Type 2 diabetes mellitus receiving BOT Therapy or insulin therapy only MedDRA version: 14.1 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Trade Name: Lantus
Product Name: Lantus
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: INSULIN GLARGINE
CAS Number: 160337-95-1
Current Sponsor code: Lantus
Other d
Sponsors
ikfe GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Type 2 diabetes mellitus 2. Improvement of an existing BOT with Insulin Glargine + OAD or Insulin Glargine alone 3. HbA1c between 6.5% and 9.5% inclusively 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 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: 1. Type 1 diabetes mellitus 2. Instable OAD therapy during the last 6 weeks prior to the study 3. Severe retinopathy, hepatic or renal dysfunction or clinically relevant other major diseases 4. Lack of compliance or other justifications that, in the discretion of the investigator, precludes satisfactory participation in the study 5. Subject without legal capacity 6. Pregnant or lactating women 7. History of drug or alcohol abuse within the last five years prior to screening 8. Anamnestic history of hypersensitivity to the study drugs (or any component of the study drug) or to drugs with similar chemical structures 9. History of severe or multiple allergies 10. Treatment with any other investigational drug within 3 months prior to screening 11. Progressive fatal disease 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Collection of data sets regarding the use of titration algorithms for implementation of BOT with insulin Glargine in patients previously treated with insuline Glargine or for optimizing BOT by means of titration rules.;Secondary Objective: • Assessment of effectiveness of the applied titration rules. • Number of patients, with stable Glargine dose after 4 weeks ;Primary end point(s): Collection of 50 well documented clinical datasets applicable for the development of a long acting insulin titration meter (LTM);Timepoint(s) of evaluation of this end point: After 28 days of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Time to reach a stable dose of insulin Glargine applying the chosen algorithm - number of patients with stable dose of insulin Glargine after 28 days - type and nature of interfering conditions which might require an adaption of the algorithm;Timepoint(s) of evaluation of this end point: After 28 days of treatment | — |
Countries
Germany
Contacts
Public ContactContract Research Organistaion
ikfe CRO GmbH
Outcome results
None listed