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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02002221
Recruitment Status : Completed
First Posted : December 5, 2013
Results First Posted : March 1, 2016
Last Update Posted : March 1, 2016
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus (T2DM) Drug: Vildagliptin (LAF237) Drug: Placebo Drug: Insulin Drug: Metformin Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 156 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Study Start Date : December 2013
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine


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 Name: 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: Placebo
Matching placebo of vildagliptin 50 mg twice daily

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   20 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02002221


Locations
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Japan
Novartis Investigative Site
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
Koriyama-city, Fukushima, Japan, 963-8851
Novartis Investigative Site
Mito-city, Ibaraki, Japan, 311-4153
Novartis Investigative Site
Ibusuki-city, Kagoshima, Japan, 891-0401
Novartis Investigative Site
Yokohama-city, Kanagawa, Japan, 221-0802
Novartis Investigative Site
Kumamoto-city, Kumamoto, Japan, 861-8039
Novartis Investigative Site
Kumamoto-city, Kumamoto, Japan, 861-8520
Novartis Investigative Site
Yatsushiro-city, Kumamoto, Japan, 866-8533
Novartis Investigative Site
Kyoto-city, Kyoto, Japan, 615-0035
Novartis Investigative Site
Sendai-city, Miyagi, Japan, 980-0021
Novartis Investigative Site
Hirakata-City, Osaka, Japan, 573-0153
Novartis Investigative Site
Izumisano-city, Osaka, Japan, 598-8577
Novartis Investigative Site
Osaka-city, Osaka, Japan, 530-0001
Novartis Investigative Site
Osaka-city, Osaka, Japan, 534-0021
Novartis Investigative Site
Takatsuki-city, Osaka, Japan, 569-1096
Novartis Investigative Site
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
Adachi-ku, Tokyo, Japan, 123-0845
Novartis Investigative Site
Chiyoda-ku, Tokyo, Japan, 101-0024
Novartis Investigative Site
Chuo-ku, Tokyo, Japan, 103-0027
Novartis Investigative Site
Chuo-ku, Tokyo, Japan, 103-0028
Novartis Investigative Site
Chuo-ku, Tokyo, Japan, 104-0061
Novartis Investigative Site
Nerima-ku, Tokyo, Japan, 177-0041
Novartis Investigative Site
Nerima-ku, Tokyo, Japan, 177-0051
Novartis Investigative Site
Ota-ku, Tokyo, Japan, 144-0051
Novartis Investigative Site
Suginami-ku, Tokyo, Japan, 166-0004
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02002221    
Other Study ID Numbers: CLAF237A1405
First Posted: December 5, 2013    Key Record Dates
Results First Posted: March 1, 2016
Last Update Posted: March 1, 2016
Last Verified: January 2016
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Diabetes Mellitus (DM) ,
diabetes,
noninsulin-dependent diabetes mellitus (NIDDM),
adult-onset diabetes,
high blood sugar,
T2DM
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Vildagliptin
Hypoglycemic Agents
Physiological Effects of Drugs
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action