AzTrials
AzTrials

Type 2 Diabetes MellitusPhase 4NCT02449603

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

A Phase 4 study testing Exenatide and Biphasic insulin Aspart 30 in people with Type 2 Diabetes Mellitus, run by Xijing Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Exenatide and Biphasic insulin Aspart 30
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteChina
Study dates
Nov 2015to Apr 2018
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 24Show fewer
  • 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.
  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Xijing Hospital, Fourth Military Medical university

    Xi'an, Shaanxi, 710032

Other trials in China

About this study

Official title: Comparison of Exenatide vs. Biphasic Insulin Aspart 30 on Glucose Variability in Type 2 Diabetes : a Randomised Open Parallel-controlled Study

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.

Read the 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).

Being tested
Exenatide, Biphasic insulin Aspart 30
Keywords
Chinese population
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExenatideDrug

    Also called Byetta

  • Biphasic insulin Aspart 30Drug

Study groups in NCT02449603
Study groupRoleWhat they receive
ExenatideExperimentalExenatide (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.
Receives: Drug: Exenatide
Biphasic insulin Aspart 30Active comparatorBiphasic 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.
Receives: Drug: Biphasic insulin Aspart 30

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of mean amplitude of glycemic excursions

    Measured: from baseline to Week 16

Secondary outcomes (11)

  1. HbA1c

    Measured: at baseline and Week 16

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

    Measured: at baseline and Week 16

  3. Blood pressure

    Measured: at baseline and Week 16

  4. Lipids

    Measured: at baseline and Week 16

  5. Body mass index

    Measured: at baseline and Week 16

  6. Waist circumference

    Measured: at baseline and Week 16

  7. Monocyte chemotactic protein-1 (MCP-1)

    Measured: at baseline and Week 16

  8. High-sensitivity C-reactive protein (hs-CRP)

    Measured: at baseline and Week 16

  9. Urinary albumin

    Measured: at baseline and Week 16

  10. Number of participants with adverse events/severe adverse events

    Measured: from baseline to Week 16

  11. Number of participants with clinical hypoglycemia

    Measured: from baseline to Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2015 (estimated)
  2. Study startNov 2015
  3. Primary completionApr 2018
  4. Study completionApr 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02449603
Sponsor's protocol ID
ESR-14-10319
Status last verified
Nov 2018
First submitted
11 May 2015
Last updated
14 Nov 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 32856226

  • 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.

    PubMed 27009108

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Exenatide and Biphasic insulin Aspart 30 in people with Type 2 Diabetes Mellitus, run by Xijing Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of mean amplitude of glycemic excursions (time frame: from baseline to Week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02449603, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in