Diabetes Mellitus, Type 1 MedDRA version: 15.0 Level: PT Classification code 10067584 Term: Type 1 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Trade Name: Victoza
Product Name: Victoza
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Liraglutide
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Conce
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range 17
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to investigate if treatment with liraglutide can increase the proportion of subjects who are insulin-independent one year after islet cell transplantation, and required only one (single-donor) islet cell transplant.;Secondary Objective: The secondary objective is to investigate the safety of liraglutide treatment in subjects undergoing islet cell transplantation.;Primary end point(s): Proportion of subjects who are insulin-independant at 52 weeks after islet cell transplant, and required only one (single-donor) islet cell transplant.;Timepoint(s) of evaluation of this end point: At week 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. The proportion of subjects with HbA1c 6.5% at week 52 that are free from severe hypoglycaemic events from week 0 to week 52 after initial transplantation 2. The proportion of insulin independent subjects who at 52 weeks after initial transplantation among all randomised subjects having one or more transplantations after randomisation. 3. The average number of transplantations for all randomised subjects having one or more transplantations after randomisation 4. Glucose level variability and hypoglycaemia duration derived from the continuous glucose monitoring system (CGMS) at baseline, weekly during liraglutide dose escalation, at 12 weeks pre-transplant, at 24 weeks post-transplant, 52 weeks post-transplant and 56 weeks (4 weeks after withdrawal of liraglutide or liraglutide placebo) 5. Change in islet cell yield during culture from (0 hours) pre-culture to (24 to 72 hours) post-culture ;Timepoint(s) of evaluation of this end point: 1. From week 0 to week 52 after initial transplantation 2. At 52 weeks 3. From week 0 to week 52 4. From week 0 to week 92 5. From 0 to 72 hours | — |
Countries
Canada, France, Germany, Switzerland, United Kingdom, United States
Contacts
Public ContactGlobal Clinical Registry (GCR,1452)
Novo Nordisk A/S
Outcome results
None listed