Type 2 Diabetes Mellitus
Conditions
Keywords
Type 2 diabetes mellitus, diabetes
Brief summary
This study is designed to evaluate safety and efficacy of vildagliptin versus NPH insulin add-on to glimepiride in patients with type 2 diabetes mellitus that do not reach adequate glycemic control on their current sulfonylurea monotherapy to give treating physicians a guidance which additional anti-diabetic treatment can be used if sulfonylurea monotherapy is not sufficient to reach glycemic control.
Interventions
DRUGLAF237
Vildagliptin will be used as commercially available tablets of 50mg.
DRUGProtaphane
Protaphane will be used as commercially available injection pens
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Confirmed diagnosis of type 2 diabetes mellitus. * Contraindicated or intolerant to take metformin. * HbA1c of ≥ 7.0% and ≤ 8.5% * Current sulfonylurea (glimepiride) monotherapy and judged by the investigator to be inadequately controlled * Other protocol-defined inclusion/
Exclusion criteria
may apply
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients reaching HbA1c below 7.0% without confirmed hypoglycemia and weight gain | 24 weeks | Primary endpoint is proportion of patients reaching the combined endpoint, defined as a blood glucose target (HbA1c below 7.0%) without any confirmed hypoglycemic events (BG measurement \< 3.9mM (71mg/dL)) and weight gain. |
| Rate of confirmed hypoglycemic events | 24 weeks | Co-primary endpoint is to evaluate the rate of confirmed hypoglycemic events (BG measurement \< 3.9mM (71mg/dL)) in type 2 diabetes patients treated with vildagliptin versus NPH insulin add-on to glimepiride. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients who reach their blood glucose target (HbA1c below 7.0%) without any confirmed hypoglycemic event | 24 weeks | To evaluate the percentage of patients treated with vildagliptin versus NPH insulin add-on to glimepiride who reach their blood glucose target (HbA1c below 7.0%) without any confirmed hypoglycemic events. |
| Change from baseline in body weight at 24 weeks | Baseline, 24 week | To evaluate body weight changes between study begin and study end in patients treated with vildagliptin versus NPH insulin add-on to glimepiride. |
| Incidence of severe hypoglycemic events | 24 weeks | To evaluate the incidence of severe hypoglycemic events (suspected grade 2 and confirmed grade 2 events) in patients treated with vildagliptin versus NPH insulin add-on to glimepiride. |
| Change from baseline in Treatment Satisfaction Questionnaire for Medication (TSQM-9) at 24 week | Baseline, 24 week | The TSQM-9 is a psychometrically sound and valid measure of the major dimensions of patients' satisfaction with medication. |
| Change from baseline in HbA1c at 24 weeks | Baseline, 24 week | To evaluate changes in HbA1c between study begin and study end in patients treated with vildagliptin versus NPH insulin add-on to glimepiride. |
| Incidence of symptomatic hypoglycemic events | 24 weeks | To evaluate the incidence of symptomatic hypoglycemic events in patients treated with vildagliptin versus NPH insulin add-on to glimepiride. |
Countries
Germany
Outcome results
None listed