Brief Summary

This trial is conducted in Africa, Asia, Europe and the United States of America (USA). The aim of this trial is to investigate the potential of liraglutide to induce and maintain weight loss in overweight or obese subjects with type 2 diabetes. Treatment will be added onto subject's pre-trial background diabetes treatment of either diet and exercise only or single compound oral antidiabetic drug (OAD) treatment (metformin, sulphonylurea \[SU\] or glitazone) or combination OAD treatment (metformin, sulphonylurea or glitazone). The duration of the trial will be 56 weeks followed by a 12 week observational follow-up period.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

846

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Jun 2011

Geographic Reach

13 countries

161 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

1.7 years study duration

First Submitted

Initial submission to the registry

January 6, 2011

Completed

1 day until next milestone

First Posted

Study publicly available on registry

January 7, 2011

Completed

5 months until next milestone

Study Start

First participant enrolled

June 1, 2011

Completed

1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed

24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2013

Completed

2 years until next milestone

Results Posted

Study results publicly available

February 9, 2015

Completed

Last Updated

December 29, 2017

Status Verified

December 1, 2017

Enrollment Period

1.6 years

First QC Date

January 6, 2011

Results QC Date

January 22, 2015

Last Update Submit

December 6, 2017

Conditions

Metabolism and Nutrition Disorder Obesity

Outcome Measures

Primary Outcomes (3)

Change (%) From Baseline in Body Weight (Fasting)
Weight was recorded to the nearest 0.1 kg for a subject in the fasting state with an empty bladder, without shoes and only wearing light clothing. The same calibrated scale was used throughout the trial.
Week 0, week 56
Proportion of Subjects Losing at Least 5% of Baseline Body Weight
Weight was recorded to the nearest 0.1 kg for a subject in the fasting state with an empty bladder, without shoes and only wearing light clothing. The same calibrated scale was used throughout the trial.
at 56 weeks
Proportion of Subjects Losing More Than 10% of Baseline Body Weight
Weight was recorded to the nearest 0.1 kg for a subject in the fasting state with an empty bladder, without shoes and only wearing light clothing. The same calibrated scale was used throughout the trial.
at 56 weeks

Secondary Outcomes (9)

Change (%-Points) From Baseline in HbA1c (Glycosylated Haemoglobin A1c)
Week 0, week 56
Proportion of Subjects Reaching Target HbA1c Below 7%
at 56 weeks
Proportion of Subjects Reaching Target HbA1c Below or Equal to 6.5%
at 56 weeks
Change From Baseline in Waist Circumference
Week 0, week 56
Change (%) From Baseline in Body Weight (Fasting)
Week 0, week 68
+4 more secondary outcomes

Study Arms (3)

Lira 3.0 mg

EXPERIMENTAL

Drug: liraglutide

Lira 1.8 mg

EXPERIMENTAL

Drug: liraglutide

Placebo

EXPERIMENTAL

Drug: placebo

Interventions

liraglutideDRUG

Liraglutide 3.0 mg for subcutaneous (under the skin) injection once daily for 56 weeks.

Lira 3.0 mg

placeboDRUG

Liraglutide placebo of either 3.0 mg or 1.8 mg for subcutaneous (under the skin) injection once daily for 56 weeks.

Placebo

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Informed consent obtained
Subjects diagnosed with type 2 diabetes and treated with either diet and exercise alone, metformin, sulphonylurea, glitazone as single agent therapy or a combination of the previously mentioned compounds
HbA1c 7.0-10.0% (both inclusive)
Body Mass Index (BMI) at least 27.0 kg/m\^2
Stable body weight
Preceding failed dietary effort

You may not qualify if:

Treatment with glucagon-like peptide-1 (GLP-1) receptor agonists, dipeptidyl peptidase-4 (DPP-4) inhibitors or insulin within the last 3 months
Known proliferative retinopathy or maculopathy
History of acute or chronic pancreatitis
Obesity induced by drug treatment
Use of approved weight lowering pharmacotherapy
Previous surgical treatment of obesity
History of major depressive disorder or suicide attempt
Uncontrolled hypertension (systolic blood pressure above or equal to 160 mmHg and/or diastolic blood pressure above or equal to 100 mmHg)
Screening calcitonin of 50 ng/L or above
Familial or personal history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma (FMTC)
Personal history of non-familial medullary thyroid carcinoma

Contact the study team to confirm eligibility.