DiabetesPhase 3NCT00097877

Comparison of Biphasic Insulin Aspart 70/30 Versus Insulin Glargine in Subjects With Type 2 Diabetes

A Phase 3 study testing biphasic insulin aspart and insulin glargine in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 73 sites in 2 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?: biphasic insulin aspart and insulin glargine
How many people: 293 participants
Where: 73 sitesin 2 countries
Study dates: Jan 2005to Nov 2006
Phase: Phase 3
Are there results?: None posted in the registry

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

Who cannot join

None listed.

Trial locations and contacts

73 sites in 2 countries.

Country

City, postcode or hospital

73 sites in 2 countries

United States71 sites

Novo Nordisk Investigational Site
Arlington, Texas, 76014
Novo Nordisk Investigational Site
Atlanta, Georgia, 30303
Novo Nordisk Investigational Site
Atlanta, Georgia, 30339
Novo Nordisk Investigational Site
Aventura, Florida, 33180
Novo Nordisk Investigational Site
Baltimore, Maryland, 21204
Novo Nordisk Investigational Site
Baton Rouge, Louisiana, 70808
Novo Nordisk Investigational Site
Bellevue, Washington, 98004
Novo Nordisk Investigational Site
Birmingham, Alabama, 35235
Novo Nordisk Investigational Site
Boise, Idaho, 83702
Novo Nordisk Investigational Site
Cherry Hill, New Jersey, 08034
Novo Nordisk Investigational Site
Chesterfield, Missouri, 63017
Novo Nordisk Investigational Site
Chicago, Illinois, 60607
Novo Nordisk Investigational Site
Chiefland, Florida, 32626
Novo Nordisk Investigational Site
Chula Vista, California, 91911
Novo Nordisk Investigational Site
Clinton, Oklahoma, 73601
Novo Nordisk Investigational Site
Dallas, Texas, 75208
Novo Nordisk Investigational Site
Dallas, Texas, 75230
Novo Nordisk Investigational Site
Dallas, Texas, 75231
Novo Nordisk Investigational Site
Dallas, Texas, 75246
Novo Nordisk Investigational Site
Dallas, Texas, 75390-8858
Novo Nordisk Investigational Site
Dayton, Ohio, 45406
Novo Nordisk Investigational Site
Dayton, Ohio, 45439
Novo Nordisk Investigational Site
Des Moines, Iowa, 50314
Novo Nordisk Investigational Site
Eugene, Oregon, 97401
Novo Nordisk Investigational Site
Fort Myers, Florida, 33907
Novo Nordisk Investigational Site
Fullerton, California, 92835
Novo Nordisk Investigational Site
Greensboro, North Carolina, 27408
Novo Nordisk Investigational Site
Greer, South Carolina, 29651
Novo Nordisk Investigational Site
Houston, Texas, 77030
Novo Nordisk Investigational Site
Jacksonville, Florida, 32208
Novo Nordisk Investigational Site
Kettering, Ohio, 45429
Novo Nordisk Investigational Site
Lancaster, Pennsylvania, 17601
Novo Nordisk Investigational Site
Las Vegas, Nevada, 89119-6100
Novo Nordisk Investigational Site
Lawrenceville, New Jersey, 08648
Novo Nordisk Investigational Site
Lewisville, Texas, 75067
Novo Nordisk Investigational Site
Melbourne, Florida, 32901
Novo Nordisk Investigational Site
Melrose Park, Pennsylvania, 19027
Novo Nordisk Investigational Site
Memphis, Tennessee, 38115
Novo Nordisk Investigational Site
Midland, Texas, 79707
Novo Nordisk Investigational Site
Milwaukee, Wisconsin, 53209
Novo Nordisk Investigational Site
New Albany, Indiana, 47150
Novo Nordisk Investigational Site
New Britain, Connecticut, 06050
Novo Nordisk Investigational Site
New Hyde Park, New York, 11042
Novo Nordisk Investigational Site
Newport News, Virginia, 23606
Novo Nordisk Investigational Site
Norristown, Pennsylvania, 19401
Novo Nordisk Investigational Site
Ocala, Florida, 34471
Novo Nordisk Investigational Site
Ogden, Utah, 84403
Novo Nordisk Investigational Site
Omaha, Nebraska, 68114
Novo Nordisk Investigational Site
Orange, California, 92868
Novo Nordisk Investigational Site
Orange, California, 92869
Novo Nordisk Investigational Site
Overland Park, Kansas, 66209
Novo Nordisk Investigational Site
Plainsboro, New Jersey, 08536
Novo Nordisk Investigational Site
Plano, Texas, 75074
Novo Nordisk Investigational Site
Plano, Texas, 75093
Novo Nordisk Investigational Site
Plantation, Florida, 33324
Novo Nordisk Investigational Site
Portland, Oregon, 97239
Novo Nordisk Investigational Site
Richmond, Virginia, 23249
Novo Nordisk Investigational Site
Salem, Oregon, 97302
Novo Nordisk Investigational Site
San Antonio, Texas, 78229
Novo Nordisk Investigational Site
Searcy, Arkansas, 72143
Novo Nordisk Investigational Site
Springfield, Massachusetts, 01107
Novo Nordisk Investigational Site
St Louis, Missouri, 63017
Novo Nordisk Investigational Site
St Louis, Missouri, 63141
Novo Nordisk Investigational Site
Staten Island, New York, 10305
Novo Nordisk Investigational Site
Syracuse, New York, 13210
Novo Nordisk Investigational Site
Topeka, Kansas, 66606
Novo Nordisk Investigational Site
Tulsa, Oklahoma, 74104
Novo Nordisk Investigational Site
Tuscaloosa, Alabama, 35406
Novo Nordisk Investigational Site
Vestavia Hills, Alabama, 35209
Novo Nordisk Investigational Site
Warrenton, Virginia, 20186
Novo Nordisk Investigational Site
West Reading, Pennsylvania, 19611

Other trials in United States

Puerto Rico2 sites

Novo Nordisk Investigational Site
Manati, 00674
Novo Nordisk Investigational Site
Santurce, 00907

Other trials in Puerto Rico

About this study

Official title: Comparison of the Effect on Glycemic Control of Biphasic Insulin Aspart 70/30 Versus Insulin Glargine in Combination With Metformin in Subjects With Type 2 Diabetes

This trial is conducted in the United States of America (USA). The purpose of this study is to test whether Biphasic Insulin Aspart 70/30 twice a day with Metformin improves glycemic control vs. once daily Insulin Glargine with Metformin in subjects with Type 2 Diabetes who are inadequately controlled on basal insulin plus oral anti-diabetic therapy.

Conditions: Diabetes, Diabetes Mellitus, Type 2
Being tested: biphasic insulin aspart, insulin glargine
Keywords: Type 2 Diabetes
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.

biphasic insulin aspartDrug
insulin glargineDrug

What is being measured

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

HbA1c
Measured: After 24 weeks

Secondary outcomes (3)

safety variables
8-point plasma glucose profile
other glycemic variables

Timeline

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

Jan 2005Nov 2006

First posted1 Dec 2004 (estimated)
Study startJan 2005
Primary completionNov 2006
Study completionNov 2006

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)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: 293 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00097877
Sponsor's protocol ID: BIASP-2191
Status last verified: Jan 2017
First submitted: 30 Nov 2004
Last updated: 11 Jan 2017
Results posted: No
Data monitoring committee: No

Publications

Ligthelm RJ, Gylvin T, DeLuzio T, Raskin P. A comparison of twice-daily biphasic insulin aspart 70/30 and once-daily insulin glargine in persons with type 2 diabetes mellitus inadequately controlled on basal insulin and oral therapy: a randomized, open-label study. Endocr Pract. 2011 Jan-Feb;17(1):41-50. doi: 10.4158/EP10079.OR.
PubMed 20713345
Oyer DS, Shepherd MD, Coulter FC, Bhargava A, Deluzio AJ, Chu PL, Trippe BS; Initiateplus Study Group. Efficacy and tolerability of self-titrated biphasic insulin aspart 70/30 in patients aged >65 years with type 2 diabetes: an exploratory post hoc subanalysis of the INITIATEplus trial. Clin Ther. 2011 Jul;33(7):874-83. doi: 10.1016/j.clinthera.2011.05.093. Epub 2011 Jul 8.
PubMed 21741089
Trippe BS, Shepherd MD, Coulter FC, Bhargava A, Brett J, Chu PL, Oyer DS. Efficacy and safety of biphasic insulin aspart 70/30 in type 2 diabetes patients of different race or ethnicity (INITIATEplus trial). Curr Med Res Opin. 2012 Jul;28(7):1203-11. doi: 10.1185/03007995.2012.686444. Epub 2012 Jun 25.
PubMed 22509859
Bergenstal R, Lewin A, Bailey T, Chang D, Gylvin T, Roberts V; NovoLog Mix-vs.-Exenatide Study Group. Efficacy and safety of biphasic insulin aspart 70/30 versus exenatide in subjects with type 2 diabetes failing to achieve glycemic control with metformin and a sulfonylurea. Curr Med Res Opin. 2009 Jan;25(1):65-75. doi: 10.1185/03007990802597951.
PubMed 19210140

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

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
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Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
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Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
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PAW-Hydrogel for Chronic Wound Healing
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Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
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All Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of the Effect on Glycemic Control of Biphasic Insulin Aspart 70/30 Versus Insulin Glargine in Combination With Metformin in Subjects With Type 2 Diabetes
ClinicalTrials.gov ID: NCT00097877
Acronym / sponsor ID: BIASP-2191
Conditions: Diabetes, Diabetes Mellitus, Type 2
Keywords: Type 2 Diabetes
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 293 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: Jan 2005
Primary completion: Nov 2006 (actual)
Study completion: Nov 2006 (actual)
First posted: 1 Dec 2004 (estimated)
Results: Not posted in the source record

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)

Who may qualify

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

Key inclusion criteria (1 listed)

Type 2 Diabetes

Key exclusion criteria (0 listed)

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
biphasic insulin aspart	Drug	–
insulin glargine	Drug	–

Primary outcome

HbA1c
Time frame: After 24 weeks

3 secondary outcomes

safety variables
8-point plasma glucose profile
other glycemic variables

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2017.
Results publication: PubMed 20713345Ligthelm RJ, Gylvin T, DeLuzio T, Raskin P. A comparison of twice-daily biphasic insulin aspart 70/30 and once-daily insulin glargine in persons with type 2 diabetes mellitus inadequately controlled on basal insulin and oral therapy: a randomized, open-label study. Endocr Pract. 2011 Jan-Feb;17(1):41-50. doi: 10.4158/EP10079.OR.
Results publication: PubMed 21741089Oyer DS, Shepherd MD, Coulter FC, Bhargava A, Deluzio AJ, Chu PL, Trippe BS; Initiateplus Study Group. Efficacy and tolerability of self-titrated biphasic insulin aspart 70/30 in patients aged >65 years with type 2 diabetes: an exploratory post hoc subanalysis of the INITIATEplus trial. Clin Ther. 2011 Jul;33(7):874-83. doi: 10.1016/j.clinthera.2011.05.093. Epub 2011 Jul 8.
Results publication: PubMed 22509859Trippe BS, Shepherd MD, Coulter FC, Bhargava A, Brett J, Chu PL, Oyer DS. Efficacy and safety of biphasic insulin aspart 70/30 in type 2 diabetes patients of different race or ethnicity (INITIATEplus trial). Curr Med Res Opin. 2012 Jul;28(7):1203-11. doi: 10.1185/03007995.2012.686444. Epub 2012 Jun 25.
Derived from this study: PubMed 19210140Bergenstal R, Lewin A, Bailey T, Chang D, Gylvin T, Roberts V; NovoLog Mix-vs.-Exenatide Study Group. Efficacy and safety of biphasic insulin aspart 70/30 versus exenatide in subjects with type 2 diabetes failing to achieve glycemic control with metformin and a sulfonylurea. Curr Med Res Opin. 2009 Jan;25(1):65-75. doi: 10.1185/03007990802597951.
Clinical Trials at Novo NordiskLink provided by the sponsor.

Related trials for Diabetes

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
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

73 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing biphasic insulin aspart and insulin glargine in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 73 sites in 2 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 1 inclusion and 0 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 11 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 73 sites in United States, Puerto Rico. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

HbA1c (time frame: After 24 weeks). 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 NCT00097877, which also lists 4 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 11 Jan 2017.