Comparison of NN1250 With Sitagliptin in Subjects With Type 2 Diabetes Never Treated With Insulin

NCT ID: NCT01046110

Last Updated: 2017-03-03

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

458 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-11-30

Brief Summary

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This trial will be conducted in Africa, Asia, North America and South America. The aim of this clinical trial is to compare NN1250 (insulin degludec) with sitagliptin, as add-on to subject's own current oral antidiabetic (OAD) treatment, in subjects with type 2 diabetes inadequately controlled with 1-2 OADs (metformin, sulphonylurea, glinides or pioglitazone).

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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IDeg OD

Group Type EXPERIMENTAL

insulin degludec

Intervention Type DRUG

Injected under the skin once daily for 26 weeks. The doses will be individually adjusted.

DPP-IV inhibitor

Group Type EXPERIMENTAL

sitagliptin

Intervention Type DRUG

Sitagliptin tablets administered orally once a day at the same time every day for 26 weeks

Interventions

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insulin degludec

Injected under the skin once daily for 26 weeks. The doses will be individually adjusted.

Intervention Type DRUG

sitagliptin

Sitagliptin tablets administered orally once a day at the same time every day for 26 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Type 2 diabetes (diagnosed clinically) for at least 6 months
* Ongoing treatment with 1 or 2 of the following OADs (metformin, insulin secretagogue (sulphonylurea or glinides) or pioglitazone) in any combination with unchanged dosing for at least 3 months prior to Visit 1 with the minimum doses stated: -Metformin: alone or in combination (including fixed combination)1500 mg or maximum tolerated dose (at least 1000 mg daily) -Insulin secretagogue (sulfonylurea or glinide): minimum half of the maximal daily dose according to local labelling -Pioglitazone: minimum half of the maximal daily dose according to local labelling or maximum tolerated dose
* Body Mass Index (BMI) below or equal to 40.0 kg/m\^2
* HbA1c 7.5-11.0 % (both inclusive) by central laboratory analysis

Exclusion Criteria

* Use within the last 3 months prior to Visit 1 of: exenatide, liraglutide, rosiglitazone or acarbose
* Cardiovascular disease, within the last 6 months prior to Visit 1, defined as: stroke; decompensated heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
* Uncontrolled treated/untreated severe hypertension (systolic blood pressure at least 180 millimetre (mm) mercury (Hg) and/or diastolic blood pressure at least 100 mmHg)
* Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the Investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months
* Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate
* Cancer and medical history hereof (except basal cell skin cancer or squamous cell skin cancer)
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

Huntsville, Alabama, United States

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Concord, California, United States

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Fresno, California, United States

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Greenbrae, California, United States

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La Jolla, California, United States

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Long Beach, California, United States

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Mission Hills, California, United States

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Palm Springs, California, United States

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Torrance, California, United States

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Walnut Creek, California, United States

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Denver, Colorado, United States

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Clearwater, Florida, United States

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Inverness, Florida, United States

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Kissimmee, Florida, United States

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Miami, 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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Ponte Vedra, Florida, United States

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Tampa, Florida, United States

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Columbus, Georgia, United States

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Decatur, Georgia, United States

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Dunwoody, Georgia, United States

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Roswell, Georgia, United States

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Chicago, Illinois, United States

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Chicago, Illinois, United States

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Springfield, Illinois, United States

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Huntington, Indiana, United States

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Council Bluffs, Iowa, United States

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Des Moines, Iowa, United States

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Paducah, Kentucky, United States

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Metairie, Louisiana, United States

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Brockton, Massachusetts, United States

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Livonia, Michigan, United States

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Troy, Michigan, United States

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Saint Paul, Minnesota, United States

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Jackson, Mississippi, United States

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Albuquerque, New Mexico, United States

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Albuquerque, New Mexico, United States

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New Hyde Park, New York, United States

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West Seneca, New York, United States

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Durham, North Carolina, United States

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Greenville, North Carolina, United States

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Oklahoma City, Oklahoma, United States

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Pittsburgh, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Charleston, South Carolina, United States

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Murrells Inlet, South Carolina, United States

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Corpus Christi, Texas, United States

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El Paso, Texas, United States

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El Paso, Texas, United States

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Houston, Texas, United States

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Sugar Land, Texas, United States

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Tomball, Texas, United States

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Salt Lake City, Utah, United States

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Virginia Beach, Virginia, United States

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Spokane, Washington, United States

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Buenos Aires, , Argentina

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Caba, , Argentina

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Ciudad Autónoma de BsAs, , Argentina

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Córdoba, , Argentina

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Mar del Plata, , Argentina

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Mendoza, , Argentina

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Surrey, British Columbia, Canada

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Cambridge, Ontario, Canada

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Chatham, Ontario, Canada

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London, Ontario, Canada

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London, Ontario, Canada

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Smiths Falls, Ontario, Canada

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St. Catharines, Ontario, Canada

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Gatineau, Quebec, Canada

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Laval, Quebec, Canada

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Montreal, Quebec, Canada

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Saint-Marc-des-Carrieres, Quebec, Canada

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Hyderabad, Andhra Pradesh, India

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Bangalore, Karnataka, India

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Bangalore, Karnataka, India

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Mumbai, Maharashtra, India

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Chennai, Tamil Nadu, India

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Madurai, Tamil Nadu, India

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Nagpur, , India

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Pune, , India

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Pune, , India

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Guadalajara, , Mexico

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Mexico City, , Mexico

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Durban, KwaZulu-Natal, South Africa

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Cape Town, Western Cape, South Africa

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Umhlanga, , South Africa

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Ankara, , Turkey (Türkiye)

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Denizli, , Turkey (Türkiye)

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Istanbul, , Turkey (Türkiye)

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Istanbul, , Turkey (Türkiye)

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Izmir, , Turkey (Türkiye)

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Countries

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United States Argentina Canada India Mexico South Africa Turkey (Türkiye)

References

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Philis-Tsimikas A, Del Prato S, Satman I, Bhargava A, Dharmalingam M, Skjoth TV, Rasmussen S, Garber AJ. Effect of insulin degludec versus sitagliptin in patients with type 2 diabetes uncontrolled on oral antidiabetic agents. Diabetes Obes Metab. 2013 Aug;15(8):760-6. doi: 10.1111/dom.12115. Epub 2013 May 6.

Reference Type RESULT
PMID: 23577643 (View on PubMed)

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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U1111-1111-7126

Identifier Type: OTHER

Identifier Source: secondary_id

NN1250-3580

Identifier Type: -

Identifier Source: org_study_id

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