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

Diabetes Mellitus, Type 2 Clinical Trial

— CLMF237A1303  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01811485
• Other study ID #: CLMF237A1303
• Status: Completed
• Phase: Phase 3
• First received: March 12, 2013
• Last updated: February 4, 2015
• Start date: May 2013
• Est. completion date: February 2014

Study information

• Verified date: February 2015
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 171
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 74 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• LMF237 50/250 mg
Corresponds to vildagliptin 50 mg twice daily and metformin 250 mg twice daily
• LMF237 50/500 mg
Corresponds to vildagliptin 50 mg twice daily and metformin 500 mg twice daily
• Placebo
Matching placebo of LMF237 (contained vildagliptin 50 mg as active ingredient) twice daily

Locations

Country	Name	City	State
Japan	Novartis Investigative Site	Ageo-city	Saitama
Japan	Novartis Investigative Site	Bunkyo-ku	Tokyo
Japan	Novartis Investigative Site	Chikushino-city	Fukuoka
Japan	Novartis Investigative Site	Edogawa-ku	Tokyo
Japan	Novartis Investigative Site	Fukuoka-city	Fukuoka
Japan	Novartis Investigative Site	Fukuoka-city	Fukuoka
Japan	Novartis Investigative Site	Hachioji	Tokyo
Japan	Novartis Investigative Site	Hachioji-city	Tokyo
Japan	Novartis Investigative Site	Iizuka-city	Fukuoka
Japan	Novartis Investigative Site	Katsushika-ku	Tokyo
Japan	Novartis Investigative Site	Kawasaki-city	Kanagawa
Japan	Novartis Investigative Site	Kitakyushu-city	Fukuoka
Japan	Novartis Investigative Site	Kitakyushu-city	Fukuoka
Japan	Novartis Investigative Site	Kiyose-city	Tokyo
Japan	Novartis Investigative Site	Koga-city	Ibaraki
Japan	Novartis Investigative Site	Kyoto-city	Kyoto
Japan	Novartis Investigative Site	Kyoto-city	Kyoto
Japan	Novartis Investigative Site	Minato-ku	Tokyo
Japan	Novartis Investigative Site	Minato-ku	Tokyo
Japan	Novartis Investigative Site	Nerima-ku	Tokyo
Japan	Novartis Investigative Site	Sakai-city	Osaka
Japan	Novartis Investigative Site	Shibuya-ku	Tokyo
Japan	Novartis Investigative Site	Shinagawa-ku	Tokyo
Japan	Novartis Investigative Site	Takatsuki-city	Osaka
Japan	Novartis Investigative Site	Tokorozawa-city	Saitama
Japan	Novartis Investigative Site	Toshima-ku	Tokyo
Japan	Novartis Investigative Site	Yatsushiro-city	Kumamoto
Japan	Novartis Investigative Site	Yatsushiro-city	Kumamoto
Japan	Novartis Investigative Site	Yokohama-city	Kanagawa
Japan	Novartis Investigative Site	Yokohama-city	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change From Baseline in HbA1c at 14 Weeks Within LMF237 Treatment Groups	HbA1c will be performed on a blood sample obtained and measured by HPLC. HPCL was performed at a central laboratory.	Baseline to 14 weeks	No
Secondary	Percentage of Patients Meeting Responder Rates in HbA1c	Responder rate was 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%.; Categories 1, 2, and 4 - 'n' includes only patients with baseline HbA1c > 6.5%, = 7%, = 6.9% and endpoint HbA1c measurement. Category 3, 'n' includes only patients with 7% = baseline HbA1c = 8% and endpoint HbA1c. Category 5 and 6, 'n' indicates number of patients with both baseline and endpoint HbA1c measurements.	Baseline, 14 weeks	No
Secondary	Change From Baseline in Fasting Plasma Glucose (FPG) at 14 Weeks	FPG was performed on a blood sample obtained and analyzed at a central laboratory.	Baseline to 14 weeks	No
Secondary	Number of Patients With Adverse Events (Including Hypoglycemia), Serious Adverse Events and Death	The occurrence of adverse events were 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.	14 weeks	Yes