DiabetesPhase 3BEGIN™NCT01135992
Switching From Insulin Glargine to Insulin Degludec in Subjects With Type 2 Diabetes Mellitus (BEGIN™)
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 27 sites in United States.
Trial summary
This trial is conducted in the United States of America (USA). The aim of this clinical trial is to assess the implications of switching from insulin glargine (IGlar) to insulin degludec (IDeg) in subjects with type 2 diabetes mellitus. 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
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- 27 sitesUnited States
- Study dates
- Jun 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
- Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months
- HbA1c maximum 10 % by central laboratory analysis
- Current treatment with basal-oral therapy (BOT) (no prandial insulin ever) consisting of: at least three months with insulin glargine once daily (average prescribed dose must have been unchanged (within plus/minus 10%) for four weeks prior to Visit 1 as confirmed by patient records or verbal confirmation by the subject) in combination with stable (unchanged doses for at least 3 months prior to Visit 1) OAD (metformin, insulin secretagogues, pioglitazone, sitagliptin or alpha-glucosidase-inhibitor) treatment in any approved (according to label) dose or combination
Who cannot join
- Use within the last three months prior to Visit 1 of: Exenatide, Liraglutide or Thiazoledinediones (TZDs) other than Pioglitazone
- Cardiovascular disease (CVD) 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 within the last six months prior to Visit 1
- Recurrent severe hypoglycaemia (more than one severe hypoglycaemic episode during the last 12 months), or hypoglycaemic unawareness as judged by the Investigator, or hospitalisation for diabetic ketoacidosis during the previous six months
- Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
- Previous participation in this trial. Participation is defined as started on trial medication. Rescreening of screening failures is allowed only once within the limits of the recruitment period
- Known or suspected hypersensitivity to trial products or related products
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
United States27 sites
Novo Nordisk Clinical Trial Call Center
Albany, New York, 12206
Novo Nordisk Clinical Trial Call Center
Anaheim, California, 92801
Novo Nordisk Clinical Trial Call Center
Austin, Texas, 78731
Novo Nordisk Clinical Trial Call Center
Charlotte, North Carolina, 28209
Novo Nordisk Clinical Trial Call Center
Chattanooga, Tennessee, 37411
Novo Nordisk Clinical Trial Call Center
Chicago, Illinois, 60616
Novo Nordisk Clinical Trial Call Center
Chino, California, 91710
Novo Nordisk Clinical Trial Call Center
Concord, California, 94520
Novo Nordisk Clinical Trial Call Center
Dover, New Hampshire, 03820
Novo Nordisk Clinical Trial Call Center
Fort Worth, Texas, 76113
Novo Nordisk Clinical Trial Call Center
Fresno, California, 93720
Novo Nordisk Clinical Trial Call Center
Goodyear, Arizona, 85395
Novo Nordisk Clinical Trial Call Center
Greenbrae, California, 94904
Novo Nordisk Clinical Trial Call Center
Henderson, Nevada, 89052-2649
Novo Nordisk Clinical Trial Call Center
Kingsport, Tennessee, 37660
Novo Nordisk Clinical Trial Call Center
Kissimmee, Florida, 34741
Novo Nordisk Clinical Trial Call Center
Lawrenceville, New Jersey, 08648
Novo Nordisk Clinical Trial Call Center
Melrose Park, Pennsylvania, 19027
Novo Nordisk Clinical Trial Call Center
Metairie, Louisiana, 70002
Novo Nordisk Clinical Trial Call Center
Metairie, Louisiana, 70006-2930
Novo Nordisk Clinical Trial Call Center
Nashua, New Hampshire, 03063
Novo Nordisk Clinical Trial Call Center
Olympia, Washington, 98502
Novo Nordisk Clinical Trial Call Center
Omaha, Nebraska, 68114
Novo Nordisk Clinical Trial Call Center
Palm Springs, California, 92262-6972
Novo Nordisk Clinical Trial Call Center
Phoenix, Arizona, 85018
Novo Nordisk Clinical Trial Call Center
Pittsburgh, Pennsylvania, 15224-2215
Novo Nordisk Clinical Trial Call Center
Toms River, New Jersey, 08755-8050
About this study
Official title: A Trial Assessing the Implications of Switching From Insulin Glargine to Insulin Degludec in Subjects With Type 2 Diabetes Mellitus (BEGIN™: SIMPLIFY)
This trial is conducted in the United States of America (USA). The aim of this clinical trial is to assess the implications of switching from insulin glargine (IGlar) to insulin degludec (IDeg) in subjects with type 2 diabetes mellitus.
- 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
Individually adjusted insulin degludec administered three times weekly with continued unchanged pre-trial OAD (oral anti-diabetic drug) treatment for 12 weeks
insulin glargineDrug
Subjects continue their pre-trial insulin glargine once daily plus OAD (oral anti-diabetic drug) treatment for four weeks before switch to insulin degludec
| Study group | Role | What they receive |
|---|---|---|
| IGlar/IDeg | Experimental | Not described Receives: Drug: insulin glargine |
| IDeg 3TW | Experimental | Not described Receives: Drug: insulin degludec |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c (Glycosylated Haemoglobin)
HbA1C at week 4 and 16
Measured: Week 4 and Week 16
Secondary outcomes (5)
Fasting Plasma Glucose (FPG)
FPG at week 4 and 16
Measured: Week 4 and Week 16
Change in Body Weight
Change from baseline in body weight after week 4 and after week 16
Measured: Week 0, Week 4, Week 16
Rate of Treatment Emergent Adverse Events (AEs)
Corresponds to rate of AEs per 100 patient years of exposure. Mild AEs: no or transient symptoms, no interference with subject's daily activities. Moderate AEs: marked symptoms, moderate interference with subject's daily activities. Severe AEs: considerable interference with subject's daily activities, unacceptable. Serious adverse event (SAE): 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: Weeks 0-4 (IGlar), Weeks 4-16 (IDeg 3TW)
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 with a confirmed plasma glucose value of less than 3.1 mmol/L.
Measured: Weeks 0-4 (IGlar), Weeks 4-16 (IDeg 3TW)
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 with a confirmed plasma glucose value of less than 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occuring between 00:01 and 05:59 a.m.
Measured: Weeks 0-4 (IGlar), Weeks 4-16 (IDeg 3TW)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2010 (estimated)
- Study startJun 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.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01135992
- Sponsor's protocol ID
- NN1250-3839
- Other IDs
- U1111-1114-8802
- Acronym
- BEGIN™
- Status last verified
- Dec 2015
- First submitted
- 31 May 2010
- Last updated
- 22 Jan 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial Assessing the Implications of Switching From Insulin Glargine to Insulin Degludec in Subjects With Type 2 Diabetes Mellitus (BEGIN™: SIMPLIFY)
- ClinicalTrials.gov ID
- NCT01135992
- Acronym / sponsor ID
- BEGIN™ / NN1250-3839
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 3 Jun 2010 (estimated)
- Results
- Posted 22 Jan 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial is conducted in the United States of America (USA). The aim of this clinical trial is to assess the implications of switching from insulin glargine (IGlar) to insulin degludec (IDeg) in subjects with type 2 diabetes mellitus.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IGlar/IDeg | Experimental | Drug: insulin glargine |
| IDeg 3TW | Experimental | Drug: insulin degludec |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months
- HbA1c maximum 10 % by central laboratory analysis
- Current treatment with basal-oral therapy (BOT) (no prandial insulin ever) consisting of: at least three months with insulin glargine once daily (average prescribed dose must have been unchanged (within plus/minus 10%) for four weeks prior to Visit 1 as confirmed by patient records or verbal confirmation by the subject) in combination with stable (unchanged doses for at least 3 months prior to Visit 1) OAD (metformin, insulin secretagogues, pioglitazone, sitagliptin or alpha-glucosidase-inhibitor) treatment in any approved (according to label) dose or combination
Key exclusion criteria (6 listed)
- Use within the last three months prior to Visit 1 of: Exenatide, Liraglutide or Thiazoledinediones (TZDs) other than Pioglitazone
- Cardiovascular disease (CVD) 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 within the last six months prior to Visit 1
- Recurrent severe hypoglycaemia (more than one severe hypoglycaemic episode during the last 12 months), or hypoglycaemic unawareness as judged by the Investigator, or hospitalisation for diabetic ketoacidosis during the previous six months
- Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
- Previous participation in this trial. Participation is defined as started on trial medication. Rescreening of screening failures is allowed only once within the limits of the recruitment period
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 degludecIndividually adjusted insulin degludec administered three times weekly with continued unchanged pre-trial OAD (oral anti-diabetic drug) treatment for 12 weeks | Drug | IDeg 3TW |
| insulin glargineSubjects continue their pre-trial insulin glargine once daily plus OAD (oral anti-diabetic drug) treatment for four weeks before switch to insulin degludec | Drug | IGlar/IDeg |
Primary outcome
HbA1c (Glycosylated Haemoglobin)
Time frame: Week 4 and Week 16
HbA1C at week 4 and 16
5 secondary outcomes
Fasting Plasma Glucose (FPG)
Time frame: Week 4 and Week 16
Change in Body Weight
Time frame: Week 0, Week 4, Week 16
Rate of Treatment Emergent Adverse Events (AEs)
Time frame: Weeks 0-4 (IGlar), Weeks 4-16 (IDeg 3TW)
Rate of Confirmed Hypoglycaemic Episodes
Time frame: Weeks 0-4 (IGlar), Weeks 4-16 (IDeg 3TW)
Rate of Nocturnal Confirmed Hypoglycaemic Episodes
Time frame: Weeks 0-4 (IGlar), Weeks 4-16 (IDeg 3TW)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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
27 sites in 1 country: 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 27 sites in United States.
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 3 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 22 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States. 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 22 Jan 2016). 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?
HbA1c (Glycosylated Haemoglobin) (time frame: Week 4 and Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jan 2016.