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Completed

NCT Number: NCT01059799

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

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novo Nordisk Investigational Site, Shatin, New Territories, Hong Kong

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

insulin degludec

Drug

Insulin degludec injected subcutaneously (under the skin) once daily. The doses will be individually adjusted

insulin glargine

Drug

Insulin glargine injected subcutaneously (under the skin) once daily. The doses will be individually adjusted

Primary outcomes

  1. Change in Glycosylated Haemoglobin (HbA1c)

    Time frame: Week 0, Week 26

    Change from baseline in HbA1c after 26 weeks of treatment

Secondary outcomes

  1. Rate of Confirmed Hypoglycaemic Episodes

    Time frame: Week 0 to Week 26 + 7 days follow up

    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.

  2. Rate of Nocturnal Confirmed Hypoglycaemic Episodes

    Time frame: Week 0 to Week 26 + 7 days follow up

    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.

  3. Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)

    Time frame: Week 26

    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.

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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)

Acronym: BEGIN™

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Feb 1, 2010
Registry last updated
Mar 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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