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Completed

NCT Number: NCT02002221

Study of Efficacy and Safety of Vildagliptin as add-on Insulin Therapy in T2DM Patients

The purpose of this study was to assess the efficacy and safety of vildagliptin 50 mg bid add-on therapy to improve overall glycemic control in patients with T2DM inadequately controlled by insulin, with or without concomitant metformin treatment. It was agreed with PMDA to conduct a postmarketing clinical trial to further collect the efficacy and safety data of vildagliptin especially in Japanese patients when it iwas used on top of insulin.

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Key information

Conditions

Type 2 Diabetes Mellitus (T2DM) Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

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

  • Confirmed diagnosis of T2DM by standard criteria.
  • HbA1c ≥ 7.0 to ≤ 10% at Visit 1.
  • Age: ≥ 20 to < 75 years old at Visit 1.
  • BMI ≥ 20 to ≤ 35 kg/m2 at Visit 1.

Exclusion criteria

  • FPG ≥ 270 mg/dL (≥15 mmol/L) at Visit 1.
  • Type 1 diabetes, monogenic diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes.
  • Significant heart diseases
  • Hepatic disorder

Other protocol defined inclusion/exclusion criteria may apply

Treatment and study plan

Vildagliptin (LAF237)

Drug

Corresponds to vildagliptin (LAF237) 50 mg tablets twice daily

Other names: Vildagliptin

Placebo

Drug

Matching placebo of vildagliptin 50 mg twice daily

Insulin

Drug

Patients continued their prescribed insulin dose. The dose of insulin remained within a 10% increase of the baseline dose throughout the trial (with no change in frequency or insulin type) unless dose adjustments were required for safety reasons.

The insulin dose was allowed to be decreased for safety reasons at anytime without specific dose limits at the Investigator's discretion.

metformin

Drug

Patients continued their prescribed metformin dose, if applicable.

Primary outcomes

  1. Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 12 Weeks Between Treatment Groups

    Time frame: Baseline, week 12

    HbA1c was performed on a blood sample obtained and measured by high performance liquid chromatography performed at a central laboratory.

Secondary outcomes

  1. Percentage of Patients Meeting Responder Rates in HbA1c

    Time frame: Baseline, week 12

    Responder rate was analyzed in categories: Criterion 1- Endpoint HbA1c ≤ 6.5%, Criterion 2- Endpoint HbA1c < 7% , Criterion 3- Endpoint HbA1c < 7% in patients with baseline HbA1c ≤ 8%, Criterion 4- HbA1c reduction from baseline at endpoint ≥ 1%, Criterion 5- HbA1c reduction from baseline at endpoint ≥ 0.5%. The number of patients analyzed for Criterion 1 and 2 include only patients with baseline HbA1c ≥ 7% (> 6.5%) and endpoint HbA1c measurement. The number of patients analyzed for Criterion 3 includes only patients with 7% ≤ baseline HbA1c ≤ 8% and endpoint HbA1c measurement. The number of patients analyzed for Criterion 4 and 5 include patients with both baseline and endpoint HbA1c measurements.

  2. Change From Baseline in Fasting Plasma Glucose (FPG) at 12 Weeks

    Time frame: Baseline, week 12

    FPG was performed on a blood sample obtained and analyzed at a central laboratory.

  3. Number of Participants With Incidence of Hypoglycemia and Severe Hypoglycemia

    Time frame: 12 weeks

    Hypoglycemic events are defined as a) symptoms suggestive of hypoglycemia, where the patient is able to initiate self-treatment and plasma glucose measurement is < 56 mg/dL (grade 1), b) symptoms suggestive of hypoglycemia, where the patient is unable to initiate self-treatment and plasma glucose measurement is < 56 mg/dL (grade 2), c) symptoms suggestive of hypoglycemia, where the patient is unable to initiate self-treatment and no plasma glucose measurement is available (suspected grade 2)

  4. Number of Participants With Adverse Events, Serious Adverse Events and Death

    Time frame: 12 weeks

    The occurrence of adverse events was sought by non-directive questioning of the patient at each visit. Adverse events are defined as appearance or worsening of any undesirable symptom, vital sign, 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 12-week, Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Equa (Vildagliptin) 50 mg Bid as an add-on Therapy to Insulin, With or Without Metformin, in Patients With Type 2 Diabetes Mellitus

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Dec 5, 2013
Registry last updated
Mar 1, 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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