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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 24, 2014
Last verified: February 2014

March 12, 2013
February 24, 2014
May 2013
February 2014   (final data collection date for primary outcome measure)
Change from baseline in glycosylated hemoglobin (HbA1c) at 14 weeks between treatment groups [ Time Frame: Baseline to 14 weeks ] [ Designated as safety issue: No ]
HbA1c will be performed on a blood sample obtained and measured by High performance liquid chromatography (HPLC) performed at a central laboratory.
Change from baseline in glycosylated hemoglobin (HbA1c) at 14 weeks between treatment groups [ Time Frame: Baseline to 14 weeks ] [ Designated as safety issue: No ]
HbA1c will be performed on a blood sample obtained and measured by HPLC performed at a central laboratory.
Complete list of historical versions of study NCT01811485 on ClinicalTrials.gov Archive Site
  • Change from baseline in HbA1c at 14 weeks within each dose strength [ Time Frame: Baseline to 14 weeks ] [ Designated as safety issue: No ]
    HbA1c will be performed on a blood sample obtained and measured by HPLC performed at a central laboratory.
  • Percentage of patients meeting Responder rates in HbA1c [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]

    Responder rates will be analyzed in categories:

    1. Endpoint HbA1c ≤ 6.5%
    2. Endpoint HbA1c < 7%
    3. Endpoint HbA1c < 7% in patients with baseline HbA1c ≤ 8%
    4. Endpoint HbA1c < 6.9%
    5. HbA1c reduction from baseline at endpoint ≥ 1%
    6. HbA1c reduction from baseline at endpoint ≥ 0.5%
  • Change from baseline in Fasting plasma glucose (FPG) at 14 weeks [ Time Frame: Baseline to 14 weeks ] [ Designated as safety issue: No ]
    FPG will be performed on a blood sample obtained and analyzed at a central laboratory.
  • Number of patients with adverse events (including hypoglycemia), serious adverse events and death [ Time Frame: 14 weeks ] [ Designated as safety issue: Yes ]
    The occurrence of adverse events will be sought by non-directive questioning of the patient at each visit. Adverse events are defined as appearance or worsening of any undesirable symptom, sign (including an abnormal laboratory finding), or medical conditions. 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.
Same as current
Not Provided
Not Provided
 
Study of Efficacy and Safety LMF237 in Patients With Type 2 Diabetes Mellitus (T2DM) Inadequately Controlled With Vildagliptin Monotherapy
A Multicenter, Double-Blind, Randomized, Parallel-Group Study to Compare the Effect of 14 Weeks Treatment With LMF237 Bid to Placebo in Patients With Type 2 Diabetes Inadequately Controlled With Vildagliptin 50 mg Bid Monotherapy

The purpose of the study is to evaluate the efficacy and safety of LMF237 50/250 mg and 50/500 mg bid in Japanese patients with T2DM inadequately controlled with vildagliptin monotherapy. This study is being conducted to support registration of the fixed-dose combination of vildagliptin and metformin for the treatment of T2DM in Japan.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: LMF237 50/250 mg
    Corresponds to vildagliptin 50 mg twice daily and metformin 250 mg twice daily
  • Drug: LMF237 50/500 mg
    Corresponds to vildagliptin 50 mg twice daily and metformin 500 mg twice daily
  • Drug: Placebo
    Matching placebo of LMF237 (vildagliptin 50 mg) twice daily
  • Experimental: LMF237
    Patients should take LMF237 50/250 mg twice daily or LMF237 50/500 mg (with a starting dose of LMF 237 50/250 mg for 2 weeks) twice daily, switching from vildagliptin 50 mg twice daily
    Interventions:
    • Drug: LMF237 50/250 mg
    • Drug: LMF237 50/500 mg
  • Placebo Comparator: Placebo
    Patients should take matching placebo of LMF237 (vildagliptin 50 mg) twice daily, switching from vildagliptin 50 mg twice daily
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
171
February 2014
February 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with type 2 diabetes inadequately controlled with diet, exercise and oral anti-diabetic therapy
  • HbA1c in the range of 7.0-10.0%
  • Body mass index in the range of 20-35 kg/m^2

Exclusion Criteria:

  • Type 1 diabetes, monogenic diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes
  • Significant heart diseases Other protocol-defined inclusion/exclusion criteria may apply
Both
20 Years to 74 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01811485
CLMF237A1303
No
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
February 2014

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