Comparison of NN5401 Versus Insulin Glargine, Both Combined With Metformin Treatment, in Subjects With Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

— BOOST™  

Official title:

NN5401-3590: A Trial Comparing Efficacy and Safety of NN5401 With Insulin Glargine in Insulin Naive Subjects With Type 2 Diabetes (BOOST™ : START 1) / NN5401-3726: An Extension Trial Comparing Safety and Efficacy of NN5401 With Insulin Glargine in Subjects With Type 2 Diabetes (BOOST™: START 1)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01045707
• Other study ID #: NN5401-3590
• Secondary ID: 2009-011271-78U1
• Status: Completed
• Phase: Phase 3
• First received: January 8, 2010
• Last updated: November 25, 2015
• Start date: January 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: Austria: Federal Ministry for Health and WomenIndia: Ministry of HealthRussia: Federal Service for Control of Health Care and Social DevelopmentSouth Korea: Korea Food and Drug Administration (KFDA)Spain: Spanish Drug Agency and Medicinal ProductsTurkey: Ministry of HealthPoland: Ministry of HealthUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This trial is conducted in Asia, Europe and the United States of America (USA). The aim of this trial is to compare the efficacy and safety of NN5401 (insulin degludec/insulin aspart (IDegAsp)) with insulin glargine (IGlar), both as add-on to subject's ongoing treatment with metformin + at least one OAD (oral anti-diabetic drug).

The main period is registered internally at Novo Nordisk as NN5401-3590 while the extension period is registered as NN5401-3726.

Other known NCT identifiers

• NCT01169766

Recruitment information / eligibility

• Status: Completed
• Enrollment: 530
• Est. completion date: May 2011
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• For MAIN period (NN5401-3590):

• Diagnosis of type 2 diabetes mellitus for at least 6 months

• Insulin naïve subjects

• Treatment with metformin and at least one other oral antidiabetic drug for at least 3 months before trial start

• Glycosylated haemoglobin (HbA1c) between 7.5 - 11.0% (both inclusive)

• Body Mass Index (BMI) no higher than 40.0 kg/m^2

• For EXTENSION period (NN5401-3726):

• Informed consent obtained before any trial-related activities

• Must have completed the 26-week treatment period (visit 28) in trial NN5401-3590

Exclusion Criteria:

• For MAIN period (NN5401-3590):

• Treatment with glucagon like peptide-1 (GLP-1) receptor agonists and/or thiazolidinedione(s) within the last 3 months prior to trial start

• Cardiovascular disease diagnosed within 6 months before trial start

• For EXTENSION period (NN5401-3726):

• Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers, Monoamine oxidase (MAO) inhibitors

• Anticipated significant lifestyle changes during the trial, e.g. shift work (including permanent night/evening shift workers), as well as highly variable eating habits as judged by the physician)

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

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 2

Intervention

Drug:
• insulin degludec/insulin aspart
Injected s.c. (under the skin) once daily with the breakfast meal. Dose was individually adjusted.
• insulin glargine
Injected s.c. (under the skin) once daily. 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	Birmingham	Alabama
United States	Novo Nordisk Clinical Trial Call Center	Brooklyn	New York
United States	Novo Nordisk Clinical Trial Call Center	Chattanooga	Tennessee
United States	Novo Nordisk Clinical Trial Call Center	Concord	California
United States	Novo Nordisk Clinical Trial Call Center	Council Bluffs	Iowa
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	Detroit	Michigan
United States	Novo Nordisk Clinical Trial Call Center	Greenbrae	California
United States	Novo Nordisk Clinical Trial Call Center	Greensboro	North Carolina
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	Honolulu	Hawaii
United States	Novo Nordisk Clinical Trial Call Center	Honolulu	Hawaii
United States	Novo Nordisk Clinical Trial Call Center	Idaho Falls	Idaho
United States	Novo Nordisk Clinical Trial Call Center	Los Angeles	California
United States	Novo Nordisk Clinical Trial Call Center	Lubbock	Texas
United States	Novo Nordisk Clinical Trial Call Center	Memphis	Tennessee
United States	Novo Nordisk Clinical Trial Call Center	Metairie	Louisiana
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	Miami	Florida
United States	Novo Nordisk Clinical Trial Call Center	Morehead City	North Carolina
United States	Novo Nordisk Clinical Trial Call Center	New Orleans	Louisiana
United States	Novo Nordisk Clinical Trial Call Center	Norfolk	Virginia
United States	Novo Nordisk Clinical Trial Call Center	North Miami	Florida
United States	Novo Nordisk Clinical Trial Call Center	Olympia	Washington
United States	Novo Nordisk Clinical Trial Call Center	Pembroke Pines	Florida
United States	Novo Nordisk Clinical Trial Call Center	Portland	Oregon
United States	Novo Nordisk Clinical Trial Call Center	San Antonio	Texas
United States	Novo Nordisk Clinical Trial Call Center	Smithtown	New York
United States	Novo Nordisk Clinical Trial Call Center	Springfield	Missouri
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	Tomball	Texas
United States	Novo Nordisk Clinical Trial Call Center	Troy	Michigan
United States	Novo Nordisk Clinical Trial Call Center	Vestavia	Alabama
United States	Novo Nordisk Clinical Trial Call Center	Waterbury	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Austria,  India,  Korea, Republic of,  Poland,  Puerto Rico,  Russian Federation,  Spain,  Turkey, 

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 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 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 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 the subject's daily activities. Moderate: marked symptoms, moderate interference with the subject's daily activities. Severe: considerable interference with the 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 hospitalisation/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect	Week 0 to Week 53 + 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 53	No
Secondary	Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 26	Mean of 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

External Links

•   Clinical Trials at Novo Nordisk