Safety and Efficacy of Vildagliptin Plus Metformin (SPC) Treatment in Type 2 Diabetes Mellitus Patients

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A Prospective, Open-label, Interventional Study to Assess the HbA1c Change an 24-hr Glucose Fluctuation After Vildagliptin Plus Metformain (SPC) Treatment in Metformin Monotherapy Uncontrolled Type 2 Diabetes Mellitus Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01582243
• Other study ID #: CLAF237ATW03
• Status: Completed
• Phase: Phase 4
• First received: April 18, 2012
• Last updated: November 5, 2015
• Start date: April 2013
• Est. completion date: September 2015

Study information

• Verified date: November 2015
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

This study will assess the efficacy of vildagliptin plus metformin (SPC) treatment in type 2 diabetes mellitus patients uncontrolled by metformin monotherapy after 24 weeks treatment

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Outpatients who are 20 years of age or older with diagnosis of T2DM

• Patients who have been treated with stable dose of metformin (=1000 mg/day) monotherapy at least 4 weeks prior to Visit 1 and have failed to achieve the glucose control goal (defined as HbA1c =6.5%)

Exclusion Criteria:

• Patients with renal dysfunction defined as creatinine clearance <50 ml/min at Visit 1

• Patients with history of hepatic impairment but not limited to those with pretreatment AST or ALT >2.5x ULN at Visit 1

Other protocol-defined inclusion/exclusion criteria may apply.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Vildagliptin
Vildagliptin 50 mg plus metformin 500 mg as Single Pill combination (SPC)

Locations

Country	Name	City	State
Taiwan	Novartis Investigative Site	Changhua

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in glycosylated hemoglobin (HbA1c) at week 24	HbA1c analysis will be performed on a blood sample obtained by study personnel at every visit.	Baseline, Week 24 +/- 4 weeks	No
Secondary	Change from baseline in glycosylated hemoglobin (HbA1c) at week 12	HbA1c analysis will be performed on a blood sample obtained by study personnel at every visit.	Baseline, week 12 +/- 4 weeks	No
Secondary	Change from baseline in fasting plasma glucose(FPG) at week 12 and 24	FPG analysis will be performed on a blood sample obtained by study personnel at every visit.	Baseline, week 12 +/- 4 weeks, week 24 +/- 4 weeks	No
Secondary	Change from baseline in postprandial plasma glucose(PPG) at week 12 and 24	PPG analysis will be performed on a blood sample obtained by study personnel at every visit.	Baseline, week 12 +/- 4, week 24 +/- 4	No
Secondary	Change from baseline in mean amplitude of glycemic excursions (MAGE) by 72-hour continuous glucose monitoring system (CGMS) after 24-week	CGMS sensor will be inserted 3 days prior to visit 2 and removed at visit 2 (day 1), and 3 days prior to Visit 5 (Week 24 ±4 weeks) and removed at Visit 5. 72-hr CGMS records before and after vildagliptin treatment will be collected.	Baseline, week 24 +/- 4 weeks	No
Secondary	Percentage of patients reaching the glycemic goal at week 12 and 24	Patients reaching glycemic goal of HbA1c = 6.5% and = 7.0% at week 12 and 24 will be calculated respectively.	week 12 +/- 4 weeks, week 24 + / - 4 weeks	No
Secondary	Number of patients with adverse events, serious adverse events and hypoglycemic events		24 weeks (+/- 4 weeks)	Yes