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

Phase 4

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: LAF237; Drug: Protaphane

• Registration Number: NCT01649466
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-07-20
• Study First Submitted QC: 2012-07-24
• Study First Posted: 2012-07-25
• Study Start: 2012-08
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-16
• Last Update Posted: 2016-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 162

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vildagliptin	LAF237	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.
Protaphane	Protaphane	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.
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.
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.

Trial Locations

Locations (1)

Novartis Investigative Site; 🇩🇪 Würzburg, Germany