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Comparison of Two Insulin Degludec Formulations in Subjects With Type 2 Diabetes Mellitus | Clinical Trials | Clareo Health

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

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)

NCT01364428•Novo Nordisk A/S

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

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)

Locations (45)

Novo Nordisk Investigational Site

Huntsville, Alabama, United States

Novo Nordisk Investigational Site

Goodyear, Arizona, United States

Novo Nordisk Investigational Site

Mesa, Arizona, United States

Novo Nordisk Investigational Site

Phoenix, Arizona, United States

Novo Nordisk Investigational Site

Concord, California, United States

Novo Nordisk Investigational Site

Greenbrae, California, United States

Novo Nordisk Investigational Site

Montclair, California, United States

Novo Nordisk Investigational Site

National City, California, United States

Novo Nordisk Investigational Site

Palm Springs, California, United States

Novo Nordisk Investigational Site

Bradenton, Florida, United States

Key Dates

Start Date

June 1, 2011

Primary Completion Date

January 1, 2012

Completion Date

January 1, 2012

Last Updated

March 6, 2017

Enrollment

373

ACTUAL participants

Conditions

DiabetesDiabetes Mellitus, Type 2

Interventions

insulin degludec

DRUG

insulin degludec

DRUG

Sponsors

Lead Sponsor

Novo Nordisk A/S

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 6, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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