Vildagliptin add-on to Glimepiride Versus Placebo Added to Glimepiride in Type 2 Diabetes
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.
1 other identifier
interventional
279
1 country
18
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 type-2-diabetes-mellitus
Started Apr 2011
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 13, 2011
CompletedFirst Posted
Study publicly available on registry
May 20, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedApril 3, 2014
April 1, 2014
1.8 years
May 13, 2011
April 2, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in HbA1c
24 weeks
Secondary Outcomes (3)
Change from baseline in Fasting Plasma Glucose
24 weeks
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
Responder rates - proportion of subjects reaching predefined HbA1c targets
24 weeks
Study Arms (2)
vildagliptin
EXPERIMENTALplacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Confirmed diagnosis of T2DM by standard criteria
- Patients who have received a stable dose of SU for at least 12 weeks prior to Visit 1
- HbA1c ≥7.5% to ≤ 11.0% at Visit 1 and Visit 3 (Week -1)
- Age: ≥18 to ≤ 80 years at Visit 1.
- BMI ≥ 20 and ≤ 40 kg/m\^2 at visit 1.
You may not qualify if:
- FPG ≥ 270mg/dl (15.0 mmol/L) at Visit 1 or Visit 3 (Week -1)
- Severe or repetitive hypoglycemia, as defined in section 3.1, during the run-in period (between Visit 2 and Visit 4)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Novartis Investigative Site
Beijing, Beijing Municipality, 100088, China
Novartis Investigative Site
Shijiazhuang, Hebei, 050051, China
Novartis Investigative Site
Wuhan, Hubei, 430070, China
Novartis Investigative Site
Changsha, Hunan, 410003, China
Novartis Investigative Site
Nanjing, Jiangsu, 210006, China
Novartis Investigative Site
Nanjing, Jiangsu, 210008, China
Novartis Investigative Site
Nanjing, Jiangsu, 210029, China
Novartis Investigative Site
Zhenjiang, Jiangsu, 212001, China
Novartis Investigative Site
Shenyang, Liaoning, 110003, China
Novartis Investigative Site
Shanghai, Shanghai Municipality, China
Novartis Investigative Site
Tianjin, Tianjin Municipality, 300211, China
Novartis Investigative Site
Beijing, 100029, China
Novartis Investigative Site
Beijing, 100034, China
Novartis Investigative Site
Beijing, 100730, China
Novartis Investigative Site
Beijing, China
Novartis Investigative Site
Guangzhou, 510080, China
Novartis Investigative Site
Shanghai, 200040, China
Novartis Investigative Site
Shanghai, 200233, China
Related Publications (1)
Yang W, Xing X, Lv X, Li Y, Ma J, Yuan G, Sun F, Wang W, Woloschak M, Lukashevich V, Kozlovski P, Kothny W; all investigators. Vildagliptin added to sulfonylurea improves glycemic control without hypoglycemia and weight gain in Chinese patients with type 2 diabetes mellitus. J Diabetes. 2015 Mar;7(2):174-81. doi: 10.1111/1753-0407.12169. Epub 2014 Jul 29.
PMID: 24823599DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 13, 2011
First Posted
May 20, 2011
Study Start
April 1, 2011
Primary Completion
January 1, 2013
Study Completion
January 1, 2013
Last Updated
April 3, 2014
Record last verified: 2014-04