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

Phase 4

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Vildagliptin

• Registration Number: NCT01582243
• Lead Sponsor: Novartis Pharmaceuticals

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-04-18
• Study First Submitted QC: 2012-04-19
• Study First Posted: 2012-04-20
• Study Start: 2013-04
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2016-09
• Results First Submitted: 2016-09-15
• Results First Submitted QC: 2016-09-15
• Last Update Submitted: 2016-09-15
• Results First Posted: 2016-11-03
• Last Update Posted: 2016-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vildagliptin plus metformin (SPC)	Vildagliptin	Eligible participants received oral vildagliptin 50 mg plus metformin 500 mg (SPC) twice daily from week 1 to week 24.

Primary Outcome Measures

Name	Time	Method
Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24	Baseline, Week 24	HbA1c analysis will be performed on a blood sample obtained by study personnel.

Secondary Outcome Measures

Name	Time	Method
Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12	Baseline, week 12	HbA1c analysis will be performed on a blood sample obtained by study personnel.
Mean Change From Baseline in Fasting Plasma Glucose(FPG) at Week 12 and 24	Baseline, week 12, week 24	FPG analysis will be performed on a blood sample obtained by study personnel.
Mean Change From Baseline in Postprandial Plasma Glucose(PPG) at Week 12 and 24	Baseline, week, week 24	PPG analysis will be performed on a blood sample obtained by study personnel.
Mean Change From Baseline in Mean Amplitude of Glycemic Excursions (MAGE) Detected by Continuous Glucose Monitoring System (CGMS) After 24-week	Baseline, week 24	Mean amplitude of glycemic excursions (MAGE), which was used to quantify major swings of glycaemia and assess intra-day glycemic variability, was measured by inserting continuous glucose monitoring system (CGMS) in patients for 72 consecutive hours before Day 1 (Visit 2) and Week 24 (Visit 5). In order to unify the different initial time and time of completion in each patient, only the data recorded from Day 2 00:00 to Day 3 23:59 with total 48 hours were analyzed.
The Percentage of Patients Achieving the Two Glycemic Goals After 12- and 24-week Treatment	week 12, week 24	Patients reaching glycemic goal of HbA1c ≤ 6.5% and ≤ 7.0% at week 12 and 24 will be calculated respectively.

Trial Locations

Locations (1)

Novartis Investigative Site; 🇨🇳 Changhua, Taiwan