Type II diabetes mellitus MedDRA version: 9.1 Level: LLT Classification code 10012601 Term: Diabetes mellitus
Conditions
Interventions
Trade Name: Lantus 100 Units/ml solution for injection in a pre-filled pen
Pharmaceutical Form: Solution for injection
INN or Proposed INN: INSULIN GLARGINE
Sponsors
Aventis Pharma Ltd trading as sanofi-aventis
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Main inclusion criteria: 1. Men or women, aged 18 to 75 2. Type 2 diabetes mellitus 3. Patients being treated with Lantus® once daily, Levemir once or twice daily or NPH insulin once or twice daily as a single insulin for at least three months 4. 11.0% = HbA1c = 7.5% 5. BMI =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Main exclusion criteria: 1. Type 1 diabetes mellitus 2. Current or previous treatment with an insulin other than basal insulin (biphasic insulin, short acting insulin, rapid-acting insulin analogue) in the 3 month prior to screening 3. Treatment with GLP-1 receptor agonists or with DPP-IV inhibitors in the 3 months before screening 4. Active proliferative diabetic retinopathy, as defined by the application of photocoagulation or surgery, in the 6 months before screening or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgery during the study (confirmed by an appropriate fundus examination performed in the 2 years prior to screening, such as retinal photograph or fundoscopy) 5. Unable or unwilling to enter either of the treatment arms 6. Women who are pregnant or lactating (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraceptive method) 7. History of hypersensitivity to the study drugs or to drugs with a similar chemical structure 8. Treatment with systemic corticosteroids in the 3 months prior to study entry 9. Treatment with any investigational product in the 2 months prior to study entry 10. Current treatment with any non-selective beta-blockers 11. Likelihood of requiring treatment during the study period with drugs not permitted by this clinical protocol 12. Clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major disease making implementation of the protocol or interpretation of the study results difficult 13. Impaired hepatic function as shown by ALT and/or AST greater than three times the upper limit of normal at screening 14. Impaired renal function as shown by serum creatinine>150 µmol/l in men or women at screening 15. History of drug or alcohol abuse 16. Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study 17. Patient unlikely to comply with protocol, e.g. uncooperative attitude, inability to return for follow-up visits, or unlikey to complete the study 18. Patient is the investigator or any sub investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol or a relative thereof.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Demonstrate non-inferiority at six months of a basal plus one insulin regimen (Lantus® plus one injection of Apidra®) compared with a biphasic insulin regimen (NovoMix® 30) at controlling HbA1c in type 2 diabetes.; Secondary Objective: a)To compare the proportion of patients in each treatment group reaching HbA1c target (< 7%) at the end of the treatment period. b)To compare the rates of hypoglycaemia (total, severe, nocturnal) c)To compare the change in body weight from visit 10 to visit 24 d)To compare the change in diabetes specific quality of life and other patient reported outcomes from visit 10 to visit 24. •Diabetes Treatment Satisfaction Questionnaire - status and change (DTSQs + c) •Audit of Diabetes-Dependent Quality of Life (ADDQoL) questionnaire •Insulin Treatment Satisfaction Questionnaire (ITSQ) •EuroQoL 5 Dimensions (EQ5D) questionnaire e)To record the change in the daily dose of insulin from visit 2 to visit 10 and visit 10 to visit 24 ; Primary end point(s): Primary Change in HbA1c from visit 9 or 9a and visit 24. Secondary • HbA1c value at visit 24 • Rates of hypoglycaemic episodes from visit 10 to visit 24 • Change in body weight from visit 10 to visit 24 • Change in diabetes specific quality of life and patient reported outcomes from visit 10 to visit 24 • Change in daily dose of insulin from visit 2 to visit 10 and visit 10 to visit 24 | — |
Countries
United Kingdom
Outcome results
None listed