Diabetes Mellitus, Type 2
Conditions
Interventions
investigational material(s)
Generic name etc : LMF237
INN of investigational material :
Therapeutic category code : 396 Antidiabetic agents
Dosage and Administration for Investigational material : tw
Sponsors
Novartis Pharma K.K.
Eligibility
Sex/Gender
All
Inclusion 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/m2
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change 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
| Measure | Time frame |
|---|---|
| Change 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 == 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. | — |
Outcome results
None listed