Type 2 diabetes mellitus
Conditions
Interventions
Trade Name: Lantus
Product Name: Lantus
Product Code: HOU901
Pharmaceutical Form: Solution for injection
INN or Proposed INN: insulin glargine
Current Sponsor code: HOE901
Concentration unit: IU inter
Sponsors
sanofi-aventis, s.r.o.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Men or women, aged from 18 to 80 years inclusive 2.Diabetes type 2 3.Patients treated NPH insulin with stable dosage of OADs for at least 2 months prior to study start and OADs treatment with metformin at lest 1,7 g /day in combination with sulfonylurea or glinides.. 4.Patients must have a HbA1c range of = 4,5% ( 6,2% DCCT) and = 8% ( 9,4 % DCCT) 5.Ability and willingness to perform CGMS 6.Written informed consent obtained prior to enrollment in the study 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.Fasting value C peptide = 400 pmol/l 2.Active proliferative diabetic retinopathy, as defined by the application of photocoagulation or surgery, in the 6 months retinopathy that may require photocoagulation or surgery during the study 3.Pregnancy women or women planning gravidity during clinical study protocol 4.Breast-feeding 5.History of hypersensitivity to the study drugs or to drugs with a similar chemical structure 6.Treatment with systemic corticosteroids in the 3 months prior to study entry and during study and other treatment, that can significantly have impression to glycaemia. 7.Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol 8.Clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major disease making implementation of the protocol or interpretation of the study results difficult 9.Impaired hepatic function as shown by Alamine aminotransferase (ALT) and/or Aspartate aminotransferase (AST) greater than three times the upper limit of normal range at study entry 10.Impaired renal function as shown by serum creatinine >/= 133 ?mol/L in men and >/= 124 ?mol/L 1 in women at study entry 11.History of drug or alcohol abuse in the last 12.Mental condition causing the patient unable to understand the nature, scope and possible consequences of the study 13.Patient unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits and unlikelihood of completing the study 14.Patient is the investigator or any sub-investigator, research assistant, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol 15.Use of insulin glargine outside the scope of the current SPC (Summary of Product Characteristics); 16.Patients included in other clinical studies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare blood glucose (BG) variability of the two treatment regimens (insulin Lantus as basal insulin vs insulin NPH) by the Continuous Glucose Monitoring System (CGMS®, Medtronic MiniMed, Inc.) in terms of Area Under Curve (AUC) for blood glucose( BG): = greater/equal 15 mmol/l, 10mmol/l and 7,5 mmol/l according to the mean change from baseline to the endpoint of study = smaller/equal 3,3 mmol/l and 3,9 mmol/l ;Secondary Objective: Change of -mean amplitude of glycaemic excursion from the baseline to the endpoint of study –time spending at the range of:=15mmol/l,=10mmol/l,=7,5mmol/l,further=3,3mmol/L and=3,9mmol/l -HbA1c,venous FBG,insulin doses -intra individual variability of capillary BG profile value from selfmonitoring by the BG meter during 4 weeks before CGMS with NPH and during last 4 weeks before CGMS with HOE901 -the evolution of BG profiles, data from SBGM To compare: -incidence of symptom. hypoglycaemia confirmed by PG=3.3mmol/l and without confirmation during NPH treatment phase with incidence during last 4 weeks before CGMS with HOE901 -incidence of severe hypoglycaemia during NPH treatment phase with incidence during last 4 weeks before CGMS with HOE901 -safety (AE, SAE) -change of secretion of stress hormones Stability of the body weight To determine whether the levels of transforming growth factor ß1 are influenced by actual glycaemia and/or long-term metabolic compensation;Primary end point(s): Area under curve (AUC) for bood glucose during CGMS: baseline and endpoint of study | — |
Countries
Czech Republic
Outcome results
None listed