Efficacy and Safety of Vildagliptin as add-on Therapy to Metformin in Patients With Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A Multicenter, Double-Blind, Randomized, Parallel-Group Study to Compare the Effect of 12 Weeks Treatment With LAF237 50 mg Bid to Placebo as Add-On Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Monotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01497522
• Other study ID #: CLMF237A1301
• Status: Completed
• Phase: Phase 3
• First received: December 20, 2011
• Last updated: February 23, 2017
• Start date: December 2011
• Est. completion date: February 2013

Study information

• Verified date: February 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to evaluate the efficacy and safety of vildagliptin 50 mg bid as an add-on therapy to metformin in Japanese patients with T2DM. This study is being conducted to support registration of the fixed-dose combination of vildagliptin and metformin for the treatment of Type 2 diabetes mellitus (T2DM) in Japan.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 183
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Patients with type 2 diabetes inadequately controlled with diet, exercise and oral anti-diabetic therapy.

• HbA1c in the range of 7.0-10.0%

• Body mass index in the range 20-35 kg/m2

Exclusion Criteria:

• Type 1 diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes

• Significant heart diseases

Other protocol-defined inclusion/exclusion criteria may apply

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Vildagliptin
vildagliptin 50 mg twice daily
• Placebo
Matching Placebo of vildagliptin 50 mg twice daily

Locations

Country	Name	City	State
Japan	Novartis Investigative Site	Ageo-city	Saitama
Japan	Novartis Investigative Site	Bunkyo-ku	Tokyo
Japan	Novartis Investigative Site	Edogawa-ku	Tokyo
Japan	Novartis Investigative Site	Fukuoka
Japan	Novartis Investigative Site	Fukuoka
Japan	Novartis Investigative Site	Hachioji	Tokyo
Japan	Novartis Investigative Site	Kawasaki-city	Kanagawa
Japan	Novartis Investigative Site	Kitakyushu	Fukuoka
Japan	Novartis Investigative Site	Kiyose	Tokyo
Japan	Novartis Investigative Site	Kurume	Fukuoka
Japan	Novartis Investigative Site	Kyoto
Japan	Novartis Investigative Site	Kyoto-city	Kyoto
Japan	Novartis Investigative Site	Minato-ku	Tokyo
Japan	Novartis Investigative Site	Minato-ku	Tokyo
Japan	Novartis Investigative Site	Nerima-ku	Tokyo
Japan	Novartis Investigative Site	Ohkawa-city	Fukuoka
Japan	Novartis Investigative Site	Shinagawa-ku	Tokyo
Japan	Novartis Investigative Site	Takatsuki	Osaka
Japan	Novartis Investigative Site	Toshima-ku	Tokyo
Japan	Novartis Investigative Site	Yokohama	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Japan, 

References & Publications (1)

Odawara M, Hamada I, Suzuki M. Efficacy and Safety of Vildagliptin as Add-on to Metformin in Japanese Patients with Type 2 Diabetes Mellitus. Diabetes Ther. 2014 Jun;5(1):169-81. doi: 10.1007/s13300-014-0059-x. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in glycosylated hemoglobin (HbA1c) at 12 weeks between treatment groups	HbA1c will be performed on a blood sample obtained by study personnel and measured by high-performance liquid chromatography (HPLC) performed at a central laboratory.	Baseline to 12 weeks
Secondary	Change from baseline in HbA1c at 12 weeks within subgroups of metformin doses	HbA1c will be performed on a blood sample obtained by study personnel and measured by high-performance liquid chromatography (HPLC) performed at a central laboratory.	Baseline to 12 weeks
Secondary	Change from baseline in Fasting plasma glucose (FPG) at 12 weeks	FPG will be performed on a blood sample obtained by study personnel and analyzed at a central laboratory.	Baseline to 12 weeks
Secondary	Percentage of patients meeting Responder rates in HbA1c	Responder rates will be categorized by predefined HbA1c value at 12 weeks : Endpoint HbA1c = 6.5%; Endpoint HbA1c = 7%; Endpoint HbA1c = 7% in patients with baseline HbA1c = 8%	12 weeks
Secondary	Number of patients with adverse events (including hypoglycemia), serious adverse events and death	The occurrence of adverse events will be sought by non-directive questioning of the patient at each visit. Adverse events are defined as appearance or worsening of any undesirable symptom, sign (including an abnormal laboratory finding), 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

External Links

•   Results for CLMF237A1301 from the Novartis Clinical Trials website