Efficacy and safety of liraglutide in subjects with type 1 diabetes undergoing islet cell

• Conditions: Diabetes Mellitus, Type 1; MedDRA version: 15.0Level: PTClassification code 10067584Term: Type 1 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2009-013090-18-DE
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07-28
• Last Update Posted: 18 March 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Diagnosis of type 1 diabetes (T1DM) for >= 5 years
• Men or women 18-65 years of age (both inclusive) at the time of screening
•Involvement in intensive diabetes management defined as self-monitoring of glucose values no less than a mean of three times each day averaged over each week and by the administration of three or more insulin injections each day or insulin pump therapy. Such management must be under the direction of an endocrinologist, diabetologist or diabetes specialist with at least 3 clinical evaluations during the 12 months prior to study enrolment.
• Evidence of at least 1 episode of severe hypoglycaemia per ADA criteria during the 12 months prior to study screening
• Evidence of reduced awareness of hypoglycaemia prior to randomisation, as defined by one or more of the following:
a.Clarke score of 4 or more (see Appendix K)
OR
b.HYPO score >= 1000 (see Appendix K)
OR
c.Glycaemic lability despite optimal diabetes therapy defined by a Lability Index (LI score >= 400 mmol/L^2/h·wk^-1) (see Appendix K)
OR
d. The combination of a HYPO score >= 400 and a LI >= 300
• Evidence of adequate pre-existing renal reserve prior to screening, as determined by BOTH of the following criteria:
a. Glomerular filtration rate >60 mL/min/1.73 m^2 estimated by the MDRD equation based on serum creatinine (As specified by National Kidney Disease Education Program [NKDEP] at http://www.nkdep.nih.gov/professionals/gfr_calculators/index.htm)
AND
b. Albumin excretion rate < 300 mg/g creatinine

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 103
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 17

Exclusion Criteria

• A panel-reactive anti-HLA antibody > 20% analysed by local laboratory according to standard practice
• HbA1c >= 10%
• Fasting C-peptide > 0.5 ng/mL
• Any coagulopathy or medical condition requiring long-term anticoagulant therapy (e.g., warfarin) after transplantation (low-dose aspirin treatment is allowed) or subjects with a pre-transplant international normalised ratio (INR) >1.5
• Use of any medications to treat diabetes other than treatment with any
basal bolus insulin regimen including insulin pump within 4 weeks of enrolment
• Any previous organ transplantation
• A history of acute idiopathic or chronic pancreatitis

Study & Design

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