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

April 2, 2014 updated by: Novartis Pharmaceuticals

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

The purpose of the study is to evaluate the efficacy, tolerability and short-term safety of LIK066 to support dose selection for phase 3.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: LIK066 2.5 mg
Patients receive 2.5 mg of LIK066 once daily for 12 weeks
Drug: LIK066
Experimental treatment doses
Experimental: LIK066 5 mg
Patients receive 5 mg of LIK066 once daily for 12 weeks
Drug: LIK066
Experimental treatment doses
Experimental: LIK066 10 mg
Patients receive 10 mg of LIK066 once daily for 12 weeks
Drug: LIK066
Experimental treatment doses
Experimental: LIK066 25 mg
Patients receive 25 mg of LIK066 once daily for 12 weeks
Drug: LIK066
Experimental treatment doses
Experimental: LIK066 50 mg
Patients receive 50 mg of LIK066 once daily for 12 weeks
Drug: LIK066
Experimental treatment doses
Experimental: LIK066 100 mg
Patients receive 100 mg of LIK066 once daily for 12 weeks
Drug: LIK066
Experimental treatment doses
Experimental: LIK066 150 mg
Patients receive 150 mg of LIK066 once daily for 12 weeks
Drug: LIK066
Experimental treatment doses
Active Comparator: Sitagliptin 100 mg
Patients receive 100 mg sitagliptin once daily for 12 weeks
Drug: Sitagliptin
Active comparator treatment dose
Placebo Comparator: Placebo
Patients receive placebo for 12 weeks
Drug: Placebo
Placebo comparator dose

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline in glycated hemoglobin (HbA1c) after 12 weeks
Time Frame: baseline, 12 weeks
Change from baseline in HbA1c after 12 weeks of treatment in each of the LIK066 doses and placebo
baseline, 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline in Fasting Plasma Glucose
Time Frame: baseline, 12 weeks
The effect of LIK066 on fasting plasma glucose after 12 weeks of treatment will be evaluated.
baseline, 12 weeks
Change from baseline in urinary glucose to creatinine ratio
Time Frame: baseline, 12 weeks
The effect of LIK066 on urinary glucose to creatinine ratio after 12 weeks of treatment will be evaluated
baseline, 12 weeks
Change from baseline in Body weight
Time Frame: baseline, 12 weeks
The effect of LIK066 on change in body weight after 12 weeks of treatment will be evaluated.
baseline, 12 weeks
Change from baseline in Blood pressure
Time Frame: baseline, 12 weeks
The effect of LIK066 on change in systolic and diastolic blood pressure after 12 weeks of treatment will be evaluated.
baseline, 12 weeks
Change from baseline in postprandial glucose during a meal test
Time Frame: baseline, 12 weeks
The effect of LIK066 on change in postprandial glucose during a meal test after 12 weeks of treatment will be evaluated.
baseline, 12 weeks
Change from baseline in beta cell function during a meal test
Time Frame: baseline, 12 weeks
The effect of LIK066 on change in beta cell function during a meal test after 12 weeks of treatment will be evaluated.
baseline, 12 weeks
Change from baseline in insulin secretion relative to glucose during a meal test
Time Frame: baseline, 12 weeks
The effect of LIK066on change in insulin secretion relative to glucose during a meal test after 12 weeks of treatment will be evaluated.
baseline, 12 weeks
Change from baseline in oral glucose insulin sensitivity during a meal test
Time Frame: baseline, 12 weeks
The effect of LIK066 on change in oral glucose insulin sensitivity during a meal test after 12 weeks of treatment will be evaluated.
baseline, 12 weeks
Change from baseline in glucagon-like peptide response during a meal test
Time Frame: baseline, 12 weeks
The effect of LIK066 on change in glucagon-like peptide during a meal test after 12 weeks of treatment will be evaluated.
baseline, 12 weeks
Change from baseline in Peptide YY response during a meal test
Time Frame: baseline, 12 weeks
The effect of LIK066 on change in peptide YY response during a meal test after 12 weeks of treatment will be evaluated.
baseline, 12 weeks
Number of patients with adverse events to assess safety and tolerability of LIK066
Time Frame: 12 weeks
The safety and tolerability of 7 doses of LIK066 after 12 weeks of treatment will be evaluated with number of patients reported for total adverse events, serious adverse events and death.
12 weeks
Change from baseline in renal threshold for glucose excretion
Time Frame: baseline, 12 weeks
The effect of LIK066 on renal threshold for glucose excretion will be calculated from glucose values in an overnight urine collection
baseline, 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2016

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 1, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 4, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 3, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CLIK066A2202
  • 2012-005793-63 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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