Dose-finding study of LIK066 compared with placebo or sitagliptin to evaluate change in HbA1c in patients with diabetes
- Conditions
- Type II Diabetes mellitusTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2012-005793-63-PL
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 750
1.Confirmed diagnosis of T2DM by standard criteria
2.Drug-naïve patients, defined as patients not having received any anti-diabetic medication previously,
3.Currently untreated patients , who, after the diagnosis of T2DM, have received anti-diabetic medication for not more than 12 consecutive weeks, and have not received any anti-diabetic treatment within 12 weeks prior to Visit 1
4.Patients being treated with mono-therapy for at least 8 consecutive weeks prior to Visit 1 with the following OADs: metformin, dipeptidyl peptidase-4 inhibitors (DPP-4i), SU, glinide, alpha-glucosidase inhibitor (AGI)
5.HbA1c = 7 to = 10.5% at Visit 1 for drug-naïve/currently untreated patients
6.HbA1c = 7 to = 9.5% at Visit 1 for patients treated with OAD monotherapy
7.HbA1c = 7 to = 10.5% at Visit 199 for ALL patients
8.Age: =18 and = 75 years old at Visit 1
9.BMI =22 to =45 kg/m2 at Visit 1
Other protocol-defined inclusion criteria may apply
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 502
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 248
1.FPG =270 mg/dl (15 mmol/L) for drug-naïve/currently untreated patients or =240 mg/dl (13.3 mmol/L) for patients on OAD monotherapy at Visit 1
2.Insulin treatment >4 consecutive weeks in the last 6 months, corticosteroid use >7 days in the last 8 weeks, use of growth hormones in the last 6 months, or use of weight control products > 4 weeks in the last 6 months
3.History of acute metabolic complications, CV disease, type 1 diabetes mellitus, hepatic disorders, pancreatitis, chronic diarrhea
4.Significant lab abnormalities such as TSH outside of normal range, UACR>300 mg/g creatinine, eGFR <60 ml/min/1.73m2, hemoglobin <12 g/L in men and <11 g/L in women, hematuria
5.ECG abnormalities including AV block, long QT syndrome or QTc>450 msec for men and >460 msec for women
6.History of malignancy
7.Women of child-bearing potential not using effective methods of contraception
Other protocol-defined exclusion criteria may apply
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate and model the HbA1c dose-response relationship for LIK066<br>q.d., b.i.d., or t.i.d., dosing regimens after 12 weeks of treatment with<br>LIK066 oral doses ranging from 2.5mg to 150mg daily compared to<br>placebo;Primary end point(s): change from baseline in HbA1c after 12 weeks of treatment in each of the LIK066 doses and placebo;Timepoint(s) of evaluation of this end point: 12 weeks;Secondary Objective: 1. To evaluate the effect of LIK066 doses and regimens on:<br>• fasting plasma glucose (FPG)<br>• urinary glucose-to-creatinine ratio (UGCR)<br>• body weight<br>• systolic and diastolic blood pressure<br>• postprandial glucose, beta cell function (HOMA-B), insulin secretion<br>relative to glucose (ISR/G), oral glucose insulin sensitivity (OGIS),<br>HOMA-IR, total GLP-1 and PYY response during a meal test in a subset of<br>patients<br>2. To evaluate the safety and tolerability of LIK066
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Change from baseline after 12 weeks of treatment<br>- Fasting plasma glucose (FPG)<br>- Urinary glucose-to-creatinine ratio (UGCR)<br>- body weight<br>- systolic and diastolic blood pressure<br>- postprandial glucose, beta cell function (HOMA-B), insulin secretion<br>relative to glucose (ISR/G), oral glucose insulin sensitivity (OGIS),<br>HOMA-IR, total GLP-1 and PYY response during a meal test<br>-the safety and tolerability of LIK066 after 12 weeks of treatment will be<br>evluated with number of patients reported for total adverse events,<br>serious adverse events and death;Timepoint(s) of evaluation of this end point: 12 weeks