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NCT01076647 Clinical Trial

Comparison of NN1250 With Insulin Glargine in Subjects With Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

— BEGIN™  

Official title:
A 26-week Randomised, Confirmatory, Controlled, Open Label, Multicentre, Multinational Treat-to-target Trial Comparing the Efficacy and Safety of SIBA 200 U/ml Three Times Weekly Injected in the Evening and Insulin Glargine Once Daily in a Population of Insulin naïve Subjects With Type 2 Diabetes Mellitus Currently Treated With OADs Qualifying for Intensified Treatment (BEGIN™: EASY™)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01076647
Other study ID # NN1250-3718
Secondary ID 2009-011399-31U1
Status Completed
Phase Phase 3
First received February 25, 2010
Last updated November 10, 2015
Start date March 2010
Est. completion date December 2010

Study information
Verified date November 2015
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority Canada: Health CanadaRomania: National Medicines AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Bulgaria: Bulgarian Drug AgencyNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Hungary: National Institute of PharmacyUnited States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This trial was conducted in Europe and North America. The aim of this clinical trial was to compare NN1250 (insulin degludec (IDeg)), a soluble insulin basal analogue (SIBA), with insulin glargine (IGlar), as add-on to subject's ongoing treatment with metformin and/or DPP-4 (dipeptyl peptidase 4) inhibitors, in patients with type 2 diabetes being treated with oral anti-diabetic drugs (OADs).

Recruitment information / eligibility
Status Completed
Enrollment 467
Est. completion date December 2010
Est. primary completion date December 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Type 2 diabetes (diagnosed clinically) for at least 6 months

- Insulin naïve subjects (allowed are: previous short term insulin treatment up to 14 days; treatment during hospitalisation or during gestational diabetes is allowed for periods longer than 14 days)

- Current treatment: metformin monotherapy or metformin in any combination with insulin secretagogues (sulphonylurea (SU) or glinide), DPP-4 inhibitor, alpha-glucosidase-inhibitor (acarbose) with unchanged dosing for at least 3 months prior to visit 1 with the minimum doses stated: -Metformin: alone or in combination (including fixed combination) 1500 mg daily or maximum tolerated dose (at least 1000 mg daily)-Insulin secretagogue (sulfonylurea (SU) or glinide): minimum half of the daily maximal dose according to local labelling -DPP-4 inhibitor: minimum half of the daily maximal dose according to local labelling -alpha-glucosidase-inhibitor (acarbose): minimum half of the daily maximal dose or maximum tolerated dose

- HbA1c 7.0-10.0 % (both inclusive) by central laboratory analysis

- BMI (Body Mass Index) below or equal to 45.0 kg/m^2

Exclusion Criteria:

- Use within the last 3 months prior to Visit 1 of: Thiazoledinediones (TZDs), Exenatide or Liraglutide

- Cardiovascular disease, within the last 6 months prior to visit 1, defined as: stroke; decompensated heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty

- Uncontrolled treated/untreated severe hypertension (systolic blood pressure at least 180 millimetre (mm) mercury (Hg) and/or diastolic blood pressure at least 100 mmHg)

- Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements

- Cancer and medical history of cancer hereof (except basal cell skin cancer or squamous cell skin cancer)

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
Will be injected subcutaneously (under the skin) once daily three times weekly.
• insulin glargine
Will be injected subcutaneously (under the skin) once daily administered at the same time each day.

Locations
Country Name City State
United States Novo Nordisk Clinical Trial Call Center Altoona Pennsylvania
United States Novo Nordisk Clinical Trial Call Center Arlington Texas
United States Novo Nordisk Clinical Trial Call Center Arlington Heights Illinois
United States Novo Nordisk Clinical Trial Call Center Austin Texas
United States Novo Nordisk Clinical Trial Call Center Birmingham Alabama
United States Novo Nordisk Clinical Trial Call Center Boynton Beach Florida
United States Novo Nordisk Clinical Trial Call Center Burlington North Carolina
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 Chicago Illinois
United States Novo Nordisk Clinical Trial Call Center Cincinnati Ohio
United States Novo Nordisk Clinical Trial Call Center Crestview Hills Kentucky
United States Novo Nordisk Clinical Trial Call Center Dallas Texas
United States Novo Nordisk Clinical Trial Call Center Dayton Ohio
United States Novo Nordisk Clinical Trial Call Center DeLand Florida
United States Novo Nordisk Clinical Trial Call Center Denver Colorado
United States Novo Nordisk Clinical Trial Call Center Dunwoody Georgia
United States Novo Nordisk Clinical Trial Call Center Eagan Minnesota
United States Novo Nordisk Clinical Trial Call Center Escondido California
United States Novo Nordisk Clinical Trial Call Center Glen Burnie Maryland
United States Novo Nordisk Clinical Trial Call Center Golden Colorado
United States Novo Nordisk Clinical Trial Call Center Harrisburg Pennsylvania
United States Novo Nordisk Clinical Trial Call Center Houston Texas
United States Novo Nordisk Clinical Trial Call Center Kingsport Tennessee
United States Novo Nordisk Clinical Trial Call Center La Jolla California
United States Novo Nordisk Clinical Trial Call Center Los Angeles California
United States Novo Nordisk Clinical Trial Call Center Los Banos California
United States Novo Nordisk Clinical Trial Call Center Madisonville Kentucky
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 Monterey California
United States Novo Nordisk Clinical Trial Call Center Ogden Utah
United States Novo Nordisk Clinical Trial Call Center Orange Park Florida
United States Novo Nordisk Clinical Trial Call Center Palm Springs California
United States Novo Nordisk Clinical Trial Call Center Pasadena California
United States Novo Nordisk Clinical Trial Call Center Peoria Arizona
United States Novo Nordisk Clinical Trial Call Center Plantation Florida
United States Novo Nordisk Clinical Trial Call Center Redondo Beach California
United States Novo Nordisk Clinical Trial Call Center Reisterstown Maryland
United States Novo Nordisk Clinical Trial Call Center San Mateo California
United States Novo Nordisk Clinical Trial Call Center Seattle Washington
United States Novo Nordisk Clinical Trial Call Center Spokane Washington
United States Novo Nordisk Clinical Trial Call Center Staten Island New York
United States Novo Nordisk Clinical Trial Call Center Tampa Florida
United States Novo Nordisk Clinical Trial Call Center Tarzana California
United States Novo Nordisk Clinical Trial Call Center Tucson Arizona
United States Novo Nordisk Clinical Trial Call Center Tustin California
United States Novo Nordisk Clinical Trial Call Center West Palm Beach Florida
United States Novo Nordisk Clinical Trial Call Center Wichita Kansas

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

Countries where clinical trial is conducted

United States,  Bulgaria,  Canada,  France,  Hungary,  Netherlands,  Romania, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in Glycosylated Haemoglobin (HbA1c) Change from baseline in HbA1c after 26 weeks of treatment Week 0, Week 26 No
Secondary Change in Body Weight Change from baseline in body weight after 26 weeks of treatment Week 0, Week 26 No
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