Skip to main content
OpenTrials
Completed

NCT Number: NCT01079234

Comparison of NN1250 With Insulin Glargine in Type 1 Diabetes

This trial is conducted in Europe and in the United States of America (USA). The aim of this trial is to investigate the efficacy and safety of NN1250 (insulin degludec) in subjects with type 1 diabetes.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases 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, Aalst, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Type 1 diabetes for 12 months or longer, hereof the last 3 months with injection based therapies
  • Current treatment with any basal insulin (e.g. insulin glargine, insulin detemir, NPH insulin) using one or two daily injections and with three or more daily meal-time insulin injections (e.g. insulin aspart, insulin lispro, insulin glulisine, human insulin) used as bolus insulin therapy
  • HbA1c maximum 10.0 % by central laboratory analysis
  • Body Mass Index (BMI) below or equal to 35.0 kg/m^2
  • Ability to self-manage insulin therapy as assessed by confirmation (verbal confirmation at screening visit) of a changed insulin dose in the preceding two months prior to screening
  • Ability and willingness to adhere to the protocol including performance of self measured plasma glucose (SMPG) profiles and self adjustment of insulin doses

Exclusion criteria

  • Use within the last 3 months prior to Visit 1 of any antidiabetic glucose lowering drug other than insulin
  • 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 above or equal to 180 millimetre (mm) mercury (Hg) and/or diastolic blood pressure above or equal to 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 (except basal cell skin cancer or squamous cell skin cancer)

Treatment and study plan

insulin degludec

Drug

Injected subcutaneously (under the skin) once daily

insulin glargine

Drug

Insulin glargine injected subcutaneously (under the skin) once daily

insulin aspart

Drug

At least three daily doses at meal-time

Primary outcomes

  1. Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment

    Time frame: Week 0, Week 26

    Change from baseline in HbA1c after 26 weeks of treatment

  2. Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes

    Time frame: Week 0 to Week 52 + 7 days follow up

    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.

  3. Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes

    Time frame: Week 0 to Week 52 + 7 days follow up

    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. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.

Secondary outcomes

  1. Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment

    Time frame: Week 0, Week 52

    Change from baseline in HbA1c after 52 weeks of treatment.

  2. Main Trial (Secondary Endpoint): Change in Fasting Plasma Glucose (FPG) After 26 Weeks of Treatment

    Time frame: Week 0, Week 26

    Change from baseline in FPG after 26 weeks of treatment

  3. Extension Trial (Secondary Endpoint): Change in Fasting Plasma Glucose (FPG) After 52 Weeks of Treatment

    Time frame: Week 0, Week 52

    Change from baseline in FPG after 52 weeks of treatment.

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A 26-week Trial Investigating the Dosing Flexibility, Efficacy and Safety of NN1250 in Subjects With Type 1 Diabetes With a 26-week Extension (Begin™: Flex T1)

Acronym: BEGIN™

Important dates

Study start
2010
Primary completion
2010
Study completion
2011
First posted
Mar 3, 2010
Registry last updated
Feb 9, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.