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Effect of Insulin Detemir and Insulin Glargine on Blood Glucose Control in Subjects With Type 2 Diabetes

NCT ID: NCT00909480

Last Updated: 2017-03-10

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

457 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2010-06-30

Brief Summary

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This trial is conducted in Asia, South America and the United States of America (USA).

The aim of this clinical trial is to determine whether two insulin treatments given once daily are equally effective with respect to the blood glucose lowering effect in subjects with type 2 diabetes inadequately controlled on metformin treatment with or without an additional anti-diabetic drug (OAD).

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Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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IDet

Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day

Group Type EXPERIMENTAL

insulin detemir

Intervention Type DRUG

Treat-to-target (individually adjusted dose) titration according to titration algorithm.

S.c. (under the skin) injection once daily as an add-on to subjects' stable pre-trial metformin dose (at least 1500 mg/day). Any other use of OAD will be discontinued

IGlar

Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day

Group Type ACTIVE_COMPARATOR

insulin glargine

Intervention Type DRUG

Treat-to-target (individually adjusted dose) titration according to titration algorithm.

S.c. (under the skin) injection once daily as an add-on to subjects' stable pre-trial metformin dose (at least 1500 mg/day). Any other use of OAD will be discontinued

Interventions

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insulin detemir

Treat-to-target (individually adjusted dose) titration according to titration algorithm.

S.c. (under the skin) injection once daily as an add-on to subjects' stable pre-trial metformin dose (at least 1500 mg/day). Any other use of OAD will be discontinued

Intervention Type DRUG

insulin glargine

Treat-to-target (individually adjusted dose) titration according to titration algorithm.

S.c. (under the skin) injection once daily as an add-on to subjects' stable pre-trial metformin dose (at least 1500 mg/day). Any other use of OAD will be discontinued

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with type 2 diabetes for at least 6 months
* Stable treatment with a total daily dose of at least 1500 mg metformin or maximum tolerated dose (minimum 1000 mg) with or without one other OAD (sulphonylureas, meglitinides, thiazolidinediones or dipeptidyl peptidase-4 (DPP-4) inhibitors) for at least 3 months
* Subject is insulin-naive (short-term insulin treatment of up to 14 days is allowed)
* HbA1c (glycosylated haemoglobin) 7.0-9.0 % (both inclusive) by central laboratory analysis (one re-test within one week is allowed)
* Body Mass Index (BMI) less than or equal to 35.0 kg/m\^2

Exclusion Criteria

* Any contraindication to insulin detemir or insulin glargine according to the local labelling
* Receipt of any investigational product within 4 weeks
* Anticipated change of dose of any systemic treatment with products, which in the Investigator's opinion could interfere with glucose metabolism (e.g. systemic corticosteroids)
* Clinically significant diseases which, in the Investigator's opinion may confound the results of the trial or pose additional risk in administering trial product
* Any other condition that the Investigator feels would interfere with trial participation or evaluation of results
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Litchfield Park, Arizona, United States

Site Status

Novo Nordisk Investigational Site

Searcy, Arkansas, United States

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Anaheim, California, United States

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Concord, California, United States

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Escondido, California, United States

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Fresno, California, United States

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Long Beach, California, United States

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Los Angeles, California, United States

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Redlands, California, United States

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Santa Ana, California, United States

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Spring Valley, California, United States

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Aurora, Colorado, United States

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Norwalk, Connecticut, United States

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Hollywood, Florida, United States

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Jacksonville, Florida, United States

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Jacksonville, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Ocala, Florida, United States

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Orlando, Florida, United States

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Plantation, Florida, United States

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Ponte Vedra, Florida, United States

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Winter Haven, Florida, United States

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Powder Springs, Georgia, United States

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Roswell, Georgia, United States

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Idaho Falls, Idaho, United States

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Independence, Kansas, United States

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Shawnee Mission, Kansas, United States

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Portland, Maine, United States

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Rockville, Maryland, United States

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Waltham, Massachusetts, United States

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Buckley, Michigan, United States

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Chesterfield, Missouri, United States

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Jefferson City, Missouri, United States

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St Louis, Missouri, United States

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Butte, Montana, United States

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Clilfton, New Jersey, United States

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Northport, New York, United States

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Staten Island, New York, United States

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Syracuse, New York, United States

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Charlotte, North Carolina, United States

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Greensboro, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Cayahoga Falls, Ohio, United States

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Cincinnati, Ohio, United States

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Dayton, Ohio, United States

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Gallipolis, Ohio, United States

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Tulsa, Oklahoma, United States

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Altoona, Pennsylvania, United States

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Clarion, Pennsylvania, United States

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Lancaster, Pennsylvania, United States

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Norristown, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Greer, South Carolina, United States

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Spartanburg, South Carolina, United States

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Taylors, South Carolina, United States

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Chattanooga, Tennessee, United States

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Chattanooga, Tennessee, United States

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Corpus Christi, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Hurst, Texas, United States

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Odessa, Texas, United States

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San Antonio, Texas, United States

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St. George, Utah, United States

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Virginia Beach, Virginia, United States

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Renton, Washington, United States

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Martinsburg, West Virginia, United States

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Milwaukee, Wisconsin, United States

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Buenos Aires, , Argentina

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Capital Federal, , Argentina

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Capital Federal, , Argentina

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Mar del Plata, , Argentina

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Bangalore, Karnataka, India

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Chennai, Tamil Nadu, India

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Thriruvananthapuram, , India

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Manatí, , Puerto Rico

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Novo Nordisk Investigational Site

Trujillo Alto, , Puerto Rico

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Seoul, , South Korea

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Novo Nordisk Investigational Site

Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Novo Nordisk Investigational Site

Bangkok, , Thailand

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Bangkok, , Thailand

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Bangkok, , Thailand

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Novo Nordisk Investigational Site

Pathum Thani, , Thailand

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Countries

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United States Argentina India Puerto Rico South Korea Thailand

References

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Meneghini L, Kesavadev J, Demissie M, Nazeri A, Hollander P. Once-daily initiation of basal insulin as add-on to metformin: a 26-week, randomized, treat-to-target trial comparing insulin detemir with insulin glargine in patients with type 2 diabetes. Diabetes Obes Metab. 2013 Aug;15(8):729-36. doi: 10.1111/dom.12083. Epub 2013 Mar 13.

Reference Type RESULT
PMID: 23421331 (View on PubMed)

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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NN304-1768

Identifier Type: -

Identifier Source: org_study_id

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