Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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18 November 2013 |
Main ID: |
EUCTR2012-005793-63-PL |
Date of registration:
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06/06/2013 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Dose-finding study of LIK066 compared with placebo or sitagliptin to evaluate change in HbA1c in patients with diabetes
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Scientific title:
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A multi-center, randomized, double-blind, double-dummy, parallel-group
dose-finding study to evaluate the change in HbA1c after 12 weeks
monotherapy with LIK066 doses ranging from 2.5mg to 150mg daily taken
q.d., b.i.d., or t.i.d. compared with placebo or sitagliptin in patients with
type 2 diabetes |
Date of first enrolment:
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Target sample size:
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750 |
Recruitment status: |
Authorised-recruitment may be ongoing or finished |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-005793-63 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: yes
Other trial design description: double-dummy
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: yes
Other: no
Number of treatment arms in the trial: 12
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Phase:
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Countries of recruitment
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Argentina
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Canada
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Germany
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Guatemala
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Hungary
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India
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Italy
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Mexico
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Poland
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Portugal
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Russian Federation
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Slovakia
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South Africa
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Taiwan
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United States
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Contacts
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Name:
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Clinical trial information desk
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Address:
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Lichtstrasse 35
4056
Basel
Switzerland |
Telephone:
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0041613241111 |
Email:
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clinicaltrial.enquiries@novartis.com |
Affiliation:
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Novartis Pharma AG |
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Name:
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Clinical trial information desk
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Address:
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Lichtstrasse 35
4056
Basel
Switzerland |
Telephone:
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0041613241111 |
Email:
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clinicaltrial.enquiries@novartis.com |
Affiliation:
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Novartis Pharma AG |
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Key inclusion & exclusion criteria
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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 502 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 248
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 >460 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
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Type II Diabetes mellitus
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Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
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Intervention(s)
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Product Name: LIK066 Product Code: LIK066 Pharmaceutical Form: Tablet Other descriptive name: LIK066 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2.5- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use
Trade Name: JANUVIA Product Name: sitagliptin Pharmaceutical Form: Capsule INN or Proposed INN: sitagliptin CAS Number: 654671-78-0 Other descriptive name: SITAGLIPTIN PHOSPHATE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use
Product Name: LIK066 Product Code: LIK066 Pharmaceutical Form: Tablet Other descriptive name: LIK066 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use
Product Name: LIK066 Product Code: LIK066 Pharmaceutical Form: Tablet Other descriptive name: LIK066 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Timepoint(s) of evaluation of this end point: 12 weeks
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Primary end point(s): change from baseline in HbA1c after 12 weeks of treatment in each of the LIK066 doses and placebo
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Secondary Objective: 1. To evaluate the effect of LIK066 doses and regimens on: • fasting plasma glucose (FPG) • urinary glucose-to-creatinine ratio (UGCR) • body weight • systolic and diastolic blood pressure • postprandial glucose, beta cell function (HOMA-B), insulin secretion relative to glucose (ISR/G), oral glucose insulin sensitivity (OGIS), HOMA-IR, total GLP-1 and PYY response during a meal test in a subset of patients 2. To evaluate the safety and tolerability of LIK066
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Main Objective: To evaluate and model the HbA1c dose-response relationship for LIK066 q.d., b.i.d., or t.i.d., dosing regimens after 12 weeks of treatment with LIK066 oral doses ranging from 2.5mg to 150mg daily compared to placebo
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Secondary Outcome(s)
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Secondary end point(s): Change from baseline after 12 weeks of treatment
- Fasting plasma glucose (FPG)
- Urinary glucose-to-creatinine ratio (UGCR)
- body weight
- systolic and diastolic blood pressure
- postprandial glucose, beta cell function (HOMA-B), insulin secretion
relative to glucose (ISR/G), oral glucose insulin sensitivity (OGIS),
HOMA-IR, total GLP-1 and PYY response during a meal test
-the safety and tolerability of LIK066 after 12 weeks of treatment will be
evluated with number of patients reported for total adverse events,
serious adverse events and death
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Timepoint(s) of evaluation of this end point: 12 weeks
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Secondary ID(s)
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2012-005793-63-HU
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CLIK066A2202
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Source(s) of Monetary Support
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Novartis Pharma Services AG
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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