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NCT01068678 Clinical Trial

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

Diabetes Mellitus, Type 2 Clinical Trial

— BEGIN™  

Official title:
A Trial Comparing Efficacy and Safety of NN1250 and Insulin Glargine in Subjects With Type 2 Diabetes (BEGIN™: EASY AM)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01068678
Other study ID # NN1250-3724
Secondary ID 2009-011398-33U1
Status Completed
Phase Phase 3
First received February 12, 2010
Last updated November 19, 2015
Start date February 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 Canada: Health CanadaCzech Republic: State Institute for Drug ControlIsrael: Ministry of HealthSlovakia: State Institute for Drug ControlSouth Africa: Medicines Control CouncilUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This trial is conducted in Africa, Asia, Europe, and North America. The aim of this clinical trial is to compare the efficacy and safety of NN1250 (insulin degludec (IDeg)) with insulin glargine (IGlar) in subjects with type 2 diabetes currently treated with metformin alone or with metformin combined with an oral anti-diabetic drug (OAD) qualifying for intensified treatment.

Recruitment information / eligibility
Status Completed
Enrollment 460
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:

- Insulin naïve subject (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 three 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 secretaguogue (sulfonylurea 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

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

Exclusion Criteria:

- Use within the last 3 months prior to Visit 1 of: thiazoledinediones, 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 (for UK: adequate contraceptive measures are defined as established use of oral, injected or implanted hormonal methods of contraception, sterilisation, intrauterine device or intrauterine system, or consistent use of barrier methods)

- 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
Injected subcutaneously (under the skin) three times weekly. Dose was individually adjusted.
• insulin glargine
Injected subcutaneously (under the skin) once daily. Dose was individually adjusted.

Locations
Country Name City State
United States Novo Nordisk Clinical Trial Call Center Amarillo Texas
United States Novo Nordisk Clinical Trial Call Center Arlington Texas
United States Novo Nordisk Clinical Trial Call Center Atlanta Georgia
United States Novo Nordisk Clinical Trial Call Center Avon Indiana
United States Novo Nordisk Clinical Trial Call Center Billings Montana
United States Novo Nordisk Clinical Trial Call Center Canton Ohio
United States Novo Nordisk Clinical Trial Call Center Charleston South Carolina
United States Novo Nordisk Clinical Trial Call Center Chesterfield Missouri
United States Novo Nordisk Clinical Trial Call Center Columbus Georgia
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 Des Moines Iowa
United States Novo Nordisk Clinical Trial Call Center Durham North Carolina
United States Novo Nordisk Clinical Trial Call Center Fishers Indiana
United States Novo Nordisk Clinical Trial Call Center Fort Worth Texas
United States Novo Nordisk Clinical Trial Call Center Franklin Indiana
United States Novo Nordisk Clinical Trial Call Center Fredericksburg Virginia
United States Novo Nordisk Clinical Trial Call Center Greer South Carolina
United States Novo Nordisk Clinical Trial Call Center Houston Texas
United States Novo Nordisk Clinical Trial Call Center Houston Texas
United States Novo Nordisk Clinical Trial Call Center Hyattsville Maryland
United States Novo Nordisk Clinical Trial Call Center Indianapolis Indiana
United States Novo Nordisk Clinical Trial Call Center Irving Texas
United States Novo Nordisk Clinical Trial Call Center Jackson Mississippi
United States Novo Nordisk Clinical Trial Call Center Lexington Kentucky
United States Novo Nordisk Clinical Trial Call Center Menomonee Falls Wisconsin
United States Novo Nordisk Clinical Trial Call Center Muncie Indiana
United States Novo Nordisk Clinical Trial Call Center Nashville Tennessee
United States Novo Nordisk Clinical Trial Call Center Northridge California
United States Novo Nordisk Clinical Trial Call Center Paducah Kentucky
United States Novo Nordisk Clinical Trial Call Center Pittsburgh Pennsylvania
United States Novo Nordisk Clinical Trial Call Center Plano Texas
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 Santa Ana California
United States Novo Nordisk Clinical Trial Call Center Simpsonville South Carolina
United States Novo Nordisk Clinical Trial Call Center Spring Valley California
United States Novo Nordisk Clinical Trial Call Center St. Peters Missouri
United States Novo Nordisk Clinical Trial Call Center Syracuse New York
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 Virginia Beach Virginia
United States Novo Nordisk Clinical Trial Call Center West Seneca New York
United States Novo Nordisk Clinical Trial Call Center Winston Salem North Carolina

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

Countries where clinical trial is conducted

United States,  Canada,  Czech Republic,  Israel,  Slovakia,  South Africa,  United Kingdom, 

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