NCT01206101 trial results
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
- Participants
- 3
- Status
- terminated
- Completed
- 2013-06-03
- Sponsor
- Novo Nordisk A/S
As posted on ClinicalTrials.gov (NCT01206101), updated at source Mar 30, 2017. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.
Side effects in NCT01206101
Percent of participants affected, Adverse events were collected from week 0 to week 52.. The most common events the registry lists.
| Event | Liraglutide | Liraglutide Placebo |
|---|---|---|
| Any serious event | 0% | 0% |
| Gastric ulcer | 0% | 100% |
| Nausea | 100% | 100% |
| Pyrexia | 0% | 100% |
| Pharyngitis | 0% | 100% |
| Computerised tomogram abnormal | 0% | 100% |
| Musculoskeletal chest pain | 0% | 100% |
| Headache | 50% | 100% |
| Depression | 0% | 100% |
| Nasal congestion | 0% | 100% |
| Vomiting | 50% | 0% |
| Fatigue | 50% | 0% |
| Decreased appetite | 50% | 0% |
| Hypoglycaemia | 50% | 0% |
How NCT01206101 was run
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.
- Liraglutide
- Liraglutide placebo
Who could join the trial
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)
Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.