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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Novartis ( Novartis Pharmaceuticals )

ClinicalTrials.gov Identifier:

NCT01915849

First received: August 1, 2013

Last updated: January 22, 2015

Last verified: January 2015

History of Changes

Results First Received: January 22, 2015

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Pharmacodynamics Study; Intervention Model: Crossover Assignment; Masking: Double Blind (Subject, Investigator)
Condition:	Type 2 Diabetes Mellitus
Interventions:	Drug: LIK066 Drug: Placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Sequence 1: LIK066 15 mg/Placebo/LIK066 50 mg/LIK066 150 mg	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.
Sequence 2: LIK066 50 mg/LIK066 15 mg/LIK066 150 mg/Placebo	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.
Sequence 3: LIK066 150 mg/LIK066 50 mg/Placebo/LIK066 15 mg	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.
Sequence 4: Placebo/LIK066 150 mg/LIK066 15 mg/LIK066 50 mg	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.

Participant Flow for 4 periods

Period 1: Treatment Period 1 (4 Days)

	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 4: Placebo/LIK066 150 mg/LIK066 15 mg/LIK066 50 mg
STARTED	5	3	3	3
COMPLETED	3	3	3	3
NOT COMPLETED	2	0	0	0
Protocol Violation	1	0	0	0
Withdrawal by Subject	1	0	0	0

Period 2: Treatment Period 2 (4 Days)

	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 4: Placebo/LIK066 150 mg/LIK066 15 mg/LIK066 50 mg
STARTED	3	3	3	3
COMPLETED	3	3	3	3
NOT COMPLETED	0	0	0	0

Period 3: Treatment Period 3 (4 Days)

	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 4: Placebo/LIK066 150 mg/LIK066 15 mg/LIK066 50 mg
STARTED	3	3	3	3
COMPLETED	3	3	3	3
NOT COMPLETED	0	0	0	0

Period 4: Treatment Period 4 (4 Days)

	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 4: Placebo/LIK066 150 mg/LIK066 15 mg/LIK066 50 mg
STARTED	3	3	3	3
COMPLETED	3	3	3	3
NOT COMPLETED	0	0	0	0

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety analysis set: all patients that received study drug and with no protocol deviations with relevant impact on safety.

Reporting Groups

	Description
Sequence 1: LIK066 15 mg/Placebo/LIK066 50 mg/LIK066 150 mg	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.
Sequence 2: LIK066 50 mg/LIK066 15 mg/LIK066 150 mg/Placebo	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.
Sequence 3: LIK066 150 mg/LIK066 50 mg/Placebo/LIK066 15 mg	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.
Sequence 4: Placebo/LIK066 150 mg/LIK066 15 mg/LIK066 50 mg	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.
Total	Total of all reporting groups

Baseline Measures

	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 4: Placebo/LIK066 150 mg/LIK066 15 mg/LIK066 50 mg	Total
Number of Participants [units: participants]	5	3	3	3	14
Age [units: Years] Mean ± Standard Deviation	53.4 ± 9.29	54.0 ± 10.54	62.3 ± 3.06	56.0 ± 8.19	56.0 ± 8.26
Gender [units: Participants]
Female	3	1	2	1	7
Male	2	2	1	2	7

Outcome Measures

1. Primary:

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) ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.

Results Point of Contact:

Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300
e-mail: trialandresults.registries@novartis.com

No publications provided

Responsible Party:	Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:	NCT01915849 History of Changes
Other Study ID Numbers:	CLIK066A2201
Study First Received:	August 1, 2013
Results First Received:	January 22, 2015
Last Updated:	January 22, 2015
Health Authority:	United States: Food and Drug Administration

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