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

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. Identifier: NCT01357252
Recruitment Status : Completed
First Posted : May 20, 2011
Last Update Posted : April 3, 2014
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief 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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: vildagliptin Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 279 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.
Study Start Date : April 2011
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Glimepiride

Arm Intervention/treatment
Experimental: vildagliptin Drug: vildagliptin
Placebo Comparator: placebo Drug: Placebo

Primary Outcome Measures :
  1. Change from baseline in HbA1c [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Change from baseline in Fasting Plasma Glucose [ Time Frame: 24 weeks ]
  2. 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 [ Time Frame: 24 weeks ]
  3. Responder rates - proportion of subjects reaching predefined HbA1c targets [ Time Frame: 24 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT01357252

China, Beijing
Novartis Investigative Site
Beijing, Beijing, China, 100088
China, Hebei
Novartis Investigative Site
Shijiazhuang, Hebei, China, 050051
China, Hubei
Novartis Investigative Site
Wuhan, Hubei, China, 430070
China, Hunan
Novartis Investigative Site
Changsha, Hunan, China, 410003
China, Jiangsu
Novartis Investigative Site
Nanjing, Jiangsu, China, 210006
Novartis Investigative Site
Nanjing, Jiangsu, China, 210008
Novartis Investigative Site
Nanjing, Jiangsu, China, 210029
Novartis Investigative Site
Zhenjiang, Jiangsu, China, 212001
China, Liaoning
Novartis Investigative Site
ShenYang, Liaoning, China, 110003
China, Shanghai
Novartis Investigative Site
Shanghai, Shanghai, China
China, Tianjin
Novartis Investigative Site
Tianjin, Tianjin, China, 300211
Novartis Investigative Site
Beijing, China, 100029
Novartis Investigative Site
Beijing, China, 100034
Novartis Investigative Site
Beijing, China, 100730
Novartis Investigative Site
Beijing, China
Novartis Investigative Site
Guang zhou, China, 510080
Novartis Investigative Site
Shanghai, China, 200040
Novartis Investigative Site
Shanghai, China, 200233
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Novartis Pharmaceuticals Identifier: NCT01357252     History of Changes
Other Study ID Numbers: CLAF237A23154
First Posted: May 20, 2011    Key Record Dates
Last Update Posted: April 3, 2014
Last Verified: April 2014

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Diabetes mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Anti-Arrhythmia Agents
Hypoglycemic Agents
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action