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Comparison of NN1250 With Insulin Glargine Plus Insulin Aspart With/Without Metformin and With/Without Pioglitazone in Type 2 Diabetes

NCT ID: NCT00972283

Last Updated: 2017-04-06

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1006 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-01

Study Completion Date

2010-10-28

Brief Summary

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

The aim of this clinical trial is to compare NN1250 (insulin degludec (IDeg)) with insulin glargine (IGlar) plus insulin aspart (IAsp) with/without metformin and with/without pioglitazone in subjects with type 2 diabetes (main period) followed by investigating the long-term safety in terms of comparing NN1250 with insulin glargine plus insulin aspart with or without metformin and with or without pioglitazone in subjects with type 2 diabetes.

All oral anti-diabetic drug (OAD) treatment will be discontinued, if applicable, when trial participant enters the trial (NN1250-3582) with the exception of metformin and pioglitazone.

Subjects who consent to participate in the extension trial (NN1250-3667) will continue to receive the treatment to which they were randomly allocated in the 52 week trial NN1250-3582.

The main period is registered internally at Novo Nordisk as NN1250-3582 while the extension period is registered as NN1250-3667.

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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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IDeg OD

Group Type EXPERIMENTAL

insulin degludec

Intervention Type DRUG

Injected subcutaneously (under the skin) with main evening meal. Dose was individually adjusted.

insulin aspart

Intervention Type DRUG

Injected subcutaneously (under the skin) at each main meal. Dose was individually adjusted.

IGlar OD

Group Type ACTIVE_COMPARATOR

insulin glargine

Intervention Type DRUG

Injected subcutanoeusly (under the skin) according to approved label. Dose was individually adjusted.

insulin aspart

Intervention Type DRUG

Injected subcutaneously (under the skin) at each main meal. Dose was individually adjusted.

Interventions

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insulin degludec

Injected subcutaneously (under the skin) with main evening meal. Dose was individually adjusted.

Intervention Type DRUG

insulin glargine

Injected subcutanoeusly (under the skin) according to approved label. Dose was individually adjusted.

Intervention Type DRUG

insulin aspart

Injected subcutaneously (under the skin) at each main meal. Dose was individually adjusted.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* For MAIN period (NN1250-3582):
* Type 2 diabetes mellitus for at least 6 months
* Ongoing daily treatment with insulin (premix, self-mix, basal only, basal bolus) for at least 3 months with/without oral anti-diabetics drug (OAD) prior to trial start
* HbA1c 7.0-10.0 % (both inclusive)
* Body Mass Index (BMI) below or equal to 40.0 kg/m\^2
* For EXTENSION period (NN1250-3667):
* Completion of the 52 week treatment period in NN1250-3582

Exclusion Criteria

* For MAIN period (NN1250-3582):
* Treatment with other insulin regimens than premix, self-mix, basal only, basal bolus within 3 months
* Cardiovascular disease within the last 6 months
* Uncontrolled treated/untreated severe hypertension
* Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures
* Cancer and medical history of 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

Alexander City, Alabama, United States

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Birmingham, Alabama, United States

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Goodyear, Arizona, United States

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Peoria, Arizona, United States

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Anaheim, California, United States

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Huntington Beach, California, United States

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Los Gatos, California, United States

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Salinas, California, United States

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Santa Monica, California, United States

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Spring Valley, California, United States

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Tustin, California, United States

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Walnut Creek, California, United States

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Milford, Connecticut, United States

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Norwalk, Connecticut, United States

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Waterbury, Connecticut, United States

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Washington D.C., District of Columbia, United States

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Gainesville, Florida, United States

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Jacksonville, Florida, United States

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Lake Mary, Florida, United States

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Orlando, Florida, United States

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Plantation, Florida, United States

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West Palm Beach, Florida, United States

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Atlanta, Georgia, United States

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Fort Valley, Georgia, United States

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Honolulu, Hawaii, United States

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Nampa, Idaho, United States

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Evansville, Indiana, United States

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Indianapolis, Indiana, United States

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New Albany, Indiana, United States

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Metairie, Louisiana, United States

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Metairie, Louisiana, United States

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Hyattsville, Maryland, United States

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North East, Maryland, United States

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Rockville, Maryland, United States

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Eagan, Minnesota, United States

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Jefferson City, Missouri, United States

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St Louis, Missouri, United States

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Lincoln, Nebraska, United States

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Omaha, Nebraska, United States

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Las Vegas, Nevada, United States

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Lawrenceville, New Jersey, United States

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Toms River, New Jersey, United States

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Charlotte, North Carolina, United States

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Greenville, North Carolina, United States

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Columbus, Ohio, United States

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Toledo, Ohio, United States

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Danville, Pennsylvania, United States

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Kingston, Pennsylvania, United States

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Melrose Park, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Wilkes-Barre, Pennsylvania, United States

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Charleston, South Carolina, United States

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Greer, South Carolina, United States

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Newberry, South Carolina, United States

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Chattanooga, Tennessee, United States

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Kingsport, 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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Fort Worth, Texas, United States

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Houston, Texas, United States

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Round Rock, Texas, United States

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Salt Lake City, Utah, United States

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Richmond, Virginia, United States

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Olympia, Washington, United States

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Renton, Washington, United States

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Dimitrovgrad, , Bulgaria

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Rousse, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Stara Zagora, , Bulgaria

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Varna, , Bulgaria

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Dresden, , Germany

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Dresden, , Germany

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Frankfurt, , Germany

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Hamburg, , Germany

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Ludwigshafen, , Germany

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Münster, , Germany

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Völklingen, , Germany

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Wangen, , Germany

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Warburg, , Germany

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Shatin, New Territories, , Hong Kong

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Dublin, , Ireland

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Dublin, , Ireland

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Dublin, , Ireland

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Dublin, , Ireland

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Bari, , Italy

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Bergamo, , Italy

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Catania, , Italy

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Chieti Scalo, , Italy

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Florence, , Italy

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Foggia, , Italy

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Gazi, , Italy

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Messina, , Italy

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Milan, , Italy

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Perugia, , Italy

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Pisa, , Italy

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Roma, , Italy

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Torino, , Italy

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Baia Mare, Maramureş, Romania

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Suceava, Suceava, Romania

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Bucharest, , Romania

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Constanța, , Romania

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Timișoara, , Romania

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Krasnoyarsk, , Russia

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Perm, , Russia

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Saint Petersburg, , Russia

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Yaroslavl, , Russia

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Bratislava, , Slovakia

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Bratislava, , Slovakia

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Lučenec, , Slovakia

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Pretoria, Gauteng, South Africa

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Durban, KwaZulu-Natal, South Africa

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Durban, KwaZulu-Natal, South Africa

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Bloemfontein, , South Africa

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A Coruña, , Spain

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Alcorcón, , Spain

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Almería, , Spain

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Barcelona, , Spain

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Granada, , Spain

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L'Hospitalet de Llobregat, , Spain

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Madrid, , Spain

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Mostoles - Madrid -, , Spain

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Sabadell, , Spain

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San Juan, , Spain

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Valencia, , Spain

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Antalya, , Turkey (Türkiye)

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Istanbul, , Turkey (Türkiye)

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Istanbul, , Turkey (Türkiye)

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Mersin, , Turkey (Türkiye)

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Countries

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United States Bulgaria Germany Hong Kong Ireland Italy Romania Russia Slovakia South Africa Spain Turkey (Türkiye)

References

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Ratner RE, Gough SC, Mathieu C, Del Prato S, Bode B, Mersebach H, Endahl L, Zinman B. Hypoglycaemia risk with insulin degludec compared with insulin glargine in type 2 and type 1 diabetes: a pre-planned meta-analysis of phase 3 trials. Diabetes Obes Metab. 2013 Feb;15(2):175-84. doi: 10.1111/dom.12032. Epub 2012 Dec 3.

Reference Type RESULT
PMID: 23130654 (View on PubMed)

Heller S, Mathieu C, Kapur R, Wolden ML, Zinman B. A meta-analysis of rate ratios for nocturnal confirmed hypoglycaemia with insulin degludec vs. insulin glargine using different definitions for hypoglycaemia. Diabet Med. 2016 Apr;33(4):478-87. doi: 10.1111/dme.13002. Epub 2015 Dec 13.

Reference Type RESULT
PMID: 26484727 (View on PubMed)

Sorli C, Warren M, Oyer D, Mersebach H, Johansen T, Gough SC. Elderly patients with diabetes experience a lower rate of nocturnal hypoglycaemia with insulin degludec than with insulin glargine: a meta-analysis of phase IIIa trials. Drugs Aging. 2013 Dec;30(12):1009-18. doi: 10.1007/s40266-013-0128-2.

Reference Type RESULT
PMID: 24170235 (View on PubMed)

Einhorn D, Handelsman Y, Bode BW, Endahl LA, Mersebach H, King AB. PATIENTS ACHIEVING GOOD GLYCEMIC CONTROL (HBA1c <7%) EXPERIENCE A LOWER RATE OF HYPOGLYCEMIA WITH INSULIN DEGLUDEC THAN WITH INSULIN GLARGINE: A META-ANALYSIS OF PHASE 3A TRIALS. Endocr Pract. 2015 Aug;21(8):917-26. doi: 10.4158/EP14523.OR. Epub 2015 Jun 29.

Reference Type RESULT
PMID: 26121451 (View on PubMed)

Russell-Jones D, Gall MA, Niemeyer M, Diamant M, Del Prato S. Insulin degludec results in lower rates of nocturnal hypoglycaemia and fasting plasma glucose vs. insulin glargine: A meta-analysis of seven clinical trials. Nutr Metab Cardiovasc Dis. 2015 Oct;25(10):898-905. doi: 10.1016/j.numecd.2015.06.005. Epub 2015 Jun 18.

Reference Type RESULT
PMID: 26232910 (View on PubMed)

Vora J, Christensen T, Rana A, Bain SC. Insulin degludec versus insulin glargine in type 1 and type 2 diabetes mellitus: a meta-analysis of endpoints in phase 3a trials. Diabetes Ther. 2014 Dec;5(2):435-46. doi: 10.1007/s13300-014-0076-9. Epub 2014 Aug 1.

Reference Type RESULT
PMID: 25081590 (View on PubMed)

Aye MM, Atkin SL. Patient safety and minimizing risk with insulin administration - role of insulin degludec. Drug Healthc Patient Saf. 2014 Apr 30;6:55-67. doi: 10.2147/DHPS.S59566. eCollection 2014.

Reference Type RESULT
PMID: 24812526 (View on PubMed)

Garber AJ, King AB, Del Prato S, Sreenan S, Balci MK, Munoz-Torres M, Rosenstock J, Endahl LA, Francisco AM, Hollander P; NN1250-3582 (BEGIN BB T2D) Trial Investigators. Insulin degludec, an ultra-longacting basal insulin, versus insulin glargine in basal-bolus treatment with mealtime insulin aspart in type 2 diabetes (BEGIN Basal-Bolus Type 2): a phase 3, randomised, open-label, treat-to-target non-inferiority trial. Lancet. 2012 Apr 21;379(9825):1498-507. doi: 10.1016/S0140-6736(12)60205-0.

Reference Type RESULT
PMID: 22521072 (View on PubMed)

Hollander P, King AB, Del Prato S, Sreenan S, Balci MK, Munoz-Torres M, Rosenstock J, Hansen CT, Niemeyer M, Garber AJ. Insulin degludec improves long-term glycaemic control similarly to insulin glargine but with fewer hypoglycaemic episodes in patients with advanced type 2 diabetes on basal-bolus insulin therapy. Diabetes Obes Metab. 2015 Feb;17(2):202-6. doi: 10.1111/dom.12411. Epub 2014 Nov 27.

Reference Type RESULT
PMID: 25387855 (View on PubMed)

Freemantle N, Mamdani M, Vilsboll T, Kongso JH, Kvist K, Bain SC. IDegLira Versus Alternative Intensification Strategies in Patients with Type 2 Diabetes Inadequately Controlled on Basal Insulin Therapy. Diabetes Ther. 2015 Dec;6(4):573-591. doi: 10.1007/s13300-015-0142-y. Epub 2015 Nov 18.

Reference Type RESULT
PMID: 26582052 (View on PubMed)

Evans M, Chubb B, Gundgaard J. Cost-effectiveness of Insulin Degludec Versus Insulin Glargine in Adults with Type 1 and Type 2 Diabetes Mellitus. Diabetes Ther. 2017 Apr;8(2):275-291. doi: 10.1007/s13300-017-0236-9. Epub 2017 Feb 16.

Reference Type RESULT
PMID: 28210866 (View on PubMed)

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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2008-005777-35

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1111-8648

Identifier Type: OTHER

Identifier Source: secondary_id

2009-015816-17

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1114-9067

Identifier Type: OTHER

Identifier Source: secondary_id

NN1250-3582

Identifier Type: -

Identifier Source: org_study_id

NCT01193322

Identifier Type: -

Identifier Source: nct_alias

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