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

• ClinicalTrials.gov Identifier: NCT01582243
• Recruitment Status: Completed
• First Posted: April 20, 2012
• Results First Posted: November 3, 2016
• Last Update Posted: November 3, 2016
• Sponsor: Novartis Pharmaceuticals
• Information provided by (Responsible Party): Novartis ( Novartis Pharmaceuticals )

Study Description

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

Condition or disease	Intervention/treatment	Phase
Diabetes Mellitus, Type 2	Drug: Vildagliptin	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: April 2013
• Actual Primary Completion Date: September 2015
• Actual Study Completion Date: September 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: Vildagliptin plus metformin (SPC); Eligible participants received oral vildagliptin 50 mg plus metformin 500 mg (SPC) twice daily from week 1 to week 24.	Drug: Vildagliptin; Vildagliptin 50 mg plus metformin 500 mg as Single Pill combination (SPC); Other Name: LAF237, Galvus Met

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12 [ Time Frame: Baseline, week 12 ]
   HbA1c analysis will be performed on a blood sample obtained by study personnel.
2. Mean Change From Baseline in Fasting Plasma Glucose(FPG) at Week 12 and 24 [ Time Frame: Baseline, week 12, week 24 ]
   FPG analysis will be performed on a blood sample obtained by study personnel.
3. Mean Change From Baseline in Postprandial Plasma Glucose(PPG) at Week 12 and 24 [ Time Frame: Baseline, week, week 24 ]
   PPG analysis will be performed on a blood sample obtained by study personnel.
4. Mean Change From Baseline in Mean Amplitude of Glycemic Excursions (MAGE) Detected by Continuous Glucose Monitoring System (CGMS) After 24-week [ Time Frame: 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.
5. The Percentage of Patients Achieving the Two Glycemic Goals After 12- and 24-week Treatment [ Time Frame: week 12, week 24 ]
   Patients reaching glycemic goal of HbA1c ≤ 6.5% and ≤ 7.0% at week 12 and 24 will be calculated respectively.

Eligibility Criteria

• Ages Eligible for Study: 20 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion criteria

1. Outpatients who were 20 years of age and older with diagnosis of T2DM.
2. Patients who had been treated with stable dose of metformin (≥1000 mg/day) monotherapy at least 4 weeks prior to Visit 1 and had failed to achieve the glucose control goal. The glucose control goal was defined as HbA1c ≤ 6.5%.
3. Male or female with child-bearing potential agreed to use an effective method of contraception approved by the investigator during the study.
4. Understood the nature of the study, and had signed informed consent form.

Exclusion criteria

1. Patients with contraindications mentioned in the Summary of Product Characteristics for vildagliptin or metformin.
2. Patients with renal dysfunction defined as creatinine clearance < 60 ml/min at Visit 1.
3. Patients with history of hepatic impairment, including but not limited to those with pretreatment AST or ALT > 3 ULN at Visit 1.
4. Female patients who needed to lactate during the study.

Contacts and Locations

Locations

Taiwan

Novartis Investigative Site

Changhua, Taiwan, 500

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

• Study Director: Novartis Pharmaceuticals; Novartis Pharmaceuticals

More Information

• Responsible Party: Novartis Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT01582243
• Other Study ID Numbers: CLAF237ATW03
• First Posted: April 20, 2012
• Results First Posted: November 3, 2016
• Last Update Posted: November 3, 2016
• Last Verified: September 2016

Keywords provided by Novartis ( Novartis Pharmaceuticals ):

Diabetes Mellitus, type 2; vildagliptin

Additional relevant MeSH terms:

Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Vildagliptin; Hypoglycemic Agents; Physiological Effects of Drugs; Dipeptidyl-Peptidase IV Inhibitors; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action