Diabetes Mellitus type 2
Conditions
Interventions
One group receives HOE901-U300 as basal insulin and the other group receives
Lantus® (insulin glargine) as basal insulin.
Sponsors
Sanofi-aventis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients with type 2 diabetes mellitus
Exclusion criteria
Exclusion criteria: - Age 10% at screening; - Diabetes other than type 2 diabetes mellitus; - Less than 1 year on basal plus mealtime insulin and self-monitoring of blood glucose; - Patients using pre-mix insulins or basal insulins other than insulin glargine or NPH and patients using any non-insulin antihyperglycemic drugs other than metformin in the last 3 months before screening; - Any contraindication to use of insulin glargine as defined in the national product label; - Patients using human regular insulin as mealtime insulin in the last 3 months before screening visit; - Use of an insulin pump in the last 6 months before screening visit; - Initiation of new glucose-lowering agents and/or weight loss drugs in the last 3 months before screening visit; - History or presence of clinical significant macular edema likely to require treatment during the study period; - Most recent eye examination by an opthalmologist>12 months prior randomization visit - Pregnant or breast-feeding women or women who intend to become pregnant during the study period. - Patient who has taken other investigational drugs within 1 month or 5 half-lives, whichever is longer
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Main secondary endpoints: • Incidence of patients (%) with at least one nocturnal hypoglycemia between start of week 9 and endpoint (month 6), indicated as severe and/or confirmed by plasma glucose | — |
Primary
| Measure | Time frame |
|---|---|
| Efficacy: HbA1c [change from baseline to endpoint (week 24)] | — |
Countries
Netherlands
Outcome results
None listed