Comparison of NN1250 With Insulin Glargine Plus Insulin Aspart With/Without Metformin and With/Without Pioglitazone in Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

— BEGIN™  

Official title:

NN1250-3582: A 52-week Randomised, Controlled, Open Label, Multicentre, Multinational 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 ± Treatment With Metformin, ± Pioglitazone in Subjects With Type 2 Diabetes Currently Treated With Insulin Qualifying for Intensified Treatment/NN1250-3667: An Extension Trial to NN1250-3582 Comparing Safety and Efficacy of NN1250 and Insulin Glargine, Both With Insulin Aspart as Meal-time Insulin ± OADs in Type 2 Diabetes (BEGIN™: BB)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00972283
• Other study ID #: NN1250-3582
• Secondary ID: 2008-005777-35U1
• Status: Completed
• Phase: Phase 3
• First received: September 3, 2009
• Last updated: November 24, 2015
• Start date: September 2009
• 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: Germany: Federal Institute for Drugs and Medical DevicesItaly: The Italian Medicines AgencyBulgaria: Bulgarian Drug AgencyRomania: National Medicines AgencySlovakia: State Institute for Drug ControlIreland: Irish Medicines BoardSpain: Spanish agency of medicines and health care productsSouth Africa: Medicines Control CouncilHong Kong: Department of HealthRussia: Federal Service for Control of Health Care and Social DevelopmentTurkey: Ministry of Health Drug and Pharmaceutical DepartmentUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

The aim of this clinical trial is to compare NN1250 (insulin degludec (IDeg)) with insulin glargine (IGlar) plus insulin aspart (IAsp) with/without metformin and with/without pioglitazone in subjects with type 2 diabetes (main period) followed by investigating the long-term safety in terms of comparing NN1250 with insulin glargine plus insulin aspart with or without metformin and with or without pioglitazone in subjects with type 2 diabetes.

All oral anti-diabetic drug (OAD) treatment will be discontinued, if applicable, when trial participant enters the trial (NN1250-3582) with the exception of metformin and pioglitazone.

Subjects who consent to participate in the extension trial (NN1250-3667) will continue to receive the treatment to which they were randomly allocated in the 52 week trial NN1250-3582.

The main period is registered internally at Novo Nordisk as NN1250-3582 while the extension period is registered as NN1250-3667.

Other known NCT identifiers

• NCT01193322

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1006
• 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 (NN1250-3582):

• Type 2 diabetes mellitus for at least 6 months

• Ongoing daily treatment with insulin (premix, self-mix, basal only, basal bolus) for at least 3 months with/without oral anti-diabetics drug (OAD) prior to trial start

• HbA1c 7.0-10.0 % (both inclusive)

• Body Mass Index (BMI) below or equal to 40.0 kg/m^2

• For EXTENSION period (NN1250-3667):

• Completion of the 52 week treatment period in NN1250-3582

Exclusion Criteria:

• For MAIN period (NN1250-3582):

• Treatment with other insulin regimens than premix, self-mix, basal only, basal bolus 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

• 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 2

Intervention

Drug:
• insulin degludec
Injected subcutaneously (under the skin) with main evening meal. Dose was individually adjusted.
• insulin glargine
Injected subcutanoeusly (under the skin) according to approved label. Dose was individually adjusted.
• insulin aspart
Injected subcutaneously (under the skin) at each main meal. Dose was individually adjusted.

Locations

Country	Name	City	State
United States	Novo Nordisk Clinical Trial Call Center	Anaheim	California
United States	Novo Nordisk Clinical Trial Call Center	Atlanta	Georgia
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	Charlotte	North Carolina
United States	Novo Nordisk Clinical Trial Call Center	Corpus Christi	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	Danville	Pennsylvania
United States	Novo Nordisk Clinical Trial Call Center	Evansville	Indiana
United States	Novo Nordisk Clinical Trial Call Center	Fort Valley	Georgia
United States	Novo Nordisk Clinical Trial Call Center	Fort Worth	Texas
United States	Novo Nordisk Clinical Trial Call Center	Gainesville	Florida
United States	Novo Nordisk Clinical Trial Call Center	Goodyear	Arizona
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	Houston	Texas
United States	Novo Nordisk Clinical Trial Call Center	Hyattsville	Maryland
United States	Novo Nordisk Clinical Trial Call Center	Indianapolis	Indiana
United States	Novo Nordisk Clinical Trial Call Center	Jefferson City	Missouri
United States	Novo Nordisk Clinical Trial Call Center	Kingsport	Tennessee
United States	Novo Nordisk Clinical Trial Call Center	Kingston	Pennsylvania
United States	Novo Nordisk Clinical Trial Call Center	Lake Mary	Florida
United States	Novo Nordisk Clinical Trial Call Center	Las Vegas	Nevada
United States	Novo Nordisk Clinical Trial Call Center	Lawrenceville	New Jersey
United States	Novo Nordisk Clinical Trial Call Center	Lincoln	Nebraska
United States	Novo Nordisk Clinical Trial Call Center	Los Gatos	California
United States	Novo Nordisk Clinical Trial Call Center	Metairie	Louisiana
United States	Novo Nordisk Clinical Trial Call Center	Metairie	Louisiana
United States	Novo Nordisk Clinical Trial Call Center	Nampa	Idaho
United States	Novo Nordisk Clinical Trial Call Center	New Albany	Indiana
United States	Novo Nordisk Clinical Trial Call Center	Newberry	South Carolina
United States	Novo Nordisk Clinical Trial Call Center	North East	Maryland
United States	Novo Nordisk Clinical Trial Call Center	Olympia	Washington
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	Philadelphia	Pennsylvania
United States	Novo Nordisk Clinical Trial Call Center	Plantation	Florida
United States	Novo Nordisk Clinical Trial Call Center	Renton	Washington
United States	Novo Nordisk Clinical Trial Call Center	Rockville	Maryland
United States	Novo Nordisk Clinical Trial Call Center	Round Rock	Texas
United States	Novo Nordisk Clinical Trial Call Center	Salinas	California
United States	Novo Nordisk Clinical Trial Call Center	Salt Lake City	Utah
United States	Novo Nordisk Clinical Trial Call Center	Santa Monica	California
United States	Novo Nordisk Clinical Trial Call Center	Spring Valley	California
United States	Novo Nordisk Clinical Trial Call Center	St. Louis	Missouri
United States	Novo Nordisk Clinical Trial Call Center	Toms River	New Jersey
United States	Novo Nordisk Clinical Trial Call Center	Tustin	California
United States	Novo Nordisk Clinical Trial Call Center	Walnut Creek	California
United States	Novo Nordisk Clinical Trial Call Center	Waterbury	Connecticut
United States	Novo Nordisk Clinical Trial Call Center	West Palm Beach	Florida
United States	Novo Nordisk Clinical Trial Call Center	Willkes Barre	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Bulgaria,  Germany,  Hong Kong,  Ireland,  Italy,  Romania,  Russian Federation,  Slovakia,  South Africa,  Spain,  Turkey, 

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 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 78 + 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 78 + 7 days follow up	No
Primary	Rate of Treatment Emergent Adverse Events (AEs)	Corresponds to rate of AEs per 100 patient years of exposure. Mild AEs: no or transient symptoms, no interference with subject's daily activities. Moderate AEs: marked symptoms, moderate interference with subject's daily activities. Severe AEs: considerable interference with subject's daily activities, unacceptable. Serious adverse event (SAE): 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 78 + 7 days follow up	No
Secondary	Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 78 Weeks of Treatment	Change from baseline in HbA1c after 78 weeks of treatment	Week 0, Week 78	No
Secondary	Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 52	Mean of 9-point SMPG at 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
Secondary	Extension Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 78	Mean of the SMPG at 78 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, before breakfast.	Week 78	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 occurring between 00:01 and 05:59 a.m.	Week 0 to Week 52 + 7 days follow up	No

External Links

•   Clinical Trials at Novo Nordisk