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
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: LMF237 50/250 mg
Drug: LMF237 50/500 mg
Drug: Placebo
Phase 3

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
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 171
Study Start Date: May 2013
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
Placebo Comparator: Placebo
Patients should take matching placebo of LMF237 (vildagliptin 50 mg) twice daily, switching from vildagliptin 50 mg twice daily
Drug: Placebo
Matching placebo of LMF237 (vildagliptin 50 mg) twice daily

  Eligibility

Ages Eligible for Study:   20 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01811485

Locations
Japan
Novartis Investigative Site
Chikushino-city, Fukuoka, Japan, 818-0083
Novartis Investigative Site
Fukuoka-city, Fukuoka, Japan, 819-0006
Novartis Investigative Site
Fukuoka-city, Fukuoka, Japan, 810-0014
Novartis Investigative Site
Iizuka, Fukuoka, Japan, 820-8505
Novartis Investigative Site
Kitakyushu, Fukuoka, Japan, 800-0296
Novartis Investigative Site
Kitakyushu-city, Fukuoka, Japan, 807-0857
Novartis Investigative Site
Koga-city, Ibaraki, Japan, 306-0232
Novartis Investigative Site
Kawasaki, Kanagawa, Japan, 210-0852
Novartis Investigative Site
Yokohama-city, Kanagawa, Japan, 221-0802
Novartis Investigative Site
Yokohama-city, Kanagawa, Japan, 231-0023
Novartis Investigative Site
Yatsushiro, Kumamoto, Japan, 866-8660
Novartis Investigative Site
Yatsushiro-city, Kumamoto, Japan, 866-8533
Novartis Investigative Site
Kyoto-city, Kyoto, Japan, 615-0035
Novartis Investigative Site
Sakai-city, Osaka, Japan, 590-0064
Novartis Investigative Site
Takatsuki-city, Osaka, Japan, 569-1096
Novartis Investigative Site
Ageo-city, Saitama, Japan, 362-8588
Novartis Investigative Site
Tokorozawa-city, Saitama, Japan, 359-1161
Novartis Investigative Site
Bunkyo-ku, Tokyo, Japan, 113-0031
Novartis Investigative Site
Edogawa-ku, Tokyo, Japan, 134-0084
Novartis Investigative Site
Hachioji, Tokyo, Japan, 192-0046
Novartis Investigative Site
Hachioji-city, Tokyo, Japan, 192-0918
Novartis Investigative Site
Katsushika-ku, Tokyo, Japan, 124-0024
Novartis Investigative Site
Kiyose, Tokyo, Japan, 204-0021
Novartis Investigative Site
Minato-ku, Tokyo, Japan, 108-0075
Novartis Investigative Site
Minato-ku, Tokyo, Japan, 105-7390
Novartis Investigative Site
Nerima-ku, Tokyo, Japan, 177-0051
Novartis Investigative Site
Shibuya-ku, Tokyo, Japan, 150-0002
Novartis Investigative Site
Shinagawa-ku, Tokyo, Japan, 141-0032
Novartis Investigative Site
Toshima-ku, Tokyo, Japan, 171-0021
Novartis Investigative Site
Kyoto, Japan, 607-8062
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

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
Last Updated: February 24, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vildagliptin
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 22, 2014