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Early add-on Vildagliptin in Patients With Type 2 Diabetes Inadequately Controlled by Metformin

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01766778
First Posted: January 11, 2013
Last Update Posted: May 15, 2017
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.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
Results First Submitted: February 23, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Type-2 Diabetes Mellitus
Interventions: Drug: LAF237 (vildagliptin)
Drug: Metformin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
There was 117 patients randomized and received either Vildagliptin 50mg QD or 50 mg BID.

Reporting Groups
  Description
LAF237 (Vildagliptin) 50mg Once Daily (QD) Vildagliptin 50mg QD plus stabilized or maximum tolerated dose of Metformin
LAF237 (Vildagliptin) 50mg Twice Daily (BID) Vildagliptin 50mg BID plus stabilized or maximum tolerated dose of Metformin

Participant Flow:   Overall Study
    LAF237 (Vildagliptin) 50mg Once Daily (QD)   LAF237 (Vildagliptin) 50mg Twice Daily (BID)
STARTED   56 [1]   61 
COMPLETED   51   57 
NOT COMPLETED   5   4 
Adverse Event                4                4 
Withdrawal by Subject                1                0 
[1] Intent to treat population



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent to treat (ITT) included all randomized patients who received at least one dose of study medication.

Reporting Groups
  Description
LAF237 (Vildagliptin) 50mg Once Daily (QD) Vildagliptin 50mg QD plus stabilized or maximum tolerated dose of Metformin
LAF237 (Vildagliptin) 50mg Twice Daily (BID) Vildagliptin 50mg BID plus stabilized or maximum tolerated dose of Metformin
Total Total of all reporting groups

Baseline Measures
   LAF237 (Vildagliptin) 50mg Once Daily (QD)   LAF237 (Vildagliptin) 50mg Twice Daily (BID)   Total 
Overall Participants Analyzed 
[Units: Participants]
 56   61   117 
Age 
[Units: Years]
Mean (Standard Deviation)
 58  (10.3)   59  (10.0)   58  (10.1) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      26  46.4%      31  50.8%      57  48.7% 
Male      30  53.6%      30  49.2%      60  51.3% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change of Glycosylated Hemoglobin A1c (HbA1c) From Baseline to Month 12   [ Time Frame: Baseline, Month 12 (weeK 52) ]

2.  Secondary:   Change of Glycosylated Hemoglobin A1c (HbA1c) From Baseline to Month 3, 6, 9 and 12 (Based on MMRM Analysis)   [ Time Frame: Baseline, Month 3, 6, 9 and 12 ]

3.  Secondary:   Change in Fasting Plasma Glucose (FPG) From Baseline to Month 3, 6, 9 and 12 (Based on MMRM Analysis)   [ Time Frame: Baseline, Month 3, 6, 9 and 12 ]

4.  Secondary:   Percentage of Patients Achieving Good Glycemic Control   [ Time Frame: Month 3, 6, 9, 12 ]

5.  Secondary:   Percentage of Overall Drug Compliance in 12 Months   [ Time Frame: Month 12 ]

6.  Secondary:   Number of Patients With Adverse Events, Serious Adverse Events and Death as an Assessment of Overall Safety and Tolerability   [ Time Frame: Month 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300
e-mail: trialandresults.registries@novartis.com



Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01766778     History of Changes
Other Study ID Numbers: CLAF237AHK01
First Submitted: January 9, 2013
First Posted: January 11, 2013
Results First Submitted: February 23, 2017
Results First Posted: April 10, 2017
Last Update Posted: May 15, 2017