A trial investigating liraglutide on the liver glucose production during induced hypoglycaemic in type 1 diabetes mellitussubjects

Phase 1

• Conditions: Diabetes Mellitus Type 1; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2014-001381-96-AT
• Lead Sponsor: Medizinische Universität Graz / Endokrinologie und Stoffwechsel

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05-14
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
2.Type 1 diabetes mellitus as diagnosed (including I - III):
I.history of type 1 diabetes mellitus manifestation with acute hyperglycaemia and ketonuria
II.positive results for at least one of four islet antibodies (glutamic acid decarboxy-lase, protein tyrosine phosphatase, zinc transporter 8, or islet cell antibodies)
III.residual basal fasting C-peptide of = 0.1 nmol/L
3.Male or female, aged 18 – 64 years (both inclusive)
4.Body mass index (BMI) 19.0 - 28.0 kg/m2 (both inclusive)
5.HbA1c = 80 mmol/mol (= 9.5%)
6.Treated with daily insulin injections or continuous s.c. insulin infusion (CSII) = 1 months. Stable insulin dose as judged by the investigator
7.Able and willing to perform self-monitoring of PG according to the protocol, to keep a diabetes diary and willing to use liraglutide pen-device
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 15
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Known or suspected hypersensitivity to trial product(s) or related products
2.Use of liraglutide or exenatide within 3 months before screening
3.Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the last 3 months)
4.Severe hypoglycaemia within 1 month of screening
5.Hypoglycaemia unawareness as judged by the Investigator or hospitalisation for dia-betic ketoacidosis during the previous 2 months
6.Clinically significant abnormal haematology, biochemistry, lipids, or urinalysis or coagulation screening tests, as judged by the investigator and any of the following laboratory safety results:
•ASAT, ALAT, lipase, alkaline phosphatase > 2.0 times upper limit of reference range (ULN)
•Haemoglobin < 8.0 mmol/L (male) or < 6.4 mmol/L (female), total leukocyte count < 3.0 x 109/L, thrombocytes <100 x 109/L
•Serum creatinine levels = 126 µmol/L (male) or = 111 µmol/L (female)
•Amylase above normal range
7.Screening calcitonin > 50 ng/L
8.Family or personal history of multiple endocrine neoplasia type 2 (MEN2), or family history of medullary thyroid cancer (MTC)
9.Personal history of non-familial medullary thyroid carcinoma
10.History of chronic or idiopathic acute pancreatitis
11.Suffer from or history of a life threatening disease (e.g. cancer except basal cell skin cancer or squamous cell skin cancer), or any clinically significant respiratory, meta-bolic, renal, hepatic, gastrointestinal, endocrinological (with the exception of diabetes mellitus and euthyroid struma), haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders as judged by the investigator.
12.Cardiac problems defined as decompensated heart failure (New York Heart Associa-tion (NYHA) class III and IV) at any time and/or angina pectoris within the last 12 months prior to screening and/or acute myocardial infarction at any time.
13.Supine blood pressure at screening (after resting for 5 min) outside the range of 90?140 mmHg for systolic or 50?90 mmHg for diastolic (repeated measurement on a second screening Visit allowed to exclude white-coat hypertension). This exclusion criterion also pertains to subjects being on antihypertensives.
14.Clinically significant abnormal ECG at screening, as judged by the investigator.
15.Proliferative retinopathy or maculopathy and/or severe neuropathy, in particular auto-nomic neuropathy, as judged by the investigator.
16.Any disease or condition that, in the opinion of the investigator, would represent an unacceptable risk for the subject’s safety.
17.Subject positive for Hepatitis B surface antigen (HBsAg) or Hepatitis C antibodies (or diagnosed with active hepatitis according to local practice).
18.Positive result of the screening test for HIV-1 antibodies, HIV-2 antibodies and/or HIV-1 antigen according to locally used diagnostic testing.
19.History of multiple and/or severe allergies to drugs or foods or a history of severe ana-phylactic reaction.
20.Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening.
21.Surgery or trauma with significant blood loss (more than 500 mL) within the last 3 months prior to screening.
22.Current treatment with systemic (oral or i.v.) corticosteroids, MAO inhibitors, non-selective beta-blockers, growth hormone, herbal products or non-routine vitamins. Fur-thermore, thyroid hormones are not allowed unless the use of these has been stable during the p

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified