Vildagliptin add-on to Glimepiride Versus Placebo Added to Glimepiride in Type 2 Diabetes

Type 2 Diabetes Mellitus Clinical Trial

Official title:

A Multicenter, Double-blind, Randomized, Parallel-group Study to Compare the Effect of 24 Weeks Treatment With Vildagliptin 50mg qd to Placebo as add-on Therapy to Glimepiride in Patients With Type 2 Diabetes Inadequately Controlled With Sulfonylurea Monotherapy.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01357252
• Other study ID #: CLAF237A23154
• Status: Completed
• Phase: Phase 3
• First received: May 13, 2011
• Last updated: April 2, 2014
• Start date: April 2011
• Est. completion date: January 2013

Study information

• Verified date: April 2014
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationChina: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to demonstrate the efficacy and safety of vildagliptin 50mg qd as add-on therapy to sulfonylurea in patients with type 2 diabetes inadequately controlled with prior sulfonylurea monotherapy as compared to placebo. This study is aimed at supporting the regulatory approval in China of vildagliptin as combination therapy with sulfonylureas in the treatment of type 2 diabetes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 279
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Confirmed diagnosis of T2DM by standard criteria

2. Patients who have received a stable dose of SU for at least 12 weeks prior to Visit 1

3. HbA1c =7.5% to = 11.0% at Visit 1 and Visit 3 (Week -1)

4. Age: =18 to = 80 years at Visit 1.

5. BMI = 20 and = 40 kg/m^2 at visit 1.

Exclusion Criteria:

1. FPG = 270mg/dl (15.0 mmol/L) at Visit 1 or Visit 3 (Week -1)

2. Severe or repetitive hypoglycemia, as defined in section 3.1, during the run-in period (between Visit 2 and Visit 4)

Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Allocation: Randomized, 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

Intervention

Drug:
• vildagliptin

• Placebo

Locations

Country	Name	City	State
China	Novartis Investigative Site	Beijing	Beijing
China	Novartis Investigative Site	Beijing
China	Novartis Investigative Site	Beijing
China	Novartis Investigative Site	Beijing
China	Novartis Investigative Site	Beijing
China	Novartis Investigative Site	Changsha	Hunan
China	Novartis Investigative Site	Guang zhou
China	Novartis Investigative Site	Nanjing	Jiangsu
China	Novartis Investigative Site	Nanjing	Jiangsu
China	Novartis Investigative Site	Nanjing	Jiangsu
China	Novartis Investigative Site	Shanghai	Shanghai
China	Novartis Investigative Site	Shanghai
China	Novartis Investigative Site	Shanghai
China	Novartis Investigative Site	ShenYang	Liaoning
China	Novartis Investigative Site	Shijiazhuang	Hebei
China	Novartis Investigative Site	Tianjin	Tianjin
China	Novartis Investigative Site	Wuhan	Hubei
China	Novartis Investigative Site	Zhenjiang	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in HbA1c		24 weeks	No
Secondary	Change from baseline in Fasting Plasma Glucose		24 weeks	No
Secondary	Safety and tolerability (Frequency of adverse events, serious adverse events, and notable laboratory abnormalities) of add-on therapy with vildagliptin 50 mg qd to glimepiride as compared to pbo		24 weeks	Yes
Secondary	Responder rates - proportion of subjects reaching predefined HbA1c targets		24 weeks	No