Patients with Diabetes mellitus Type 2 and a stable basal supported oral therapy MedDRA version: 14.0 Level: PT Classification code 10053247 Term: Insulin-requiring type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Trade Name: Apidra
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Insulin Glulisine
CAS Number: 207748-29-6
Other descriptive name: INSULIN GLULISINE
Concentration unit: U/ml unit(s)
Sponsors
ikfe – Institute for Clinical Research and Development
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Type 2 diabetes mellitus 2. Stable BOT (basal oral therapy) with Insulin Glargine + = 1 OHA (oral hypoglycemic agent except for TZD) for a minimum of three months before entering the study 3. HbA1c = 8.5% 4. Age between 30 and 75 years inclusively 5. Body mass index = 40 kg/m2 6. Patient consents that his/her family physician will be informed of trial participation 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: 1. Type 1 diabetes mellitus 2. Unspecific infection or inflammation (hsCRP >10mg/L in POC test) 3. Use of thiazolidinediones within the last 3 months prior to study start 4. Retinopathy, hepatic or renal dysfunction or clinically relevant other major diseases 5. History of drug or alcohol abuse within the last five years prior to screening 6. Anamnestic history of hypersensitivity to the study drugs (or any component of the study drug) or to drugs with similar chemical structures 7. History of severe or multiple allergies 8. Treatment with any other investigational drug within 3 months prior to screening 9. Progressive fatal disease 10. History of significant cardiovascular, respiratory, gastrointestinal, hepatic (ALAT and/or ASAT > 3 times the normal reference range), renal (creatinine > 1.3 mg/dl in women and > 1.6 mg/dl in men), neurological, psychiatric and/or hematological disease as judged by the investigator 11. Pregnant or lactating women 12. 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 vasectomized partner 13. 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 evaluate the difference in percent increase of the oxidative stress biomarker nitrotyrosine after stimulation with a standardized meal.;Secondary Objective: The secondary objectives are the change in skin blood flow during stimulation by a standardized meal, the change in macrophage activation, MAPK/eNOS production levels, adiponectin and hsCRP (after test meal) from baseline to endpoint, the change in insulin and intact proinsulin and their ratio from baseline to endpoint, the blood glucose control: change during test meal, HbA1c and fasting blood glucose (FBG) from baseline to endpoint and the incidence of hypoglycemia from baseline to endpoint.;Primary end point(s): Nitrotyrosine baseline, after 10 weeks and after 24 weeks;Timepoint(s) of evaluation of this end point: after 0, 12 and 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Skin blood flow - mRNA expression of proinflammatory cytokines (MAPK/eNOS, adiponectin, hsCRP, MMP-9) - Insulin, intact Proinsulin - HbA1c - Fasting blood glucose ;Timepoint(s) of evaluation of this end point: after 0, 12 and 24 weeks | — |
Countries
Germany
Contacts
Public ContactCRO
ikfe CRO GmbH
Outcome results
None listed