DiabetesPhase 3BEGIN™NCT01006291

Comparison of NN1250 With Insulin Glargine in 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 72 sites in 14 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

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
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 687 participants
Where: 72 sitesin 14 countries
Study dates: Nov 2009to Sep 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

Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months
Current treatment: oral anti-diabetic drug(s) (OAD(s)) alone, basal insulin alone or the combination of OAD(s) and basal insulin. Allowed OADs are: Metformin, insulin secretagogues (sulphonylureas (SU) or glinides), pioglitazone with unchanged dosing for at least 3 months prior to Visit 1
HbA1c: OADs only users 7.0-11.0 % (both inclusive), basal insulin with/without OADs users 7.0-10.0% (both inclusive) by central laboratory analysis
Body Mass Index (BMI) below or equal to 40.0 kg/m^2

Who cannot join

Cancer and medical history of cancer hereof
Use within the last 3 months prior to Visit 1 of: glucagon-like peptide-1(GLP-1) receptor agonist (exenatide, liraglutide), rosiglitazone, dipeptidyl peptidase IV (DPP-IV) inhibitors, alpha-glucosidase-inhibitors
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
Cancer and medical history of cancer hereof (except basal cell skin cancer and squamous cell skin cancer)

Trial locations and contacts

72 sites in 14 countries.

Country

City, postcode or hospital

72 sites in 14 countries

India11 sites

Novo Nordisk Investigational Site
Chandigarh, Punjab, 160012
Novo Nordisk Investigational Site
Chennai, 600020
Novo Nordisk Investigational Site
Hyderabad, Andhra Pradesh, 500082
Novo Nordisk Investigational Site
Hyderabad, 600034
Novo Nordisk Investigational Site
Indore, Madhya Pradesh, 452010
Novo Nordisk Investigational Site
Kochi, Kerala, 682041
Novo Nordisk Investigational Site
Kolkata, West Bengal, 700020
Novo Nordisk Investigational Site
Kolkata, West Bengal, 700038
Novo Nordisk Investigational Site
Mumbai, Maharashtra, 400012
Novo Nordisk Investigational Site
New Dehli, New Delhi, 110029
Novo Nordisk Investigational Site
Vellore, Tamil Nadu, 632004

Other trials in India

Israel8 sites

Novo Nordisk Investigational Site
Beersheba, 84101
Novo Nordisk Investigational Site
Haifa, 31096
Novo Nordisk Investigational Site
Holon, 58100
Novo Nordisk Investigational Site
Jerusalem, 91120
Novo Nordisk Investigational Site
Kfar Saba, 44281
Novo Nordisk Investigational Site
Netanya, 42449
Novo Nordisk Investigational Site
Petah Tikva, 49100
Novo Nordisk Investigational Site
Rehovot, 76100

Other trials in Israel

United Kingdom8 sites

Novo Nordisk Investigational Site
Belfast, BT16 1RH
Novo Nordisk Investigational Site
Edgbaston, Birmingham, B15 2TH
Novo Nordisk Investigational Site
Edinburgh, EH4 2XU
Novo Nordisk Investigational Site
Glasgow, G45 9AW
Novo Nordisk Investigational Site
Hull, HU3 2JZ
Novo Nordisk Investigational Site
Ipswich, IP4 5PD
Novo Nordisk Investigational Site
Londonderry, BT47 6SB
Novo Nordisk Investigational Site
Swansea, SA6 6NL

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Finland7 sites

Novo Nordisk Investigational Site
Hanko, 10900
Novo Nordisk Investigational Site
Harjavalta, FI-29200
Novo Nordisk Investigational Site
Oulu, 90029
Novo Nordisk Investigational Site
Tampere, FI-33520
Novo Nordisk Investigational Site
Turku, 20520
Novo Nordisk Investigational Site
Turku, FI-20100
Novo Nordisk Investigational Site
Vantaa, FIN-01600

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Russia7 sites

Novo Nordisk Investigational Site
Kazan', 420064
Novo Nordisk Investigational Site
Moscow, 117036
Novo Nordisk Investigational Site
Moscow, 119435
Novo Nordisk Investigational Site
Moscow, 121356
Novo Nordisk Investigational Site
Moscow, 127644
Novo Nordisk Investigational Site
Saint Petersburg, 195257
Novo Nordisk Investigational Site
Saint-Peterburg, 190068

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Norway6 sites

Novo Nordisk Investigational Site
Gjøvik, NO-2819
Novo Nordisk Investigational Site
Hamar, 2317
Novo Nordisk Investigational Site
Hønefoss, 3511
Novo Nordisk Investigational Site
Oslo, 0586
Novo Nordisk Investigational Site
Stavanger, 4005
Novo Nordisk Investigational Site
Tønsberg, 3116

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Malaysia5 sites

Novo Nordisk Investigational Site
Cheras, 56000
Novo Nordisk Investigational Site
George Town, 10459
Novo Nordisk Investigational Site
Kota Bharu, Kelantan, 16150
Novo Nordisk Investigational Site
Kuala Lumpur, 59100
Novo Nordisk Investigational Site
Putrajaya, 62250

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Argentina4 sites

Novo Nordisk Investigational Site
Buenos Aires, B1636DSU
Novo Nordisk Investigational Site
Buenos Aires, C1425AGC
Novo Nordisk Investigational Site
Ciudad Autónoma de Bs As, C1426ABP
Novo Nordisk Investigational Site
Rosario, 2000

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Hungary4 sites

Novo Nordisk Investigational Site
Budapest, 1041
Novo Nordisk Investigational Site
Debrecen, 4043
Novo Nordisk Investigational Site
Győr, 9024
Novo Nordisk Investigational Site
Szombathely, H-9700

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Taiwan4 sites

Novo Nordisk Investigational Site
Taipei, 100
Novo Nordisk Investigational Site
Taipei, 112
Novo Nordisk Investigational Site
Taipei, 114
Novo Nordisk Investigational Site
Taoyuan, 333

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Mexico3 sites

Novo Nordisk Investigational Site
Durango, Durango, 34000
Novo Nordisk Investigational Site
Mexico City, México, D.F., 03300
Novo Nordisk Investigational Site
Monterrey, 64460

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South Africa3 sites

Novo Nordisk Investigational Site
Durban, KwaZulu-Natal, 4126
Novo Nordisk Investigational Site
Johannesburg, Gauteng, 1829
Novo Nordisk Investigational Site
Johannesburg, Gauteng, 2001

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North Macedonia1 site

Novo Nordisk Investigational Site
Skopje, 1000

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Serbia1 site

Novo Nordisk Investigational Site
Belgrade, 11000

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About this study

Official title: A 26 Week Randomised, Controlled, Open Label, Multicentre, Multinational, Three-arm, Treat to Target Trial Comparing Efficacy and Safety of Three Different Dosing Regimens of Either Soluble Insulin Basal Analogue (SIBA) or Insulin Glargine With or Without Combination With OAD Treatment, in Subjects With Type 2 Diabetes Mellitus (BEGIN™ : FLEX)

This trial is conducted in Africa, Asia, Europe and South America. The aim of this clinical trial is to compare NN1250 (insulin degludec (IDeg) with insulin glargine (IGlar) in patients with type 2 diabetes. Subjects treated with oral antidiabetic drug(s) (OAD(s)) should continue their current OAD treatment at the stable, prerandomisation dose level and dosing frequency.

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 s.c. (under the skin) once daily (alternative regimen). Dose was individually adjusted.
insulin degludecDrug
Injected s.c. (under the skin) once daily. Dose was individually adjusted.
insulin glargineDrug
Insulin glargine injected s.c. (under the skin) once daily. Dose was individually adjusted.

Study groups in NCT01006291
Study group	Role	What they receive
IDeg OD FF	Experimental	Not described Receives: Drug: insulin degludec
IDeg OD	Experimental	Not described Receives: Drug: insulin degludec
IGlar OD	Experimental	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 (3)

Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)
Mean of SMPG after 26 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, before bedtime, at 4 am and before breakfast.
Measured: Week 26
Rate of Confirmed Hypoglycaemic Episodes
Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.
Measured: Week 0 to Week 26 + 7 days follow up
Rate of Nocturnal Confirmed Hypoglycaemic Episodes
Rate of nocturnal confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.
Measured: Week 0 to Week 26 + 7 days follow up

Timeline

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

Nov 2009Sep 2010

First posted2 Nov 2009 (estimated)
Study startNov 2009
Primary completionSep 2010
Study completionSep 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 (6)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: 687 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01006291
Sponsor's protocol ID: NN1250-3668
Other IDs: U1111-1111-7084, 2008-005771-10, 2008
Acronym: BEGIN™
Status last verified: Dec 2016
First submitted: 30 Oct 2009
Last updated: 9 Feb 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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
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
Meneghini L, Atkin SL, Gough SC, Raz I, Blonde L, Shestakova M, Bain S, Johansen T, Begtrup K, Birkeland KI; NN1250-3668 (BEGIN FLEX) Trial Investigators. The efficacy and safety of insulin degludec given in variable once-daily dosing intervals compared with insulin glargine and insulin degludec dosed at the same time daily: a 26-week, randomized, open-label, parallel-group, treat-to-target trial in individuals with type 2 diabetes. Diabetes Care. 2013 Apr;36(4):858-64. doi: 10.2337/dc12-1668. Epub 2013 Jan 22.
PubMed 23340894

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 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 26 Week Randomised, Controlled, Open Label, Multicentre, Multinational, Three-arm, Treat to Target Trial Comparing Efficacy and Safety of Three Different Dosing Regimens of Either Soluble Insulin Basal Analogue (SIBA) or Insulin Glargine With or Without Combination With OAD Treatment, in Subjects With Type 2 Diabetes Mellitus (BEGIN™ : FLEX)
ClinicalTrials.gov ID: NCT01006291
Acronym / sponsor ID: BEGIN™ / NN1250-3668
Conditions: Diabetes, Diabetes Mellitus, Type 2
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 687 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: Nov 2009
Primary completion: Sep 2010 (actual)
Study completion: Sep 2010 (actual)
First posted: 2 Nov 2009 (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: 3

Arm	Type	Receives
IDeg OD FF	Experimental	Drug: insulin degludec
IDeg OD	Experimental	Drug: insulin degludec
IGlar OD	Experimental	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 (4 listed)

Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months
Current treatment: oral anti-diabetic drug(s) (OAD(s)) alone, basal insulin alone or the combination of OAD(s) and basal insulin. Allowed OADs are: Metformin, insulin secretagogues (sulphonylureas (SU) or glinides), pioglitazone with unchanged dosing for at least 3 months prior to Visit 1
HbA1c: OADs only users 7.0-11.0 % (both inclusive), basal insulin with/without OADs users 7.0-10.0% (both inclusive) by central laboratory analysis
Body Mass Index (BMI) below or equal to 40.0 kg/m^2

Key exclusion criteria (6 listed)

Cancer and medical history of cancer hereof
Use within the last 3 months prior to Visit 1 of: glucagon-like peptide-1(GLP-1) receptor agonist (exenatide, liraglutide), rosiglitazone, dipeptidyl peptidase IV (DPP-IV) inhibitors, alpha-glucosidase-inhibitors
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

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 s.c. (under the skin) once daily (alternative regimen). Dose was individually adjusted.	Drug	IDeg OD FF
insulin degludecInjected s.c. (under the skin) once daily. Dose was individually adjusted.	Drug	IDeg OD
insulin glargineInsulin glargine injected s.c. (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

3 secondary outcomes

Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)
Time frame: Week 26
Rate of Confirmed Hypoglycaemic Episodes
Time frame: Week 0 to Week 26 + 7 days follow up
Rate of Nocturnal Confirmed Hypoglycaemic Episodes
Time frame: Week 0 to Week 26 + 7 days follow up

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 OD FF	229	203
IDeg OD	228	204
IGlar OD	230	203

Primary outcome: Change in Glycosylated Haemoglobin (HbA1c)

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

Measure	IDeg OD FF n = 229	IDeg OD n = 228	IGlar OD n = 230
Value	-1.28 (1.00)	-1.07 (0.99)	-1.26 (1.07)

Population analysed: The Full analysis set (FAS) included all randomised subjects and missing data is imputed using last observation carried forward (LOCF). In FAS, subjects contributed to the evaluation 'as randomised'.

3 secondary outcomes are 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 OD FF	6 of 230 (2.6%)	58 of 230 (25.2%)	Not reported
IDeg OD	8 of 226 (3.5%)	57 of 226 (25.2%)	Not reported
IGlar OD	4 of 229 (1.7%)	53 of 229 (23.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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 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.
Derived from this study: PubMed 23340894Meneghini L, Atkin SL, Gough SC, Raz I, Blonde L, Shestakova M, Bain S, Johansen T, Begtrup K, Birkeland KI; NN1250-3668 (BEGIN FLEX) Trial Investigators. The efficacy and safety of insulin degludec given in variable once-daily dosing intervals compared with insulin glargine and insulin degludec dosed at the same time daily: a 26-week, randomized, open-label, parallel-group, treat-to-target trial in individuals with type 2 diabetes. Diabetes Care. 2013 Apr;36(4):858-64. doi: 10.2337/dc12-1668. Epub 2013 Jan 22.
Clinical Trials at Novo NordiskLink provided by the sponsor.

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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

72 sites in 14 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 72 sites in 14 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 4 inclusion and 6 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 9 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 72 sites in India, Israel, United Kingdom, Finland, Russia and 9 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 NCT01006291, which also lists 6 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 9 Feb 2017.