Status:
WITHDRAWN
Dose-finding Study of LIK066 Compared With Placebo or Sitagliptin to Evaluate Change in HbA1c in Patients With Diabetes
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The purpose of the study is to evaluate the efficacy, tolerability and short-term safety of LIK066 to support dose selection for phase 3.
Eligibility Criteria
Inclusion
- Confirmed diagnosis of T2DM by standard criteria
- Drug-naïve patients, defined as patients not having received any anti-diabetic medication previously,
- 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
- 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)
- HbA1c ≥ 7 to ≤ 10.5% at Visit 1 for drug-naïve/currently untreated patients
- HbA1c ≥ 7 to ≤ 9.5% at Visit 1 for patients treated with OAD monotherapy
- HbA1c ≥ 7 to ≤ 10.5% at Visit 199 for ALL patients
- Age: ≥18 and ≤ 75 years old at Visit 1
- BMI ≥22 to ≤45 kg/m2 at Visit 1
Exclusion
- 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
- 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
- History of acute metabolic complications, CV disease, type 1 diabetes mellitus, hepatic disorders, pancreatitis, chronic diarrhea
- 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
- ECG abnormalities including AV block, long QT syndrome or QTc\>450 msec for men and \>470 msec for women
- History of malignancy
- Women of child-bearing potential not using effective methods of contraception Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
November 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2016
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01824264
Start Date
November 1 2015
End Date
November 1 2016
Last Update
April 3 2014
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