Type 2 diabetes mellitus MedDRA version: 18.0 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Trade Name: TRAJENTA®
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: LINAGLIPTIN
CAS Number: 668270-12-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration numbe
Sponsors
Profil Institut für Stoffwechselforschung GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Signed and dated written informed consent obtained before any study-related activities. 2. Have Type 2 diabetes mellitus based on the disease diagnostic criteria (WHO) classification on ongoing insulin therapy on a stable regimen of antidiabetic treatment other than metformin , GLP-1 agonists and DPP-4 antagonists for the previous 6 weeks (participants using either of these therapies will be asked to stop their treatment until the end of the study. They will be allowed a wash-out period of 6 weeks before the first GTT will be performed). 3. Male or female subjects aged between 18 and 75 years, inclusive. 4. Have an HbA1c level between 7.0-9.5 %. 5. Medical history without major pathology (with the exception of type 2 diabetes) as judged by the investigator. 6. Ability and willingness to abstain from grapefruit juice (and all grapefruit containing products) throughout the study starting 12 hours prior to first study test and from alcohol, methylxanthine-containing beverages or food (coffee, tea, Coke, chocolate, “power drinks”), tobacco products and from engaging in strenuous physical activity from 12 hours prior to each admission until discharge from the unit. 7.For female patients of childbearing potential: Use of acceptable method of contraception (Pearl-Index =65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: 1. Subjects with type 1 diabetes, maturity onset diabetes of the young (MODY) or secondary forms of diabetes such as due to pancreatitis. 2. Current or previous treatment (less than 6 weeks) with metformin, DPP-4 inhibitors or GLP-1 analogues. 3. Have any contraindications, known allergy, or hypersensitivity to linagliptin. 4. Have participated in an interventional medical, surgical, or pharmaceutical study within the last three months prior to entry into the study. 5. Women of child-bearing age who are pregnant, or plan a pregnancy. 6. Subjects on systemic glucocorticoid treatment (except topic or inhalative preparations) within the last 3 months prior to screening. 7. Subjects that underwent surgery of the upper gastrointestinal tract. 8. Subjects with any severe medical or surgical history of conditions likely to confound study assessments or study endpoints, for example but not limited to haemoglobinopathies, inflammatory bowel disease, cystic fibrosis, bariatric surgery and/or any surgery shortening the intestine, history of galactose intolerance, lactose- or glucose-galactose-malabsorption. 9. Subjects with a suspicion for medullar thyroid cancer or a multiple endocrine neoplasia will undergo a calcitonine measurement. 10. Subjects with a personal or family history of medullar thyroid cancer or a multiple endocrine neoplasia. 11. Serious and/or unstable coronary heart disease (unstable angina, myocardial infarction within the preceding 6 months), congestive heart failure of New York Heart Association Class II or worse (slight limitation of physical activity; comfortable at rest, but ordinary physical activity results in fatigue, palpitation, or dyspnoea), second/third degree heart block, superior vena cava syndrome, uncontrolled hypertension, history of congenital QTsyndrome within family, history of stroke (within the preceding 6 months) or serious peripheral vascular disease. 12. Marked diabetic complications with the exception of peripheral neuropathy: severe autonomic neuropathy including gastroparesis; proliferative retinopathy as judged by the Investigator. 13. Clinically significant vital signs including known bradycardia with pulse rate 450 msec for males or QTc > 470 msec for women (if first ECG shows increased values, 2 further ECGs will be performed at least 2 minutes apart and values will be averaged). 14. Clinically significant abnormal haematology, biochemistry, or coagulation screening tests, as judged by the Investigator. 15. Clinical or laboratory evidence of hepatic dysfunction or disease; laboratory evidence defined as any of the following parameters: ?-GT, ALT, or AST > 3x ULN. 16. Chronic pancreatitis. 17. Uncontrolled high blood pressure (DBP > 95 mmHg and/or SBP > 160 mmHg), unless clearly documented to be white-coat hypertension. 18. History of any psychiatric condition that might impair the subject’s ability to understand or to comply with the requirements of the study or to provide informed consent. 19. History of relevant drug and/or food allergies or a history of severe anaphylactic reaction. 20. Not willing to abstain from any consume of tobacco containing products 12 hours prior to each admission until discharge. 21. Currently active or history of alcohol abuse (defined as an intake of more than 24 units of alcohol per week; one unit of alcohol equals approximately 250 mL of beer, 100 mL o
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To quantify differences in GLP-1 concentrations;Secondary Objective: To quantify differences in the secretion of GIP, insulin and C-peptide;Primary end point(s): Change in active GLP-1 concentrations (incremental AUC 0-240 min and ANOVA) after oral glucose ingestion after linagliptin treatment compared between Groups.;Timepoint(s) of evaluation of this end point: End of study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ?AUCGIP-OGTT(0-240): Change in active GIP concentrations after oral glucose ingestion after linagliptin treatment compared between Groups. ?AUCIns-OGTT(0-240): Change in insulin (Ins) concentrations after oral glucose ingestion after linagliptin treatment compared between groups. ?AUCGG-OGTT(0-240): Change in glucagon (GG) concentrations after oral glucose ingestion after linagliptin treatment compared between Groups. ?InsPh1 and ?InsPh2: Change in first (Ph1)- and second-phase (Ph2) insulin secretion after i.v. glucose administration after linagliptin treatment compared between Groups ?AUCGG-ivGTT(0-120): Change in glucagon levels after i.v. glucose administration after linagliptin treatment compared between Groups.;Timepoint(s) of evaluation of this end point: End of study | — |
Countries
Germany
Contacts
Public ContactRA
Profil Institut für Stoffwechselforschung GmbH
Outcome results
None listed