Type 2 diabetes mellitus
Conditions
Interventions
Trade Name: Victoza (Liraglutide)
Product Name: Victoza
Product Code: EMA/354054/2016
Pharmaceutical Form: Solution for injection in pre-filled pen
Sponsors
Academic Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 28 -75 years of age 2. Treatment with long acting insulin = 2 years 3. On daily long acting insulin dose = 1 U/kg 4. BMI = 24 and = 40 kg/m2 5. HbA1c = 8.0% (64 mmol/mol) 6. Fasting C-peptide = 500 pmol/L (1.5 ng/ml) 7. Willing to comply with study requirements and able to understand and comply with informed consent 8. Willing to sign an informed consent form 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 16 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Diagnosed with Type 1 Diabetes or with a history of ketoacidosis 2. Fasting C-peptide < 500 pmol/L (1.5 ng/ml) 3. Current use of multiple daily doses insulin or insulin pump 4. Current use of a sulfonylurea derivate or meglitinide 5. Known autoimmune disease, as evidenced by a positive Anti-GAD test, including Celiac disease, or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder 6. Previous GI surgery that could affect the ability to treat the duodenum such as subjects who have had a Bilroth 2, Roux-en-Y gastric bypass, or other similar procedures or conditions 7. History of chronic or acute pancreatitis 8. Known active hepatitis or active liver disease 9. Symptomatic gallstones or kidney stones, acute cholecystitis or history of duodenal inflammatory diseases including Crohn’s Disease and Celiac Disease 10. History of coagulopathy, upper gastro-intestinal bleeding conditions such as ulcers, gastric varices, strictures, congenital or acquired intestinal telangiectasia 11. Use of anticoagulation therapy (such as phenprocoumon and acenocoumarol) and novel oral anticoagulants (such as rivaroxaban, apixaban, edoxaban and dabigatran) which cannot be discontinued for 7 days before and 14 days after the procedure 12. Use of P2Y12 inhibitors (clopidogrel, pasugrel, ticagrelor) which cannot be discontinued for 14 days before and 14 days after the procedure. Use of aspirin is allowed. 13. Unable to discontinue NSAIDs (non-steroidal anti-inflammatory drugs) during treatment through 4 weeks post procedure phase 14. Taking corticosteroids or drugs known to affect GI motility (e.g. Metoclopramide) 15. Receiving weight loss medications such as Meridia, Xenical, or over the counter weight loss medications 16. Persistent Anemia, defined as Hgb<10 g/dl 17. eGFR or MDRD <30 ml/min/1.73m^2 18. Active systemic infection 19. Active malignancy within the last 5 years 20. Not potential candidates for surgery or general anesthesia 21. Active illicit substance abuse or alcoholism 22. Participating in another ongoing clinical trial of an investigational drug or device 23. Any other mental or physical condition which, in the opinion of the Investigator, makes the subject a poor candidate for clinical trial participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this pilot study is to evaluate the efficacy of the Duodenal Mucosal Resurfacing procedure combined with GLP-1 administration and lifestyle intervention in subjects with insulindependent type 2 diabetes. Study success is defined as insulin independence at 6 months after DMR with an HbA1c level of = 7.5%. ;Secondary Objective: The second objective of this pilot study is to identify cardiovascular, metabolic and hepatic health benefits accompanied by this changed treatment strategy. The results of this pilot study will be used to estimate an effect size of this combined treatment in previously insulin dependent subjects. This effect size will be used for an adequate sample size calculation for a subsequent randomized controlled trial. ;Primary end point(s): Protocol driven free of insulin at 6 months including and an HbA1c = 7.5%.;Timepoint(s) of evaluation of this end point: At 6 months follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): a. HbA1c b. Change in HbA1c c. Achieving target HbA1c of 7% d. FPG e. Change in FPG f. Peak and AUC glucose in MMTT g. Gut hormones in MMTT h. Pancreatic hormones in MMTT i. Metabolic profile from MMTT j. HOMA IR k. Insulin sensitivity l. Beta cell function m. MRFF n. ALT and AST o. Change in AST and ALT p. Fibrosis-4 (FIB-4) score q. Change in FIB-4 score r. Urine microalbumin s. Blood pressure t. DEXA body scan;Timepoint(s) of evaluation of this end point: At 3 (if applicable) and 6 months follow-up | — |
Countries
Netherlands
Contacts
Public ContactAnnieke van Baar
Academic Medical Center
Outcome results
None listed