X, Yang W, Lai J, Yu X, Liu J, Gao X, Ming J, Ma K, Xu J, Tian Z, He Q, Ji Q. Comparison of Blood Glucose Variability Between Exenatide and Biphasic Insulin Aspart 30 in Chinese Participants with Type 2 Diabetes Inadequately Controlled with Metformin Monotherapy: A Multicenter, Open-Label, Randomized Trial. Diabetes Ther. 2020 Oct;11(10):2313-2328. doi: 10.1007/s13300-020-00904-z. Epub 2020 Aug 27.

  PMID: 32856226 DERIVED

• Xu S, Liu X, Ming J, Ji Q. Comparison of exenatide with biphasic insulin aspart 30 on glucose variability in type 2 diabetes: study protocol for a randomized controlled trial. Trials. 2016 Mar 24;17:160. doi: 10.1186/s13063-016-1258-8.

  PMID: 27009108 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Exenatide; insulin aspart, insulin aspart protamine drug combination 30:70

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins; Venoms; Complex Mixtures; Toxins, Biological; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2015
• First Posted: May 20, 2015
• Study Start: November 1, 2015
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: November 14, 2018

Record last verified: 2018-11

Locations

CN (1)