Vildagliptin add-on to Glimepiride Versus Placebo Added to Glimepiride in Type 2 Diabetes
NCT ID: NCT01357252
Last Updated: 2014-04-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
279 participants
INTERVENTIONAL
2011-04-30
2013-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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vildagliptin
vildagliptin
placebo
Placebo
Interventions
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vildagliptin
Placebo
Eligibility Criteria
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Inclusion 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
2. Severe or repetitive hypoglycemia, as defined in section 3.1, during the run-in period (between Visit 2 and Visit 4)
18 Years
80 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Beijing, Beijing Municipality, China
Novartis Investigative Site
Shijiazhuang, Hebei, China
Novartis Investigative Site
Wuhan, Hubei, China
Novartis Investigative Site
Changsha, Hunan, China
Novartis Investigative Site
Nanjing, Jiangsu, China
Novartis Investigative Site
Nanjing, Jiangsu, China
Novartis Investigative Site
Nanjing, Jiangsu, China
Novartis Investigative Site
Zhenjiang, Jiangsu, China
Novartis Investigative Site
Shenyang, Liaoning, China
Novartis Investigative Site
Shanghai, Shanghai Municipality, China
Novartis Investigative Site
Tianjin, Tianjin Municipality, China
Novartis Investigative Site
Beijing, , China
Novartis Investigative Site
Beijing, , China
Novartis Investigative Site
Beijing, , China
Novartis Investigative Site
Beijing, , China
Novartis Investigative Site
Guangzhou, , China
Novartis Investigative Site
Shanghai, , China
Novartis Investigative Site
Shanghai, , China
Countries
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References
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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.
Other Identifiers
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CLAF237A23154
Identifier Type: -
Identifier Source: org_study_id
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