Meal-time Administration of exenatide for Glycaemic control in type 1 diabetic Cases: A randomised, placebo-controlled trial

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 100

Inclusion Criteria

Inclusion criteria
•T1D according to WHO criteria with duration of =1 year
•Age =18 years
•BMI >22.0 kg/m2
•HbA1c >7.5% and <10.0% at visit 0 (screening)
•Able to count carbohydrates
•Able to understand the written patient information and to give informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

Exclusion criteria
•Insulin pump treatment
•Hypoglycaemia unawareness (inability to register low blood glucose)
•Diabetic gastroparesis
•Compromised kidney function (eGFR <60 ml/min/1.73m2, dialysis or kidney transplantation)
•Liver disease with elevated plasma alanine aminotransferase (ALT) > three times the upper limit of normal (measured at visit 0 with the possibility of one repeat analysis within a week, and the last measured value as being conclusive)
•History of acute and/or chronic pancreatitis
•Subjects with personal or family history of medullary carcinoma or MEN syndrome
•Inflammatory bowel disease
•Cancer unless in complete remission for >5 years
•Proliferative retinopathy
•Other concomitant disease or treatment that according to the investigator's assessment makes the patient unsuitable for study participation
•Alcohol/drug abuse
•Fertile women not using chemical (tablet/pill, depot injection of progesterone, subdermal gestagen implantation, hormonal vaginal ring or transdermal hormonal patch) or mechanical (spirals) contraceptives
•Pregnant or nursing women
•Known or suspected hypersensitivity to trial product or related products
•Receipt of an investigational drug within 30 days prior to visit 0
•Simultaneous participation in any other clinical intervention trial

Withdrawal criteria
•In case of pregnancy (or desire for pregnancy), female subjects are withdrawn
•Lack of compliance to any of the important study procedures in the discretion of the investigator
•Onset of any disorder considered to compromise the safety by participating in the study
•Unacceptable adverse effects in the discretion of the investigator
•Withdrawal on participants request will be accepted at any time without further justification

Withdrawn patients will not be replaced.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The present project aims to evaluate the safety and therapeutic effect of the short-acting GLP-1RA exenatide administered three times daily (at meal-times) as add-on therapy to standard basal-plus-prandial insulin regimen in patients with T1D. ;Secondary Objective: Not Applicable.;Primary end point(s): Specifically, the primary objective is to determine the effect of exenatide vs. placebo on glycaemic control (HbA1c) over a 26-week treatment period. .;Timepoint(s) of evaluation of this end point: Week -4 (Screening), 0, 12, 26.

Secondary Outcome Measures

Name	Time	Method

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