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

Type 2 Diabetes Mellitus (T2DM) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02002221
• Other study ID #: CLAF237A1405
• Status: Completed
• Phase: Phase 4
• First received: November 29, 2013
• Last updated: February 2, 2016
• Start date: December 2013
• Est. completion date: February 2015

Study information

• Verified date: January 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 74 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus (T2DM)

Intervention

Drug:
• Vildagliptin (LAF237)
Corresponds to vildagliptin (LAF237) 50 mg tablets twice daily
• Placebo
Matching placebo of vildagliptin 50 mg twice daily
• 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.
• Metformin
Patients continued their prescribed metformin dose, if applicable.

Locations

Country	Name	City	State
Japan	Novartis Investigative Site	Adachi-ku	Tokyo
Japan	Novartis Investigative Site	Ageo-city	Saitama
Japan	Novartis Investigative Site	Chiyoda-ku	Tokyo
Japan	Novartis Investigative Site	Chuo-ku	Tokyo
Japan	Novartis Investigative Site	Chuo-ku	Tokyo
Japan	Novartis Investigative Site	Chuo-ku	Tokyo
Japan	Novartis Investigative Site	Fukuoka-city	Fukuoka
Japan	Novartis Investigative Site	Fukuoka-city	Fukuoka
Japan	Novartis Investigative Site	Fukutsu-city	Fukuoka
Japan	Novartis Investigative Site	Hirakata-City	Osaka
Japan	Novartis Investigative Site	Ibusuki-city	Kagoshima
Japan	Novartis Investigative Site	Izumisano-city	Osaka
Japan	Novartis Investigative Site	Kitakyushu-city	Fukuoka
Japan	Novartis Investigative Site	Koriyama-city	Fukushima
Japan	Novartis Investigative Site	Kumamoto-city	Kumamoto
Japan	Novartis Investigative Site	Kumamoto-city	Kumamoto
Japan	Novartis Investigative Site	Kyoto-city	Kyoto
Japan	Novartis Investigative Site	Mito-city	Ibaraki
Japan	Novartis Investigative Site	Nerima-ku	Tokyo
Japan	Novartis Investigative Site	Nerima-ku	Tokyo
Japan	Novartis Investigative Site	Osaka-city	Osaka
Japan	Novartis Investigative Site	Osaka-city	Osaka
Japan	Novartis Investigative Site	Ota-ku	Tokyo
Japan	Novartis Investigative Site	Saitama-city	Saitama
Japan	Novartis Investigative Site	Sayama-city	Saitama
Japan	Novartis Investigative Site	Sendai-city	Miyagi
Japan	Novartis Investigative Site	Suginami-ku	Tokyo
Japan	Novartis Investigative Site	Takatsuki-city	Osaka
Japan	Novartis Investigative Site	Tokorozawa-city	Saitama
Japan	Novartis Investigative Site	Yatsushiro-city	Kumamoto
Japan	Novartis Investigative Site	Yokohama-city	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 12 Weeks Between Treatment Groups	HbA1c was performed on a blood sample obtained and measured by high performance liquid chromatography performed at a central laboratory.	Baseline, week 12	No
Secondary	Percentage of Patients Meeting Responder Rates in HbA1c	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	No
Secondary	Change From Baseline in Fasting Plasma Glucose (FPG) at 12 Weeks	FPG was performed on a blood sample obtained and analyzed at a central laboratory.	Baseline, week 12	No
Secondary	Number of Participants With Incidence of Hypoglycemia and Severe Hypoglycemia	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	Yes
Secondary	Number of Participants With Adverse Events, Serious Adverse Events and Death	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	Yes