Comparison of NN1250 With Insulin Glargine in Type 1 Diabetes

Diabetes Clinical Trial

— BEGIN™  

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01079234
• Other study ID #: NN1250-3770
• Secondary ID: U1111-1112-88132
• Status: Completed
• Phase: Phase 3
• First received: March 2, 2010
• Last updated: November 27, 2015
• Start date: March 2010
• Est. completion date: May 2011

Study information

• Verified date: November 2015
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHPGermany: Federal Institute for Drugs and Medical DevicesNorway: Norwegian Medicines AgencyPoland: Ministry of HealthUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 493
• Est. completion date: May 2011
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

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 1

Intervention

Drug:
• insulin degludec
Injected subcutaneously (under the skin) once daily
• insulin glargine
Insulin glargine injected subcutaneously (under the skin) once daily
• insulin aspart
At least three daily doses at meal-time

Locations

Country	Name	City	State
United States	Novo Nordisk Clinical Trial Call Center	Arlington	Texas
United States	Novo Nordisk Clinical Trial Call Center	Asheville	North Carolina
United States	Novo Nordisk Clinical Trial Call Center	Aurora	Colorado
United States	Novo Nordisk Clinical Trial Call Center	Austin	Texas
United States	Novo Nordisk Clinical Trial Call Center	Baltimore	Maryland
United States	Novo Nordisk Clinical Trial Call Center	Chapel Hill	North Carolina
United States	Novo Nordisk Clinical Trial Call Center	Chattanooga	Tennessee
United States	Novo Nordisk Clinical Trial Call Center	Crystal Lake	Illinois
United States	Novo Nordisk Clinical Trial Call Center	Dallas	Texas
United States	Novo Nordisk Clinical Trial Call Center	Dallas	Texas
United States	Novo Nordisk Clinical Trial Call Center	Dallas	Texas
United States	Novo Nordisk Clinical Trial Call Center	DeLand	Florida
United States	Novo Nordisk Clinical Trial Call Center	Denver	Colorado
United States	Novo Nordisk Clinical Trial Call Center	Des Moines	Iowa
United States	Novo Nordisk Clinical Trial Call Center	Des Moines	Iowa
United States	Novo Nordisk Clinical Trial Call Center	Encino	California
United States	Novo Nordisk Clinical Trial Call Center	Flemington	New Jersey
United States	Novo Nordisk Clinical Trial Call Center	Fresno	California
United States	Novo Nordisk Clinical Trial Call Center	Greenville	North Carolina
United States	Novo Nordisk Clinical Trial Call Center	Greer	South Carolina
United States	Novo Nordisk Clinical Trial Call Center	Hollywood	Florida
United States	Novo Nordisk Clinical Trial Call Center	Houston	Texas
United States	Novo Nordisk Clinical Trial Call Center	Huntington Beach	California
United States	Novo Nordisk Clinical Trial Call Center	Lawrenceville	Georgia
United States	Novo Nordisk Clinical Trial Call Center	Memphis	Tennessee
United States	Novo Nordisk Clinical Trial Call Center	Miami	Florida
United States	Novo Nordisk Clinical Trial Call Center	Morehead City	North Carolina
United States	Novo Nordisk Clinical Trial Call Center	Nampa	Idaho
United States	Novo Nordisk Clinical Trial Call Center	Nashua	New Hampshire
United States	Novo Nordisk Clinical Trial Call Center	Roswell	Georgia
United States	Novo Nordisk Clinical Trial Call Center	Round Rock	Texas
United States	Novo Nordisk Clinical Trial Call Center	Smithtown	New York
United States	Novo Nordisk Clinical Trial Call Center	Spokane	Washington
United States	Novo Nordisk Clinical Trial Call Center	St. Louis	Missouri
United States	Novo Nordisk Clinical Trial Call Center	Staten Island	New York
United States	Novo Nordisk Clinical Trial Call Center	Walnut Creek	California

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Belgium,  Germany,  Norway,  Poland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment	Change from baseline in HbA1c after 26 weeks of treatment	Week 0, Week 26	No
Primary	Extension Trial (Primary Endpoint): 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 52 + 7 days follow up	No
Primary	Extension Trial (Primary Endpoint): Rate of Nocturnal 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. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.	Week 0 to Week 52 + 7 days follow up	No
Secondary	Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment	Change from baseline in HbA1c after 52 weeks of treatment.	Week 0, Week 52	No
Secondary	Main Trial (Secondary Endpoint): Change in Fasting Plasma Glucose (FPG) After 26 Weeks of Treatment	Change from baseline in FPG after 26 weeks of treatment	Week 0, Week 26	No
Secondary	Extension Trial (Secondary Endpoint): Change in Fasting Plasma Glucose (FPG) After 52 Weeks of Treatment	Change from baseline in FPG after 52 weeks of treatment.	Week 0, Week 52	No

External Links

•   Clinical Trials at Novo Nordisk