Efficacy of VIldagliptin aS an Add-on Therapy to Metformin Compared to Metformin Up-TitratION in Chinese Patients With Type 2 Diabetes.(VISION)

Browse trials for

• Diabetes Mellitus 10,925
• Diabetes Mellitus, Type 2 9,359

Keywords

• type 2 diabetes;
• vildagliptin;
• metformin;

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 3,091 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Lead sponsor

Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.

Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.

Study arms

• Active comparator
  metformin up titration

  metformin 500 mg bid will be up titrated (total daily dose up to 2000 mg)

  Drug: Metformin

• Experimental
  vildagliptin add on to metformin

  Vildagliptin 50 mg twice daily + Metformin 500mg twice daily

  Drug: Metformin · Drug: vildagliptin

Interventions

• DrugMetformin

  500 mg twice daily

• Drugvildagliptin

  Vildagliptin 50 mg twice daily

  Also known as: LAF237

Primary outcomes

1. Change from baseline in hemoglobin A1c(HbA1C) after 24 weeks of treatment with vildagliptin

   The change from baseline in hemoglobin A1c(HbA1c) after 24 weeks treatment in vildagliptin 50 mg bid used in combination with metformin 500 mg bid is not inferior to that with metformin up to 1000 mg bid as monotherapy after 24 weeks

   Time frame: baseline, 24 weeks

Secondary outcomes

1. Change from baseline in hemoglobin A1c(HbA1C) after 24 weeks of treatment in pre-defined patient subgroups

   The changes from baseline in hemoglobin A1c(HbA1C) after 24 weeks of treatment will be analyzed in pre-defined patient subgroups based on Body Mass Index(BMI) ( \<24, ≥ 24) and age (\<60 y and ≥ 60 y)

   Time frame: baseline and 24 weeks

2. Percentage of patients achieving target hemoglobin A1c( HbA1C) of ≤6.5%

   The percentage of patients achieving target hemoglobin A1c( HbA1C) of ≤6.5% of two treatment arms in the overall population and in pre defined sub groups.

   Time frame: baseline and 24 weeks

3. Percentage of patients achieving target hemoglobin A1c(HbA1C) of ≤6.5% without adverse gastrointestinal (GI) events

   The percentage of patients achieving target hemoglobin A1c( HbA1C) of ≤6.5% without adverse GI events of two treatment arms in the overall population and in pre defined sub groups.

   Time frame: baseline and 24 weeks

4. Mean change from baseline in fasting plasma glucose (FPG)

   Mean change from baseline in FPG will be calculated in the overall population and in pre defined sub groups.

   Time frame: baseline, 24 weeks

5. Mean change from baseline in 2-hour post prandial glucose( PPG) in a sub sample

   Mean change from baseline in 2 hour post prandial glucose(PPG) in a sub sample of overall patients.

   Time frame: baseline, 24 weeks

6. Number of patients with adverse events, serious adverse events and death

   Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.

   Time frame: up to 24 weeks

Publications

• Ji LN, Pan CY, Lu JM, Li H, Zhu DL, Li Q, Li QF, Peng YD, Tian HM, Yao C, Zhao ZG, Wang L, Wang BH; VISION Study Group. Efficacy and safety of combination therapy with vildagliptin and metformin versus metformin uptitration in Chinese patients with type 2 diabetes inadequately controlled with metformin monotherapy: a randomized, open-label, prospective study (VISION). Diabetes Obes Metab. 2016 Aug;18(8):775-82. doi: 10.1111/dom.12667. Epub 2016 May 18. PubMed 27406394 ↗