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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01357252
First received: May 13, 2011
Last updated: April 2, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Type 2 Diabetes Mellitus
Drug: vildagliptin
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change from baseline in HbA1c [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in Fasting Plasma Glucose [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Responder rates - proportion of subjects reaching predefined HbA1c targets [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 279
Study Start Date: April 2011
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: vildagliptin Drug: vildagliptin
Placebo Comparator: placebo Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01357252

Locations
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, 210029
Novartis Investigative Site
Nanjing, Jiangsu, China, 210008
Novartis Investigative Site
Nanjing, Jiangsu, China, 210006
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
China
Novartis Investigative Site
Beijing, China
Novartis Investigative Site
Beijing, China, 100034
Novartis Investigative Site
Beijing, China, 100730
Novartis Investigative Site
Beijing, China, 100029
Novartis Investigative Site
Guang zhou, China, 510080
Novartis Investigative Site
Shanghai, China, 200040
Novartis Investigative Site
Shanghai, China, 200233
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01357252     History of Changes
Other Study ID Numbers: CLAF237A23154
Study First Received: May 13, 2011
Last Updated: April 2, 2014
Health Authority: United States: Food and Drug Administration
China: Food and Drug Administration

Keywords provided by Novartis:
Diabetes mellitus
vildagliptin

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

ClinicalTrials.gov processed this record on September 30, 2014