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)

Novo Nordisk A/S1 site in 1 country373 target enrollmentJune 2011

ConditionsDiabetes Diabetes Mellitus, Type 2

Interventionsinsulin degludec

Drugsinsulin degludec

Overview

Phase: Phase 3
Intervention: insulin degludec
Conditions: Diabetes
Sponsor: Novo Nordisk A/S
Enrollment: 373
Locations: 1
Primary Endpoint: Change in Glycosylated Haemoglobin (HbA1c)
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

June 2011

End Date

January 2012

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Novo Nordisk A/S

Responsible Party

Sponsor

Eligibility Criteria

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)

Arms & Interventions

IDeg 200 U/mL

Intervention: insulin degludec

IDeg 100 U/mL

Intervention: insulin degludec

Outcomes

Primary Outcomes

Change in Glycosylated Haemoglobin (HbA1c)

Time Frame: Week 0, Week 22

Change from baseline in HbA1c after 22 weeks of treatment

Secondary Outcomes

Change in Fasting Plasma Glucose (FPG)(Week 0, Week 22)
Rate of Treatment Emergent Adverse Events (AEs)(Week 0 to Week 22 + 7 days follow up)
Rate of Confirmed Hypoglycaemic Episodes(Week 0 to Week 22 + 7 days follow up)
Rate of Nocturnal Confirmed Hypoglycaemic Episodes(Week 0 to Week 22 + 7 days follow up)