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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01357252
Recruitment Status : Completed
First Posted : May 20, 2011
Last Update Posted : April 3, 2014
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

May 13, 2011
May 20, 2011
April 3, 2014
April 2011
January 2013   (Final data collection date for primary outcome measure)
Change from baseline in HbA1c [ Time Frame: 24 weeks ]
Same as current
Complete list of historical versions of study NCT01357252 on Archive Site
  • Change from baseline in Fasting Plasma Glucose [ Time Frame: 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 [ Time Frame: 24 weeks ]
  • Responder rates - proportion of subjects reaching predefined HbA1c targets [ Time Frame: 24 weeks ]
Same as current
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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.
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.
Not Provided
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: vildagliptin
  • Drug: Placebo
  • Experimental: vildagliptin
    Intervention: Drug: vildagliptin
  • Placebo Comparator: placebo
    Intervention: Drug: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
January 2013
January 2013   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
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Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP