Type II Diabetes MedDRA version: 9.1 Level: LLT Classification code 10012601 Term: Diabetes mellitus
Conditions
Interventions
Product Code: LCQ908A
Pharmaceutical Form: Tablet
Current Sponsor code: LCQ908
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2-
Pharmaceutical form of the placebo
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Written informed consent to participate in the study, before any study related activities are performed, and is likely to comply with all study requirements, including dietary guidelines. 2.Age 18-75 years, inclusive. 3.Males, non-fertile females, and females of non-childbearing potential. Women must be (a) postmenopausal, defined as age >48 with 12 months of natural (i.e. spontaneous) amenorrhea or age >42 with >6 months of spontaneous amenorrhea with serum FSH levels > 30 mIU/mL and estradiol =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.A history of type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes, e.g. Cushing’s syndrome and acromegaly 2.A history of acute metabolic diabetic complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months. 3.Evidence of significant diabetic complications, e.g., symptomatic autonomic neuropathy, severe diabetic retinopathy (e.g. associated with retinal hemorrhages or repeated photocoagulation therapy), diabetic gastroparesis or enteropathy. 4.Treatment with any oral antidiabetic agent other than metformin within 12 weeks prior to Visit 1. 5.Chronic insulin treatment (> 1 week of treatment in the absence of concurrent illness) within the 6 months prior to Visit 1. 6.Acute infections which may affect blood glucose control 4 weeks prior to Visit 1 and other concurrent medical conditions that may interfere with the interpretation of efficacy and safety during the study. 7.Donation of one unit (500 ml) or more of blood, significant blood loss equaling at least one unit of blood within 2 weeks, or a blood transfusion within 8 weeks prior to Visit 1 8.Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/mL). 9.Severe illness, trauma, or major surgery within 3 months prior to Visit 1. 10.Mean (of the last 2 of 3 consecutive determinations) sitting diastolic blood pressure >100 mmHg and/or mean sitting systolic blood pressure >150 mmHg. (patients may have their blood pressure re-evaluated on one occasion only no sooner than 4 weeks after adjustment of antihypertensive medications) 11.History of Congestive Heart Failure (New York Heart Association (NYHA) Class III-IV) or pacemaker use within the past 5 years. 12.Any of the following within the past 12 months: a.Myocardial infarction (MI). If the screening ECG reveals patterns consistent with a MI in the absence of clinical signs and symptoms of acute MI and in the absence of elevated troponin and CK-MB enzymes and the date of the event can not be determined, then the patient can enter the trial at the discretion of the investigator and/or local medical monitor b.Unstable angina c.Arterial revascularization, coronary artery bypass graft surgery, or percutaneous coronary intervention d.Cerebrovascular accident or recurrent transient ischemic attacks 13.Any of the following ECG abnormalities: a.Torsades de pointes, sustained and clinically relevant atrial or ventricular tachycardia, or atrial or ventricular fibrillation b.Second degree AV block (Mobitz 1 and 2) c.Third degree AV block d.Prolonged QTc (>450 ms for males and >470 ms for females) at screening confirmed by visual inspection of the electrocardiogram 14.Liver disease such as cirrhosis or chronic active hepatitis B and C 15.Impaired renal function including a history of dialysis or of nephrotic syndrome and/or estimated creatinine clearance less than 60 ml/min (using the Modification of Diet in Renal Disease (MDRD) formula). Proteinuria 2 times the upper limit of normal (ULN), confirmed by a repeat measurement within 3 working days b.Total bilirubin >2 times ULN and/or direct bilirubin greater than the ULN, confirmed by a re
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of five oral doses of LCQ908 (2 mg, 5 mg, 10 mg, 15 mg or 20 mg) and placebo over 12 weeks on HbA1c in obese patients with T2DM. The patients will have been on prior metformin monotherapy for at least 3 months prior to screening and will remain on a stable dose of metformin (= 1500 mg daily) throughout the study. ;Secondary Objective: To evaluate the safety and tolerability of LCQ908 (2 mg, 5 mg, 10 mg, 15 mg, 20 mg) vs. placebo and to evaluate the effect of LCQ908: •As a potential therapy for obesity, assessed by changes in body weight and waist circumference •On other measures reflecting short term control of hyperglycemia, assessed by changes in fasting plasma glucose and plasma fructosamine •As a potential therapy for dyslipidemia, assessed by changes in fasting plasma lipids •On apparent insulin sensitivity assessed by HOMA-IR •On gastrointestinal tolerability •On pharmacokinetics;Primary end point(s): The primary efficacy variable is the change from baseline of HbA1c at 12 weeks (or the last available post-randomization value). | — |
Countries
Belgium, France, Germany, Italy, Poland, Slovakia, Spain
Outcome results
None listed