Comparison of NN5401 Plus Insulin Aspart With Insulin Detemir Plus Insulin Aspart in Type 1 Diabetes

Diabetes Clinical Trial

— BOOST™  

Official title:

NN5401-3594: A 26-week, Open-labelled, Two-arm, Parallel, Randomised Trial Comparing Efficacy and Safety of NN5401 Once Daily Plus Insulin Aspart vs. Basal-bolus Treatment With Insulin Detemir Plus Insulin Aspart in Subjects With Type 1 Diabetes / NN5401-3645: An Extension Trial Comparing Safety and Efficacy of NN5401 Plus Meal-time Insulin Aspart for the Remaining Meals With Insulin Detemir Plus Meal-time Insulin Aspart in Type 1 Diabetes (BOOST™: T1)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00978627
• Other study ID #: NN5401-3594
• Secondary ID: 2008-005769-71U1
• Status: Completed
• Phase: Phase 3
• First received: September 16, 2009
• Last updated: October 19, 2015
• Start date: August 2009
• 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: United States: Food and Drug AdministrationAustralia: Department of Health and Ageing Therapeutic Goods AdministrationDenmark: Danish Medicines AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Israel: Ministry of HealthPoland: Ministry of HealthRomania: State Institute for Drug ControlRussia: Pharmacological Committee, Ministry of HealthUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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

The aim of this clinical trial is to compare NN5401 (insulin degludec/insulin aspart (IDegAsp)) with insulin detemir (IDet) plus insulin aspart in patients with type 1 diabetes (main period) followed by the extension period comparing the long-term safety of NN5401 plus insulin aspart with insulin detemir plus insulin aspart.

The main period is registered internally at Novo Nordisk as NN5401-3594 while the extension period is registered as NN5401-3645.

Other known NCT identifiers

• NCT01087606

Recruitment information / eligibility

• Status: Completed
• Enrollment: 548
• Est. completion date: December 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• FOR THE MAIN TRIAL, NN5401-3594:

• Type 1 diabetes mellitus for at least 12 months

• Ongoing daily treatment with insulin (in a basal bolus regimen, premix insulin regimen, self mix regimen) for at least 12 months

• HbA1c 7.0-10.0% (both inclusive)

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

• FOR THE EXTENSION TRIAL, NN5401-3645:

• The subject must have completed the six-month treatment period in trial NN5401-3594

Exclusion Criteria:

• FOR THE MAIN TRIAL, NN5401-3594:

• Treatment with other insulin regimens than insulin in a basal bolus regimen/premix insulin regimen/self mix regimen within 3 months

• Cardiovascular disease within the last 6 months

• Uncontrolled treated/untreated severe hypertension

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

• Cancer and medical history of cancer

• FOR THE EXTENSION TRIAL, NN5401-3645:

• Anticipated significant lifestyle changes during the trial

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

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/insulin aspart
Injected subcutaneously (under the skin) once daily with a meal. Dose was individually adjusted.
• insulin detemir
Injected subcutaneously (under the skin) once daily or twice daily. Dose was individually adjusted.
• insulin aspart
Injected subcutaneously (under the skin) at the remaining meals. Dose was individually adjusted.
• insulin aspart
Injected subcutaneously (under the skin) as meal time insulin. Dose was individually adjusted.

Locations

Country	Name	City	State
Puerto Rico	Novo Nordisk Clinical Trial Call Center	Bayamon
United States	Novo Nordisk Clinical Trial Call Center	Albany	New York
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	Butte	Montana
United States	Novo Nordisk Clinical Trial Call Center	Chicago	Illinois
United States	Novo Nordisk Clinical Trial Call Center	Dallas	Texas
United States	Novo Nordisk Clinical Trial Call Center	Eagan	Minnesota
United States	Novo Nordisk Clinical Trial Call Center	Greer	South Carolina
United States	Novo Nordisk Clinical Trial Call Center	Henderson	Nevada
United States	Novo Nordisk Clinical Trial Call Center	Honolulu	Hawaii
United States	Novo Nordisk Clinical Trial Call Center	La Mesa	California
United States	Novo Nordisk Clinical Trial Call Center	Lancaster	California
United States	Novo Nordisk Clinical Trial Call Center	Lawrenceville	Georgia
United States	Novo Nordisk Clinical Trial Call Center	Lexington	Kentucky
United States	Novo Nordisk Clinical Trial Call Center	Miami	Florida
United States	Novo Nordisk Clinical Trial Call Center	Miami	Florida
United States	Novo Nordisk Clinical Trial Call Center	Minneapolis	Minnesota
United States	Novo Nordisk Clinical Trial Call Center	Mission Hills	California
United States	Novo Nordisk Clinical Trial Call Center	Morehead City	North Carolina
United States	Novo Nordisk Clinical Trial Call Center	North Hollywood	California
United States	Novo Nordisk Clinical Trial Call Center	Omaha	Nebraska
United States	Novo Nordisk Clinical Trial Call Center	Roswell	Georgia
United States	Novo Nordisk Clinical Trial Call Center	Salinas	California
United States	Novo Nordisk Clinical Trial Call Center	San Antonio	Texas
United States	Novo Nordisk Clinical Trial Call Center	Seattle	Washington
United States	Novo Nordisk Clinical Trial Call Center	Shawnee Mission	Kansas
United States	Novo Nordisk Clinical Trial Call Center	St. Peters	Missouri
United States	Novo Nordisk Clinical Trial Call Center	Valencia	California

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Australia,  Denmark,  France,  Israel,  Poland,  Puerto Rico,  Romania,  Russian Federation,  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 were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol /L.	Week 0 to Week 53 + 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 were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes were defined as occurring between 00:01 and 05:59 a.m.	Week 0 to Week 53 + 7 days follow up	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 53 + 7 days of follow up	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 were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were 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	Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 26	Overall mean of 9-point SMPG at 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, bedtime, at 4 am and before breakfast.	Week 26	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 53	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 were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes were defined as occurring between 00:01 and 05:59 a.m.	Week 0 to Week 26 + 7 days follow up	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 53	No

External Links

•   Clinical Trials at Novo Nordisk