Diabetes mellitus, beta-cell function before and after pancreatic surgery MedDRA version: 9.1 Level: LLT Classification code 10012601 Term: Diabetes mellitus
Conditions
Interventions
Trade Name: Galvus
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sponsors
Department of Medicine I, University Hospital St.Josef-Hospital, Ruhr University Bochum
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Protocol 1: (1) Age between 18 and 80 years, inclusive. (2) Elective partial pancreatic surgery has been recommended for medical reasons by reason of benign pancreatic diseases (e.g. chronic pancreatitis, pancreatic cysts, pancreatic duct obstruction, benign focal pancreatic lesions) and has been scheduled for a date later than 14 weeks after enrollment by the attending physician (protocol 1)or has been performed one day prior to study enrollment (protocol 2). (3) Presence of either impaired fasting glucose (IFG), impaired glucose tolerance (IGT), or diabetes mellitus (DM) according to ADA criteria. (4) Patients have an HbA1c not exceeding 10.0% and fasting plasma glucose not exceeding 240 mg/dl. (5) Female patients are not breastfeeding, and female patients of childbearing potential (not surgically sterilized and between menarche and 1-year postmenopause): 1. test negative for pregnancy at the time of screening based on a blood serum test, 2. intend not to become pregnant during the study, and 3. agree to use a reliable method of birth control (for example, oral contraceptives; a reliable barrier method of birth control [diaphragms with contraceptive jelly; cervical caps with contraceptive jelly; condoms with contraceptive foam; intrauterine devices]; partner with vasectomy) during the study, as determined by the investigator. Protocol 2: (1) Age between 18 and 80 years, inclusive. (2) Partial pancreatectomy (excluding total pancreatectomy) has been performed for benign pancreatic disease prior to study enrollment (protocol 2). (3) Patients have an HbA1c not exceeding 10.0% and fasting plasma glucose not exceeding 240 mg/dl. (4) Female patients are not breastfeeding, and female patients of childbearing potential (not surgically sterilized and between menarche and 1-year postmenopause): 1. test negative for pregnancy at the time of screening based on a blood serum test, 2. intend not to become pregnant during the study, and 3. agree to use a reliable method of birth control (for example, oral contraceptives; a reliable barrier method of birth control [diaphragms with contraceptive jelly; cervical caps with contraceptive jelly; condoms with contraceptive foam; intrauterine devices]; partner with vasectomy) during the study, as determined by the investigator. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Protocol 1: (1) Patients are investigator site personnel directly affiliated with the study, or are immediate family of investigator site personnel directly affiliated with the study. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted. (2) Patients have participated in an interventional medical, surgical, or pharmaceutical study (a study in which an experimental, drug, medical, or surgical treatment was given) within 30 days prior to screening. This criterion includes drugs that have not received regulatory approval for any indication at the time of study entry. (3) Patients have normal glucose tolerance according to ADA criteria. (4) Patients have fasting glucose concentrations > 240 mg/dl. (5) Patients are currently being treated with insulin, incretin mimetics, DPP-4 inhibitors or thiazolidinediones. (6) Indication for total pancreatectomy (protocol 1); total pancreatectomy (protocol 2) (7) Indication for partial pancreatectomy within 20 mg/l) or pancreatic cancer. (10) Patients have ongoing alcohol consumption (>20 g daily for males and >10 g daily for females). (11) Patients have Galactose intolerance, Lapp lactase deficiency or Glucose- Galaktose-malabsorption. (11) Patients have had greater than three episodes of severe hypoglycemia within 3 months prior to screening. (12) Patients are undergoing therapy for a malignancy, other than basal cell or squamous cell skin cancer. (13) Patients have cardiac disease that is Class III or IV, according to the New York Heart Association criteria. (14) Patients have a known allergy or hypersensitivity to vildagliptin, or excipients contained in these agents. (15) Patients have a history of renal transplantation or are currently receiving renal dialysis or have serum creatinine >1.8 mg/dL for males and greater than or equal to >1.5 mg/dL for females. (16) Patients have known haemoglobinopathy or chronic anemia. (17) Patients are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within 2 weeks immediately prior to screening. Protocol 2: (1) Patients are investigator site personnel directly affiliated with the study, or are immediate family of investigator site personnel directly affiliated with the study. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted. (2) Patients have participated in an interventional medical, surgical, or pharmaceutical study (a study in which an experimental, drug, medical, or surgical treatment was given) within 30 days prior to screening. This criterion includes drugs that have not received regulatory approval for any indication at the time of study entry. (3) Patients have fasting glucose concentrations > 240 mg/dl. (4) Patients have ongoing alcohol consumption (>20 g daily for males and >10 g daily for females). (5) Total pancreatectomy (6) Patients have alanine aminotransaminase (ALT) levels greater than ten five three times the upper limit of the reference range. (7) Patients have Aspartat-Aminotransferase (AST) levels greater
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Protocol 1: The primary objective of this study is to examine, whether 12 weeks of treatment with vildagliptin will increase the beta-cell function and turnover in humans. Protocol 2 (Study Extension): The primary objective of this study is to examine, whether 6 months of treatment with vildagliptin will increase the beta-cell function in humans.;Secondary Objective: Protocol 1: The secondary objectives are to investigate the effects of vildagliptin on: - frequency of beta-cell replication - frequency of beta-cell apoptosis - beta-cell mass - first-, second-phase and arginine-induced insulin secretion - oral glucose tolerance - insulin sensitivity Protocol 2 (Study Extension): The secondary objectives are to investigate the effects of vildagliptin on: - oral glucose tolerance - glucagon/insulin secretion ;Primary end point(s): Protocol 1: The histological frequency of beta-cell replication in the resected pancreatic tissue. Protocol 2: Glucagon-stimulated insulin secretion after 6 months of treatment with vildagliptin or placebo following partial pancreas resection. | — |
Countries
Germany
Outcome results
None listed