Study of Efficacy and Safety LMF237 in Patients With Type 2 Diabetes Mellitus (T2DM) Inadequately Controlled With Vildagliptin Monotherapy (CLMF237A1303)
This study is not yet open for participant recruitment.
Verified March 2013 by Novartis
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01811485
First received: March 12, 2013
Last updated: March 29, 2013
Last verified: March 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
- Endpoint HbA1c ≤ 6.5%
- Endpoint HbA1c < 7%
- Endpoint HbA1c < 7% in patients with baseline HbA1c ≤ 8%
- Endpoint HbA1c < 6.9%
- HbA1c reduction from baseline at endpoint ≥ 1%
- 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.
| Estimated Enrollment: | 171 |
| Study Start Date: | May 2013 |
| Estimated Study Completion Date: | July 2014 |
| Estimated Primary Completion Date: | July 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01811485
Contacts
| Contact: Novartis Pharmaceuticals | +81337978748 ext 8748 | |
| Contact: Novartis Pharmaceuticals |
Locations
| Japan | |
| Novartis Investigative Site | Not yet recruiting |
| Fukuoka-city, Fukuoka, Japan, 819-0006 | |
| Novartis Investigative Site | Not yet recruiting |
| Fukuoka-city, Fukuoka, Japan, 810-0014 | |
| Novartis Investigative Site | Not yet recruiting |
| Kitakyushu, Fukuoka, Japan, 800-0296 | |
| Novartis Investigative Site | Not yet recruiting |
| Kitakyushu-city, Fukuoka, Japan, 807-0857 | |
| Novartis Investigative Site | Not yet recruiting |
| Kawasaki, Kanagawa, Japan, 210-0852 | |
| Novartis Investigative Site | Not yet recruiting |
| Yokohama, Kanagawa, Japan, 221-0802 | |
| Novartis Investigative Site | Not yet recruiting |
| Kyoto-city, Kyoto, Japan, 615-0035 | |
| Novartis Investigative Site | Not yet recruiting |
| Tokorozawa-city, Saitama, Japan, 359-1161 | |
| Novartis Investigative Site | Not yet recruiting |
| Bunkyo-ku, Tokyo, Japan, 113-0031 | |
| Novartis Investigative Site | Not yet recruiting |
| Edogawa-ku, Tokyo, Japan, 134-0084 | |
| Novartis Investigative Site | Not yet recruiting |
| Hachioji, Tokyo, Japan, 192-0046 | |
| Novartis Investigative Site | Not yet recruiting |
| Katsushika-ku, Tokyo, Japan, 124-0024 | |
| Novartis Investigative Site | Not yet recruiting |
| Minato-ku, Tokyo, Japan, 108-0075 | |
| Novartis Investigative Site | Not yet recruiting |
| Minato-ku, Tokyo, Japan, 105-7390 | |
| Novartis Investigative Site | Not yet recruiting |
| Shinagawa-ku, Tokyo, Japan, 141-0032 | |
| Novartis Investigative Site | Not yet recruiting |
| Toshima-ku, Tokyo, Japan, 171-0021 | |
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: | March 29, 2013 |
| 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 May 16, 2013