Effect of Liraglutide on Blood Glucose Control in Subjects With Type 2 Diabetes

This study has been completed.

Study NCT00393718 Information provided by Novo Nordisk

First Received on October 27, 2006. Last Updated on March 29, 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: glibenclamide Drug: placebo

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
75 sites in Japan.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects included in the study were patients with type 2 diabetes treated with diet therapy only or diet therapy and one OAD (Oral Anti-Diabetic Drug). Subjects on OAD therapy discontinued their current treatment during the run-in period (Weeks 4-6 before dosing). A total of 411 subjects were randomised, 11 subjects were not exposed to study drug.

Reporting Groups

	Description
Liraglutide	Liraglutide 0.9 mg + glibenclamide placebo
Glibenclamide	Glibenclamide 1.25–2.5 mg + liraglutide placebo

Participant Flow: Overall Study

	Liraglutide	Glibenclamide
STARTED	268	132
COMPLETED	225	110
NOT COMPLETED	43	22
Adverse Event	20	8
Protocol Violation	1	2
Lack of Efficacy	10	9
Hypoglycaemia	3	2
Subject decision	5	0
Withdrawal of consent	2	1
Missed measurement	1	0
Move	1	0

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
Liraglutide	Liraglutide 0.9 mg + glibenclamide placebo
Glibenclamide	Glibenclamide 1.25–2.5 mg + liraglutide placebo

Baseline Measures

	Liraglutide	Glibenclamide	Total
Number of Participants [units: participants]	268	132	400
Age, Customized [units: participants]
20-29 years	4	0	4
30-39 years	11	6	17
40-49 years	43	20	63
50-59 years	77	46	123
60-69 years	98	40	138
70- years	35	20	55
Age [units: years] Mean ± Standard Deviation	58.2 ± 10.4	58.5 ± 10.4	58.3 ± 10.4
Gender [units: participants]
Female	85	46	131
Male	183	86	269
BMI ^[1] [units: kg/m2] Mean ± Standard Deviation	24.90 ± 3.69	24.62 ± 3.84	24.81 ± 3.74
Body Weight [units: kg] Mean ± Standard Deviation	66.19 ± 12.61	65.43 ± 12.89	65.94 ± 12.69
Duration of diabetes ^[2] [units: years] Mean ± Standard Deviation	8.13 ± 6.68	8.48 ± 6.84	8.25 ± 6.73
HbA1c ^[3] [units: percentage of total haemoglobin] Mean ± Standard Deviation	8.27 ± 0.75	8.28 ± 0.78	8.28 ± 0.76

[1]	Body Mass Index
[2]	Number of years since diagnosis of diabetes
[3]	Glycosylated Haemoglobin

Outcome Measures

Show All Outcome Measures

1. Primary:

Glycosylated Haemoglobin A1c (HbA1c) After 24 Weeks of Treatment [ Time Frame: after 24 weeks of treatment ]

Show Outcome Measure 1

2. Secondary:

Glycosylated Haemoglobin A1c (HbA1c) After 52 Weeks of Treatment [ Time Frame: after 52 weeks of treatment ]

Show Outcome Measure 2

3. Secondary:

Fasting Plasma Glucose After 24 Weeks of Treatment [ Time Frame: after 24 weeks of treatment ]

Show Outcome Measure 3

4. Secondary:

Fasting Plasma Glucose After 52 Weeks of Treatment [ Time Frame: after 52 weeks of treatment ]

Show Outcome Measure 4

5. Secondary:

Postprandial Glucose AUC After 24 Weeks of Treatment [ Time Frame: after 24 weeks of treatment ]

Show Outcome Measure 5

6. Secondary:

Postprandial Glucose AUC After 52 Weeks of Treatment [ Time Frame: after 52 weeks of treatment ]

Show Outcome Measure 6

7. Secondary:

Mean PG in 7-point Plasma Glucose Profile After 24 Weeks of Treatment [ Time Frame: after 24 weeks of treatment ]

Show Outcome Measure 7

8. Secondary:

Mean PG in 7-point Plasma Glucose Profile After 52 Weeks of Treatment [ Time Frame: after 52 weeks of treatment ]

Show Outcome Measure 8

9. Secondary:

Mean Postprandial PG Increment in 7-point Plasma Glucose Profile After 24 Weeks of Treatment [ Time Frame: after 24 weeks of treatment ]

Show Outcome Measure 9

10. Secondary:

Mean Postprandial PG Increment in 7-point Plasma Glucose Profile After 52 Weeks of Treatment [ Time Frame: after 52 weeks of treatment ]

Show Outcome Measure 10

11. Secondary:

Body Weight After 24 Weeks of Treatment [ Time Frame: after 24 weeks of treatment ]

Show Outcome Measure 11

12. Secondary:

Body Weight After 52 Weeks of Treatment [ Time Frame: after 52 weeks of treatment ]

Show Outcome Measure 12

13. Secondary:

Hypoglycaemic Episodes [ Time Frame: over 52 weeks of treatment ]

Show Outcome Measure 13

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

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 acknowledges the Investigator’s right to publish the entire results of the trial. Any such scientific paper, presentation, communication or other information concerning the investigation described in this protocol, must be submitted in writing to Novo Nordisk Trial Manager prior to submission for publication/presentation for comments. Comments will be given within four weeks from receipt of the manuscript.

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:

Hegedüs L, Moses AC, Zdravkovic M, Le Thi T, Daniels GH. GLP-1 and calcitonin concentration in humans: lack of evidence of calcitonin release from sequential screening in over 5000 subjects with type 2 diabetes or nondiabetic obese subjects treated with the human GLP-1 analog, liraglutide. J Clin Endocrinol Metab. 2011 Mar;96(3):853-60. Epub 2011 Jan 5.

Seino Y, Rasmussen MF, Nishida T, Kaku K. Efficacy and safety of the once-daily human GLP-1 analogue, liraglutide, vs glibenclamide monotherapy in Japanese patients with type 2 diabetes. Curr Med Res Opin. 2010 May;26(5):1013-22.

Responsible Party:	Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier:	NCT00393718 History of Changes
Other Study ID Numbers:	NN2211-1700, JAPIC: JapicCTI-060328
Study First Received:	October 27, 2006
Results First Received:	February 23, 2010
Last Updated:	March 29, 2010
Health Authority:	Japan: Ministry of Health, Labour and Welfare (MHLW)