Type 1 Diabetes MedDRA version: 20.0 Level: PT Classification code 10067584 Term: Type 1 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Trade Name: Byetta
Product Name: Byetta
Pharmaceutical Form: Solution for injection in cartridge
INN or Proposed INN: EXENATIDE
CAS Numb
Sponsors
Center for Diabetes Research, Gentofte Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: Exclusion criteria • Insulin pump treatment • Hypoglycaemia unawareness (inability to register low blood glucose) • Diabetic gastroparesis • Compromised kidney function (eGFR 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clinical intervention trial Withdrawal criteria • In case of pregnancy (or desire for pregnancy), female subjects are withdrawn • Lack of compliance to any of the important study procedures in the discretion of the investigator • Onset of any disorder considered to compromise the safety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of the investigator • Withdrawal on participants request will be accepted at any time without further justification Withdrawn patients will not be replaced.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints will include adverse events (including hypoglycaemic episodes) and changes in insulin dosage, body weight, body mass index (BMI), body composition, FPG, PPG, fasting plasma levels of C-peptide, quality of life (QoL), dietary patterns and cardiovascular disease (CVD) risk profile (including biomarkers and cholesterol levels); Timepoint(s) of evaluation of this end point: Adverse events (including hypoglycaemic episodes) and changes in insulin dosage: Week -4 (screening), 0, 1, 2, 4, 8, 12, 16, 20, 26 Body weight, body mass index (BMI), body composition: Week -4 (screening), 0, 12, 26. FPG, PPG: Week 0, 4, 12, 26. Fasting plasma levels of C-peptide: Week -4 (screening), 0, 4, 12, 26 Quality of life (QoL): Week 0, 12, 26. Dietary patterns: Week 0, 12, 26. Cardiovascular disease (CVD) risk profile (including biomarkers and cholesterol levels): Week -4 (screening), 0, 4, 12, 26 | — |
Countries
Denmark
Contacts
Public ContactCenter for Diaebetes Research
Center for Diaebetes Research
Outcome results
None listed