DiabetesPhase 4EFFICACYNCT00909480

Effect of Insulin Detemir and Insulin Glargine on Blood Glucose Control in Subjects With Type 2 Diabetes

A Phase 4 study testing insulin detemir and insulin glargine in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 88 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, South America and the United States of America (USA). The aim of this clinical trial is to determine whether two insulin treatments given once daily are equally effective with respect to the blood glucose lowering effect in subjects with type 2 diabetes inadequately controlled on… 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 detemir and insulin glargine
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 457 participants
Where: 88 sitesin 6 countries
Study dates: May 2009to Jun 2010
Phase: Phase 4
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

Diagnosed with type 2 diabetes for at least 6 months
Stable treatment with a total daily dose of at least 1500 mg metformin or maximum tolerated dose (minimum 1000 mg) with or without one other OAD (sulphonylureas, meglitinides, thiazolidinediones or dipeptidyl peptidase-4 (DPP-4) inhibitors) for at least 3 months
Subject is insulin-naive (short-term insulin treatment of up to 14 days is allowed)
HbA1c (glycosylated haemoglobin) 7.0-9.0 % (both inclusive) by central laboratory analysis (one re-test within one week is allowed)
Body Mass Index (BMI) less than or equal to 35.0 kg/m^2

Who cannot join

Any contraindication to insulin detemir or insulin glargine according to the local labelling
Receipt of any investigational product within 4 weeks
Anticipated change of dose of any systemic treatment with products, which in the Investigator's opinion could interfere with glucose metabolism (e.g. systemic corticosteroids)
Clinically significant diseases which, in the Investigator's opinion may confound the results of the trial or pose additional risk in administering trial product
Any other condition that the Investigator feels would interfere with trial participation or evaluation of results

Trial locations and contacts

88 sites in 6 countries.

Country

City, postcode or hospital

88 sites in 6 countries

United States71 sites

Novo Nordisk Investigational Site
Altoona, Pennsylvania, 16602
Novo Nordisk Investigational Site
Anaheim, California, 92801
Novo Nordisk Investigational Site
Aurora, Colorado, 80045
Novo Nordisk Investigational Site
Buckley, Michigan, 49620
Novo Nordisk Investigational Site
Butte, Montana, 59701
Novo Nordisk Investigational Site
Cayahoga Falls, Ohio, 44223
Novo Nordisk Investigational Site
Charlotte, North Carolina, 28277
Novo Nordisk Investigational Site
Chattanooga, Tennessee, 37404
Novo Nordisk Investigational Site
Chattanooga, Tennessee, 37411
Novo Nordisk Investigational Site
Chesterfield, Missouri, 63017
Novo Nordisk Investigational Site
Cincinnati, Ohio, 45245
Novo Nordisk Investigational Site
Clarion, Pennsylvania, 16214
Novo Nordisk Investigational Site
Clilfton, New Jersey, 07011
Novo Nordisk Investigational Site
Concord, California, 94520
Novo Nordisk Investigational Site
Corpus Christi, Texas, 78404
Novo Nordisk Investigational Site
Dallas, Texas, 75230
Novo Nordisk Investigational Site
Dallas, Texas, 75246
Novo Nordisk Investigational Site
Dayton, Ohio, 45406
Novo Nordisk Investigational Site
Escondido, California, 92025
Novo Nordisk Investigational Site
Fresno, California, 93720
Novo Nordisk Investigational Site
Gallipolis, Ohio, 45631-1560
Novo Nordisk Investigational Site
Greensboro, North Carolina, 27408
Novo Nordisk Investigational Site
Greer, South Carolina, 29651
Novo Nordisk Investigational Site
Hollywood, Florida, 33021
Novo Nordisk Investigational Site
Houston, Texas, 77025
Novo Nordisk Investigational Site
Hurst, Texas, 76054
Novo Nordisk Investigational Site
Idaho Falls, Idaho, 83404-7596
Novo Nordisk Investigational Site
Independence, Kansas, 67301-3263
Novo Nordisk Investigational Site
Jacksonville, Florida, 32204
Novo Nordisk Investigational Site
Jacksonville, Florida, 32207
Novo Nordisk Investigational Site
Jefferson City, Missouri, 65109
Novo Nordisk Investigational Site
Lancaster, Pennsylvania, 17601
Novo Nordisk Investigational Site
Litchfield Park, Arizona, 85340
Novo Nordisk Investigational Site
Long Beach, California, 90822
Novo Nordisk Investigational Site
Los Angeles, California, 90057
Novo Nordisk Investigational Site
Martinsburg, West Virginia, 25401
Novo Nordisk Investigational Site
Miami, Florida, 33136
Novo Nordisk Investigational Site
Miami, Florida, 33143
Novo Nordisk Investigational Site
Milwaukee, Wisconsin, 53209
Novo Nordisk Investigational Site
Norristown, Pennsylvania, 19401
Novo Nordisk Investigational Site
Northport, New York, 11768
Novo Nordisk Investigational Site
Norwalk, Connecticut, 06851
Novo Nordisk Investigational Site
Ocala, Florida, 34471
Novo Nordisk Investigational Site
Odessa, Texas, 79761
Novo Nordisk Investigational Site
Orlando, Florida, 32804
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, 19104
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, 19107
Novo Nordisk Investigational Site
Plantation, Florida, 33324
Novo Nordisk Investigational Site
Ponte Vedra, Florida, 32081
Novo Nordisk Investigational Site
Portland, Maine, 04101
Novo Nordisk Investigational Site
Powder Springs, Georgia, 30127
Novo Nordisk Investigational Site
Redlands, California, 92374
Novo Nordisk Investigational Site
Renton, Washington, 98057
Novo Nordisk Investigational Site
Rockville, Maryland, 20852
Novo Nordisk Investigational Site
Roswell, Georgia, 30076
Novo Nordisk Investigational Site
San Antonio, Texas, 78209
Novo Nordisk Investigational Site
Santa Ana, California, 92705
Novo Nordisk Investigational Site
Searcy, Arkansas, 72143
Novo Nordisk Investigational Site
Shawnee Mission, Kansas, 66204
Novo Nordisk Investigational Site
Spartanburg, South Carolina, 29303
Novo Nordisk Investigational Site
Spring Valley, California, 91978
Novo Nordisk Investigational Site
St Louis, Missouri, 63141
Novo Nordisk Investigational Site
St. George, Utah, 84790
Novo Nordisk Investigational Site
Staten Island, New York, 10301
Novo Nordisk Investigational Site
Syracuse, New York, 13210
Novo Nordisk Investigational Site
Taylors, South Carolina, 29687
Novo Nordisk Investigational Site
Tulsa, Oklahoma, 74104
Novo Nordisk Investigational Site
Virginia Beach, Virginia, 23462
Novo Nordisk Investigational Site
Waltham, Massachusetts, 02453
Novo Nordisk Investigational Site
Winston-Salem, North Carolina, 27103
Novo Nordisk Investigational Site
Winter Haven, Florida, 33880

Other trials in United States

Argentina4 sites

Novo Nordisk Investigational Site
Buenos Aires, B1704ETD
Novo Nordisk Investigational Site
Capital Federal, 1405
Novo Nordisk Investigational Site
Capital Federal, 1429
Novo Nordisk Investigational Site
Mar del Plata, B7600FZN

Other trials in Argentina

South Korea4 sites

Novo Nordisk Investigational Site
Seoul, 110-746
Novo Nordisk Investigational Site
Seoul, 130-701
Novo Nordisk Investigational Site
Seoul, 138-736
Novo Nordisk Investigational Site
Seoul, 139-707

Other trials in South Korea

Thailand4 sites

Novo Nordisk Investigational Site
Bangkok, 10110
Novo Nordisk Investigational Site
Bangkok, 10330
Novo Nordisk Investigational Site
Bangkok, 10400
Novo Nordisk Investigational Site
Pathum Thani, 12120

Other trials in Thailand

India3 sites

Novo Nordisk Investigational Site
Bangalore, Karnataka, 560 017
Novo Nordisk Investigational Site
Chennai, Tamil Nadu, 600028
Novo Nordisk Investigational Site
Thriruvananthapuram, 695 032

Other trials in India

Puerto Rico2 sites

Novo Nordisk Investigational Site
Manati, 00674
Novo Nordisk Investigational Site
Trujillo Alto, 00976

Other trials in Puerto Rico

About this study

Official title: A 26 Week Randomised, Multinational, Open Labelled, 2 Armed, Parallel Group, Treat-to-target Once Daily Treatment Trial With Insulin Detemir Versus Insulin Glargine, Both in Combination With Metformin in Subjects With Type 2 Diabetes

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

The aim of this clinical trial is to determine whether two insulin treatments given once daily are equally effective with respect to the blood glucose lowering effect in subjects with type 2 diabetes inadequately controlled on metformin treatment with or without an additional anti-diabetic drug (OAD).

Conditions: Diabetes, Diabetes Mellitus, Type 2
Being tested: insulin detemir, 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 detemirDrug
Treat-to-target (individually adjusted dose) titration according to titration algorithm.
S.c. (under the skin) injection once daily as an add-on to subjects' stable pre-trial metformin dose (at least 1500 mg/day). Any other use of OAD will be discontinued
insulin glargineDrug
Treat-to-target (individually adjusted dose) titration according to titration algorithm.
S.c. (under the skin) injection once daily as an add-on to subjects' stable pre-trial metformin dose (at least 1500 mg/day). Any other use of OAD will be discontinued

Study groups in NCT00909480
Study group	Role	What they receive
IDet	Experimental	Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day Receives: Drug: insulin detemir
IGlar	Active comparator	Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day Receives: Drug: insulin glargine

What is being measured

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

Change in HbA1c From Baseline
Measured: Week 0, Week 26

Secondary outcomes (13)

Percentage of Subjects Achieving HbA1c Less Than or Equal to 7.0%
The percentage of subjects - overall and by previous OAD treatment - meeting the HbA1c less than or equal to 7%
Measured: Week 26
Percentage of Subjects Achieving HbA1c of 7% or Less With no Hypoglycaemia
The subjects must have reached target and not have experienced any confirmed symptomatic hypoglycaemia or any confirmed major hypoglycaemia within the last 30 days of treatment.
Measured: Week 26
Percentage of Subjects Achieving HbA1c Less Than or Equal to 6.5%
The percentage of subjects - overall and by previous OAD treatment - meeting the HbA1c of 6.5% or less
Measured: Week 26
Percentage of Subjects Achieving HbA1c of 6.5% or Less With no Hypoglycaemia
The subjects must have reached target and not have experienced any confirmed symptomatic hypoglycaemia or any confirmed major hypoglycaemia within the last 30 days of treatment.
Measured: Week 26
Fasting Plasma Glucose (FPG)
Measured: Week 26
Within-subject Variation of Self Measured Plasma Glucose (SMPG) Before Breakfast
The median values of the sample standard variation (the within subject variation) within the IDet and IGlar arms were plotted against time.
Measured: Week 26
Glycaemic Control as Measured by Plasma Glucose (9-point Self-measured Profiles)
Plasma glucose measured: before breakfast, 2 hours after breakfast, before lunch, 2 hours after lunch, before dinner, 2 hours after dinner, bedtime and at 3 am.
Measured: Week 26
Incidence of Hypoglycaemic Episodes During the Trial
Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.
Measured: Weeks 0-26
Hypoglycaemic Episodes, Diurnal
Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.
Measured: Weeks 0-26
Hypoglycaemic Episodes, Nocturnal
Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.
Measured: Weeks 0-26
Hypoglycemic Episodes, Unclassifiable
Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.
Measured: Weeks 0-26
Change in Body Weight From Baseline
Measured: Week 0, Week 26
Number of Subjects Having the Adverse Event "Incorrect Dose Administered"
Number of subjects having the adverse event "incorrect dose administered" within the system organ class "Injury, poisoning and procedural complications"
Measured: Weeks 0-26

Timeline

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

May 2009Jun 2010

First posted28 May 2009 (estimated)
Study startMay 2009
Primary completionJun 2010
Study completionJun 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 (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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 457 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00909480
Sponsor's protocol ID: NN304-1768
Acronym: EFFICACY
Status last verified: Jan 2017
First submitted: 27 May 2009
Last updated: 10 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Meneghini L, Kesavadev J, Demissie M, Nazeri A, Hollander P. Once-daily initiation of basal insulin as add-on to metformin: a 26-week, randomized, treat-to-target trial comparing insulin detemir with insulin glargine in patients with type 2 diabetes. Diabetes Obes Metab. 2013 Aug;15(8):729-36. doi: 10.1111/dom.12083. Epub 2013 Mar 13.
PubMed 23421331

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 10 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 26 Week Randomised, Multinational, Open Labelled, 2 Armed, Parallel Group, Treat-to-target Once Daily Treatment Trial With Insulin Detemir Versus Insulin Glargine, Both in Combination With Metformin in Subjects With Type 2 Diabetes
ClinicalTrials.gov ID: NCT00909480
Acronym / sponsor ID: EFFICACY / NN304-1768
Conditions: Diabetes, Diabetes Mellitus, Type 2
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 457 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: May 2009
Primary completion: Jun 2010 (actual)
Study completion: Jun 2010 (actual)
First posted: 28 May 2009 (estimated)
Results: Posted 27 Sep 2011

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

Study design

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

Arm	Type	Receives
IDet	Experimental	Drug: insulin detemirIndividually adjusted insulin detemir once daily + metformin at least 1500 mg/day
IGlar	Active comparator	Drug: insulin glargineIndividually adjusted insulin glargine once daily + metformin at least 1500 mg/day

Who may qualify

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

Key inclusion criteria (5 listed)

Diagnosed with type 2 diabetes for at least 6 months
Stable treatment with a total daily dose of at least 1500 mg metformin or maximum tolerated dose (minimum 1000 mg) with or without one other OAD (sulphonylureas, meglitinides, thiazolidinediones or dipeptidyl peptidase-4 (DPP-4) inhibitors) for at least 3 months
Subject is insulin-naive (short-term insulin treatment of up to 14 days is allowed)
HbA1c (glycosylated haemoglobin) 7.0-9.0 % (both inclusive) by central laboratory analysis (one re-test within one week is allowed)
Body Mass Index (BMI) less than or equal to 35.0 kg/m^2

Key exclusion criteria (5 listed)

Any contraindication to insulin detemir or insulin glargine according to the local labelling
Receipt of any investigational product within 4 weeks
Anticipated change of dose of any systemic treatment with products, which in the Investigator's opinion could interfere with glucose metabolism (e.g. systemic corticosteroids)
Clinically significant diseases which, in the Investigator's opinion may confound the results of the trial or pose additional risk in administering trial product
Any other condition that the Investigator feels would interfere with trial participation or evaluation of results

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 detemirTreat-to-target (individually adjusted dose) titration according to titration algorithm. S.c. (under the skin) injection once daily as an add-on to subjects' stable pre-trial metformin dose (at least 1500 mg/day). Any other use of OAD will be discontinued	Drug	IDet
insulin glargineTreat-to-target (individually adjusted dose) titration according to titration algorithm. S.c. (under the skin) injection once daily as an add-on to subjects' stable pre-trial metformin dose (at least 1500 mg/day). Any other use of OAD will be discontinued	Drug	IGlar

Primary outcome

Change in HbA1c From Baseline
Time frame: Week 0, Week 26

13 secondary outcomes

Percentage of Subjects Achieving HbA1c Less Than or Equal to 7.0%
Time frame: Week 26
Percentage of Subjects Achieving HbA1c of 7% or Less With no Hypoglycaemia
Time frame: Week 26
Percentage of Subjects Achieving HbA1c Less Than or Equal to 6.5%
Time frame: Week 26
Percentage of Subjects Achieving HbA1c of 6.5% or Less With no Hypoglycaemia
Time frame: Week 26
Fasting Plasma Glucose (FPG)
Time frame: Week 26
Within-subject Variation of Self Measured Plasma Glucose (SMPG) Before Breakfast
Time frame: Week 26
Glycaemic Control as Measured by Plasma Glucose (9-point Self-measured Profiles)
Time frame: Week 26
Incidence of Hypoglycaemic Episodes During the Trial
Time frame: Weeks 0-26
Hypoglycaemic Episodes, Diurnal
Time frame: Weeks 0-26
Hypoglycaemic Episodes, Nocturnal
Time frame: Weeks 0-26
Hypoglycemic Episodes, Unclassifiable
Time frame: Weeks 0-26
Change in Body Weight From Baseline
Time frame: Week 0, Week 26
Number of Subjects Having the Adverse Event "Incorrect Dose Administered"
Time frame: Weeks 0-26

Results and safety

Results posted to the registry on 27 Sep 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
IDet	228	190
IGlar	229	188

Primary outcome: Change in HbA1c From Baseline

Time frame: Week 0, Week 26. Mean (Standard Deviation). Unit: percentage point change

Measure	IDet n = 209	IGlar n = 203
Value	-0.48 (0.94)	-0.74 (0.76)

IDet vs IGlar: Mean Difference (Net): 0.3003 (95% CI 0.1427 to 0.4580), ANCOVA

Population analysed: Full analysis set: All randomised subjects exposed to at least one dose of trial product categorised by randomised treatment.

13 secondary outcomes are reported in the full results.

Adverse events

Time frame: Weeks 0-26. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
IDet	7 of 226 (3.1%)	26 of 226 (11.5%)	Not reported
IGlar	12 of 227 (5.3%)	18 of 227 (7.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 23421331Meneghini L, Kesavadev J, Demissie M, Nazeri A, Hollander P. Once-daily initiation of basal insulin as add-on to metformin: a 26-week, randomized, treat-to-target trial comparing insulin detemir with insulin glargine in patients with type 2 diabetes. Diabetes Obes Metab. 2013 Aug;15(8):729-36. doi: 10.1111/dom.12083. Epub 2013 Mar 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

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing insulin detemir and insulin glargine in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 88 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 5 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 10 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 88 sites in United States, Argentina, South Korea, Thailand, India 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 27 Sep 2011). 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 HbA1c From Baseline (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 NCT00909480, 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 10 Mar 2017.