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NCT01046110 Clinical Trial

Comparison of NN1250 With Sitagliptin in Subjects With Type 2 Diabetes Never Treated With Insulin

Diabetes Mellitus, Type 2 Clinical Trial

— BEGIN™  

Official title:
A Trial Comparing Efficacy and Safety of NN1250 With Sitagliptin in Insulin Naive Subjects With Type 2 Diabetes (BEGIN™ : EARLY)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01046110
Other study ID # NN1250-3580
Secondary ID U1111-1111-7126
Status Completed
Phase Phase 3
First received January 8, 2010
Last updated November 19, 2015
Start date January 2010
Est. completion date November 2010

Study information
Verified date November 2015
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority Argentina: Administracion Nacional de Medicamentos, Alimentos y TecnologiaCanada: Health CanadaIndia: Drugs Controller General of IndiaMexico: Federal Commission for Protection Against Health RisksSouth Africa: Medicines Control CouncilTurkey: Ministry of HealthUnited States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This trial will be conducted in Africa, Asia, North America and South America. The aim of this clinical trial is to compare NN1250 (insulin degludec) with sitagliptin, as add-on to subject's own current oral antidiabetic (OAD) treatment, in subjects with type 2 diabetes inadequately controlled with 1-2 OADs (metformin, sulphonylurea, glinides or pioglitazone).

Recruitment information / eligibility
Status Completed
Enrollment 458
Est. completion date November 2010
Est. primary completion date November 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

- Ongoing treatment with 1 or 2 of the following OADs (metformin, insulin secretagogue (sulphonylurea or glinides) or pioglitazone) in any combination 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 or maximum tolerated dose (at least 1000 mg daily) -Insulin secretagogue (sulfonylurea or glinide): minimum half of the maximal daily dose according to local labelling -Pioglitazone: minimum half of the maximal daily dose according to local labelling or maximum tolerated dose

- Body Mass Index (BMI) below or equal to 40.0 kg/m^2

- HbA1c 7.5-11.0 % (both inclusive) by central laboratory analysis

Exclusion Criteria:

- Use within the last 3 months prior to Visit 1 of: exenatide, liraglutide, rosiglitazone or acarbose

- 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)

- Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the Investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months

- Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate

- Cancer and medical history 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
Injected under the skin once daily for 26 weeks. The doses will be individually adjusted.
• sitagliptin
Sitagliptin tablets administered orally once a day at the same time every day for 26 weeks

Locations
Country Name City State
United States Novo Nordisk Clinical Trial Call Center Albuquerque New Mexico
United States Novo Nordisk Clinical Trial Call Center Charleston South Carolina
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 Clearwater Florida
United States Novo Nordisk Clinical Trial Call Center Concord California
United States Novo Nordisk Clinical Trial Call Center Corpus Christi Texas
United States Novo Nordisk Clinical Trial Call Center Council Bluffs Iowa
United States Novo Nordisk Clinical Trial Call Center Decatur Georgia
United States Novo Nordisk Clinical Trial Call Center Denver Colorado
United States Novo Nordisk Clinical Trial Call Center Des Moines Iowa
United States Novo Nordisk Clinical Trial Call Center El Paso Texas
United States Novo Nordisk Clinical Trial Call Center El Paso Texas
United States Novo Nordisk Clinical Trial Call Center Fresno California
United States Novo Nordisk Clinical Trial Call Center Greenbrae California
United States Novo Nordisk Clinical Trial Call Center Houston Texas
United States Novo Nordisk Clinical Trial Call Center Huntington Indiana
United States Novo Nordisk Clinical Trial Call Center Huntsville Alabama
United States Novo Nordisk Clinical Trial Call Center Inverness Florida
United States Novo Nordisk Clinical Trial Call Center Jackson Mississippi
United States Novo Nordisk Clinical Trial Call Center Kissimmee Florida
United States Novo Nordisk Clinical Trial Call Center La Jolla California
United States Novo Nordisk Clinical Trial Call Center Livonia Michigan
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 Miami Florida
United States Novo Nordisk Clinical Trial Call Center Miami Florida
United States Novo Nordisk Clinical Trial Call Center Miami Florida
United States Novo Nordisk Clinical Trial Call Center Mission Hills California
United States Novo Nordisk Clinical Trial Call Center Ocala Florida
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 Springs California
United States Novo Nordisk Clinical Trial Call Center Palm Springs California
United States Novo Nordisk Clinical Trial Call Center Pittsburgh Pennsylvania
United States Novo Nordisk Clinical Trial Call Center Ponte Vedra Florida
United States Novo Nordisk Clinical Trial Call Center Roswell Georgia
United States Novo Nordisk Clinical Trial Call Center Spokane Washington
United States Novo Nordisk Clinical Trial Call Center Springfield Illinois
United States Novo Nordisk Clinical Trial Call Center Sugar Land Texas
United States Novo Nordisk Clinical Trial Call Center Sugarland Texas
United States Novo Nordisk Clinical Trial Call Center Tampa Florida
United States Novo Nordisk Clinical Trial Call Center Tomball Texas
United States Novo Nordisk Clinical Trial Call Center Torrance California
United States Novo Nordisk Clinical Trial Call Center Troy Michigan
United States Novo Nordisk Clinical Trial Call Center Virginia Beach Virginia
United States Novo Nordisk Clinical Trial Call Center Walnut Creek California
United States Novo Nordisk Clinical Trial Call Center West Seneca New York

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

Countries where clinical trial is conducted

United States,  Argentina,  Canada,  India,  Mexico,  South Africa,  Turkey, 

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 Fasting Plasma Glucose (FPG) Change from baseline in FPG after 26 weeks of treatment Week 0, Week 26 No
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