DiabetesPhase 3BEGIN™NCT01068665

Comparison of NN1250 With Insulin Glargine in Subjects With Type 2 Diabetes

A Phase 3 study testing insulin degludec and insulin glargine in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 116 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This trial is conducted in South Africa, Europe and North America. The aim of this trial is to compare efficacy and safety of NN1250 (insulin degludec (IDeg)) with insulin glargine (IGlar), as add-on to subject's ongoing treatment with metformin and/or dipeptyl peptidase 4 (DPP-4) inhibitors, in patients with type 2… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetes, Diabetes Mellitus, Type 2
What is being tested?: insulin degludec and insulin glargine
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 460 participants
Where: 116 sitesin 8 countries
Study dates: Mar 2010to Nov 2010
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Insulin naïve subject (allowed are: previous short term insulin treatment up to 14 days; Treatment during hospitalisation or during gestational diabetes is allowed for periods longer than 14 days)
Current treatment: metformin monotherapy or metformin in any combination with an insulin secretagogue (sulfonylurea or glinide), DPP-4 inhibitor, alpha-glucosidase-inhibitors (acarbose) 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 daily, or maximum tolerated dose (at least 1000 mg daily) -Insulin secretagogue (sulfonylurea or glinide): minimum half of the daily maximal dose according to local labelling -DPP-4 inhibitor: minimum half of the daily maximal dose according to local labelling - alpha-glucosidase-inhibitors (acarbose): minimum half of the daily maximal dose or maximum tolerated dose
HbA1c 7.0-10.0 % (both inclusive) by central laboratory analysis
Body Mass Index (BMI) maximum 45.0 kg/m^2
Type 2 diabetes (diagnosed clinically) for at least 6 months
Ability and willingness to adhere to the protocol including performance of self monitored plasma glucose (SMPG) profiles according to the protocol

Who cannot join

Use within the last 3 months prior to Visit 1 of: thiazoledinediones (TZDs), exenatide or liraglutide
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)
Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements [for UK: adequate contraceptive measures are defined as established use of oral, injected or implanted hormonal methods of contraception, sterilisation, intrauterine device or intrauterine system, or consistent use of barrier methods]
Cancer and medical history of cancer hereof (except basal cell skin cancer or squamous cell skin cancer)

Trial locations and contacts

116 sites in 8 countries.

Country

City, postcode or hospital

116 sites in 8 countries

United States62 sites

Novo Nordisk Investigational Site
Anaheim, California, 92801
Novo Nordisk Investigational Site
Asheboro, North Carolina, 27203
Novo Nordisk Investigational Site
Aurora, Colorado, 80045-7402
Novo Nordisk Investigational Site
Beaver, Pennsylvania, 15009
Novo Nordisk Investigational Site
Billings, Montana, 59102
Novo Nordisk Investigational Site
Biloxi, Mississippi, 39531-4535
Novo Nordisk Investigational Site
Brick, New Jersey, 08724
Novo Nordisk Investigational Site
Brockton, Massachusetts, 02301
Novo Nordisk Investigational Site
Brooklyn, New York, 11203-2711
Novo Nordisk Investigational Site
Chapel Hill, North Carolina, 27517
Novo Nordisk Investigational Site
Charlotte, North Carolina, 28277
Novo Nordisk Investigational Site
Chicago, Illinois, 60611
Novo Nordisk Investigational Site
Chicago, Illinois, 60616
Novo Nordisk Investigational Site
Crystal Lake, Illinois, 60012
Novo Nordisk Investigational Site
Decatur, Georgia, 30033
Novo Nordisk Investigational Site
Des Moines, Iowa, 50314-2610
Novo Nordisk Investigational Site
DeSoto, Texas, 75115
Novo Nordisk Investigational Site
El Paso, Texas, 79912
Novo Nordisk Investigational Site
Evansville, Indiana, 47714
Novo Nordisk Investigational Site
Franklin, Ohio, 45005
Novo Nordisk Investigational Site
Gilbert, Arizona, 85295
Novo Nordisk Investigational Site
Greenbelt, Maryland, 20770
Novo Nordisk Investigational Site
Greenfield, Indiana, 46140
Novo Nordisk Investigational Site
Greensboro, North Carolina, 27408
Novo Nordisk Investigational Site
Hollywood, Florida, 33021
Novo Nordisk Investigational Site
Huntington Beach, California, 92648
Novo Nordisk Investigational Site
Huntsville, Alabama, 35801
Novo Nordisk Investigational Site
Jacksonville, Florida, 32209-6511
Novo Nordisk Investigational Site
Killeen, Texas, 76543
Novo Nordisk Investigational Site
Lawrenceville, Georgia, 30046
Novo Nordisk Investigational Site
Longwood, Florida, 32779
Novo Nordisk Investigational Site
Madisonville, Kentucky, 42431
Novo Nordisk Investigational Site
Melrose Park, Pennsylvania, 19027
Novo Nordisk Investigational Site
Milwaukee, Wisconsin, 53209
Novo Nordisk Investigational Site
Mine Hill, New Jersey, 07803
Novo Nordisk Investigational Site
Minneapolis, Minnesota, 55416
Novo Nordisk Investigational Site
Mission Hills, California, 91345
Novo Nordisk Investigational Site
Montclair, California, 91763
Novo Nordisk Investigational Site
National City, California, 91950
Novo Nordisk Investigational Site
New York, New York, 10025
Novo Nordisk Investigational Site
Norco, California, 92860
Novo Nordisk Investigational Site
Norristown, Pennsylvania, 19401
Novo Nordisk Investigational Site
Ocala, Florida, 34471
Novo Nordisk Investigational Site
Peak, South Carolina, 29122
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, 19107
Novo Nordisk Investigational Site
Phoenix, Arizona, 85018
Novo Nordisk Investigational Site
Plano, Texas, 75093
Novo Nordisk Investigational Site
Ponte Vedra, Florida, 32081
Novo Nordisk Investigational Site
Renton, Washington, 98057
Novo Nordisk Investigational Site
Roswell, Georgia, 30076
Novo Nordisk Investigational Site
San Diego, California, 92111
Novo Nordisk Investigational Site
Slidell, Louisiana, 70461-4231
Novo Nordisk Investigational Site
Southfield, Michigan, 48034
Novo Nordisk Investigational Site
Southfield, Michigan, 48075
Novo Nordisk Investigational Site
St Louis, Missouri, 63104
Novo Nordisk Investigational Site
St. George, Utah, 84790
Novo Nordisk Investigational Site
Sugar Land, Texas, 77479
Novo Nordisk Investigational Site
Troy, Michigan, 48098
Novo Nordisk Investigational Site
Tucson, Arizona, 85741
Novo Nordisk Investigational Site
Valencia, California, 91355
Novo Nordisk Investigational Site
Vero Beach, Florida, 32960
Novo Nordisk Investigational Site
Walnut Creek, California, 94598

Other trials in United States

United Kingdom21 sites

Novo Nordisk Investigational Site
Abergavenny, NP7 7EG
Novo Nordisk Investigational Site
Ashton-under-Lyne, OL6 9RW
Novo Nordisk Investigational Site
Atherstone, CV9 1EU
Novo Nordisk Investigational Site
Ayr, KA6 6DX
Novo Nordisk Investigational Site
Bath, BA2 1NH
Novo Nordisk Investigational Site
Bolton, BL3 6TL
Novo Nordisk Investigational Site
Chester, CH2 1UL
Novo Nordisk Investigational Site
Chorley, PR7 1PP
Novo Nordisk Investigational Site
Coventry, CV2 2DX
Novo Nordisk Investigational Site
Epworth, DN9 1EP
Novo Nordisk Investigational Site
Harrogate, HG1 5JP
Novo Nordisk Investigational Site
Letchworth Garden City, SG6 4UB
Novo Nordisk Investigational Site
Livingstone, EH54 6PP
Novo Nordisk Investigational Site
Llantrisant, CF72 8XR
Novo Nordisk Investigational Site
Maidstone, ME16 9QQ
Novo Nordisk Investigational Site
Oldham, OL1 2JH
Novo Nordisk Investigational Site
Rugby, CV22 5PX
Novo Nordisk Investigational Site
Salford, M6 8HD
Novo Nordisk Investigational Site
Trowbridge, BA14 8QA
Novo Nordisk Investigational Site
Whitby, YO21 1SD
Novo Nordisk Investigational Site
Wrexham, LL13 7TD

Other trials in United Kingdom

Canada11 sites

Novo Nordisk Investigational Site
Calgary, Alberta, T2H 2G4
Novo Nordisk Investigational Site
Cambridge, Ontario, N1R 7L6
Novo Nordisk Investigational Site
Cornwall, Ontario, K6H 4M4
Novo Nordisk Investigational Site
Edmonton, Alberta, T5J 3N4
Novo Nordisk Investigational Site
Greater Sudbury, Ontario, P3C 5K7
Novo Nordisk Investigational Site
Hamilton, Ontario, L8L 5G8
Novo Nordisk Investigational Site
Hamilton, Ontario, L8M 1K7
Novo Nordisk Investigational Site
Hamilton, Ontario, L8N 3Z5
Novo Nordisk Investigational Site
Langley, British Columbia, V3A 4H9
Novo Nordisk Investigational Site
Mississauga, Ontario, L5B 4A2
Novo Nordisk Investigational Site
Saint Romuald, Quebec, G6W 5M6

Other trials in Canada

France7 sites

Novo Nordisk Investigational Site
Antibes, 06600
Novo Nordisk Investigational Site
Besançon, 25030
Novo Nordisk Investigational Site
Narbonne, 11108
Novo Nordisk Investigational Site
Pointe à Pitre, 97159
Novo Nordisk Investigational Site
Rennes, 35056
Novo Nordisk Investigational Site
Sète, 34200
Novo Nordisk Investigational Site
Vénissieux, 69200

Other trials in France

Russia7 sites

Novo Nordisk Investigational Site
Kemerovo, 650099
Novo Nordisk Investigational Site
Krasnoyarsk, 660062
Novo Nordisk Investigational Site
Moscow, 117036
Novo Nordisk Investigational Site
Moscow, 121356
Novo Nordisk Investigational Site
Saint Petersburg, 199034
Novo Nordisk Investigational Site
Voronezh, 394018
Novo Nordisk Investigational Site
Yekaterinburg, 620102

Other trials in Russia

South Africa4 sites

Novo Nordisk Investigational Site
Alberton, 1449
Novo Nordisk Investigational Site
Durban, KwaZulu-Natal, 4000
Novo Nordisk Investigational Site
East London, Eastern Cape, 5201
Novo Nordisk Investigational Site
Port Elizabeth, Eastern Cape, 6045

Other trials in South Africa

Ireland3 sites

Novo Nordisk Investigational Site
Dublin, DUBLIN 15
Novo Nordisk Investigational Site
Dublin, DUBLIN 7
Novo Nordisk Investigational Site
Dublin, DUBLIN 8

Other trials in Ireland

Ukraine1 site

Novo Nordisk Investigational Site
Kiev, 04114

Other trials in Ukraine

About this study

Official title: A Trial Comparing Efficacy and Safety of NN1250 and Insulin Glargine in Subjects With Type 2 Diabetes (BEGIN™: LOW VOLUME)

Conditions: Diabetes, Diabetes Mellitus, Type 2
Being tested: insulin degludec, insulin glargine
Medical subject headings: Diabetes Mellitus, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

insulin degludecDrug
Injected subcutaneously (under the skin) once daily. Dose was individually adjusted.
insulin glargineDrug
Injected subcutaneously (under the skin) once daily. Dose was individually adjusted.

Study groups in NCT01068665
Study group	Role	What they receive
IDeg 200 U/mL OD	Experimental	Not described Receives: Drug: insulin degludec
IGlar OD	Active comparator	Not described Receives: Drug: insulin glargine

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Glycosylated Haemoglobin (HbA1c)
Change from baseline in HbA1c after 26 weeks of treatment
Measured: Week 0, Week 26

Secondary outcomes (1)

Change in Fasting Plasma Glucose (FPG)
Change from baseline in FPG after 26 weeks of treatment
Measured: Week 0, Week 26

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2010Nov 2010

First posted15 Feb 2010 (estimated)
Study startMar 2010
Primary completionNov 2010
Study completionNov 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (10)Papers the sponsor has linked to this study.
Other trials for DiabetesStudies of the same condition, open and under way.
More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 460 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01068665
Sponsor's protocol ID: NN1250-3672
Other IDs: 2009-010662-28, U1111-1112-8977, 2009
Acronym: BEGIN™
Status last verified: Jan 2017
First submitted: 12 Feb 2010
Last updated: 6 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Weatherall J, Bloudek L, Buchs S. Budget impact of treating commercially insured type 1 and type 2 diabetes patients in the United States with insulin degludec compared to insulin glargine. Curr Med Res Opin. 2017 Feb;33(2):231-238. doi: 10.1080/03007995.2016.1251893. Epub 2016 Nov 18.
PubMed 27764979
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.
PubMed 23130654
Gough SC, Bhargava A, Jain R, Mersebach H, Rasmussen S, Bergenstal RM. Low-volume insulin degludec 200 units/ml once daily improves glycemic control similarly to insulin glargine with a low risk of hypoglycemia in insulin-naive patients with type 2 diabetes: a 26-week, randomized, controlled, multinational, treat-to-target trial: the BEGIN LOW VOLUME trial. Diabetes Care. 2013 Sep;36(9):2536-42. doi: 10.2337/dc12-2329. Epub 2013 May 28.
PubMed 23715753
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.
PubMed 26484727
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.
PubMed 25081590
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.
PubMed 24812526
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.
PubMed 24170235
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.
PubMed 26121451
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.
PubMed 26232910
Vora J, Seufert J, Solberg H, Kinduryte O, Johansen T, Hollander P. Insulin degludec does not increase antibody formation versus insulin glargine: an evaluation of phase IIIa trials. Diabetes Obes Metab. 2016 Jul;18(7):716-20. doi: 10.1111/dom.12621. Epub 2016 Feb 8.
PubMed 26663320

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 6 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Trial Comparing Efficacy and Safety of NN1250 and Insulin Glargine in Subjects With Type 2 Diabetes (BEGIN™: LOW VOLUME)
ClinicalTrials.gov ID: NCT01068665
Acronym / sponsor ID: BEGIN™ / NN1250-3672
Conditions: Diabetes, Diabetes Mellitus, Type 2
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 460 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: Mar 2010
Primary completion: Nov 2010 (actual)
Study completion: Nov 2010 (actual)
First posted: 15 Feb 2010 (estimated)
Results: Posted 13 Nov 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
IDeg 200 U/mL OD	Experimental	Drug: insulin degludec
IGlar OD	Active comparator	Drug: insulin glargine

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Insulin naïve subject (allowed are: previous short term insulin treatment up to 14 days; Treatment during hospitalisation or during gestational diabetes is allowed for periods longer than 14 days)
Current treatment: metformin monotherapy or metformin in any combination with an insulin secretagogue (sulfonylurea or glinide), DPP-4 inhibitor, alpha-glucosidase-inhibitors (acarbose) 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 daily, or maximum tolerated dose (at least 1000 mg daily) -Insulin secretagogue (sulfonylurea or glinide): minimum half of the daily maximal dose according to local labelling -DPP-4 inhibitor: minimum half of the daily maximal dose according to local labelling - alpha-glucosidase-inhibitors (acarbose): minimum half of the daily maximal dose or maximum tolerated dose
HbA1c 7.0-10.0 % (both inclusive) by central laboratory analysis
Body Mass Index (BMI) maximum 45.0 kg/m^2
Type 2 diabetes (diagnosed clinically) for at least 6 months

Key exclusion criteria (5 listed)

Use within the last 3 months prior to Visit 1 of: thiazoledinediones (TZDs), exenatide or liraglutide
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)
Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements [for UK: adequate contraceptive measures are defined as established use of oral, injected or implanted hormonal methods of contraception, sterilisation, intrauterine device or intrauterine system, or consistent use of barrier methods]
Cancer and medical history of cancer hereof (except basal cell skin cancer or squamous cell skin cancer)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
insulin degludecInjected subcutaneously (under the skin) once daily. Dose was individually adjusted.	Drug	IDeg 200 U/mL OD
insulin glargineInjected subcutaneously (under the skin) once daily. Dose was individually adjusted.	Drug	IGlar OD

Primary outcome

Change in Glycosylated Haemoglobin (HbA1c)
Time frame: Week 0, Week 26
Change from baseline in HbA1c after 26 weeks of treatment

1 secondary outcome

Change in Fasting Plasma Glucose (FPG)
Time frame: Week 0, Week 26

Results and safety

Results posted to the registry on 13 Nov 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
IDeg 200 U/mL OD	230	200
IGlar OD	230	201

Primary outcome: Change in Glycosylated Haemoglobin (HbA1c)

Time frame: Week 0, Week 26. Mean (Standard Deviation). Unit: percentage of glycosylated haemoglobin

Measure	IDeg 200 U/mL OD n = 228	IGlar OD n = 229
Value	-1.30 (1.04)	-1.32 (0.98)

Population analysed: Full analysis set (FAS) includes all randomised subjects and missing data was imputed using last observation carried forward (LOCF). 2 subjects were withdrawn prior to exposure to the study drug in the IDeg arm as they were randomised in error and 1 subject in the IGlar arm.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: The adverse events were collected in a time frame of 26 weeks + 7 days follow up. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
IDeg 200 U/mL OD	15 of 228 (6.6%)	51 of 228 (22.4%)	Not reported
IGlar OD	10 of 228 (4.4%)	60 of 228 (26.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 27764979Weatherall J, Bloudek L, Buchs S. Budget impact of treating commercially insured type 1 and type 2 diabetes patients in the United States with insulin degludec compared to insulin glargine. Curr Med Res Opin. 2017 Feb;33(2):231-238. doi: 10.1080/03007995.2016.1251893. Epub 2016 Nov 18.
Results publication: PubMed 23130654Ratner 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.
Results publication: PubMed 23715753Gough SC, Bhargava A, Jain R, Mersebach H, Rasmussen S, Bergenstal RM. Low-volume insulin degludec 200 units/ml once daily improves glycemic control similarly to insulin glargine with a low risk of hypoglycemia in insulin-naive patients with type 2 diabetes: a 26-week, randomized, controlled, multinational, treat-to-target trial: the BEGIN LOW VOLUME trial. Diabetes Care. 2013 Sep;36(9):2536-42. doi: 10.2337/dc12-2329. Epub 2013 May 28.
Results publication: PubMed 26484727Heller 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.
Results publication: PubMed 25081590Vora 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.
Results publication: PubMed 24812526Aye 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.
Results publication: PubMed 24170235Sorli 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.
Results publication: PubMed 26121451Einhorn 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.
Results publication: PubMed 26232910Russell-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.
Results publication: PubMed 26663320Vora J, Seufert J, Solberg H, Kinduryte O, Johansen T, Hollander P. Insulin degludec does not increase antibody formation versus insulin glargine: an evaluation of phase IIIa trials. Diabetes Obes Metab. 2016 Jul;18(7):716-20. doi: 10.1111/dom.12621. Epub 2016 Feb 8.
Clinical Trials at Novo NordiskLink provided by the sponsor.

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Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Global Clinical Registry (GCR, 1452) study director

Novo Nordisk A/S

116 sites in 8 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing insulin degludec and insulin glargine in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 116 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 116 sites in United States, United Kingdom, Canada, France, Russia and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Glycosylated Haemoglobin (HbA1c) (time frame: Week 0, Week 26). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01068665, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2017.