DiabetesPhase 3onset® 3NCT01850615

Efficacy and Safety of FIAsp in a Basal-bolus Regimen Versus Basal Insulin Therapy, Both in Combination With Metformin in Adult Subjects With Type 2 Diabetes

A Phase 3 study testing Faster-acting insulin aspart and basal insulin in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 58 sites in 6 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 Asia, Europe, South America, and the United States of America (USA). The aim of the trial is to investigate efficacy and safety of FIAsp in a basal-bolus regimen versus basal insulin therapy, both in combination with metformin in adult subjects with type 2 diabetes. 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?: Faster-acting insulin aspart and basal insulin
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 323 participants
Where: 58 sitesin 6 countries
Study dates: 23 Sep 2013to 17 Nov 2014
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 (diagnosed clinically) for at least 6 months prior to the screening visit (Visit 1)
Current treatment with once daily insulin detemir, insulin glargine or human isophane insulin, NPH for at least 3 months prior to the screening visit (Visit 1)
Current treatment with a) metformin with unchanged dosing for at least 3 months prior to screening (visit 1). The metformin dose must be at least 1000 mg or b) metformin in combination with sulfonylurea (SU) or glinide or Dipeptidyl peptidase-IV inhibitors and/or alpha-glucosidase inhibitors (AGI) with unchanged dosing for at least 3 months prior to screening (visit 1). The metformin dose must be at least 1000 mg
HbA1c by central laboratory a) 7.5-9.5% (58 - 80 mmol/mol) (both inclusive) in the metformin group at the screening visit (Visit 1) or b) 7.5-9.0% (58 - 75 mmol/mol) (both inclusive) in the metformin + other oral antidiabetic drug (OAD) (sulphonylurea (SU), glinide, dipeptidyl peptidase-IV (DDP-IV) inhibitors, alpha-glucosidase inhibitors (AGI) combination group at the screening visit (Visit 1)
Body mass index (BMI) equal or less than 40.0 kg/m^2

Who cannot join

Any use of bolus insulin, except short-term use due to intermittent illness (no longer than 14 days of consecutive treatment) and not within 3 months prior to the screening visit (Visit 1)
Use of Glucagon-like peptide-1 (GLP-1) agonists and/or Thiazolidinediones (TZD) within the last 3 months prior to screening (visit 1)
Recurrent severe hypoglycaemia (more than one severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the Investigator, or hospitalisation for diabetic ketoacidosis during the previous 6 months prior to screening (Visit 1)

Trial locations and contacts

58 sites in 6 countries.

Country

City, postcode or hospital

58 sites in 6 countries

United States32 sites

Novo Nordisk Investigational Site
Asheboro, North Carolina, 27203
Novo Nordisk Investigational Site
Birmingham, Alabama, 35211
Novo Nordisk Investigational Site
Birmingham, Alabama, 35216
Novo Nordisk Investigational Site
Boston, Massachusetts, 02118
Novo Nordisk Investigational Site
Brooklyn, New York, 11229
Novo Nordisk Investigational Site
Cincinnati, Ohio, 45242
Novo Nordisk Investigational Site
Clearwater, Florida, 33765
Novo Nordisk Investigational Site
Colorado Springs, Colorado, 80907
Novo Nordisk Investigational Site
Colorado Springs, Colorado, 80922
Novo Nordisk Investigational Site
Conyers, Georgia, 30094-5965
Novo Nordisk Investigational Site
Downingtown, Pennsylvania, 19335-2620
Novo Nordisk Investigational Site
Fort Worth, Texas, 76132
Novo Nordisk Investigational Site
Greenville, South Carolina, 29605-4254
Novo Nordisk Investigational Site
Greer, South Carolina, 29651
Novo Nordisk Investigational Site
Henderson, Nevada, 89052
Novo Nordisk Investigational Site
Houston, Texas, 77025-1669
Novo Nordisk Investigational Site
Kalamazoo, Michigan, 49009
Novo Nordisk Investigational Site
Las Vegas, Nevada, 89120
Novo Nordisk Investigational Site
Little Rock, Arkansas, 72205
Novo Nordisk Investigational Site
Memphis, Tennessee, 38119-3821
Novo Nordisk Investigational Site
New Orleans, Louisiana, 70121
Novo Nordisk Investigational Site
Ogden, Utah, 84405
Novo Nordisk Investigational Site
Oklahoma City, Oklahoma, 73104
Novo Nordisk Investigational Site
Omaha, Nebraska, 68144
Novo Nordisk Investigational Site
Pembroke Pines, Florida, 33028
Novo Nordisk Investigational Site
Peoria, Arizona, 85381
Novo Nordisk Investigational Site
Reading, Pennsylvania, 19609
Novo Nordisk Investigational Site
Rockville, Maryland, 20852
Novo Nordisk Investigational Site
San Antonio, Texas, 78229
Novo Nordisk Investigational Site
Santa Ana, California, 92705
Novo Nordisk Investigational Site
Sugar Land, Texas, 77478
Novo Nordisk Investigational Site
Tarzana, California, 91356-3551

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India9 sites

Novo Nordisk Investigational Site
Bangalore, Karnataka, 560 017
Novo Nordisk Investigational Site
Chandigarh, Punjab, 160012
Novo Nordisk Investigational Site
Coimbatore, Tamil Nadu, 641018
Novo Nordisk Investigational Site
Hyderabad, Andhra Pradesh, 500034
Novo Nordisk Investigational Site
Hyderabad, Andhra Pradesh, 500082
Novo Nordisk Investigational Site
Mumbai, Maharashtra, 400007
Novo Nordisk Investigational Site
Mumbai, Maharashtra, 400058
Novo Nordisk Investigational Site
New Dehli, New Delhi, 110029
Novo Nordisk Investigational Site
Visakhapatnam, Andhra Pradesh, 530002

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Argentina5 sites

Novo Nordisk Investigational Site
Buenos Aires, C1250AAN
Novo Nordisk Investigational Site
Capital Federal, C1056ABJ
Novo Nordisk Investigational Site
Córdoba, X5006IKK
Novo Nordisk Investigational Site
Godoy Cruz, M5501ARP
Novo Nordisk Investigational Site
San Isidro, B1642DCD

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Romania5 sites

Novo Nordisk Investigational Site
Brasov, 500269
Novo Nordisk Investigational Site
Ploieşti, Prahova, 100097
Novo Nordisk Investigational Site
Suceava, 720237
Novo Nordisk Investigational Site
Târgu Mureş, Mureș County, 540142
Novo Nordisk Investigational Site
Timișoara, Timiș County, 300125

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Slovenia4 sites

Novo Nordisk Investigational Site
Brežice, 8250
Novo Nordisk Investigational Site
Koper, SI-6000
Novo Nordisk Investigational Site
Kranj, 4000
Novo Nordisk Investigational Site
Novo Mesto, 8000

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Mexico3 sites

Novo Nordisk Investigational Site
Guadalajara, Jalisco, 44150
Novo Nordisk Investigational Site
Guadalajara, Jalisco, 44650
Novo Nordisk Investigational Site
Mexico City, México, D.F., 03300

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About this study

This trial is conducted in Asia, Europe, South America, and the United States of America (USA).

The aim of the trial is to investigate efficacy and safety of FIAsp in a basal-bolus regimen versus basal insulin therapy, both in combination with metformin in adult subjects with type 2 diabetes.

Conditions: Diabetes, Diabetes Mellitus, Type 2
Being tested: Faster-acting insulin aspart, basal insulin
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.

Faster-acting insulin aspartDrug
Also called NN1218
Administrated subcutaneously (s.c., under the skin) at each main meal.
basal insulinDrug
Administrated subcutaneously (s.c., under the skin) once daily.

Study groups in NCT01850615
Study group	Role	What they receive
FIAsp and basal insulin + metformin	Experimental	Subjects will receive FIAsp combined with their pre-trial basal insulin (insulin human, insulin detemir or insulin glargine) treatment in combination with their pre-trial metformin. Receives: Drug: Faster-acting insulin aspart; Drug: basal insulin
Basal insulin + metformin	Active comparator	Subjects will continue their pre-trial basal insulin (insulin human, insulin detemir or insulin glargine) treatment in combination with their pre-trial metformin. Receives: Drug: basal insulin

What is being measured

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

Change From Baseline in HbA1c
For this endpoint, baseline (week 0) and week 18 data are presented, where week 18 data are the "end of trial" data containing last available measurements.
Measured: Week 0, week 18

Secondary outcomes (5)

Self-measured Plasma Glucose (SMPG) 7-point Profile: Post Prandial Plasma Glucose (PPG), Overall 2-hour Mean (of Breakfast, Lunch, Main Evening Meal)
For this endpoint the "end of trial" data containing last available measurements are presented. PPG measurements were recorded by the subjects at 2 hours after each meal (breakfast, lunch and main evening meal) as part of three 7-point profiles (SMPG) prior to the visits. Individual mean meal PPG (post-breakfast, post-lunch, post-main evening meal) was derived from the three measurements.
Measured: After 18 weeks of randomised treatment
Self-measured Plasma Glucose (SMPG) 7-point Profile: Prandial Plasma Glucose (PG) Increment, Overall 2-hour Mean (of Breakfast, Lunch, Main Evening Meal)
For this endpoint the "end of trial" data containing last available measurements are presented. Prandial PG increment for each meal (breakfast, lunch, main evening meal) was derived from the 7-point profiles (SMPG) as the difference between the PPG value 2 hours after each meal and the PG value before each meal. Individual mean meal PPG (post-breakfast, post-lunch, post-main evening meal) was derived from the three measurements.
Measured: After 18 weeks of randomised treatment
Change From Baseline in Body Weight
For this endpoint, baseline (week 0) and week 18 data are presented, where week 18 data are the "end of trial" data containing last available measurements.
Measured: Week 0, week 18
Number of Treatment Emergent Hypoglycaemic Episodes
Plasma glucose (PG) was measured and recorded when a hypoglycaemic episode was suspected. All PG values ≤3.9 mmol/L (70 mg/dL) or >3.9 mmol/L (70 mg/dL) when they occurred in conjunction with hypoglycaemic symptoms were recorded by the subject. Numbers of treatment emergent hypoglycaemic episodes were recorded during 18 weeks of treatment.
Measured: Weeks 0-18
Number of Adverse Events
All adverse events (AEs) described here refer to treatment emergent adverse events (TEAE). A TEAE was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment, week 18.
Measured: Weeks 0-18

Timeline

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

23 Sep 201317 Nov 2014

First posted9 May 2013 (estimated)
Study start23 Sep 2013
Primary completion17 Nov 2014
Study completion17 Nov 2014

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 (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: 323 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01850615
Sponsor's protocol ID: NN1218-4049
Other IDs: 2012-005583-10, U1111-1137-6242, CTRI/2014/01/004289
Acronym: onset® 3
Status last verified: May 2019
First submitted: 17 Apr 2013
Last updated: 12 Jun 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Peters AL, Piletic M, Ejstrud J, Salvesen-Sykes K, Snyder J, Bowering K. Baseline nocturnal glucose change: A predictor of the treatment effect of bolus intensification in insulin-treated type 2 diabetes. Diabetes Obes Metab. 2019 Jul;21(7):1752-1756. doi: 10.1111/dom.13729. Epub 2019 Apr 23.
PubMed 30924578
Rodbard HW, Tripathy D, Vidrio Velazquez M, Demissie M, Tamer SC, Piletic M. Adding fast-acting insulin aspart to basal insulin significantly improved glycaemic control in patients with type 2 diabetes: A randomized, 18-week, open-label, phase 3 trial (onset 3). Diabetes Obes Metab. 2017 Oct;19(10):1389-1396. doi: 10.1111/dom.12955. Epub 2017 Jul 6.
PubMed 28345792
Heller S, Bowering K, Raskin P, Liebl A, Buchholtz K, Gorst-Rasmussen A, Pieber TR. The effect of basal-bolus therapy varies with baseline 1,5-anhydroglucitol level in people with Type 2 diabetes: a post hoc analysis. Diabet Med. 2018 May 26;35(9):1273-8. doi: 10.1111/dme.13693. Online ahead of print.
PubMed 29802636
Bowering K, Rodbard HW, Russell-Jones D, Bode B, Harris S, Piletic M, Heller S, Woo V, Babu V, Dethlefsen C, Mathieu C. Investigating the Association Between Baseline Characteristics (HbA1c and Body Mass Index) and Clinical Outcomes of Fast-Acting Insulin Aspart in People with Diabetes: A Post Hoc Analysis. Diabetes Ther. 2019 Feb;10(1):177-188. doi: 10.1007/s13300-018-0553-7. Epub 2018 Dec 13.
PubMed 30547388

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?

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Study at a glance

From the registry record, last updated by the sponsor on 12 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety of FIAsp in a Basal-bolus Regimen Versus Basal Insulin Therapy, Both in Combination With Metformin in Adult Subjects With Type 2 Diabetes
ClinicalTrials.gov ID: NCT01850615
Acronym / sponsor ID: onset® 3 / NN1218-4049
Conditions: Diabetes, Diabetes Mellitus, Type 2
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 323 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: 23 Sep 2013 (actual)
Primary completion: 17 Nov 2014 (actual)
Study completion: 17 Nov 2014 (actual)
First posted: 9 May 2013 (estimated)
Results: Posted 17 Jan 2018

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 Asia, Europe, South America, and the United States of America (USA).

The aim of the trial is to investigate efficacy and safety of FIAsp in a basal-bolus regimen versus basal insulin therapy, both in combination with metformin in adult subjects with type 2 diabetes.

Study design

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

Arm	Type	Receives
FIAsp and basal insulin + metformin	Experimental	Drug: Faster-acting insulin aspart, Drug: basal insulinSubjects will receive FIAsp combined with their pre-trial basal insulin (insulin human, insulin detemir or insulin glargine) treatment in combination with their pre-trial metformin.
Basal insulin + metformin	Active comparator	Drug: basal insulinSubjects will continue their pre-trial basal insulin (insulin human, insulin detemir or insulin glargine) treatment in combination with their pre-trial metformin.

Who may qualify

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

Key inclusion criteria (5 listed)

Type 2 diabetes (diagnosed clinically) for at least 6 months prior to the screening visit (Visit 1)
Current treatment with once daily insulin detemir, insulin glargine or human isophane insulin, NPH for at least 3 months prior to the screening visit (Visit 1)
Current treatment with a) metformin with unchanged dosing for at least 3 months prior to screening (visit 1). The metformin dose must be at least 1000 mg or b) metformin in combination with sulfonylurea (SU) or glinide or Dipeptidyl peptidase-IV inhibitors and/or alpha-glucosidase inhibitors (AGI) with unchanged dosing for at least 3 months prior to screening (visit 1). The metformin dose must be at least 1000 mg
HbA1c by central laboratory a) 7.5-9.5% (58 - 80 mmol/mol) (both inclusive) in the metformin group at the screening visit (Visit 1) or b) 7.5-9.0% (58 - 75 mmol/mol) (both inclusive) in the metformin + other oral antidiabetic drug (OAD) (sulphonylurea (SU), glinide, dipeptidyl peptidase-IV (DDP-IV) inhibitors, alpha-glucosidase inhibitors (AGI) combination group at the screening visit (Visit 1)
Body mass index (BMI) equal or less than 40.0 kg/m^2

Key exclusion criteria (3 listed)

Any use of bolus insulin, except short-term use due to intermittent illness (no longer than 14 days of consecutive treatment) and not within 3 months prior to the screening visit (Visit 1)
Use of Glucagon-like peptide-1 (GLP-1) agonists and/or Thiazolidinediones (TZD) within the last 3 months prior to screening (visit 1)
Recurrent severe hypoglycaemia (more than one severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the Investigator, or hospitalisation for diabetic ketoacidosis during the previous 6 months prior to screening (Visit 1)

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
Faster-acting insulin aspartAlso: NN1218Administrated subcutaneously (s.c., under the skin) at each main meal.	Drug	FIAsp and basal insulin + metformin
basal insulinAdministrated subcutaneously (s.c., under the skin) once daily.	Drug	Basal insulin + metformin, FIAsp and basal insulin + metformin

Primary outcome

Change From Baseline in HbA1c
Time frame: Week 0, week 18
For this endpoint, baseline (week 0) and week 18 data are presented, where week 18 data are the "end of trial" data containing last available measurements.

5 secondary outcomes

Self-measured Plasma Glucose (SMPG) 7-point Profile: Post Prandial Plasma Glucose (PPG), Overall 2-hour Mean (of Breakfast, Lunch, Main Evening Meal)
Time frame: After 18 weeks of randomised treatment
Self-measured Plasma Glucose (SMPG) 7-point Profile: Prandial Plasma Glucose (PG) Increment, Overall 2-hour Mean (of Breakfast, Lunch, Main Evening Meal)
Time frame: After 18 weeks of randomised treatment
Change From Baseline in Body Weight
Time frame: Week 0, week 18
Number of Treatment Emergent Hypoglycaemic Episodes
Time frame: Weeks 0-18
Number of Adverse Events
Time frame: Weeks 0-18

Results and safety

Results posted to the registry on 17 Jan 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Faster Aspart + Basal	116	107
Basal	120	115

Primary outcome: Change From Baseline in HbA1c

Time frame: Week 0, week 18. Mean (Standard Deviation). Unit: Percentage of glycosylated haemoglobin

Measure	Faster Aspart + Basal n = 116	Basal n = 120
Baseline	7.93 (0.69)	7.92 (0.68)
Week 18	6.78 (0.92)	7.7 (0.93)

Faster Aspart + Basal vs Basal: Treatment difference: -0.94 (95% CI -1.17 to -0.72)

Population analysed: Full analysis set included all randomised subjects.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: During 18 weeks of randomised treatment period + 7 days of follow-up period.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Faster Aspart + Basal	6 of 115 (5.2%)	2 of 115 (1.7%)	Not reported
Basal	5 of 120 (4.2%)	6 of 120 (5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 30924578Peters AL, Piletic M, Ejstrud J, Salvesen-Sykes K, Snyder J, Bowering K. Baseline nocturnal glucose change: A predictor of the treatment effect of bolus intensification in insulin-treated type 2 diabetes. Diabetes Obes Metab. 2019 Jul;21(7):1752-1756. doi: 10.1111/dom.13729. Epub 2019 Apr 23.
Results publication: PubMed 28345792Rodbard HW, Tripathy D, Vidrio Velazquez M, Demissie M, Tamer SC, Piletic M. Adding fast-acting insulin aspart to basal insulin significantly improved glycaemic control in patients with type 2 diabetes: A randomized, 18-week, open-label, phase 3 trial (onset 3). Diabetes Obes Metab. 2017 Oct;19(10):1389-1396. doi: 10.1111/dom.12955. Epub 2017 Jul 6.
Results publication: PubMed 29802636Heller S, Bowering K, Raskin P, Liebl A, Buchholtz K, Gorst-Rasmussen A, Pieber TR. The effect of basal-bolus therapy varies with baseline 1,5-anhydroglucitol level in people with Type 2 diabetes: a post hoc analysis. Diabet Med. 2018 May 26;35(9):1273-8. doi: 10.1111/dme.13693. Online ahead of print.
Results publication: PubMed 30547388Bowering K, Rodbard HW, Russell-Jones D, Bode B, Harris S, Piletic M, Heller S, Woo V, Babu V, Dethlefsen C, Mathieu C. Investigating the Association Between Baseline Characteristics (HbA1c and Body Mass Index) and Clinical Outcomes of Fast-Acting Insulin Aspart in People with Diabetes: A Post Hoc Analysis. Diabetes Ther. 2019 Feb;10(1):177-188. doi: 10.1007/s13300-018-0553-7. Epub 2018 Dec 13.
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

58 sites in 6 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Faster-acting insulin aspart and basal insulin in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 58 sites in 6 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 3 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 12 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 58 sites in United States, India, Argentina, Romania, Slovenia and 1 more country. 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 17 Jan 2018). 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 From Baseline in HbA1c (time frame: Week 0, week 18). 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 NCT01850615, 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 12 Jun 2019.