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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02449603
• Other study ID #: ESR-14-10319
• Status: Completed
• Phase: Phase 4
• Start date: November 2015
• Est. completion date: April 2018

Study information

• Verified date: November 2018
• Source: Xijing Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Exenatide

• Biphasic insulin Aspart 30

Locations

Country	Name	City	State
China	Xijing Hospital, Fourth Military Medical university	Xi'an	Shaanxi

Sponsors (9)

Lead Sponsor	Collaborator
Xijing Hospital	Chang An Hospital, First Affiliated Hospital Xi'an Jiaotong University, Fourth Military Medical University, Second Affiliated Hospital of Xi'an Jiaotong University, Shaanxi Aerospace Hospital, Shaanxi Provincial People's Hospital, Xi'an Central Hospital, Xi’an Gaoxin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of mean amplitude of glycemic excursions		from baseline to Week 16
Secondary	HbA1c		at baseline and Week 16
Secondary	Hours of hypoglycemia as measured by continuous glucose monitoring system (CGMS)		at baseline and Week 16
Secondary	Blood pressure		at baseline and Week 16
Secondary	Lipids		at baseline and Week 16
Secondary	Body mass index		at baseline and Week 16
Secondary	Waist circumference		at baseline and Week 16
Secondary	Monocyte chemotactic protein-1 (MCP-1)		at baseline and Week 16
Secondary	High-sensitivity C-reactive protein (hs-CRP)		at baseline and Week 16
Secondary	Urinary albumin		at baseline and Week 16
Secondary	Number of participants with adverse events/severe adverse events		from baseline to Week 16
Secondary	Number of participants with clinical hypoglycemia		from baseline to Week 16