Clinical trial NCT02002221: Study of Efficacy and Safety of Vildagliptin as add-on Insulin Therapy in T2DM Patients
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus (T2DM)
Keywords: Diabetes Mellitus (DM) ,
diabetes,
noninsulin-dependent diabetes mellitus (NIDDM),
adult-onset diabetes,
high blood sugar,
T2DM
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2013-12-05
Enrollment: 156
Sex: ALL
Minimum age (years): 20
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 12 Weeks Between Treatment Groups
timeFrame: Baseline, week 12
Secondary outcomes:
measure: Percentage of Patients Meeting Responder Rates in HbA1c
timeFrame: Baseline, week 12
measure: Change From Baseline in Fasting Plasma Glucose (FPG) at 12 Weeks
timeFrame: Baseline, week 12
measure: Number of Participants With Incidence of Hypoglycemia and Severe Hypoglycemia
timeFrame: 12 weeks
measure: Number of Participants With Adverse Events, Serious Adverse Events and Death
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Fukuoka-city
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Fukuoka-city
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Fukutsu-city
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Kitakyushu-city
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Koriyama-city
country: Japan
facility: Novartis Investigative Site
state: Fukushima
city: Mito-city
country: Japan
facility: Novartis Investigative Site
state: Ibaraki
city: Ibusuki-city
country: Japan
facility: Novartis Investigative Site
state: Kagoshima
city: Yokohama-city
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Kumamoto-city
country: Japan
facility: Novartis Investigative Site
state: Kumamoto
city: Kumamoto-city
country: Japan
facility: Novartis Investigative Site
state: Kumamoto
city: Yatsushiro-city
country: Japan
facility: Novartis Investigative Site
state: Kumamoto
city: Kyoto-city
country: Japan
facility: Novartis Investigative Site
state: Kyoto
city: Sendai-city
country: Japan
facility: Novartis Investigative Site
state: Miyagi
city: Hirakata-City
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Izumisano-city
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Osaka-city
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Osaka-city
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Takatsuki-city
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Ageo-city
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Saitama-city
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Sayama-city
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Tokorozawa-city
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Adachi-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Chiyoda-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Chuo-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Chuo-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Chuo-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Nerima-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Nerima-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Ota-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Suginami-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Hirose T, Suzuki M, Tsumiyama I. Efficacy and Safety of Vildagliptin as an Add-on to Insulin with or without Metformin in Japanese Patients with Type 2 Diabetes Mellitus: A 12-week, Double-Blind, Randomized Study. Diabetes Ther. 2015 Dec;6(4):559-571. doi: 10.1007/s13300-015-0147-6. Epub 2015 Nov 30.