Dose-finding Study of LIK066 Compared With Placebo or Sitagliptin to Evaluate Change in HbA1c in Patients With Diabetes

NCT ID: NCT01824264

Last Updated: 2014-04-03

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2016-11-30

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.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

LIK066 2.5 mg

Patients receive 2.5 mg of LIK066 once daily for 12 weeks

Group Type: EXPERIMENTAL

LIK066

Intervention Type: DRUG

Experimental treatment doses

LIK066 5 mg

Patients receive 5 mg of LIK066 once daily for 12 weeks

Group Type: EXPERIMENTAL

LIK066

Intervention Type: DRUG

Experimental treatment doses

LIK066 10 mg

Patients receive 10 mg of LIK066 once daily for 12 weeks

Group Type: EXPERIMENTAL

LIK066

Intervention Type: DRUG

Experimental treatment doses

LIK066 25 mg

Patients receive 25 mg of LIK066 once daily for 12 weeks

Group Type: EXPERIMENTAL

LIK066

Intervention Type: DRUG

Experimental treatment doses

LIK066 50 mg

Patients receive 50 mg of LIK066 once daily for 12 weeks

Group Type: EXPERIMENTAL

LIK066

Intervention Type: DRUG

Experimental treatment doses

LIK066 100 mg

Patients receive 100 mg of LIK066 once daily for 12 weeks

Group Type: EXPERIMENTAL

LIK066

Intervention Type: DRUG

Experimental treatment doses

LIK066 150 mg

Patients receive 150 mg of LIK066 once daily for 12 weeks

Group Type: EXPERIMENTAL

LIK066

Intervention Type: DRUG

Experimental treatment doses

Sitagliptin 100 mg

Patients receive 100 mg sitagliptin once daily for 12 weeks

Group Type: ACTIVE_COMPARATOR

Sitagliptin

Intervention Type: DRUG

Active comparator treatment dose

Placebo

Patients receive placebo for 12 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo comparator dose

Interventions

LIK066

Experimental treatment doses

Intervention Type: DRUG

Sitagliptin

Active comparator treatment dose

Intervention Type: DRUG

Placebo

Placebo comparator dose

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Other Identifiers

2012-005793-63

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CLIK066A2202

Identifier Type: -

Identifier Source: org_study_id