Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Study of Efficacy and Safety LMF237 in Patients With Type 2 Diabetes Mellitus (T2DM) Inadequately Controlled With Vildagliptin Monotherapy (CLMF237A1303)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01811485
First received: March 12, 2013
Last updated: February 4, 2015
Last verified: February 2015
Results First Received: February 4, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Diabetes Mellitus, Type 2
Interventions: Drug: LMF237 50/250 mg
Drug: LMF237 50/500 mg
Drug: Placebo

  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
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Reporting Groups
  Description
LMF237 50/250 mg Patients took LMF237 50/250 mg twice daily for 14 weeks
LMF237 50/500 mg Patients took LMF237 50/500 mg (with a starting dose of LMF 237 50/250 mg for 2 weeks) twice daily for 14 weeks
Placebo Patients took matching placebo of LMF237 (vildagliptin 50 mg) twice daily for 14 weeks

Participant Flow:   Overall Study
    LMF237 50/250 mg     LMF237 50/500 mg     Placebo  
STARTED     56 [1]   59     56  
COMPLETED     54     55     51  
NOT COMPLETED     2     4     5  
Adverse Event                 1                 3                 2  
Unsatisfactory therapeutic effect                 0                 0                 3  
Administrative problems                 1                 0                 0  
Protocol Deviation                 0                 1                 0  
[1] "Started" indicates randomized patients



  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.
Randomized Set

Reporting Groups
  Description
LMF237 50/250 mg Patients took LMF237 50/250 mg twice daily for 14 weeks
LMF237 50/500 mg Patients took LMF237 50/500 mg (with a starting dose of LMF 237 50/250 mg for 2 weeks) twice daily for 14 weeks
Placebo Patients took matching placebo of LMF237 (vildagliptin 50 mg) twice daily for 14 weeks
Total Total of all reporting groups

Baseline Measures
    LMF237 50/250 mg     LMF237 50/500 mg     Placebo     Total  
Number of Participants  
[units: participants]
  56     59     56     171  
Age  
[units: Years]
Mean ± Standard Deviation
  56.6  ± 11.24     58.3  ± 10.50     56.2  ± 9.75     57.0  ± 10.49  
Gender  
[units: Participants]
       
Female     15     18     16     49  
Male     41     41     40     122  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 14 Weeks Between Treatment Groups   [ Time Frame: Baseline to 14 weeks ]

2.  Secondary:   Change From Baseline in HbA1c at 14 Weeks Within LMF237 Treatment Groups   [ Time Frame: Baseline to 14 weeks ]

3.  Secondary:   Percentage of Patients Meeting Responder Rates in HbA1c   [ Time Frame: Baseline, 14 weeks ]

4.  Secondary:   Change From Baseline in Fasting Plasma Glucose (FPG) at 14 Weeks   [ Time Frame: Baseline to 14 weeks ]

5.  Secondary:   Number of Patients With Adverse Events (Including Hypoglycemia), Serious Adverse Events and Death   [ Time Frame: 14 weeks ]


  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


No publications provided


Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01811485     History of Changes
Other Study ID Numbers: CLMF237A1303
Study First Received: March 12, 2013
Results First Received: February 4, 2015
Last Updated: February 4, 2015
Health Authority: Japan: Ministry of Health, Labor and Welfare