Trial record 1 of 1 for:
NCT01206101
Efficacy and Safety of Liraglutide in Subjects With Type 1 Diabetes Undergoing Islet Cell Transplantation
This study has suspended participant recruitment.
Sponsor:
Novo Nordisk
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01206101
First received: September 20, 2010
Last updated: May 14, 2013
Last verified: May 2013
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Purpose
This trial is conducted in Europe and North America. The aim of this trial is to investigate if liraglutide treatment can increase the proportion of insulin-independent subjects one year after islet cell transplantation who required only one (single-donor) islet cell transplant.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Diabetes Mellitus, Type 1 |
Drug: liraglutide Drug: placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A 52 Week Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multi-Center, Multinational Trial In Islet Cell Transplant Subjects With Type 1 Diabetes Mellitus To Determine If The Early Use Of Liraglutide As An Adjunct To Standard Care Increases The Proportion Of Subjects Achieving Insulin Independence After First Transplantation |
Resource links provided by NLM:
Genetics Home Reference related topics:
type 1 diabetes
Drug Information available for:
Liraglutide
U.S. FDA Resources
Further study details as provided by Novo Nordisk:
Primary Outcome Measures:
- Proportion of insulin-independent subjects after receiving only one (single-donor) islet cell transplant [ Time Frame: at week 52 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Number of hypoglycaemic episodes [ Time Frame: During weeks 0-52 ] [ Designated as safety issue: No ]
- The proportion of subjects with HbA1c below or equal to 6.5% at week 52 that are free from severe hypoglycaemic events [ Time Frame: From week 0 to week 52 after initial transplantation ] [ Designated as safety issue: No ]
- The proportion of insulin independent subjects [ Time Frame: at 52 weeks after initial transplantation among all randomised subjects having one or more transplantations after randomisation. ] [ Designated as safety issue: No ]
- Change in islet cell yield during culture [ Time Frame: From (0 hours) pre-culture to (24 to 72 hours) post-culture ] [ Designated as safety issue: No ]
- Glucose level variability and hypoglycaemia duration derived from the continuous glucose monitoring system (CGMS) [ Time Frame: 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) ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | April 2015 |
| Estimated Primary Completion Date: | January 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Liraglutide |
Drug: liraglutide
Dose escalation of liraglutide up to 1.2 to 1.8 mg before islet cell transplant until the planned number of transplanted subjects is complete or subject is transplanted. After islet cell transplant, subjects continue to receive the reached liraglutide dose for 52 weeks. Injected subcutaneously(under the skin) once daily.
|
| Placebo Comparator: Liraglutide placebo |
Drug: placebo
Dose escalation escalation of liraglutide up to 1.2 to 1.8 mg before islet cell transplant until the planned number of transplanted subjects is complete or subject is transplanted. After islet cell transplant, subjects continue to receive the reached liraglutide placebo dose for 52 weeks. Injected subcutaneously (under the skin) once daily.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Type 1 diabetes mellitus for at least 5 years
- Candidate for islet cell transplantation based upon local accepted practice and guidelines
- Reduced awareness of hypoglycaemia
Exclusion Criteria:
- Treatment with any anti-diabetic medication other than insulin including insulin pump within 4 weeks of trial start
- Any previous organ transplantation
- A history of acute idiopathic or chronic pancreatitis
- Family or personal history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma (FMTC)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01206101
Locations
| United States, Wisconsin | |
| Novo Nordisk Clinical Trial Call Center | |
| Madison, Wisconsin, United States, 53792-0001 | |
| Canada, Alberta | |
| Edmonton, Alberta, Canada, T6G 2C8 | |
| France | |
| Strasbourg, France, 67091 | |
| Germany | |
| Dresden, Germany, 01307 | |
| Switzerland | |
| Genève 14, Switzerland, 1211 | |
| United Kingdom | |
| Headington, United Kingdom, OX3 7LJ | |
Sponsors and Collaborators
Novo Nordisk
Investigators
| Study Director: | Birgitte Claudius | Novo Nordisk |
More Information
Additional Information:
No publications provided
| Responsible Party: | Novo Nordisk |
| ClinicalTrials.gov Identifier: | NCT01206101 History of Changes |
| Other Study ID Numbers: | NN2211-3619, 2009-013090-18, U1111-1114-8952 |
| Study First Received: | September 20, 2010 |
| Last Updated: | May 14, 2013 |
| Health Authority: | Canada: Health Canada France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices Switzerland: Swissmedic United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Autoimmune Diseases Immune System Diseases |
Glucagon-Like Peptide 1 Incretins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013