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

February 2, 2016 updated by: Novartis Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

156

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Fukuoka
      • Fukuoka-city, Fukuoka, Japan, 810-8798
        • Novartis Investigative Site
      • Fukuoka-city, Fukuoka, Japan, 815-0071
        • Novartis Investigative Site
      • Fukutsu-city, Fukuoka, Japan, 811-3217
        • Novartis Investigative Site
      • Kitakyushu-city, Fukuoka, Japan, 800-0295
        • Novartis Investigative Site
    • Fukushima
      • Koriyama-city, Fukushima, Japan, 963-8851
        • Novartis Investigative Site
    • Ibaraki
      • Mito-city, Ibaraki, Japan, 311-4153
        • Novartis Investigative Site
    • Kagoshima
      • Ibusuki-city, Kagoshima, Japan, 891-0401
        • Novartis Investigative Site
    • Kanagawa
      • Yokohama-city, Kanagawa, Japan, 221-0802
        • Novartis Investigative Site
    • Kumamoto
      • Kumamoto-city, Kumamoto, Japan, 861-8520
        • Novartis Investigative Site
      • Kumamoto-city, Kumamoto, Japan, 861-8039
        • Novartis Investigative Site
      • Yatsushiro-city, Kumamoto, Japan, 866-8533
        • Novartis Investigative Site
    • Kyoto
      • Kyoto-city, Kyoto, Japan, 615-0035
        • Novartis Investigative Site
    • Miyagi
      • Sendai-city, Miyagi, Japan, 980-0021
        • Novartis Investigative Site
    • Osaka
      • Hirakata-City, Osaka, Japan, 573-0153
        • Novartis Investigative Site
      • Izumisano-city, Osaka, Japan, 598-8577
        • Novartis Investigative Site
      • Osaka-city, Osaka, Japan, 534-0021
        • Novartis Investigative Site
      • Osaka-city, Osaka, Japan, 530-0001
        • Novartis Investigative Site
      • Takatsuki-city, Osaka, Japan, 569-1096
        • Novartis Investigative Site
    • Saitama
      • Ageo-city, Saitama, Japan, 362-8588
        • Novartis Investigative Site
      • Saitama-city, Saitama, Japan, 336-0963
        • Novartis Investigative Site
      • Sayama-city, Saitama, Japan, 350-1305
        • Novartis Investigative Site
      • Tokorozawa-city, Saitama, Japan, 359-1161
        • Novartis Investigative Site
    • Tokyo
      • Adachi-ku, Tokyo, Japan, 123-0845
        • Novartis Investigative Site
      • Chiyoda-ku, Tokyo, Japan, 101-0024
        • Novartis Investigative Site
      • Chuo-ku, Tokyo, Japan, 103-0028
        • Novartis Investigative Site
      • Chuo-ku, Tokyo, Japan, 103-0027
        • Novartis Investigative Site
      • Chuo-ku, Tokyo, Japan, 104-0061
        • Novartis Investigative Site
      • Nerima-ku, Tokyo, Japan, 177-0051
        • Novartis Investigative Site
      • Nerima-ku, Tokyo, Japan, 177-0041
        • Novartis Investigative Site
      • Ota-ku, Tokyo, Japan, 144-0051
        • Novartis Investigative Site
      • Suginami-ku, Tokyo, Japan, 166-0004
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vildagliptin (LAF237)
Patients received vildagliptin (LAF237) 50 mg tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
Drug: Vildagliptin (LAF237)
Corresponds to vildagliptin (LAF237) 50 mg tablets twice daily
Other Names:
  • Vildagliptin
Drug: Insulin

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.

Drug: Metformin
Patients continued their prescribed metformin dose, if applicable.
Placebo Comparator: Placebo
In this arm, patients received vildagliptin 50 mg matching placebo tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
Drug: Insulin

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.

Drug: Metformin
Patients continued their prescribed metformin dose, if applicable.
Drug: Placebo
Matching placebo of vildagliptin 50 mg twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, week 12
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.
Baseline, week 12
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)
12 weeks
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.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

November 29, 2013

First Submitted That Met QC Criteria

November 29, 2013

First Posted (Estimate)

December 5, 2013

Study Record Updates

Last Update Posted (Estimate)

March 1, 2016

Last Update Submitted That Met QC Criteria

February 2, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLAF237A1405

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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