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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01617434
• Other study ID #: NN2211-3917
• Secondary ID: 2011-002696-41U1
• Status: Completed
• Phase: Phase 3
• First received: June 8, 2012
• Last updated: October 31, 2014
• Start date: September 2012
• Est. completion date: October 2013

Study information

• Verified date: October 2014
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y TecnologiaCanada: Health CanadaFinland: Finnish Medicines AgencyGermany: Federal Institute for Drugs and Medical DevicesIndia: Ministry of Health and Family WellfareMexico: National Institute of Public Health, Health SecretariatNetherlands: Medicines Evaluation Board, Dutch Health Care InspectorateSerbia: Medicines and Medical Devices Agency of SerbiaUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 451
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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)

Exclusion Criteria:

• Female of child-bearing potential who is pregnant, breast-feeding or intending to become pregnant

• Recurrent severe hypoglycaemic episodes or hypoglycaemic unawareness

• Treatment with glucose-lowering agent(s) other than stated in the inclusion criteria in a period of 12 weeks prior to screening

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• liraglutide
Maximum 1.8 mg administered s.c. (subcutaneously, under the skin) once daily in addition to the subject's stable pre-trial basal insulin analogue regimen plus/minus metformin.
• placebo
Placebo administered s.c. (subcutaneously, under the skin) once daily in addition to the subject's stable pre-trial basal insulin analogue regimen plus/minus metformin.

Locations

Country	Name	City	State
United States	Novo Nordisk Clinical Trial Call Center	Anaheim	California
United States	Novo Nordisk Clinical Trial Call Center	Dallas	Texas
United States	Novo Nordisk Clinical Trial Call Center	Danville	California
United States	Novo Nordisk Clinical Trial Call Center	Fresno	California
United States	Novo Nordisk Clinical Trial Call Center	Greenfield	Indiana
United States	Novo Nordisk Clinical Trial Call Center	Gurnee	Illinois
United States	Novo Nordisk Clinical Trial Call Center	Kingsport	Tennessee
United States	Novo Nordisk Clinical Trial Call Center	Kissimmee	Florida
United States	Novo Nordisk Clinical Trial Call Center	Lexington	Kentucky
United States	Novo Nordisk Clinical Trial Call Center	Martinsburg	West Virginia
United States	Novo Nordisk Clinical Trial Call Center	Metairie	Louisiana
United States	Novo Nordisk Clinical Trial Call Center	Methuen	Massachusetts
United States	Novo Nordisk Clinical Trial Call Center	Midlothian	Virginia
United States	Novo Nordisk Clinical Trial Call Center	Newington	New Hampshire
United States	Novo Nordisk Clinical Trial Call Center	Renton	Washington
United States	Novo Nordisk Clinical Trial Call Center	Richmond	Virginia
United States	Novo Nordisk Clinical Trial Call Center	Rockville	Maryland
United States	Novo Nordisk Clinical Trial Call Center	Salt Lake City	Utah
United States	Novo Nordisk Clinical Trial Call Center	San Antonio	Texas
United States	Novo Nordisk Clinical Trial Call Center	San Antonio	Texas
United States	Novo Nordisk Clinical Trial Call Center	San Mateo	California
United States	Novo Nordisk Clinical Trial Call Center	Spartanburg	South Carolina
United States	Novo Nordisk Clinical Trial Call Center	Sugarland	Texas
United States	Novo Nordisk Clinical Trial Call Center	Tustin	California
United States	Novo Nordisk Clinical Trial Call Center	Upper St Clair	Pennsylvania
United States	Novo Nordisk Clinical Trial Call Center	Walnut Creek	California

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Argentina,  Canada,  Finland,  Germany,  India,  Mexico,  Netherlands,  Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 26	The estimated mean change from baseline in HbA1c after 26 weeks of treatment.	Week 0 to Week 26	No
Secondary	Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26	The estimated mean change from baseline in FPG after 26 weeks of treatment.	Week 0 to Week 26	No
Secondary	Change in Mean Self-Measured Plasma Glucose (SMPG) of 7-Point Profile From Baseline to Week 26	The estimated mean change from baseline in mean SMPG of 7-point profile (7-points were before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner and at bedtime) after 26 weeks of treatment.	Week 0 to Week 26	No
Secondary	Change in Body Weight From Baseline to Week 26	The estimated mean change in body weight after 26 weeks of treatment.	Week 0 to Week 26	No
Secondary	Number of Subjects Achieving HbA1c Below 7.0% (American Diabetes Association [ADA] Target)	Number of subjects achieving HbA1c below 7.0% (American Diabetes Association [ADA] target) after 26 weeks of treatment	At Week 26	No
Secondary	Number of Subjects Achieving HbA1c Below or Equal to 6.5% (American Association of Clinical Endocrinologists [AACE] Target)	Number of subjects achieving HbA1c below or equal to 6.5% (American Association of Clinical Endocrinologists [AACE] target) after 26 weeks of treatment.	At Week 26	No
Secondary	Number of Adverse Events (AEs) During The Randomised Treatment Period	An AE was defined as treatment emergent if the onset date (or increase in severity) was on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. The adverse events were categorised as 'serious' and 'non-serious' adverse events. Adverse events were also categorised according to the severity as 'mild', 'moderate' and 'severe' adverse events.	Week 0 to Week 26 + 7 days follow up	No
Secondary	Number of Minor Hypoglycaemic Episodes During The Randomised Treatment Period	A minor hypoglycaemic episode was defined as either, (a) an episode with symptoms consistent with hypoglycaemia with confirmation by blood glucose <2.8 mmol/L (50 mg/dL) or plasma glucose <3.1 mmol/L (56 mg/dL) that was handled by the subject him/herself or (b) any asymptomatic blood glucose value <2.8 mmol/L (50 mg/dL) or plasma glucose value <3.1 mmol/L (56 mg/dL).	Week 0 to Week 26 + 7 days follow up	No
Secondary	Number of Severe Hypoglycaemic Episodes During The Randomised Treatment Period	Severe hypoglycaemia episode was defined as an episode requiring assistance of another person to actively administer carbohydrate, glucagon or other resuscitative actions.	Week 0 to Week 26 + 7 days follow up	No

External Links

•   Clinical Trials at Novo Nordisk