Safety and Efficacy of Vildagliptin Versus NPH Insulin add-on to Glimepiride in Type 2 Diabetes Mellitus Patients.

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized Open-label Study to Compare 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.

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: LAF237
* Drug: Protaphane


Participation Criteria
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Eligibility Criteria
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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 Exclusion Criteria: Patients who are taking any other anti-diabetes drug (oral or injection) other than an SU component in the preceding 12 weeks. Acute metabolic conditions such a ketoacidosis, lactic acidosis or hyperosmolar state within the past 6 month Patients taking sulfonylurea for longer than 5 years History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures pregnancy Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vildagliptin<br>Patients randomized to the vildagliptin group will receive 50mg vildagliptin once daily add-on to their current glimepiride monotherapy for 24 weeks. No dose titrations are permitted during the study. | Drug: LAF237<br>* Vildagliptin will be used as commercially available tablets of 50mg.<br>|
| Active Comparator: Protaphane<br>Patients randomized to the Protaphane group will receive a individualized dose of Protaphane once daily as bedtime dose. The Protaphane dose will be titrated within the first 4 weeks to reach fasting plasma glucose values below 100 mg/dl. | Drug: Protaphane<br>* Protaphane will be used as commercially available injection pens<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients reaching HbA1c below 7.0% without confirmed hypoglycemia and weight gain | 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. | 24 weeks | 
| Rate of confirmed hypoglycemic events | 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. | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of severe hypoglycemic events | 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. | 24 weeks | 
| Incidence of symptomatic hypoglycemic events | To evaluate the incidence of symptomatic hypoglycemic events in patients treated with vildagliptin versus NPH insulin add-on to glimepiride. | 24 weeks | 
| Percentage of patients who reach their blood glucose target (HbA1c below 7.0%) without any confirmed hypoglycemic event | 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. | 24 weeks | 
| Change from baseline in body weight at 24 weeks | To evaluate body weight changes between study begin and study end in patients treated with vildagliptin versus NPH insulin add-on to glimepiride. | Baseline, 24 week | 
| Change from baseline in HbA1c at 24 weeks | To evaluate changes in HbA1c between study begin and study end in patients treated with vildagliptin versus NPH insulin add-on to glimepiride. | Baseline, 24 week | 
| Change from baseline in Treatment Satisfaction Questionnaire for Medication (TSQM-9) at 24 week | The TSQM-9 is a psychometrically sound and valid measure of the major dimensions of patients' satisfaction with medication. | Baseline, 24 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 diabetes mellitus, diabetes