Type 2 Diabetes mellitus MedDRA version: 12.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus
Conditions
Interventions
Trade Name: OnglyzaTM
Product Name: Saxagliptin
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: SAXAGLIPTIN
CAS Number: 361442-04-8
Concentration unit: mg milligram(s)
Concentration type:
Sponsors
ikfe GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Combination of OAD and basal insulin treatment (BOT) or intensified conventional therapy (ICT; > 2 injections of basal and prandial) or conventional insulin therapy (CIT; 1 or 2 injections of basal or biphasic) - HbA1c 1 year - Insulin dose 0.6 ng/l - Fasting glucose = 210 mg/dl - Full legal, mental and physical ability to give informed consent - Patient consent that the general physician will be informed of trial participation - Experience ion self measurement of blood glucose =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Type 1 Diabetes mellitus - History of drug or alcohol abuse within the last five years prior to screening - History of severe or multiple allergies - Progressive fatal disease - History of significant cardiovascular, respiratory, gastrointestinal, hepatic (ALAT and/or ASAT > 3 times the normal reference range), neurological, psychiatric and/or haematological disease as judged by the investigator - renal insufficiency or history of significant renal diseases (creatinine clearance lower than 60ml/min determined using the Cockroft-Goult equation) - Contra-indications for study drugs including contraindications for the rescue drugs - Anamnestic history of hypersensitivity to the study drugs or to drugs with similar chemical structures - Pregnancy or breast feeding - Sexually active women of childbearing potential not consistently and correctly practicing birth control by implants, injectables, combined oral contraceptives, hormonal intrauterine devices (IUDs), sexual abstinence or vasectomised partner - Treatment with any other investigational drug within 3 months prior to screening - Lack of compliance or other similar reason, that according to investigator, precludes satisfactory participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to show the effect of a switch from insulin therapy (BOT or ICT or CIT) to an oral therapy with saxagliptin & metformin over a period of six months in comparison to continuation of insulin therapy. Primary endpoint is the percentage of patients with stable HbA1c (no increase: delta < 0.5%) after switch. ;Secondary Objective: The secondary objectives are the impact of the switch on biomarkers of insulin resistance and ß-cell function, biomarkers of cardiovascular risk, patient treatment satisfaction, treatment costs, and requirement of 3rd line pioglitazone as rescue drug as well as on an oral glucose tolerance test (oGTT). Further the impact of the switch on the macrophage activation is a secondary objective in a subgroup at the site 01.;Primary end point(s): Primary endpoint is the percentage of patients with stable HbA1c after switch from insulin therapy (BOT or ICT or CIT) to an oral therapy with metformin & saxagliptin. | — |
Countries
Germany
Outcome results
None listed