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NCT01388361 Clinical Trial

Comparison of the Efficacy and Safety of Two Intensification Strategies in Subjects With Type 2 Diabetes Inadequately Controlled on Basal Insulin and Metformin

Diabetes Mellitus, Type 2 Clinical Trial

— BEGIN™  

Official title:
A Trial Comparing the Efficacy and Safety of Adding Liraglutide Versus Addition of Insulin Aspart With the Largest Meal to Insulin Degludec, Both in Combination With Metformin, in Subjects With Type 2 Diabetes Qualifying for Treatment Intensification (BEGIN™: VICTOZA® ADD-ON)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01388361
Other study ID # NN1250-3948
Secondary ID 2011-001493-25U1
Status Completed
Phase Phase 3
First received July 4, 2011
Last updated December 14, 2015
Start date September 2011
Est. completion date July 2012

Study information
Verified date December 2015
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority Austria: AGES PharmMedBelgium: Federal Agency for Medicines and Health Products, FAMHPCanada: Health CanadaCzech Republic: State Institute for Drug ControlDenmark: Danish Medicines AgencyFinland: Finnish Medicines Agency FimeaFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medicinal Devices (BfarM)Norway: Norwegian Medicines AgencySerbia: Medicines and Medical Devices Agency of SerbiaSpain: Spanish Drug Agency and Medicinal ProductsUnited States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This trial is conducted in Europe and North America. The aim of this trial is to compare the efficacy and safety of adding liraglutide versus addition of insulin aspart with the largest meal to insulin degludec in subjects with type 2 diabetes.

Eligible subjects with an HbA1c equal to or above 7% at end of treatment in NN1250-3643 (NCT01193309) trial will be randomised to receive treatment intensification while subjects with an HbA1c below 7% at end of treatment in NN1250-3643 (NCT01193309) may continue to receive insulin degludec treatment. Subjects are to continue their pre-trial metformin treatment.

Recruitment information / eligibility
Status Completed
Enrollment 413
Est. completion date July 2012
Est. primary completion date July 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject).

- The subject must have completed the end of treatment visit of NN1250-3643 with Insulin degludec once daily + metformin.

- Ability and willingness to adhere to the protocol including self measurement of plasma glucose according to the protocol

Exclusion Criteria:

- Participated in NN1250-3643 and treated with insulin glargine

- Previous treatment with glucacon like peptide (GLP-1) receptor agonists (e.g. exenatide, liraglutide)

- Impaired liver function, defined as alanine aminotransferase (ALAT) 2.5 times the upper limit of normal at end of treatment in NN1250-3643

- Impaired renal function defined as serum-creatinine = 125 µmol/l (= 1.4 mg/dl) for males and = 110 µmol/L (= 1.3 mg/dl) for females or according to local label for metformin [For France: glomerular filtration rate below 60 ml/min, calculated by the Cockroft & Gault formula] at end of treatment in NN1250-3643.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• insulin degludec
Injected s.c. (under the skin) once daily. The doses will be individually adjusted
• insulin aspart
Injected s.c. (under the skin) once daily. The doses will be individually adjusted.
• liraglutide
Injected s.c. (under the skin) once daily. The doses will be individually adjusted.

Locations
Country Name City State
United States Novo Nordisk Clinical Trial Call Center Arlington Texas
United States Novo Nordisk Clinical Trial Call Center Asheboro North Carolina
United States Novo Nordisk Clinical Trial Call Center Boynton Beach Florida
United States Novo Nordisk Clinical Trial Call Center Brentwood Tennessee
United States Novo Nordisk Clinical Trial Call Center Chattanooga Tennessee
United States Novo Nordisk Clinical Trial Call Center Chicago Illinois
United States Novo Nordisk Clinical Trial Call Center Cincinnati Ohio
United States Novo Nordisk Clinical Trial Call Center Columbia South Carolina
United States Novo Nordisk Clinical Trial Call Center Concord California
United States Novo Nordisk Clinical Trial Call Center Dallas Texas
United States Novo Nordisk Clinical Trial Call Center Dallas Texas
United States Novo Nordisk Clinical Trial Call Center Decatur Georgia
United States Novo Nordisk Clinical Trial Call Center East Providence Rhode Island
United States Novo Nordisk Clinical Trial Call Center Fort Worth Texas
United States Novo Nordisk Clinical Trial Call Center Greer South Carolina
United States Novo Nordisk Clinical Trial Call Center Humboldt Tennessee
United States Novo Nordisk Clinical Trial Call Center Irving Texas
United States Novo Nordisk Clinical Trial Call Center La Jolla California
United States Novo Nordisk Clinical Trial Call Center Lancaster California
United States Novo Nordisk Clinical Trial Call Center Los Angeles California
United States Novo Nordisk Clinical Trial Call Center Lubbock Texas
United States Novo Nordisk Clinical Trial Call Center Melbourne Florida
United States Novo Nordisk Clinical Trial Call Center Melrose Park Pennsylvania
United States Novo Nordisk Clinical Trial Call Center Metairie Louisiana
United States Novo Nordisk Clinical Trial Call Center Miami Florida
United States Novo Nordisk Clinical Trial Call Center Milwaukee Wisconsin
United States Novo Nordisk Clinical Trial Call Center Nashville Tennessee
United States Novo Nordisk Clinical Trial Call Center National City California
United States Novo Nordisk Clinical Trial Call Center New Port Richey Florida
United States Novo Nordisk Clinical Trial Call Center North East Maryland
United States Novo Nordisk Clinical Trial Call Center Northport New York
United States Novo Nordisk Clinical Trial Call Center Northridge California
United States Novo Nordisk Clinical Trial Call Center Oklahoma City Oklahoma
United States Novo Nordisk Clinical Trial Call Center Paducah Kentucky
United States Novo Nordisk Clinical Trial Call Center Palm Harbor Florida
United States Novo Nordisk Clinical Trial Call Center Palm Springs California
United States Novo Nordisk Clinical Trial Call Center Rockville Maryland
United States Novo Nordisk Clinical Trial Call Center San Antonio Texas
United States Novo Nordisk Clinical Trial Call Center Slidell Louisiana
United States Novo Nordisk Clinical Trial Call Center Spring Valley California
United States Novo Nordisk Clinical Trial Call Center Staten Island New York
United States Novo Nordisk Clinical Trial Call Center Sugar Land Texas
United States Novo Nordisk Clinical Trial Call Center Tarzana California
United States Novo Nordisk Clinical Trial Call Center Toms River New Jersey
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 West Palm Beach Florida

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Austria,  Canada,  Czech Republic,  Denmark,  Finland,  France,  Germany,  Norway,  Serbia,  Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change From Baseline in HbA1c (%) (Glycosylated Haemoglobin) Values for change in HbA1c from baseline to 26 weeks of treatment period. week 0, week 26 No
Secondary Change From Baseline in Fasting Plasma Glucose (FPG) Values for change in FPG in mmol/L from baseline to week 26 of randomised period. week 0, week 26 No
Secondary Change From Baseline in Body Weight Corresponds to the values of change in body weight in kilograms from baseline to week 26. week 0, week 26 No
Secondary Number of Severe and Minor Treatment Emergent Hypoglycaemic Episodes Corresponds to number of treatment emergent hypoglycaemic events from onset on or after the first day of exposure to investigational product and no later than 7 days after last exposure to investigational product. Confirmed hypoglycaemia was defined as the pool of severe hypoglycaemic episodes and minor episodes with a plasma glucose (PG) value < 3.1 mmol/L (56 mg/dL). Onset on or after the first day of exposure to investigational product for 26 weeks of treatment period and no later than 7 days after last exposure to investigational product. No
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