Comparison of NN1250 Versus Insulin Glargine in Subjects With Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

— BEGIN™  

Official title:

NN1250-3579: A 52-week Randomised, Controlled, Open Label, Multicentre, Multinational Treat-to-target Trial Comparing the Efficacy and Safety of SIBA and Insulin Glargine, Both Injected Once Daily in Combination With Oral Anti-diabetic Drugs (OAD), in Subjects With Type 2 Diabetes Mellitus Currently Treated With OAD(s) and Qualifying for More Intensified Treatment / NN1250-3643: An Extension Trial to NN1250-3579 Comparing Safety and Efficacy of NN1250 Plus OAD(s) With Insulin Glargine Plus OAD(s) in Type 2 Diabetes (BEGIN™: Once Long)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00982644
• Other study ID #: NN1250-3579
• Secondary ID: 2008-005776-27U1
• Status: Completed
• Phase: Phase 3
• First received: September 22, 2009
• Last updated: November 20, 2015
• Start date: September 2009
• Est. completion date: December 2011

Study information

• Verified date: November 2015
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food SafetyBelgium: Federal Agency for Medicines and Health Products, FAMHPCanada: Health CanadaCzech Republic: State Institute for Drug ControlDenmark: Danish Medicines AgencyFinland: Finnish Medicines AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesNorway: Norwegian Medicines AgencySerbia: Agency for Drugs and Medicinal DevicesSpain: Spanish Agency of MedicinesUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to compare NN1250 (insulin degludec (IDeg)) with insulin glargine (IGlar) in subjects with type 2 diabetes never treated with insulin followed by the extension trial investigating the long-term safety and tolerability in terms of comparing NN1250 with insulin glargine in subjects with type 2 diabetes.

All oral anti-diabetic drug (OAD) treatment will be discontinued when trial participant enters the main trial (NN1250-3579) with the exception of metformin and dipeptidyl peptidase-IV (DPP-IV) inhibitor treatment (only in countries where DPP-IV inhibitor treatment is approved for combination treatment together with insulin, otherwise DPP-IV inhibitor treatment is also discontinued). Subjects who consent to participate in the extension trial will continue the treatment (NN1250 or insulin glargine + oral antidiabetic drugs (OADs)) to which they were randomly allocated in the 52 week main trial.

The main period is registered internally at Novo Nordisk as NN1250-3579 while the extension period is registered as NN1250-3643.

Other known NCT identifiers

• NCT01193309

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1030
• Est. completion date: December 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Type 2 diabetes mellitus

• Treatment with oral antidiabetic drugs (OADs) for at least three months before trial start at an unchanged dose

• HbA1c: 7.0-10.0%

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

• For the extension trial only: Completion of the 52 week treatment period in trial NN1250-3579 (NCT00982644)

Exclusion Criteria:

• Treatment with exenatide or liraglutide within the last 3 months before trial start

• 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) once daily. Dose was individually adjusted.
• insulin glargine
Injected subcutaneously (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	Anaheim	California
United States	Novo Nordisk Clinical Trial Call Center	Arlington	Texas
United States	Novo Nordisk Clinical Trial Call Center	Asheboro	North Carolina
United States	Novo Nordisk Clinical Trial Call Center	Bay Minette	Alabama
United States	Novo Nordisk Clinical Trial Call Center	Boynton Beach	Florida
United States	Novo Nordisk Clinical Trial Call Center	Brockton	Massachusetts
United States	Novo Nordisk Clinical Trial Call Center	Charlotte	North Carolina
United States	Novo Nordisk Clinical Trial Call Center	Chicago	Illinois
United States	Novo Nordisk Clinical Trial Call Center	Cincinnati	Ohio
United States	Novo Nordisk Clinical Trial Call Center	Columbia	South Carolina
United States	Novo Nordisk Clinical Trial Call Center	Concord	California
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	Dayton	Ohio
United States	Novo Nordisk Clinical Trial Call Center	Decatur	Georgia
United States	Novo Nordisk Clinical Trial Call Center	East Providence	Rhode Island
United States	Novo Nordisk Clinical Trial Call Center	El Paso	Texas
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	Goodyear	Arizona
United States	Novo Nordisk Clinical Trial Call Center	Greenbelt	Maryland
United States	Novo Nordisk Clinical Trial Call Center	Greer	South Carolina
United States	Novo Nordisk Clinical Trial Call Center	Harriman	Tennessee
United States	Novo Nordisk Clinical Trial Call Center	Henderson	Nevada
United States	Novo Nordisk Clinical Trial Call Center	Humboldt	Tennessee
United States	Novo Nordisk Clinical Trial Call Center	Huntsville	Alabama
United States	Novo Nordisk Clinical Trial Call Center	Hurst	Texas
United States	Novo Nordisk Clinical Trial Call Center	Irving	Texas
United States	Novo Nordisk Clinical Trial Call Center	Jacksonville	Florida
United States	Novo Nordisk Clinical Trial Call Center	Kingston	Pennsylvania
United States	Novo Nordisk Clinical Trial Call Center	La Jolla	California
United States	Novo Nordisk Clinical Trial Call Center	Lancaster	California
United States	Novo Nordisk Clinical Trial Call Center	Langhorne	Pennsylvania
United States	Novo Nordisk Clinical Trial Call Center	Las Vegas	Nevada
United States	Novo Nordisk Clinical Trial Call Center	Lexington	Kentucky
United States	Novo Nordisk Clinical Trial Call Center	Long Beach	California
United States	Novo Nordisk Clinical Trial Call Center	Lubbock	Texas
United States	Novo Nordisk Clinical Trial Call Center	Melbourne	Florida
United States	Novo Nordisk Clinical Trial Call Center	Melrose Park	Pennsylvania
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	Mission Hills	California
United States	Novo Nordisk Clinical Trial Call Center	Nashville	Tennessee
United States	Novo Nordisk Clinical Trial Call Center	National City	California
United States	Novo Nordisk Clinical Trial Call Center	New Port Richey	Florida
United States	Novo Nordisk Clinical Trial Call Center	Newberry	South Carolina
United States	Novo Nordisk Clinical Trial Call Center	North Dartmouth	Massachusetts
United States	Novo Nordisk Clinical Trial Call Center	North East	Maryland
United States	Novo Nordisk Clinical Trial Call Center	North Hollywood	California
United States	Novo Nordisk Clinical Trial Call Center	Northport	New York
United States	Novo Nordisk Clinical Trial Call Center	Northridge	California
United States	Novo Nordisk Clinical Trial Call Center	Norwalk	Connecticut
United States	Novo Nordisk Clinical Trial Call Center	Oklahoma City	Oklahoma
United States	Novo Nordisk Clinical Trial Call Center	Orange Park	Florida
United States	Novo Nordisk Clinical Trial Call Center	Paducah	Kentucky
United States	Novo Nordisk Clinical Trial Call Center	Palm Harbor	Florida
United States	Novo Nordisk Clinical Trial Call Center	Palm Springs	California
United States	Novo Nordisk Clinical Trial Call Center	Pittsburgh	Pennsylvania
United States	Novo Nordisk Clinical Trial Call Center	Reisterstown	Maryland
United States	Novo Nordisk Clinical Trial Call Center	Richmond	Virginia
United States	Novo Nordisk Clinical Trial Call Center	Rockville	Maryland
United States	Novo Nordisk Clinical Trial Call Center	San Antonio	Texas
United States	Novo Nordisk Clinical Trial Call Center	San Mateo	California
United States	Novo Nordisk Clinical Trial Call Center	Slidell	Louisiana
United States	Novo Nordisk Clinical Trial Call Center	Spokane	Washington
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	Staten Island	New York
United States	Novo Nordisk Clinical Trial Call Center	Sugar Land	Texas
United States	Novo Nordisk Clinical Trial Call Center	Tarzana	California
United States	Novo Nordisk Clinical Trial Call Center	Toledo	Ohio
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	West Palm Beach	Florida
United States	Novo Nordisk Clinical Trial Call Center	West Reading	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Canada,  Czech Republic,  Denmark,  Finland,  France,  Germany,  Norway,  Puerto Rico,  Serbia,  Spain, 

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 104 + 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 104 + 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 104 + 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 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	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	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 104	Mean of 9-point SMPG at 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.	Week 104	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