Comparison of NN1250 Plus Insulin Aspart With Insulin Glargine Plus Insulin Aspart in Type 1 Diabetes

Diabetes Clinical Trial

— BEGIN™  

Official title:

NN1250-3583: A 52 Week Randomised, Controlled, Open Label, Multicentre, Multinational, Parallel, Treat-to-target Trial Comparing Efficacy and Safety of SIBA and Insulin Glargine Both Administered Once Daily in a Basal-bolus Regimen With Insulin Aspart as Mealtime Insulin in Subjects With Type 1 Diabetes (BEGIN™: BB T1 LONG) / NN1250-3644: An Extension Trial to Trial NN1250-3583 Comparing Safety and Efficacy of NN1250 With Insulin Glargine, Both With Insulin Aspart as Meal-time Insulin, in Type 1 Diabetes (BEGIN™: T1)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00982228
• Other study ID #: NN1250-3583
• Secondary ID: 2008-005774-13U1
• Status: Completed
• Phase: Phase 3
• First received: September 22, 2009
• Last updated: November 24, 2015
• Start date: September 2009
• Est. completion date: November 2011

Study information

• Verified date: November 2015
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)United Kingdom: Medicines and Healthcare Products Regulatory AgencySouth Africa: Medicines Control CouncilUnited States: Food and Drug AdministrationRussia: Federal Service for Control of Health Care and Social Development
• Study type: Interventional

Clinical Trial Summary

This trial is conducted in Africa, Europe and the United States of America (USA).

The aim of the trial is to compare NN1250 (insulin degludec, soluble insulin basal analogue (SIBA)) plus insulin aspart with insulin glargine (IGlar) plus insulin aspart in patients with type 1 diabetes.

The main period is registered internally at Novo Nordisk as NN1250-3583 while the extension period is registered as NN1250-3644.

Other known NCT identifiers

• NCT01198041

Recruitment information / eligibility

• Status: Completed
• Enrollment: 629
• Est. completion date: November 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 mellitus for at least 12 months

• Current treatment with any basal bolus insulin for at least 12 months

• HbA1c below or equal to 10.0%

• BMI (Body Mass Index) below or equal to 35.0 kg/m^2

• For the extension trial only: Completion of the 52 week treatment period in trial NN1250-3583 (NCT00982228)

Exclusion Criteria:

• Use of any other antidiabetic drug than insulin within the last 3 months

• Cardiovascular disease within the last 6 months

• Uncontrolled treated/untreated severe hypertension

• Recurrent severe hypoglycemia or hypoglycemic unawareness or hospitalisation for diabetic ketoacidosis during the previous 6 months

• Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements

• Cancer and medical history of 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 once daily. Dose was individually adjusted.
• insulin glargine
Injected subcutaneously once daily. Dose individually adjusted.
• insulin aspart
Injected subcutaneously as mealtime insulin. Dose was individually adjusted.

Locations

Country	Name	City	State
United States	Novo Nordisk Clinical Trial Call Center	Atlanta	Georgia
United States	Novo Nordisk Clinical Trial Call Center	Aurora	Colorado
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	Birmingham	Alabama
United States	Novo Nordisk Clinical Trial Call Center	Brockton	Massachusetts
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	Chattanooga	Tennessee
United States	Novo Nordisk Clinical Trial Call Center	Chesterfield	Missouri
United States	Novo Nordisk Clinical Trial Call Center	Chicago	Illinois
United States	Novo Nordisk Clinical Trial Call Center	Columbus	Ohio
United States	Novo Nordisk Clinical Trial Call Center	Concord	California
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	Dover	New Hampshire
United States	Novo Nordisk Clinical Trial Call Center	Eagan	Minnesota
United States	Novo Nordisk Clinical Trial Call Center	Flint	Michigan
United States	Novo Nordisk Clinical Trial Call Center	Flushing	New York
United States	Novo Nordisk Clinical Trial Call Center	Fresno	California
United States	Novo Nordisk Clinical Trial Call Center	Great Falls	Montana
United States	Novo Nordisk Clinical Trial Call Center	Greenbrae	California
United States	Novo Nordisk Clinical Trial Call Center	Hollywood	Florida
United States	Novo Nordisk Clinical Trial Call Center	Honolulu	Hawaii
United States	Novo Nordisk Clinical Trial Call Center	Huntington Beach	California
United States	Novo Nordisk Clinical Trial Call Center	Huntsville	Alabama
United States	Novo Nordisk Clinical Trial Call Center	Hyattsville	Maryland
United States	Novo Nordisk Clinical Trial Call Center	Jefferson City	Missouri
United States	Novo Nordisk Clinical Trial Call Center	La Mesa	California
United States	Novo Nordisk Clinical Trial Call Center	Lake Mary	Florida
United States	Novo Nordisk Clinical Trial Call Center	Lawrenceville	Georgia
United States	Novo Nordisk Clinical Trial Call Center	Lawrenceville	New Jersey
United States	Novo Nordisk Clinical Trial Call Center	Lexington	Kentucky
United States	Novo Nordisk Clinical Trial Call Center	Lexington	Kentucky
United States	Novo Nordisk Clinical Trial Call Center	Livonia	Michigan
United States	Novo Nordisk Clinical Trial Call Center	Los Gatos	California
United States	Novo Nordisk Clinical Trial Call Center	Lubbock	Texas
United States	Novo Nordisk Clinical Trial Call Center	Miami	Florida
United States	Novo Nordisk Clinical Trial Call Center	Milwaukee	Wisconsin
United States	Novo Nordisk Clinical Trial Call Center	Oklahoma City	Oklahoma
United States	Novo Nordisk Clinical Trial Call Center	Omaha	Nebraska
United States	Novo Nordisk Clinical Trial Call Center	Omaha	Nebraska
United States	Novo Nordisk Clinical Trial Call Center	Peoria	Arizona
United States	Novo Nordisk Clinical Trial Call Center	Pittsburgh	Pennsylvania
United States	Novo Nordisk Clinical Trial Call Center	Pittsburgh	Pennsylvania
United States	Novo Nordisk Clinical Trial Call Center	Raleigh	North Carolina
United States	Novo Nordisk Clinical Trial Call Center	Rapid City	South Dakota
United States	Novo Nordisk Clinical Trial Call Center	Renton	Washington
United States	Novo Nordisk Clinical Trial Call Center	Rochester	New York
United States	Novo Nordisk Clinical Trial Call Center	Rockville	Maryland
United States	Novo Nordisk Clinical Trial Call Center	Santa Barbara	California
United States	Novo Nordisk Clinical Trial Call Center	Scarborough	Maine
United States	Novo Nordisk Clinical Trial Call Center	St. Charles	Missouri
United States	Novo Nordisk Clinical Trial Call Center	St. George	Utah
United States	Novo Nordisk Clinical Trial Call Center	Tustin	California
United States	Novo Nordisk Clinical Trial Call Center	Ventura	California
United States	Novo Nordisk Clinical Trial Call Center	Vincennes	Indiana
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,  France,  Germany,  Russian Federation,  South Africa,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Main Trial (Primary 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
Primary	Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs)	Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.	Week 0 to Week 104 + 7 days follow up	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 104 + 7 days follow up	No
Primary	Extension Trial (Primary Endpoint): Cross-reacting Antibodies to Human Insulin	The unit for measuring antibody levels is amount of tracer bound to the antibodies in the precipitate (B) expressed in percentage of the total amount of tracer (T) added to the mixture (%B/T). Samples were taken before 1st dosing and after a 1-week wash-out period.	Week 0, Week 106	No
Secondary	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 occuring between 00:01 and 05:59 a.m.	Week 0 to Week 104 + 7 days follow up	No
Secondary	Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 104 Weeks of Treatment	Change from baseline in HbA1c after 104 weeks of treatment	Week 0, Week 104	No
Secondary	Extension Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 104 of Treatment	Mean of 9-point self-measured plasma glucose profile (SMPG) after 104 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, bedtime, at 4 am and before breakfast.	Treatment week 104	No
Secondary	Main Trial (Secondary 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
Secondary	Main Trial (Secondary 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 occuring between 00:01 and 05:59 a.m.	Week 0 to Week 52 + 7 days follow up	No
Secondary	Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 52	Mean of 9-point self-measured plasma glucose profile (SMPG) after 52 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, bedtime, at 4 am and before breakfast.	Week 52	No

External Links

•   Clinical Trials at Novo Nordisk