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Completed

NCT Number: NCT01582243

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

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

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis Investigative Site

Changhua, 500, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Outpatients who were 20 years of age and older with diagnosis of T2DM.
  • 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%.
  • Male or female with child-bearing potential agreed to use an effective method of contraception approved by the investigator during the study.
  • Understood the nature of the study, and had signed informed consent form.

Exclusion criteria

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

Treatment and study plan

Vildagliptin

Drug

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

Other names: LAF237, Galvus Met

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Apr 20, 2012
Registry last updated
Nov 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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