DiabetesPhase 2NCT00611884

Comparison of Two NN1250 Formulations Versus Insulin Glargine, All in Combination With Metformin in Subjects With Type 2 Diabetes

A Phase 2 study testing insulin glargine, insulin degludec and metformin in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 29 sites in 4 countries.

Completed

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

Official record

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Trial summary

This trial is conducted in Africa, Asia and North America. The aim of this trial is to compare two insulin degludec (NN1250, SIBA) formulations with each other and with insulin glargine, all in combination with metformin in insulin naive subjects with type 2 diabetes. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Diabetes, Diabetes Mellitus, Type 2
What is being tested?: insulin glargine, insulin degludec and metformin
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 245 participants
Where: 29 sitesin 4 countries
Study dates: Jan 2008to Aug 2008
Phase: Phase 2
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 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.)
Insulin naïve type 2 diabetes subjects (as diagnosed clinically) for at least 3 months (no previous insulin treatment or previous short term insulin treatment maximeum 14 days within the last 3 months)
Treatment with one or two oral anti-diabetic drug (OADs): metformin, sulphonylurea (SU) (or other insulin secretagogue e.g. repaglinide, nateglinide), alpha-glucosidase inhibitors for at least 2 months at a stable maximally tolerated dose or at least half maximally allowed dose according to the summary of product characteristics (SPC) or locally approved PI
HbA1c 7.0-11.0 % (both inclusive)
Body Mass Index (BMI) 23-42 kg/m^2 [lb/in^2 x 703] (both inclusive)

Who cannot join

Metformin contraindication according to local practice
Thiazolidinedione (TZD) treatment within previous three months prior to visit 1
Any systemic treatment with products which in the Investigator's opinion could interfere with glucose or lipid metabolism (e.g. systemic corticosteroids) three months prior to randomisation
Subject has a clinically significant, active (during the past 12 months) disease of the gastrointestinal, pulmonary, neurological, genitourinary, or haematological system (except for conditions associated with type 2 diabetes) that, in the opinion of the Investigator, may confound the results of the trial or pose additional risk in administering trial drug

Trial locations and contacts

29 sites in 4 countries.

Country

City, postcode or hospital

29 sites in 4 countries

United States18 sites

Novo Nordisk Investigational Site
Chicago, Illinois, 60607
Novo Nordisk Investigational Site
Chicago, Illinois, 60616
Novo Nordisk Investigational Site
Dallas, Texas, 75230
Novo Nordisk Investigational Site
Greensboro, North Carolina, 27408
Novo Nordisk Investigational Site
Idaho Falls, Idaho, 83404-7596
Novo Nordisk Investigational Site
Inglewood, California, 90301
Novo Nordisk Investigational Site
Jacksonville, Florida, 32204
Novo Nordisk Investigational Site
Kingsport, Tennessee, 37660
Novo Nordisk Investigational Site
Los Angeles, California, 90057
Novo Nordisk Investigational Site
Medford, Oregon, 97504
Novo Nordisk Investigational Site
Milwaukee, Wisconsin, 53209
Novo Nordisk Investigational Site
Newport News, Virginia, 23606
Novo Nordisk Investigational Site
Redlands, California, 92374
Novo Nordisk Investigational Site
Renton, Washington, 98057
Novo Nordisk Investigational Site
San Antonio, Texas, 78229
Novo Nordisk Investigational Site
Simpsonville, South Carolina, 29681
Novo Nordisk Investigational Site
Spring Valley, California, 91978
Novo Nordisk Investigational Site
Springfield, Illinois, 62711

Other trials in United States

Canada4 sites

Novo Nordisk Investigational Site
Cambridge, Ontario, N1R 7L6
Novo Nordisk Investigational Site
Etobicoke, Ontario, M9R 4E1
Novo Nordisk Investigational Site
Toronto, Ontario, M5C 2T2
Novo Nordisk Investigational Site
Toronto, Ontario, M5T 3L9

Other trials in Canada

India4 sites

Novo Nordisk Investigational Site
Hyderabad, Andhra Pradesh, 500082
Novo Nordisk Investigational Site
Kochi, Kerala, 682041
Novo Nordisk Investigational Site
Mumbai, Maharashtra, 400012
Novo Nordisk Investigational Site
Vellore, Tamil Nadu, 632004

Other trials in India

South Africa3 sites

Novo Nordisk Investigational Site
Durban, KwaZulu-Natal, 4001
Novo Nordisk Investigational Site
Durban, KwaZulu-Natal, 4126
Novo Nordisk Investigational Site
Johannesburg, Gauteng, 2001

Other trials in South Africa

About this study

Official title: A 16 Week Randomised, Open-labelled, Four-armed, Treat-to-target, Parallel-group Trial Comparing SIBA D Once Daily, SIBA E Once Daily, SIBA D Monday, Wednesday and Friday and Insulin Glargine Once Daily, All in Combination With Metformin in Subjects With Type 2 Diabetes Failing on OAD Treatment

Conditions: Diabetes, Diabetes Mellitus, Type 2
Being tested: insulin glargine, insulin degludec, metformin
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 glargineDrug
Treat-to-target dose titration scheme, s.c. injection.
insulin degludecDrug
Formulation D: Treat-to-target dose titration scheme, s.c. injection, once daily
insulin degludecDrug
Formulation E: Treat-to-target dose titration scheme, s.c. injection, once daily
insulin degludecDrug
Formulation D: Treat-to-target dose titration scheme, s.c. injection, 3 times weekly
metforminDrug
Tablets, 1500-2000 mg/day

Study groups in NCT00611884
Study group	Role	What they receive
SIBA (D)	Experimental	Not described Receives: Drug: insulin degludec; Drug: metformin
SIBA (E)	Experimental	Not described Receives: Drug: insulin degludec; Drug: metformin
SIBA (D) M, W, F	Experimental	Not described Receives: Drug: insulin degludec; Drug: metformin
IGlar	Active comparator	Not described Receives: Drug: insulin glargine; Drug: metformin

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 16 weeks of treatment
Measured: Week 0, Week 16

Secondary outcomes (11)

Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)
Mean of SMPG after 16 weeks of treatment. Plasma glucose measured: before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, before bedtime, at 4 am and before breakfast.
Measured: Week 16
Rate of Major and Minor Hypoglycaemic Episodes
Rate of major and minor hypoglycaemic episodes per 100 patient years of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L.
Measured: Week 0 to Week 16 + 5 days follow up
Rate of Nocturnal Major and Minor Hypoglycaemic Episodes
Rate of nocturnal major and minor hypoglycaemic episodes per 100 patient years of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Episodes were defined as nocturnal if the time of onset was between 23:00 (included) and 05:59 (included).
Measured: Week 0 to Week 16 + 5 days follow up
Rate of Treatment Emergent Adverse Events (AEs)
Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.
Measured: Week 0 to Week 16 + 5 days follow up
Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT)
Mean values at Week -4 and at Week 16
Measured: Week -4, Week 16
Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT)
Mean values at Week -4 and at Week 16
Measured: Week -4, Week 16
Laboratory Safety Parameters (Biochemistry): Serum Creatinine
Mean values at Week -4 and at Week 16
Measured: Week -4, Week 16
Vital Signs: Diastolic Blood Pressure (BP)
Mean values at baseline (Week 0) and at Week 16
Measured: Week 0, Week 16
Vital Signs: Systolic Blood Pressure (BP)
Mean values at baseline (Week 0) and at Week 16
Measured: Week 0, Week 16
Vital Signs: Pulse
Mean values at baseline (Week 0) and at Week 16
Measured: Week 0, Week 16
Physical Examination
Physical examination was performed at screening (Week -4), randomisation (Week 0) and after 8 and 16 weeks of treatment. If any new findings or deterioration in previous findings were observed during the trial, these were recorded as AEs and are therefore not presented separately as no analysis was performed.
Measured: Week -4, Week 0, Week 8, Week 16

Timeline

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

Jan 2008Aug 2008

First posted11 Feb 2008 (estimated)
Study startJan 2008
Primary completionAug 2008
Study completionAug 2008

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 (1)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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 245 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00611884
Sponsor's protocol ID: NN1250-1836
Status last verified: Jan 2017
First submitted: 29 Jan 2008
Last updated: 3 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Zinman B, Fulcher G, Rao PV, Thomas N, Endahl LA, Johansen T, Lindh R, Lewin A, Rosenstock J, Pinget M, Mathieu C. Insulin degludec, an ultra-long-acting basal insulin, once a day or three times a week versus insulin glargine once a day in patients with type 2 diabetes: a 16-week, randomised, open-label, phase 2 trial. Lancet. 2011 Mar 12;377(9769):924-31. doi: 10.1016/S0140-6736(10)62305-7.
PubMed 21396703

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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All Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 16 Week Randomised, Open-labelled, Four-armed, Treat-to-target, Parallel-group Trial Comparing SIBA D Once Daily, SIBA E Once Daily, SIBA D Monday, Wednesday and Friday and Insulin Glargine Once Daily, All in Combination With Metformin in Subjects With Type 2 Diabetes Failing on OAD Treatment
ClinicalTrials.gov ID: NCT00611884
Acronym / sponsor ID: NN1250-1836
Conditions: Diabetes, Diabetes Mellitus, Type 2
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 245 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: Jan 2008
Primary completion: Aug 2008 (actual)
Study completion: Aug 2008 (actual)
First posted: 11 Feb 2008 (estimated)
Results: Posted 16 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: 4

Arm	Type	Receives
SIBA (D)	Experimental	Drug: insulin degludec, Drug: metformin
SIBA (E)	Experimental	Drug: insulin degludec, Drug: metformin
SIBA (D) M, W, F	Experimental	Drug: insulin degludec, Drug: metformin
IGlar	Active comparator	Drug: insulin glargine, Drug: metformin

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.)
Insulin naïve type 2 diabetes subjects (as diagnosed clinically) for at least 3 months (no previous insulin treatment or previous short term insulin treatment maximeum 14 days within the last 3 months)
Treatment with one or two oral anti-diabetic drug (OADs): metformin, sulphonylurea (SU) (or other insulin secretagogue e.g. repaglinide, nateglinide), alpha-glucosidase inhibitors for at least 2 months at a stable maximally tolerated dose or at least half maximally allowed dose according to the summary of product characteristics (SPC) or locally approved PI
HbA1c 7.0-11.0 % (both inclusive)
Body Mass Index (BMI) 23-42 kg/m^2 [lb/in^2 x 703] (both inclusive)

Key exclusion criteria (4 listed)

Metformin contraindication according to local practice
Thiazolidinedione (TZD) treatment within previous three months prior to visit 1
Any systemic treatment with products which in the Investigator's opinion could interfere with glucose or lipid metabolism (e.g. systemic corticosteroids) three months prior to randomisation
Subject has a clinically significant, active (during the past 12 months) disease of the gastrointestinal, pulmonary, neurological, genitourinary, or haematological system (except for conditions associated with type 2 diabetes) that, in the opinion of the Investigator, may confound the results of the trial or pose additional risk in administering trial drug

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 glargineTreat-to-target dose titration scheme, s.c. injection.	Drug	IGlar
insulin degludecFormulation D: Treat-to-target dose titration scheme, s.c. injection, once daily	Drug	SIBA (D)
insulin degludecFormulation E: Treat-to-target dose titration scheme, s.c. injection, once daily	Drug	SIBA (E)
insulin degludecFormulation D: Treat-to-target dose titration scheme, s.c. injection, 3 times weekly	Drug	SIBA (D) M, W, F
metforminTablets, 1500-2000 mg/day	Drug	IGlar, SIBA (D), SIBA (D) M, W, F, SIBA (E)

Primary outcome

Change in Glycosylated Haemoglobin (HbA1c)
Time frame: Week 0, Week 16
Change from baseline in HbA1c after 16 weeks of treatment

11 secondary outcomes

Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)
Time frame: Week 16
Rate of Major and Minor Hypoglycaemic Episodes
Time frame: Week 0 to Week 16 + 5 days follow up
Rate of Nocturnal Major and Minor Hypoglycaemic Episodes
Time frame: Week 0 to Week 16 + 5 days follow up
Rate of Treatment Emergent Adverse Events (AEs)
Time frame: Week 0 to Week 16 + 5 days follow up
Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT)
Time frame: Week -4, Week 16
Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT)
Time frame: Week -4, Week 16
Laboratory Safety Parameters (Biochemistry): Serum Creatinine
Time frame: Week -4, Week 16
Vital Signs: Diastolic Blood Pressure (BP)
Time frame: Week 0, Week 16
Vital Signs: Systolic Blood Pressure (BP)
Time frame: Week 0, Week 16
Vital Signs: Pulse
Time frame: Week 0, Week 16
Physical Examination
Time frame: Week -4, Week 0, Week 8, Week 16

Results and safety

Results posted to the registry on 16 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
SIBA (D)	61	52
SIBA (E)	60	51
SIBA (D) M, W, F	62	58
IGlar	62	56

Primary outcome: Change in Glycosylated Haemoglobin (HbA1c)

Time frame: Week 0, Week 16. Mean (Standard Deviation). Unit: percentage of glycosylated haemoglobin

Measure	SIBA (D) n = 61	SIBA (E) n = 60	SIBA (D) M, W, F n = 62	IGlar n = 62
Value	-1.26 (1.11)	-1.28 (1.11)	-1.46 (1.06)	-1.49 (1.12)

Population analysed: The full analysis set (FAS) included all randomised subjects and missing data is imputed using last observation carried forward (LOCF).

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: The adverse events were collected in a time frame of 16 weeks + 5 days follow up. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SIBA (D)	1 of 57 (1.8%)	22 of 57 (38.6%)	Not reported
SIBA (E)	0 of 59 (0%)	16 of 59 (27.1%)	Not reported
SIBA (D) M, W, F	1 of 62 (1.6%)	19 of 62 (30.6%)	Not reported
IGlar	0 of 61 (0%)	23 of 61 (37.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 21396703Zinman B, Fulcher G, Rao PV, Thomas N, Endahl LA, Johansen T, Lindh R, Lewin A, Rosenstock J, Pinget M, Mathieu C. Insulin degludec, an ultra-long-acting basal insulin, once a day or three times a week versus insulin glargine once a day in patients with type 2 diabetes: a 16-week, randomised, open-label, phase 2 trial. Lancet. 2011 Mar 12;377(9769):924-31. doi: 10.1016/S0140-6736(10)62305-7.
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

29 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing insulin glargine, insulin degludec and metformin in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 29 sites in 4 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 5 inclusion and 4 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 3 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 29 sites in United States, Canada, India, South Africa. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 16 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 16). 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 NCT00611884, which also lists 1 linked publication.

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 3 Mar 2017.