None listed
Conditions
Interventions
Group 1 Type of group
LGQ908 2 mg per day, orally
Group name:Group 7 Type of group
Sitagliptin 100 mg, per day, orally
Sponsors
NOVARTIS BIOSCIENSES PERU S.A.,
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: • 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. • Age 18-75 years, inclusive. • 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 <30 pg/ml ; (b) 6 weeks post-surgical bilateral oophorectomy with or without hysterectomy; or (c) have a documented history of tubal ligation at least 1 year prior to screening. • Patients with T2DM with HbA1c 7.0 to 10.0%, inclusive, at Visit 1. • Fasting plasma glucose =250mg/dL (13.9 mmol/L) at Visit 1 assessed by the central laboratory • Patients treated with metformin for at least 3 months prior to Visit 1 (screening) and on a stable dose =1500 mg for 4 weeks prior to Visit 3 (randomization). Patients must agree to maintain the same dose of metformin from 4 weeks before Visit 3 to the end of the study. • Body mass index (BMI) of 28 to 42 kg/m2 inclusive • Body weight at Visit 1 within 5% of their self-reported weight over the past three months and agreement to maintain the study-recommended diet (counseled during screening) and usual exercise habits during the full course of the study. • Patients on stable doses of statins or fibrates for 6 weeks prior to Visit 1 must agree to maintain those doses during the study period.
Exclusion criteria
Exclusion criteria: • 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 • A history of acute metabolic diabetic complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months. • 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. • Treatment with any oral antidiabetic agent other than metformin within 12 weeks prior to Visit 1. • Chronic insulin treatment (> 1 week of treatment in the absence of concurrent illness) within the 6 months prior to Visit 1. • 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. • 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 • 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). • Severe illness, trauma, or major surgery within 3 months prior to Visit 1. • 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) • History of Congestive Heart Failure (New York Heart Association (NYHA) Class III-IV) or pacemaker use within the past 5 years. • 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 • 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 • Liver disease such as cirrhosis or chronic active hepatitis B and C • 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 <300 mg/gram creatinine will be allowed.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Five possible models were selected to describe the potential dose-response curve for HbA1c based on data from the CLCQ908A2201 study. Measure:Cambio desde la evaluacion basal en la HbA1c a las 12 semanas Timepoints:12 semanas | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Measurement of body weight and waist circumference during the study. Measure:Variation in body weight and waist circumference Timepoints:12 weeks ; Outcome name:Measurement of fasting plasma Fructosamine and fasting plasma Glucose during the study. Measure:Fasting plasma Fructosamine variation and Fasting plasma Glucose Timepoints:12 weeks ; Outcome name:Laboratory measurement of fasting insulin and glucose during the study. Measure:Apparent insulin sensitivity evaluated by HOMA-IR, determined from fasting insulin and glucose. Timepoints:12 weeks | — |
Countries
Belgium, France, Germany, Italy, Peru, Poland, Slovakia, Spain
Contacts
Public ContactJuan Reyes
NOVARTIS BIOSCIENCES PERU S.A.
Outcome results
None listed