Type 2 Diabetes MellitusPhase 1/2NCT01915849

Effect of LIK066 on Glucose Absorption in Patients With Type 2 Diabetes Mellitus

A Phase 1/2 study testing LIK066 in people with Type 2 Diabetes Mellitus, run by Novartis Pharmaceuticals at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of the study was to assess the effect of LIK066 on intestinal glucose absorption immediately after a single dose (immediate effect) and 6 hours following the dose (after multiple daily doses; sustained effect) in patients with type 2 diabetes mellitus (T2DM). Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: LIK066
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 14 participants
Where: 1 siteUnited States
Study dates: Jul 2013to Jan 2014
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients, age 18-65 years, must have been diagnosed with T2DM at least 6 months prior to screening with HbA1c 6.5 to 10.0%, inclusive, at screening.
Fasting plasma glucose ≤250mg/dL at screening.
If treated with metformin, patients must be on a stable dose for 12 weeks prior to randomization and maintain the dose until the end of the study.

Who cannot join

Patients with type 1 diabetes mellitus.
Patients with history of acute diabetic complications within the 6 months prior to screening.
Pregnant or nursing (lactating) women.
Women of child-bearing potential unless they are using effective methods of contraception during dosing of study treatment.
Patients with signs or symptoms of significant diabetic complications.
Patients treated with certain blood pressure or lipid lowering medications unless patients have been on stable doses for the 12 weeks prior to dosing.

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History of drug or alcohol abuse within the 12 months prior to dosing.
Any surgical or medical condition, acute or unstable chronic disease which may, based on the investigator's opinion, jeopardize the patient in case of participation in the study.
Other protocol-defined inclusion/exclusion criteria may apply

Trial locations and contacts

1 site in 1 country.

United States1 site

Novartis Investigative Site
Chula Vista, California, 91910

Other trials in United States

About this study

Official title: A Randomized, Double-blinded, Placebo-controlled, Crossover Trial to Assess the Effect of Orally Administered LIK066 on Glucose Absorption in Patients With Type 2 Diabetes Mellitus

Conditions: Type 2 Diabetes Mellitus
Being tested: LIK066, Placebo
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LIK066Drug
LIK066 15 mg, 50 mg and 150 mg
PlaceboDrug

Study groups in NCT01915849
Study group	Role	What they receive
Sequence 1: LIK066 15 mg/Placebo/LIK066 50 mg/LIK066 150 mg	Experimental	Period 1- LIK066 15 mg treatment once daily (q.d.) for 4 days. Period 2- Placebo treatment once daily for 4 days Period 3 - LIK066 50 mg treatment once daily (q.d.) for 4 days. Period 4- LIK066 150 mg treatment once daily (q.d.) for 4 days. 14 days washout periods between treatment periods. Receives: Drug: LIK066; Drug: Placebo
Sequence 2: LIK066 50 mg/LIK066 15 mg/LIK066 150 mg/Placebo	Experimental	Period 1- LIK066 50 mg treatment once daily (q.d.) for 4 days. Period 2- LIK066 15 mg treatment once daily (q.d.) for 4 days. Period 3- LIK066 150 mg treatment once daily (q.d.) for 4 days. Period 4- Placebo treatment once daily for 4 days. 14 days washout periods between treatment periods. Receives: Drug: LIK066; Drug: Placebo
Sequence 3: LIK066 150 mg/LIK066 50 mg/Placebo/LIK066 15 mg	Experimental	Period 1- LIK066 150 mg treatment once daily (q.d.) for 4 days. Period 2- LIK066 50 mg treatment once daily (q.d.) for 4 days. Period 3- Placebo treatment once daily for 4 days. Period 4- LIK066 15 mg treatment once daily (q.d.) for 4 days. 14 days washout periods between treatment periods. Receives: Drug: LIK066; Drug: Placebo
Sequence 3: Placebo/LIK066 150 mg/LIK066 15 mg/LIK066 50 mg	Experimental	Period 1- Placebo treatment once daily (q.d.) for 4 days. Period 2- LIK066 150 mg treatment once daily (q.d.) for 4 days. Period 3- LIK066 15 mg treatment once daily (q.d.) for 4 days. Period 4- LIK066 50 mg treatment once daily (q.d.) for 4 days. 14 days washout periods between treatment periods. Receives: Drug: LIK066; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Area Under the Postprandial Curve (AUC) for Rate of Appearance (Ra) of Exogenous Glucose
Glucose fluxes during a mixed meal were measured using a dual glucose tracer method and non-steady state Steele equations. The rate of appearance of meal (or exogenous) glucose in the blood (also referred to as intestinal glucose absorption or Ra meal) after a mixed meal following LIK066 administration on Days 1 and 4 was the primary PD assessment in this study.The postprandial AUC was calculated using the linear trapezoidal rule. The sample collected at 7 hours after the start of the infusion was treated as the pre-meal, 0 hour measurement for the AUC0-5 hr calculation.
Measured: Day 1 and Day 4 (pre-meal, every half hour till 5 hour on Day 1 and Day 4)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2013Jan 2014

First posted5 Aug 2013 (estimated)
Study startJul 2013
Primary completionJan 2014
Study completionJan 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01915849
Sponsor's protocol ID: CLIK066A2201
Status last verified: Jan 2015
First submitted: 1 Aug 2013
Last updated: 6 Feb 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Type 2 Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blinded, Placebo-controlled, Crossover Trial to Assess the Effect of Orally Administered LIK066 on Glucose Absorption in Patients With Type 2 Diabetes Mellitus
ClinicalTrials.gov ID: NCT01915849
Acronym / sponsor ID: CLIK066A2201
Conditions: Type 2 Diabetes Mellitus
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 14 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Jul 2013
Primary completion: Jan 2014 (actual)
Study completion: Jan 2014 (actual)
First posted: 5 Aug 2013 (estimated)
Results: Posted 6 Feb 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Sequence 1: LIK066 15 mg/Placebo/LIK066 50 mg/LIK066 150 mg	Experimental	Drug: LIK066, Drug: PlaceboPeriod 1- LIK066 15 mg treatment once daily (q.d.) for 4 days. Period 2- Placebo treatment once daily for 4 days Period 3 - LIK066 50 mg treatment once daily (q.d.) for 4 days. Period 4- LIK066 150 mg treatment once daily (q.d.) for 4 days. 14 days washout periods between treatment periods.
Sequence 2: LIK066 50 mg/LIK066 15 mg/LIK066 150 mg/Placebo	Experimental	Drug: LIK066, Drug: PlaceboPeriod 1- LIK066 50 mg treatment once daily (q.d.) for 4 days. Period 2- LIK066 15 mg treatment once daily (q.d.) for 4 days. Period 3- LIK066 150 mg treatment once daily (q.d.) for 4 days. Period 4- Placebo treatment once daily for 4 days. 14 days washout periods between treatment periods.
Sequence 3: LIK066 150 mg/LIK066 50 mg/Placebo/LIK066 15 mg	Experimental	Drug: LIK066, Drug: PlaceboPeriod 1- LIK066 150 mg treatment once daily (q.d.) for 4 days. Period 2- LIK066 50 mg treatment once daily (q.d.) for 4 days. Period 3- Placebo treatment once daily for 4 days. Period 4- LIK066 15 mg treatment once daily (q.d.) for 4 days. 14 days washout periods between treatment periods.
Sequence 3: Placebo/LIK066 150 mg/LIK066 15 mg/LIK066 50 mg	Experimental	Drug: LIK066, Drug: PlaceboPeriod 1- Placebo treatment once daily (q.d.) for 4 days. Period 2- LIK066 150 mg treatment once daily (q.d.) for 4 days. Period 3- LIK066 15 mg treatment once daily (q.d.) for 4 days. Period 4- LIK066 50 mg treatment once daily (q.d.) for 4 days. 14 days washout periods between treatment periods.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Patients, age 18-65 years, must have been diagnosed with T2DM at least 6 months prior to screening with HbA1c 6.5 to 10.0%, inclusive, at screening.
Fasting plasma glucose ≤250mg/dL at screening.
If treated with metformin, patients must be on a stable dose for 12 weeks prior to randomization and maintain the dose until the end of the study.

Key exclusion criteria (9 listed)

Patients with type 1 diabetes mellitus.
Patients with history of acute diabetic complications within the 6 months prior to screening.
Pregnant or nursing (lactating) women.
Women of child-bearing potential unless they are using effective methods of contraception during dosing of study treatment.
Patients with signs or symptoms of significant diabetic complications.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LIK066LIK066 15 mg, 50 mg and 150 mg	Drug	Sequence 1: LIK066 15 mg/Placebo/LIK066 50 mg/LIK066 150 mg, Sequence 2: LIK066 50 mg/LIK066 15 mg/LIK066 150 mg/Placebo, Sequence 3: LIK066 150 mg/LIK066 50 mg/Placebo/LIK066 15 mg, Sequence 3: Placebo/LIK066 150 mg/LIK066 15 mg/LIK066 50 mg
Placebo	Drug	Sequence 1: LIK066 15 mg/Placebo/LIK066 50 mg/LIK066 150 mg, Sequence 2: LIK066 50 mg/LIK066 15 mg/LIK066 150 mg/Placebo, Sequence 3: LIK066 150 mg/LIK066 50 mg/Placebo/LIK066 15 mg, Sequence 3: Placebo/LIK066 150 mg/LIK066 15 mg/LIK066 50 mg

Primary outcome

Area Under the Postprandial Curve (AUC) for Rate of Appearance (Ra) of Exogenous Glucose
Time frame: Day 1 and Day 4 (pre-meal, every half hour till 5 hour on Day 1 and Day 4)
Glucose fluxes during a mixed meal were measured using a dual glucose tracer method and non-steady state Steele equations. The rate of appearance of meal (or exogenous) glucose in the blood (also referred to as intestinal glucose absorption or Ra meal) after a mixed meal following LIK066 administration on Days 1 and 4 was the primary PD assessment in this study.The postprandial AUC was calculated using the linear trapezoidal rule. The sample collected at 7 hours after the start of the infusion was treated as the pre-meal, 0 hour measurement for the AUC0-5 hr calculation.

Results and safety

Results posted to the registry on 6 Feb 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sequence 1: LIK066 15 mg/Placebo/LIK066 50 mg/LIK066 150 mg	5	3
Sequence 2: LIK066 50 mg/LIK066 15 mg/LIK066 150 mg/Placebo	3	3
Sequence 3: LIK066 150 mg/LIK066 50 mg/Placebo/LIK066 15 mg	3	3
Sequence 4: Placebo/LIK066 150 mg/LIK066 15 mg/LIK066 50 mg	3	3

Primary outcome: Area Under the Postprandial Curve (AUC) for Rate of Appearance (Ra) of Exogenous Glucose

Time frame: Day 1 and Day 4 (pre-meal, every half hour till 5 hour on Day 1 and Day 4). Mean (Standard Deviation). Unit: (umol/kg FFM/min)*hr

Measure	LIK066 15 mg n = 14	LIK066 50 mg n = 12	LIK066 150 mg n = 12	Placebo n = 11
Day 1	101.97 (29.348)	93.89 (25.852)	63.84 (22.589)	97.76 (30.615)
Day 4	109.99 (27.144)	117.81 (30.881)	112.45 (31.129)	103.97 (23.335)

Population analysed: The pharmacodynamic (PD) analysis set included all patients with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 12 (0%)	5 of 12 (41.7%)	Not reported
LIK066 15 mg	0 of 14 (0%)	8 of 14 (57.1%)	Not reported
LIK066 50 mg	0 of 12 (0%)	7 of 12 (58.3%)	Not reported
LIK066 150 mg	0 of 12 (0%)	11 of 12 (91.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Novartis Pharmaceuticals study director

Novartis Pharmaceuticals

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing LIK066 in people with Type 2 Diabetes Mellitus, run by Novartis Pharmaceuticals at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area Under the Postprandial Curve (AUC) for Rate of Appearance (Ra) of Exogenous Glucose (time frame: Day 1 and Day 4 (pre-meal, every half hour till 5 hour on Day 1 and Day 4)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01915849.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2015.