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

NCT01824264 | Withdrawn Phase 2

• 2 other identifiers: CLIK066A22022012-005793-63
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Keywords

Type 2 Diabetes mellitus, SGLT inhibitors, dose-response

Outcome Measures

Primary Outcomes (1)

• Change from baseline in glycated hemoglobin (HbA1c) after 12 weeks

  Change from baseline in HbA1c after 12 weeks of treatment in each of the LIK066 doses and placebo

  baseline, 12 weeks

Secondary Outcomes (12)

• Change from baseline in Fasting Plasma Glucose

  baseline, 12 weeks

• Change from baseline in urinary glucose to creatinine ratio

  baseline, 12 weeks

• Change from baseline in Body weight

  baseline, 12 weeks

• Change from baseline in Blood pressure

  baseline, 12 weeks

• Change from baseline in postprandial glucose during a meal test

  baseline, 12 weeks

Study Arms (9)

LIK066 2.5 mg

EXPERIMENTAL

Patients receive 2.5 mg of LIK066 once daily for 12 weeks

Drug: LIK066

LIK066 5 mg

EXPERIMENTAL

Patients receive 5 mg of LIK066 once daily for 12 weeks

Drug: LIK066

LIK066 10 mg

EXPERIMENTAL

Patients receive 10 mg of LIK066 once daily for 12 weeks

Drug: LIK066

LIK066 25 mg

EXPERIMENTAL

Patients receive 25 mg of LIK066 once daily for 12 weeks

Drug: LIK066

LIK066 50 mg

EXPERIMENTAL

Patients receive 50 mg of LIK066 once daily for 12 weeks

Drug: LIK066

LIK066 100 mg

EXPERIMENTAL

Patients receive 100 mg of LIK066 once daily for 12 weeks

Drug: LIK066

LIK066 150 mg

EXPERIMENTAL

Patients receive 150 mg of LIK066 once daily for 12 weeks

Drug: LIK066

Sitagliptin 100 mg

ACTIVE COMPARATOR

Patients receive 100 mg sitagliptin once daily for 12 weeks

Drug: Sitagliptin

Placebo

PLACEBO COMPARATOR

Patients receive placebo for 12 weeks

Drug: Placebo

Interventions

LIK066 DRUG

Experimental treatment doses

LIK066 10 mg; LIK066 100 mg; LIK066 150 mg; LIK066 2.5 mg; LIK066 25 mg; LIK066 5 mg; LIK066 50 mg

Sitagliptin DRUG

Active comparator treatment dose

Sitagliptin 100 mg

Placebo DRUG

Placebo comparator dose

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

licogliflozin; Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2013
• First Posted: April 4, 2013
• Study Start: November 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: April 3, 2014

Record last verified: 2014-04