Clinical trial NCT01824264: Dose-finding Study of LIK066 Compared With Placebo or Sitagliptin to Evaluate Change in HbA1c in Patients With Diabetes
Official title: A Multi-center, Randomized, Double-blind, Parallel-group Dose-finding Study to Evaluate Change in HbA1c After 12 Weeks Monotherapy With 7 Doses of LIK066 Compared With Placebo or Sitagliptin in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 Diabetes mellitus, SGLT inhibitors, dose-response
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2013-04-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

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 inclusion/exclusion criteria may apply

Primary outcomes:
measure: Change from baseline in glycated hemoglobin (HbA1c) after 12 weeks
timeFrame: baseline, 12 weeks
Secondary outcomes:
measure: Change from baseline in Fasting Plasma Glucose
timeFrame: baseline, 12 weeks
measure: Change from baseline in urinary glucose to creatinine ratio
timeFrame: baseline, 12 weeks
measure: Change from baseline in Body weight
timeFrame: baseline, 12 weeks
measure: Change from baseline in Blood pressure
timeFrame: baseline, 12 weeks
measure: Change from baseline in postprandial glucose during a meal test
timeFrame: baseline, 12 weeks
measure: Change from baseline in beta cell function during a meal test
timeFrame: baseline, 12 weeks
measure: Change from baseline in insulin secretion relative to glucose during a meal test
timeFrame: baseline, 12 weeks
measure: Change from baseline in oral glucose insulin sensitivity during a meal test
timeFrame: baseline, 12 weeks
measure: Change from baseline in glucagon-like peptide response during a meal test
timeFrame: baseline, 12 weeks
measure: Change from baseline in Peptide YY response during a meal test
timeFrame: baseline, 12 weeks
measure: Number of patients with adverse events to assess safety and tolerability of LIK066
timeFrame: 12 weeks
measure: Change from baseline in renal threshold for glucose excretion
timeFrame: baseline, 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: