Dose-finding study of LIK066 compared with placebo or sitagliptin to evaluate change in HbA1c in patients with diabetes.

• Conditions: Type II Diabetes mellitus; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2012-005793-63-SK
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05-09
• Last Update Posted: 11 April 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 491

Inclusion Criteria

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 368
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 123

Exclusion Criteria

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 >470 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