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

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

NCT01617434•Novo Nordisk A/S

View on ClinicalTrials.gov

Summary

This trial is conducted in Asia, Europe and North and South America. The aim of the trial is to investigate the effect of liraglutide versus placebo when added to basal insulin analogues with or without metformin in subjects with type 2 diabetes.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Diagnosed with type 2 diabetes for at least 180 days prior to screening and treated with stable basal insulin analogue dose of minimum 20 U/day with or without stable metformin equal to or above 1500 mg/day for at least 8 weeks prior to screening (defined as insulin adjustments less than 10% during the past 8 weeks as assessed by the investigator)
•HbA1c (glycosylated haemoglobin A1c) 7.0-10.0% (both inclusive)
•Body mass index (BMI) 20-45 kg/m\^2 (both inclusive)
•Impaired liver or renal function
•Uncontrolled treated or untreated hypertension (systolic blood pressure (SBP) equal to or above 180 mmHg and/or diastolic blood pressure (DBP) equal to or above 100 mmHg)
•Any clinically significant disorder, except for conditions associated with type 2 diabetes history which in the investigator's opinion could interfere with results of the trial
•Known or suspected abuse of alcohol or narcotics

Exclusion Criteria

•Female of child-bearing potential who is pregnant, breast-feeding or intending to become pregnant
•Recurrent severe hypoglycaemic episodes or hypoglycaemic unawareness

Locations (86)

Novo Nordisk Investigational Site

Phoenix, Arizona, United States

Novo Nordisk Investigational Site

Anaheim, California, United States

Novo Nordisk Investigational Site

Fresno, California, United States

Novo Nordisk Investigational Site

Los Angeles, California, United States

Novo Nordisk Investigational Site

San Mateo, California, United States

Novo Nordisk Investigational Site

San Ramon, California, United States

Novo Nordisk Investigational Site

Tustin, California, United States

Novo Nordisk Investigational Site

Ventura, California, United States

Novo Nordisk Investigational Site

Walnut Creek, California, United States

Novo Nordisk Investigational Site

Kissimmee, Florida, United States

Key Dates

Start Date

September 1, 2012

Primary Completion Date

October 1, 2013

Completion Date

October 1, 2013

Last Updated

March 8, 2017

Enrollment

451

ACTUAL participants

Conditions

DiabetesDiabetes Mellitus, Type 2

Interventions

liraglutide

DRUG

placebo

DRUG

Sponsors

Lead Sponsor

Novo Nordisk A/S

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 8, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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