Effect of Liraglutide or Glimepiride Added to Metformin on Blood Glucose Control in Subjects With Type 2 Diabetes

This study has been completed.

Study NCT00614120 Information provided by Novo Nordisk

First Received on January 15, 2008. Last Updated on April 16, 2010 History of Changes

Results First Received: February 23, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Diabetes Mellitus, Type 2
Interventions:	Drug: liraglutide Drug: placebo Drug: glimepiride Drug: metformin

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
A total of 51 centres in three countries: China (17), India (24) and South Korea (10)

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A metformin run-in period of 3 weeks followed by a metformin maintenance period of 3 weeks before randomisation with dose levels increased to 2000 mg/day. Subjects already on metformin therapy at enrolment could go through a modified titration period or advance directly to the metformin maintenance period at the discretion of the investigator.

Reporting Groups

	Description
Lira 0.6 + Met	Liraglutide 0.6 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
Lira 1.2 + Met	Liraglutide 1.2 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
Lira 1.8 + Met	Liraglutide 1.8 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
Glim + Met	Glimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo

Participant Flow: Overall Study

	Lira 0.6 + Met	Lira 1.2 + Met	Lira 1.8 + Met	Glim + Met
STARTED	231 ^[1]	233 ^[1]	234 ^[1]	231 ^[1]
Exposed to Study Drug	231	233	233 ^[2]	231
COMPLETED	202	187	175	215
NOT COMPLETED	29	46	59	16
Adverse Event	9	22	30	3
Lack of Efficacy	3	3	2	2
Protocol Violation	2	5	3	1
Withdrawal criteria	1	0	0	0
Withdrawal by Subject	9	10	16	3
Did not meet trial criteria	0	1	1	1
hCG positive (not pregnant)	0	0	1	0
Hypoglycaemia	0	0	0	1
Lack of trial product	3	3	2	0
Late syphilis, latent	1	0	0	0
Taken inhibition medication eg Prandin	0	0	1	1
Lost to Follow-up	1	2	3	4

[1]	Randomised
[2]	Subject withdrew before exposure to study products, and thus not included in full analysis set.

Baseline Characteristics

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Reporting Groups

	Description
Lira 0.6 + Met	Liraglutide 0.6 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
Lira 1.2 + Met	Liraglutide 1.2 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
Lira 1.8 + Met	Liraglutide 1.8 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
Glim + Met	Glimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo

Baseline Measures

	Lira 0.6 + Met	Lira 1.2 + Met	Lira 1.8 + Met	Glim + Met	Total
Number of Participants [units: participants]	231	233	234	231	929
Age [units: years] Mean ± Standard Deviation	53.5 ± 9.5	53.5 ± 9.6	52.7 ± 9.1	53.6 ± 9.7	53.3 ± 9.5
Gender [units: participants]
Female	106	105	108	96	415
Male	125	128	126	135	514
Previous OAD treatment ^[1] [units: participants]
Mono-therapy	72	74	75	68	289
Combination therapy	159	159	159	163	640
BMI ^[2] [units: kg/m2] Mean ± Standard Deviation	25.9 ± 4.2	25.4 ± 3.7	25.8 ± 3.8	25.3 ± 3.7	25.6 ± 3.8
Duration of diabetes ^[3] [units: years] Mean ± Standard Deviation	7.4 ± 5.4	7.5 ± 5.3	7.2 ± 5.2	7.8 ± 6.1	7.5 ± 5.5
Height [units: m] Mean ± Standard Deviation	1.63 ± 0.09	1.63 ± 0.09	1.62 ± 0.08	1.64 ± 0.09	1.63 ± 0.09
Weight [units: kg] Mean ± Standard Deviation	68.6 ± 11.6	67.4 ± 11.3	68.2 ± 11.9	68.2 ± 11.9	68.1 ± 11.7

[1]	OAD = Oral Anti-Diabetic Drug
[2]	Body Mass Index
[3]	Number of years since diagnosis

Outcome Measures

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1. Primary:

Change in Glycosylated Haemoglobin A1c (HbA1c) [ Time Frame: week 0, week 16 ]

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2. Secondary:

Change in Body Weight [ Time Frame: week 0, week 16 ]

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3. Secondary:

Change in Self-measured Fasting Plasma Glucose [ Time Frame: week 0, week 16 ]

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4. Secondary:

7-point Self-measured Plasma Glucose Profiles [ Time Frame: week 0, 8, 12 and 16 ]

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5. Secondary:

Change in Beta-cell Function [ Time Frame: week 0, week 16 ]

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6. Secondary:

Change in Fasting Lipid Profile [ Time Frame: week 0, week 16 ]

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7. Secondary:

Change in Fasting Lipid Profile, APO-B [ Time Frame: week 0, week 16 ]

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8. Secondary:

Hypoglycaemic Episodes [ Time Frame: weeks 0-16 ]

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Serious Adverse Events

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Other Adverse Events

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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: Novo Nordisk maintains the right to be informed of any investigator plans for publication and to review any scientific paper, presentation, communication and other information concerning the investigation described in this protocol. Any such communication must be submitted in writing to the Novo Nordisk trial manager prior to submission for comments. Comments will be given within four weeks from receipt of the planned communication.

Limitations and Caveats

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
No text entered.

Results Point of Contact:

Name/Title: Public Access to Clinical Trials
Organization: Novo Nordisk A/S
e-mail: clinicaltrials@novonordisk.com

No publications provided by Novo Nordisk

Publications automatically indexed to this study:

Buse JB, Garber A, Rosenstock J, Schmidt WE, Brett JH, Videbæk N, Holst J, Nauck M. Liraglutide treatment is associated with a low frequency and magnitude of antibody formation with no apparent impact on glycemic response or increased frequency of adverse events: results from the Liraglutide Effect and Action in Diabetes (LEAD) trials. J Clin Endocrinol Metab. 2011 Jun;96(6):1695-702. Epub 2011 Mar 30.

Responsible Party:	Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier:	NCT00614120 History of Changes
Other Study ID Numbers:	NN2211-1796
Study First Received:	January 15, 2008
Results First Received:	February 23, 2010
Last Updated:	April 16, 2010
Health Authority:	China: State Food and Drug Administration; South Korea: Korea Food and Drug Administration (KFDA); India: Ministry of Health