NCT01811485

Brief Summary

The purpose of the study was 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 was conducted to support registration of the fixed-dose combination of vildagliptin and metformin for the treatment of T2DM in Japan.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
171

participants targeted

Target at below P25 for phase_3 diabetes-mellitus-type-2

Timeline
Completed

Started May 2013

Shorter than P25 for phase_3 diabetes-mellitus-type-2

Geographic Reach
1 country

30 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 12, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 14, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

February 23, 2015

Completed
Last Updated

February 23, 2015

Status Verified

February 1, 2015

Enrollment Period

9 months

First QC Date

March 12, 2013

Results QC Date

February 4, 2015

Last Update Submit

February 4, 2015

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 14 Weeks Between Treatment Groups

    HbA1c was performed on a blood sample obtained and measured by High performance liquid chromatography (HPLC). HPCL was performed at a central laboratory.

    Baseline to 14 weeks

Secondary Outcomes (4)

  • Change From Baseline in HbA1c at 14 Weeks Within LMF237 Treatment Groups

    Baseline to 14 weeks

  • Percentage of Patients Meeting Responder Rates in HbA1c

    Baseline, 14 weeks

  • Change From Baseline in Fasting Plasma Glucose (FPG) at 14 Weeks

    Baseline to 14 weeks

  • Number of Patients With Adverse Events (Including Hypoglycemia), Serious Adverse Events and Death

    14 weeks

Study Arms (3)

LMF237 50/250 mg

EXPERIMENTAL

Patients took LMF237 50/250 mg twice daily for 14 weeks

Drug: LMF237 50/250 mgDrug: LMF237 50/500 mg

LMF237 50/500 mg

EXPERIMENTAL

Patients took LMF237 50/500 mg (with a starting dose of LMF 237 50/250 mg for 2 weeks) twice daily for 14 weeks

Drug: LMF237 50/250 mg

Placebo

PLACEBO COMPARATOR

Patients took matching placebo of LMF237 (vildagliptin 50 mg) twice daily for 14 weeks

Drug: Placebo

Interventions

LMF237 50/250 mgDRUG

Corresponds to vildagliptin 50 mg twice daily and metformin 250 mg twice daily

LMF237 50/250 mgLMF237 50/500 mg
LMF237 50/500 mgDRUG

Corresponds to vildagliptin 50 mg twice daily and metformin 500 mg twice daily

LMF237 50/250 mg
PlaceboDRUG

Matching placebo of LMF237 (contained vildagliptin 50 mg as active ingredient) twice daily

Placebo

Eligibility Criteria

Age20 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Type 1 diabetes, monogenic diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (30)

Novartis Investigative Site

Chikushino-shi, Fukuoka, 818-0083, Japan

Location

Novartis Investigative Site

Fukuoka, Fukuoka, 810-0014, Japan

Location

Novartis Investigative Site

Fukuoka, Fukuoka, 819-0006, Japan

Location

Novartis Investigative Site

Iizuka, Fukuoka, 820-8505, Japan

Location

Novartis Investigative Site

Kitakyushu, Fukuoka, 800-0296, Japan

Location

Novartis Investigative Site

Kitakyushu, Fukuoka, 807-0857, Japan

Location

Novartis Investigative Site

Koga, Ibaraki, 306-0232, Japan

Location

Novartis Investigative Site

Kawasaki, Kanagawa, 210-0852, Japan

Location

Novartis Investigative Site

Yokohama, Kanagawa, 221-0802, Japan

Location

Novartis Investigative Site

Yokohama, Kanagawa, 231-0023, Japan

Location

Novartis Investigative Site

Yatsushiro, Kumamoto, 866-8533, Japan

Location

Novartis Investigative Site

Yatsushiro, Kumamoto, 866-8660, Japan

Location

Novartis Investigative Site

Kyoto, Kyoto, 607-8062, Japan

Location

Novartis Investigative Site

Kyoto, Kyoto, 615-0035, Japan

Location

Novartis Investigative Site

Sakai, Osaka, 590-0064, Japan

Location

Novartis Investigative Site

Takatsuki, Osaka, 569-1096, Japan

Location

Novartis Investigative Site

Ageo, Saitama, 362-8588, Japan

Location

Novartis Investigative Site

Tokorozawa, Saitama, 359-1161, Japan

Location

Novartis Investigative Site

Bunkyo-ku, Tokyo, 113-0031, Japan

Location

Novartis Investigative Site

Edogawa-ku, Tokyo, 134-0084, Japan

Location

Novartis Investigative Site

Hachiōji, Tokyo, 192-0046, Japan

Location

Novartis Investigative Site

Hachiōji, Tokyo, 192-0918, Japan

Location

Novartis Investigative Site

Katsushika-ku, Tokyo, 124-0024, Japan

Location

Novartis Investigative Site

Kiyose, Tokyo, 204-0021, Japan

Location

Novartis Investigative Site

Minato-ku, Tokyo, 105-7390, Japan

Location

Novartis Investigative Site

Minato-ku, Tokyo, 108-0075, Japan

Location

Novartis Investigative Site

Nerima-ku, Tokyo, 177-0051, Japan

Location

Novartis Investigative Site

Shibuya-ku, Tokyo, 150-0002, Japan

Location

Novartis Investigative Site

Shinagawa-ku, Tokyo, 141-0032, Japan

Location

Novartis Investigative Site

Toshima-ku, Tokyo, 171-0021, Japan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Study Director
Organization
Novartis Pharmaceuticals
trialandresults.registries@novartis.com
862-778-8300

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2013

First Posted

March 14, 2013

Study Start

May 1, 2013

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

February 23, 2015

Results First Posted

February 23, 2015

Record last verified: 2015-02

Locations

JP(30)