NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JAPIC ID: JapicCTI-132092

Registered date:

Basic Information

Recruitment status
Health condition(s) or Problem(s) studiedDiabetes Mellitus, Type 2
Date of first enrollment01/5/2013
Target sample size
Countries of recruitment
Study typeINTERVENTIONAL
Intervention(s)Intervention name : LMF237 Dosage And administration of the intervention : twice daily, 50/250 or 50/500 mg Control intervention name : Placebo Dosage And administration of the control intervention : twice daily

Outcome(s)

Primary OutcomeChange from baseline in glycosylated hemoglobin (HbA1c) at 14 weeks between treatment groups [ Time Frame: Baseline to 14 weeks ] HbA1c will be performed on a blood sample obtained and measured by High performance liquid chromatography (HPLC) performed at a central laboratory.
Secondary OutcomeChange from baseline in HbA1c at 14 weeks within each dose strength [ Time Frame: Baseline to 14 weeks ] 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 ] 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 &#8804; 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 ] 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 ] 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.

Key inclusion & exclusion criteria

Age minimum20
Age maximum74
GenderBOTH
Include criteriaPatients 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/m2
Exclude criteriaType 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

Related Information

Contact

public contact
Name Novartis Pharma K.K. Novartis Direct
Address 0120-003-293
Telephone
E-mail
Affiliation
scientific contact
Name
Address
Telephone
E-mail
Affiliation