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Completed

NCT Number: NCT01497522

Efficacy and Safety of Vildagliptin as add-on Therapy to Metformin in Patients With Type 2 Diabetes

The purpose of the study is to evaluate the efficacy and safety of vildagliptin 50 mg bid as an add-on therapy to metformin in Japanese patients with T2DM. This study is being conducted to support registration of the fixed-dose combination of vildagliptin and metformin for the treatment of Type 2 diabetes mellitus (T2DM) in Japan.

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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 3

Primary location

Novartis Investigative Site, Fukuoka, Japan

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with type 2 diabetes inadequately controlled with diet, exercise and oral anti-diabetic therapy.
  • HbA1c in the range of 7.0-10.0%
  • Body mass index in the range 20-35 kg/m2

Exclusion criteria

  • Type 1 diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes
  • Significant heart diseases

Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

Vildagliptin

Drug

vildagliptin 50 mg twice daily

Other names: LAF237

Placebo

Drug

Matching Placebo of vildagliptin 50 mg twice daily

Primary outcomes

  1. Change from baseline in glycosylated hemoglobin (HbA1c) at 12 weeks between treatment groups

    Time frame: Baseline to 12 weeks

    HbA1c will be performed on a blood sample obtained by study personnel and measured by high-performance liquid chromatography (HPLC) performed at a central laboratory.

Secondary outcomes

  1. Change from baseline in HbA1c at 12 weeks within subgroups of metformin doses

    Time frame: Baseline to 12 weeks

    HbA1c will be performed on a blood sample obtained by study personnel and measured by high-performance liquid chromatography (HPLC) performed at a central laboratory.

  2. Change from baseline in Fasting plasma glucose (FPG) at 12 weeks

    Time frame: Baseline to 12 weeks

    FPG will be performed on a blood sample obtained by study personnel and analyzed at a central laboratory.

  3. Percentage of patients meeting Responder rates in HbA1c

    Time frame: 12 weeks

    Responder rates will be categorized by predefined HbA1c value at 12 weeks :

    • Endpoint HbA1c ≤ 6.5%
    • Endpoint HbA1c ≤ 7%
    • Endpoint HbA1c ≤ 7% in patients with baseline HbA1c ≤ 8%

  4. Number of patients with adverse events (including hypoglycemia), serious adverse events and death

    Time frame: 12 weeks

    The occurrence of adverse events will be sought by non-directive questioning of the patient at each visit. Adverse events are defined as appearance or worsening of any undesirable symptom, sign (including an abnormal laboratory finding), or medical conditions. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A Multicenter, Double-Blind, Randomized, Parallel-Group Study to Compare the Effect of 12 Weeks Treatment With LAF237 50 mg Bid to Placebo as Add-On Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Monotherapy

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Dec 22, 2011
Registry last updated
Feb 27, 2017

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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