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

Diabetes Mellitus, Type 2 Clinical Trial

— BEGIN™  

Official title:

A Pan Asian Trial Comparing Efficacy and Safety of Insulin NN1250 and Insulin Glargine as Add on to OAD(s) in Subjects With Type 2 Diabetes (BEGIN™: ONCE ASIA)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01059799
• Other study ID #: NN1250-3586
• Secondary ID: U1111-1113-2441J
• Status: Completed
• Phase: Phase 3
• First received: January 29, 2010
• Last updated: October 12, 2015
• Start date: February 2010
• Est. completion date: December 2010

Study information

• Verified date: October 2015
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and WelfareMalaysia: Ministry of HealthSouth Korea: Korea Food and Drug Administration (KFDA)Taiwan: Department of HealthHong Kong: Department of HealthThailand: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This trial is conducted in Asia and Japan. The aim of this trial is to compare insulin degludec (NN1250) with insulin glargine both combined with oral antidiabetic drugs (OADs) in subjects with type 2 diabetes never treated with insulin.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 435
• 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:

• For Japan only: minimum age is 20 years

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

• Current treatment with monotherapy or combination of an insulin secretagouge (sulfonylurea or glinide) and metformin, with or without addition of alfa-glucosidase-inhibitors or a DPP-4 inhibitor with unchanged dosing for at least 3 months prior to visit 1. The dose(s) should as minimum be as stated: -Insulin secretagogue (sulfonylurea or glinide): Minimum half of the daily maximal dose according to local labelling -Metformin: alone or in combination (including fixed combination): Maximum tolerated dose - alfa-glucosidase-inhibitors: Minimum half of the daily maximal dose or maximum tolerated dose -DPP-4 (dipeptyl peptidase 4) inhibitor: According to local labelling

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

• Body Mass Index (BMI) no higher than 35.0 kg/m^2

Exclusion Criteria:

• Use within the last 3 months prior to Visit 1 of: TZDs (thiazolidinediones), 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, or the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements (for Thailand: adequate contraceptive measures are: diaphragm, condom (by the partner), intrauterine device in place for last three months before trial starts, sponge, cap with spermicide, contraceptive patch, approved hormonal implant (i.e. Norplant), oral contraceptives taken without difficulty for the last three months before trial starts, post menopausal state or sterilisation.)

• Cancer and medical history of cancer (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

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• insulin degludec
Insulin degludec injected subcutaneously (under the skin) once daily. The doses will be individually adjusted
• insulin glargine
Insulin glargine injected subcutaneously (under the skin) once daily. The doses will be individually adjusted

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Hong Kong,  Japan,  Korea, Republic of,  Malaysia,  Taiwan,  Thailand, 

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	Rate of Confirmed Hypoglycaemic Episodes	Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure 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
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

External Links

•   Clinical Trials at Novo Nordisk