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

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

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
Overall Participants Analyzed  [Units: Participants]	225	225	450
Age  [Units: Years] Mean (Standard Deviation)	59.3  (9.2)	57.5  (11.1)	58.4  (10.2)
Sex: Female, Male  [Units: Participants] Count of Participants
Female	105  46.7%	89  39.6%	194  43.1%
Male	120  53.3%	136  60.4%	256  56.9%
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)

1.  Primary:

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

2.  Secondary:

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

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 ]

4.  Secondary:

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

5.  Secondary:

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

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 ]

7.  Secondary:

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

8.  Secondary:

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

9.  Secondary:

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

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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