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A 24-week, Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Vildagliptin 50mg Bid as an add-on Therapy to Insulin, With or Without Metformin, in Patients With Type 2 Diabetes Mellitus

ClinicalTrials.gov · COMPLETED, 2013

293 participants

Abstract

The purpose of this study is to assess the efficacy and safety of vildagliptin 50mg bid add-on therapy to improve overall glycemic control in patients with type 2 diabetes mellitus inadequately controlled on insulin with or without metformin treatment.

Conditions: Type 2 Diabetes Mellitus.

Primary outcome: Change from baseline in glycosylated hemoglobin (HbA1c) at study endpoint, assessed in overall study population; Change from baseline in glycosylated hemoglobin (HbA1c) at study endpoint, assessed in Chinese study population.

Enrollment: 293 participants.

How strong is the evidence?

Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 293 participants or records.

How the five levels of evidence work. The level is assigned automatically from the abstract and can be wrong, so check the paper.

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