Comparison of Two Insulin Degludec Formulations in Subjects With Type 2 Diabetes Mellitus

Diabetes Mellitus, Type 2 Clinical Trial

— BEGIN™  

Official title:

A Trial Comparing the Efficacy and Safety of Insulin Degludec 200 U/mL and Insulin Degludec 100 U/mL in Subjects With Type 2 Diabetes Mellitus (BEGIN™: COMPARE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01364428
• Other study ID #: NN1250-3923
• Secondary ID: U1111-1119-2518
• Status: Completed
• Phase: Phase 3
• First received: May 31, 2011
• Last updated: November 18, 2015
• Start date: June 2011
• Est. completion date: January 2012

Study information

• Verified date: November 2015
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This trial is conducted in the United States of America (USA). The aim of this trial is to compare the efficacy and safety of two different formulations of insulin degludec (IDeg) in subjects with type 2 diabetes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 373
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Type 2 diabetes (diagnosed clinically) for minimum 24 weeks prior to randomisation (visit 2)

• Current treatment with basal-only insulin (no prandial insulin) consisting of either insulin detemir once daily (OD), insulin glargine OD or neutral protamine hagedorn (NPH) insulin OD/twice daily (BID) for at least 12 weeks prior to randomisation (visit 2), in combination with stable doses of OAD(s) (metformin, insulin secretagogue (sulfonylurea or glinide), alpha-glucosidase inhibitor, pioglitazone or dipeptidyl peptidase IV (DPP-IV) inhibitor in any approved (according to label) dose or combination. Stable OAD doses are defined as unchanged doses for at least 12 weeks prior to randomisation (visit 2)

• HbA1c (glycosylated haemoglobin) between 7.0-10.0% (both inclusive) by central laboratory analysis

• Body mass index (BMI) below or equal to 45 kg/m^2

• Ability and willingness to adhere to the protocol including self-measured plasma glucose (SMPG) according to the protocol

Exclusion Criteria:

• Treatment with rosiglitazone within the last 12 weeks prior to randomisation (visit 2)

• Treatment with glucagon like peptide-1 (GLP-1) receptor agonists within the last 12 weeks prior to randomisation (visit 2)

• Recurrent severe hypoglycaemia (more than one severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the Investigator (trial physician)

• Previous participation in this trial. Participation is defined as randomised. Re-screening is allowed once during the recruitment period

• Known or suspected hypersensitivity to trial products or related products

• The receipt of any investigational drug within 4 weeks prior to randomisation (visit 2)

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, in combination with unchanged pre-trial oral anti-diabetic drug (OAD) treatment. Dose was individually adjusted.
• insulin degludec
Injected subcutaneously, (under the skin) once daily, in combination with unchanged pre-trial oral anti-diabetic drug (OAD) treatment. 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	Austin	Texas
United States	Novo Nordisk Clinical Trial Call Center	Bradenton	Florida
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	Chino	California
United States	Novo Nordisk Clinical Trial Call Center	Clearwater	Florida
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	Detroit	Michigan
United States	Novo Nordisk Clinical Trial Call Center	Evansville	Indiana
United States	Novo Nordisk Clinical Trial Call Center	Franklin	Ohio
United States	Novo Nordisk Clinical Trial Call Center	Goodyear	Arizona
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	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	Jefferson City	Missouri
United States	Novo Nordisk Clinical Trial Call Center	Kissimmee	Florida
United States	Novo Nordisk Clinical Trial Call Center	Lawrenceville	New Jersey
United States	Novo Nordisk Clinical Trial Call Center	Melrose Park	Pennsylvania
United States	Novo Nordisk Clinical Trial Call Center	Mesa	Arizona
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	Nashville	Tennessee
United States	Novo Nordisk Clinical Trial Call Center	National City	California
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	Palm Springs	California
United States	Novo Nordisk Clinical Trial Call Center	Phoenix	Arizona
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	San Antonio	Texas
United States	Novo Nordisk Clinical Trial Call Center	Slidell	Louisiana
United States	Novo Nordisk Clinical Trial Call Center	Springfield	Illinois
United States	Novo Nordisk Clinical Trial Call Center	Staten Island	New York
United States	Novo Nordisk Clinical Trial Call Center	Tampa	Florida
United States	Novo Nordisk Clinical Trial Call Center	Toms River	New Jersey
United States	Novo Nordisk Clinical Trial Call Center	Waltham	Massachusetts
United States	Novo Nordisk Clinical Trial Call Center	West Palm Beach	Florida
United States	Novo Nordisk Clinical Trial Call Center	West Seneca	New York

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Glycosylated Haemoglobin (HbA1c)	Change from baseline in HbA1c after 22 weeks of treatment	Week 0, Week 22	No
Secondary	Change in Fasting Plasma Glucose (FPG)	Change from baseline in FPG after 22 weeks of treatment.	Week 0, Week 22	No
Secondary	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 22 + 7 days follow up	No
Secondary	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 22 + 7 days follow up	No
Secondary	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 22 + 7 days follow up	No

External Links

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