The Effect of Liraglutide Versus Placebo When Added to Basal Insulin Analogues With or Without Metformin in Subjects With Type 2 Diabetes

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Novo Nordisk A/S

ClinicalTrials.gov Identifier:

NCT01617434

First received: June 8, 2012

Last updated: October 31, 2014

Last verified: October 2014

History of Changes

Results First Received: October 22, 2014

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Conditions:	Diabetes Diabetes Mellitus, Type 2
Interventions:	Drug: liraglutide 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
The trial was conducted at 76 sites in 9 countries i.e. 3 sites in Argentina; 9 sites in Canada; 5 sites in Finland; 9 sites in Germany; 9 sites in India; 2 sites in Mexico; 7 sites in Netherlands; 3 sites in Serbia; 29 sites in United States.

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

Liraglutide

Liraglutide was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the liraglutide was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.

Placebo

Placebo was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the placebo was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.

Participant Flow: Overall Study

	Liraglutide	Placebo
STARTED	226	225
Exposed	225	225
COMPLETED	191	174
NOT COMPLETED	35	51
Adverse Event	12	3
Protocol Violation	8	7
Withdrawal Criteria	12	37
Unclassified	3	4

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.
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Reporting Groups

	Description
Liraglutide	Liraglutide was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the liraglutide was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
Placebo	Placebo was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the placebo was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
Total	Total of all reporting groups

Baseline Measures

	Liraglutide	Placebo	Total
Number of Participants [units: participants]	225	225	450
Age [units: years] Mean (Standard Deviation)	59.3 (9.2)	57.5 (11.1)	58.4 (10.2)
Gender [units: participants]
Female	105	89	194
Male	120	136	256
Body Weight [units: kg] Mean (Standard Deviation)	90.23 (19.98)	91.85 (21.33)	91.04 (20.66)
Fasting Plasma Glucose (FPG) [units: mmol/L] Mean (Standard Deviation)	8.32 (2.89)	8.21 (2.90)	8.27 (2.89)
Glycosylated Haemoglobin (HbA1c) [units: percentage of glycosylated haemoglobin] Mean (Standard Deviation)	8.22 (0.81)	8.28 (0.90)	8.25 (0.86)

Outcome Measures

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1. Primary:

Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 26 [ Time Frame: Week 0 to Week 26 ]

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2. Secondary:

Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26 [ Time Frame: Week 0 to Week 26 ]

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3. Secondary:

Change in Mean Self-Measured Plasma Glucose (SMPG) of 7-Point Profile From Baseline to Week 26 [ Time Frame: Week 0 to Week 26 ]

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4. Secondary:

Change in Body Weight From Baseline to Week 26 [ Time Frame: Week 0 to Week 26 ]

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5. Secondary:

Number of Subjects Achieving HbA1c Below 7.0% (American Diabetes Association [ADA] Target) [ Time Frame: At Week 26 ]

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6. Secondary:

Number of Subjects Achieving HbA1c Below or Equal to 6.5% (American Association of Clinical Endocrinologists [AACE] Target) [ Time Frame: At Week 26 ]

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7. Secondary:

Number of Adverse Events (AEs) During The Randomised Treatment Period [ Time Frame: Week 0 to Week 26 + 7 days follow up ]

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8. Secondary:

Number of Minor Hypoglycaemic Episodes During The Randomised Treatment Period [ Time Frame: Week 0 to Week 26 + 7 days follow up ]

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9. Secondary:

Number of Severe Hypoglycaemic Episodes During The Randomised Treatment Period [ Time Frame: Week 0 to Week 26 + 7 days follow up ]

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

Results Point of Contact:

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

Responsible Party:	Novo Nordisk A/S
ClinicalTrials.gov Identifier:	NCT01617434 History of Changes
Other Study ID Numbers:	NN2211-3917 2011-002696-41 ( EudraCT Number ) U1111-1121-9874 ( Other Identifier: WHO )
Study First Received:	June 8, 2012
Results First Received:	October 22, 2014
Last Updated:	October 31, 2014
Health Authority:	Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Canada: Health Canada Finland: Finnish Medicines Agency Germany: Federal Institute for Drugs and Medical Devices India: Ministry of Health and Family Wellfare Mexico: National Institute of Public Health, Health Secretariat Netherlands: Medicines Evaluation Board, Dutch Health Care Inspectorate Serbia: Medicines and Medical Devices Agency of Serbia United States: Food and Drug Administration

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