Loading clinical trials...

A Trial Comparing the Efficacy, Patient-reported Outcomes and Safety of Insulin Degludec 200 U/mL vs Insulin Glargine in Subjects With Type 2 Diabetes Mellitus Requiring High-dose Insulin | Clinical Trials | Clareo Health

COMPLETEDPHASE3

A Trial Comparing the Efficacy, Patient-reported Outcomes and Safety of Insulin Degludec 200 U/mL vs Insulin Glargine in Subjects With Type 2 Diabetes Mellitus Requiring High-dose Insulin

NCT01570751•Novo Nordisk A/S

View on ClinicalTrials.gov

Summary

This trial is conducted in the United States of America (USA). The aim of the trial is to confirm the efficacy of IDeg (insulin degludec) versus IGlar (insulin glargine) in controlling glycaemia. Subjects are to continue their pre-trial metformin treatment.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Type 2 diabetes
•Current treatment with once daily insulin glargine in vials with a daily dose equal to or above 65 U and equal to or below 100 U
•Current treatment with a stable dose of metformin plus/minus one additional oral antidiabetic drug (OAD) for at least 12 weeks
•Glycosylated haemoglobin (HbA1c) equal to or above 7.5%

Exclusion Criteria

•Current treatment with insulin other than insulin glargine in vials
•Treatment with thiazolidinediones or glucagon-like peptide-1 (GLP-1) receptor agonists within 12 weeks
•Stroke; heart failure; myocardial infarction; unstable angina pectoris; coronary arterial bypass graft or angioplasty
•Suffer from cancer (except basal cell skin cancer and squamous-cell cancer)

Locations (46)

Novo Nordisk Investigational Site

Mesa, Arizona, United States

Novo Nordisk Investigational Site

Fresno, California, United States

Novo Nordisk Investigational Site

Greenbrae, California, United States

Novo Nordisk Investigational Site

San Ramon, California, United States

Novo Nordisk Investigational Site

Bradenton, Florida, United States

Novo Nordisk Investigational Site

Hialeah, Florida, United States

Novo Nordisk Investigational Site

Homestead, Florida, United States

Novo Nordisk Investigational Site

Jacksonville, Florida, United States

Novo Nordisk Investigational Site

Kissimmee, Florida, United States

Novo Nordisk Investigational Site

Miami, Florida, United States

Key Dates

Start Date

April 1, 2012

Primary Completion Date

January 1, 2014

Completion Date

January 1, 2014

Last Updated

March 7, 2017

Enrollment

145

ACTUAL participants

Conditions

DiabetesDiabetes Mellitus, Type 2

Interventions

insulin degludec

DRUG

insulin glargine

DRUG

Sponsors

Lead Sponsor

Novo Nordisk A/S

Related Studies

Genetic Studies of Insulin and Diabetes

NCT00001987

Diabetes MellitusSevere Insulin Resistance

Feasibility of a Tailored Online Self-compassion Intervention

NCT07051005

Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

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 7, 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.

View ClinicalTrials.gov Terms and Conditions