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NCT Number: NCT01582230

Efficacy and Safety of Vildagliptin 50mg Bid as an add-on Therapy to Insulin With or Without Metformin, in Patients With Type 2 Diabetes Mellitus

The purpose of this study is to assess the efficacy and safety of vildagliptin 50mg bid add-on therapy to improve overall glycemic control in patients with type 2 diabetes mellitus inadequately controlled on insulin with or without metformin treatment.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigative Site, Beijing, Beijing Municipality, China

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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 confirmed diagnosis of Type2 diabetes mellitus (T2DM) by standard criteria
  • C-peptide >0.6 ng/ml (>0.20 nmol/L).
  • HbA1c ≥7.5 to ≤11% at Visit 1
  • Treatment with stable, once or twice daily doses (maximum dose of < 1 unit/kg/day) of basal (long-acting, intermediate-acting) insulin alone or pre-mixed insulin for at least 12 weeks prior to Visit 1. Stable is defined as ±10% of the Visit 1 dose during the previous 12 weeks
  • Patients receiving metformin must be on a stable dose of metformin (at least 1500 mg daily or a maximally tolerated dose) for at least 12 weeks prior to Visit 1
  • Body Mass Index (BMI) ≥20 to ≤40 kg/m2 at Visit

Exclusion criteria

Patients fulfilling any of the following criteria are not eligible for participation in the study

  • Fasting plasma glucose (FPG) ≥240 mg/dl (13.3 mmol/L) at Visit 1
  • Pregnant or lactating women
  • Acute metabolic diabetes complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months
  • Current diagnosis of congestive heart failure (NYHA III or IV).
  • Myocardial infarction (MI) within the past 6 months
  • Liver disease such as cirrhosis or chronic active hepatitis

Other protocol defined inclusion/excusion criteria may apply

Treatment and study plan

Vildagliptin

Drug

Patient will receive vildagliptin 50mg twice daily (bid) in addition to their stable dose of insulin with or without metformin for 24 weeks

Other names: Galvus, LAF237

Placebo

Drug

Patient will receive matching placebo to vildagliptin in addition to their stable dose of insulin with or without metformin for 24 weeks

Primary outcomes

  1. Change from baseline in glycosylated hemoglobin (HbA1c) at study endpoint, assessed in overall study population

    Time frame: Baseline and every study visit up to 24 weeks

    HbA1c analysis will be performed on a blood sample obtained by study personnel at every visit and measured by ion exchange HPLC. Study endpoint is defined as final available post- randomization assessment obtained at any visit prior to or at the start of major change in insulin use, up to final scheduled study visit (week 24 visit) inclusive.

  2. Change from baseline in glycosylated hemoglobin (HbA1c) at study endpoint, assessed in Chinese study population

    Time frame: Baseline and every study visit up to 24 weeks

    HbA1c analysis will be performed on a blood sample obtained by study personnel at every visit and measured by ion exchange HPLC. Study endpoint is defined as final available post- randomization assessment obtained at any visit prior to or at the start of major change in insulin use, up to final scheduled study visit (week 24 visit) inclusive.

Secondary outcomes

  1. Number of patients with adverse events, serious adverse events and death on over all population

    Time frame: 24 weeks

    Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. 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.

  2. Change from baseline after 24 weeks of treatment in fasting plasma glucose (FPG)on overall population

    Time frame: Baseline, week 24

    FPG will be performed on the blood samples collected at all every study visits from baseline to week 24.

  3. Percentage of patients meeting responder criteria after 24 weeks treatment on overall population

    Time frame: After 24 weeks

    Responder rate will be analyzed in the following categories:

    • Endpoint HbA1c ≤ 6.5%
    • Endpoint HbA1c < 7%
    • Endpoint HbA1c <7% in patients with baseline HbA1c ≤ 8% The percentage of patients meeting each of the responder criteria as described, as well as the percentage of patients meeting any of these criteria in each treatment group will be computed

  4. Number of patients with adverse events, serious adverse events and death on Chinese population

    Time frame: 24 weeks

    Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. 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.

  5. Change from baseline after 24 weeks of treatment in fasting plasma glucose (FPG) on Chinese population

    Time frame: Baseline, week 24

    FPG will be performed on the blood samples collected at all every study visits from baseline to week 24.

  6. Percentage of patients meeting responder criteria after 24 weeks treatment on Chinese population

    Time frame: After 24 weeks

    Responder rate will be analyzed in the following categories: • Endpoint HbA1c ≤ 6.5% • Endpoint HbA1c < 7% • Endpoint HbA1c <7% in patients with baseline HbA1c ≤ 8% The percentage of patients meeting each of the responder criteria as described, as well as the percentage of patients meeting any of these criteria in each treatment group will be computed

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A 24-week, Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Vildagliptin 50mg Bid as an add-on Therapy to Insulin, With or Without Metformin, in Patients With Type 2 Diabetes Mellitus

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Apr 20, 2012
Registry last updated
Aug 30, 2013

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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