Comparison of NN1250 With Insulin Glargine in Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

— BEGIN™  

Official title:

A 26 Week Randomised, Controlled, Open Label, Multicentre, Multinational, Three-arm, Treat to Target Trial Comparing Efficacy and Safety of Three Different Dosing Regimens of Either Soluble Insulin Basal Analogue (SIBA) or Insulin Glargine With or Without Combination With OAD Treatment, in Subjects With Type 2 Diabetes Mellitus (BEGIN™ : FLEX)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01006291
• Other study ID #: NN1250-3668
• Secondary ID: U1111-1111-70842
• Status: Completed
• Phase: Phase 3
• First received: October 30, 2009
• Last updated: October 12, 2015
• Start date: November 2009
• Est. completion date: September 2010

Study information

• Verified date: October 2015
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y TecnologiaFinland: Finnish Medicines AgencyHungary: National Institute of PharmacyIndia: Ministry of HealthIsrael: Israeli Health Ministry Pharmaceutical AdministrationMacedonia, The Former Yugoslav Republic of: Drug Agency, Ministry of HealthMalaysia: Ministry of HealthMexico: National Institute of Public Health, Health SecretariatNorway: Norwegian Medicines AgencyRussia: Pharmacological Committee, Ministry of HealthSerbia: Agency for Drugs and Medicinal DevicesSouth Africa: Medicines Control CouncilTaiwan: Department of Health, Executive Yuan, R.O.C.United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

This trial is conducted in Africa, Asia, Europe and South America. The aim of this clinical trial is to compare NN1250 (insulin degludec (IDeg) with insulin glargine (IGlar) in patients with type 2 diabetes. Subjects treated with oral antidiabetic drug(s) (OAD(s)) should continue their current OAD treatment at the stable, prerandomisation dose level and dosing frequency.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 687
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

• Current treatment: oral anti-diabetic drug(s) (OAD(s)) alone, basal insulin alone or the combination of OAD(s) and basal insulin. Allowed OADs are: Metformin, insulin secretagogues (sulphonylureas (SU) or glinides), pioglitazone with unchanged dosing for at least 3 months prior to Visit 1

• HbA1c: OADs only users 7.0-11.0 % (both inclusive), basal insulin with/without OADs users 7.0-10.0% (both inclusive) by central laboratory analysis

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

Exclusion Criteria:

• Cancer and medical history of cancer hereof

• Use within the last 3 months prior to Visit 1 of: glucagon-like peptide-1(GLP-1) receptor agonist (exenatide, liraglutide), rosiglitazone, dipeptidyl peptidase IV (DPP-IV) inhibitors, alpha-glucosidase-inhibitors

• 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 and 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

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• insulin degludec
Injected s.c. (under the skin) once daily (alternative regimen). Dose was individually adjusted.
• insulin degludec
Injected s.c. (under the skin) once daily. Dose was individually adjusted.
• insulin glargine
Insulin glargine injected s.c. (under the skin) once daily. Dose was individually adjusted.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Argentina,  Finland,  Hungary,  India,  Israel,  Macedonia, The Former Yugoslav Republic of,  Malaysia,  Mexico,  Norway,  Russian Federation,  Serbia,  South Africa,  Taiwan,  United Kingdom, 

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	Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)	Mean of SMPG after 26 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, before bedtime, at 4 am and before breakfast.	Week 26	No
Secondary	Rate of Confirmed Hypoglycaemic Episodes	Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.	Week 0 to Week 26 + 7 days follow up	No
Secondary	Rate of Nocturnal Confirmed Hypoglycaemic Episodes	Rate of nocturnal confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.	Week 0 to Week 26 + 7 days follow up	No

External Links

•   Clinical Trials at Novo Nordisk