Diabetes Mellitus, Type 2Phase 2NCT01012037

Linagliptin 2.5 mg Twice Daily Versus 5 mg Once Daily as add-on Therapy to Twice Daily Metformin in Type 2 Diabetes

A Phase 2 study testing linagliptin low dose and linagliptin medium dose in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 84 sites in 9 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

The objective of the study is to investigate the efficacy and safety of linagliptin 2.5 mg twice daily compared to 5 mg once daily compared to placebo given orally for 12 weeks as add-on therapy to metformin in patients with type 2 diabetes mellitus with insufficient glycaemic control. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: linagliptin low dose and linagliptin medium dose
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 491 participants
Where: 84 sitesin 9 countries
Study dates: Nov 2009to Sep 2010
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 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis of type 2 diabetes mellitus.
Current treatment with metformin alone (>/= 1500 mg or maximally tolerated dose) or metformin plus 1 other antidiabetic drug. Metformin must be administered in twice daily dosing regimen. Patients taking metformin three times daily can be included if posology is switched to twice daily and total daily dose is maintained.
Glycosylated haemoglobin (HbA1c) is between 7.0% - 10.0%.
Body Mass Index (BMI) </=45 kg/m2.

Who cannot join

Treatment with extended release metformin.
Uncontrolled hyperglycaemia (fasting plasma glucose > 240 mg/dL or 13.3 mmol/L).
Myocardial infarction (MI), stroke or transient ischaemic attack (TIA) within 6 months prior to informed consent.
Impaired hepatic or renal function, or gastric bypass surgery.
Treatment with glitazones, glucagon like peptide-1 (GLP-1) analogues/mimetics, antiobesity agents, or insulin within 3 months of informed consent.
Current treatment with systemic steroids or change in dosage of thyroid hormones.

Show all 9Show fewer

Alcohol or drug abuse within 3 months of informed consent.
Participation in another trial with investigational drug within 2 months prior to informed consent.
Pre-menopausal women who are nursing, pregnant or not practicing an acceptable method of birth control.

Trial locations and contacts

84 sites in 9 countries.

Country

City, postcode or hospital

84 sites in 9 countries

France21 sites

1218.62.3303C Boehringer Ingelheim Investigational Site
Bort-les-Orgues
1218.62.3306A Boehringer Ingelheim Investigational Site
Bourg Des Cptes
1218.62.3303D Boehringer Ingelheim Investigational Site
Bugeat
1218.62.3302H Boehringer Ingelheim Investigational Site
Corsept
1218.62.3308A Boehringer Ingelheim Investigational Site
Derval
1218.62.3302B Boehringer Ingelheim Investigational Site
La Chapelle-sur-Erdre
1218.62.3304A Boehringer Ingelheim Investigational Site
Levallois-Perret
1218.62.3305A Boehringer Ingelheim Investigational Site
Marseille
1218.62.3305B Boehringer Ingelheim Investigational Site
Marseille
1218.62.3305G Boehringer Ingelheim Investigational Site
Marseille
1218.62.3305H Boehringer Ingelheim Investigational Site
Marseille
1218.62.3301A Boehringer Ingelheim Investigational Site
Nantes
1218.62.3302A Boehringer Ingelheim Investigational Site
Nantes
1218.62.3304B Boehringer Ingelheim Investigational Site
Paris
1218.62.3304D Boehringer Ingelheim Investigational Site
Paris
1218.62.3305F Boehringer Ingelheim Investigational Site
Roquevaire
1218.62.3305I Boehringer Ingelheim Investigational Site
Roquevaire
1218.62.3303A Boehringer Ingelheim Investigational Site
Rosiers-d'Égletons
1218.62.3303H Boehringer Ingelheim Investigational Site
Sainte-Fortunade
1218.62.3302I Boehringer Ingelheim Investigational Site
Sautron
1218.62.3302G Boehringer Ingelheim Investigational Site
Vue

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Canada14 sites

1218.62.11001 Boehringer Ingelheim Investigational Site
Barrie, Ontario
1218.62.11003 Boehringer Ingelheim Investigational Site
Brampton, Ontario
1218.62.11007 Boehringer Ingelheim Investigational Site
Burnaby, British Columbia
1218.62.11012 Boehringer Ingelheim Investigational Site
Calgary, Alberta
1218.62.11010 Boehringer Ingelheim Investigational Site
Charlottetown, Prince Edward Island
1218.62.11006 Boehringer Ingelheim Investigational Site
Halifax, Nova Scotia
1218.62.11004 Boehringer Ingelheim Investigational Site
Markham, Ontario
1218.62.11002 Boehringer Ingelheim Investigational Site
Montreal, Quebec
1218.62.11009 Boehringer Ingelheim Investigational Site
Point Claire, Quebec
1218.62.11005 Boehringer Ingelheim Investigational Site
Sarnia, Ontario
1218.62.11008 Boehringer Ingelheim Investigational Site
Smiths Falls, Ontario
1218.62.11011 Boehringer Ingelheim Investigational Site
St. John's, Newfoundland and Labrador
1218.62.11013 Boehringer Ingelheim Investigational Site
Strathroy, Ontario
1218.62.11014 Boehringer Ingelheim Investigational Site
Toronto, Ontario

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Italy10 sites

1218.62.39010 Boehringer Ingelheim Investigational Site
Ancona
1218.62.39006 Boehringer Ingelheim Investigational Site
Catania
1218.62.39004 Boehringer Ingelheim Investigational Site
Genova
1218.62.39009 Boehringer Ingelheim Investigational Site
Gissi (CH)
1218.62.39003 Boehringer Ingelheim Investigational Site
Palermo
1218.62.39001 Boehringer Ingelheim Investigational Site
Pisa
1218.62.39002 Boehringer Ingelheim Investigational Site
Pordenone
1218.62.39012 Boehringer Ingelheim Investigational Site
Ravenna
1218.62.39007 Boehringer Ingelheim Investigational Site
Roma
1218.62.39011 Boehringer Ingelheim Investigational Site
Roma

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Belgium8 sites

1218.62.32003 Boehringer Ingelheim Investigational Site
De Pinte
1218.62.32008 Boehringer Ingelheim Investigational Site
Kortenaken
1218.62.32009 Boehringer Ingelheim Investigational Site
Kumtich
1218.62.32005 Boehringer Ingelheim Investigational Site
Massemen-Wetteren
1218.62.32004 Boehringer Ingelheim Investigational Site
Natoye
1218.62.32007 Boehringer Ingelheim Investigational Site
Sint-Job-in't-Goor
1218.62.32002 Boehringer Ingelheim Investigational Site
Tessenderlo
1218.62.32006 Boehringer Ingelheim Investigational Site
Wilsele

Other trials in Belgium

Netherlands8 sites

1218.62.31007 Boehringer Ingelheim Investigational Site
Almere Stad
1218.62.31004 Boehringer Ingelheim Investigational Site
Breezerveld
1218.62.31005 Boehringer Ingelheim Investigational Site
Etten-Leur
1218.62.31002 Boehringer Ingelheim Investigational Site
Lieshout
1218.62.31001 Boehringer Ingelheim Investigational Site
Oude Pekela
1218.62.31008 Boehringer Ingelheim Investigational Site
Voerendaal
1218.62.31009 Boehringer Ingelheim Investigational Site
Wildervank
1218.62.31003 Boehringer Ingelheim Investigational Site
Woerden

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Spain7 sites

1218.62.34003 Boehringer Ingelheim Investigational Site
Badia Del Vallés (Barcelona)
1218.62.34002 Boehringer Ingelheim Investigational Site
L'Hospitalet de Llobregat (Barcelona)
1218.62.34005 Boehringer Ingelheim Investigational Site
Madrid
1218.62.34006 Boehringer Ingelheim Investigational Site
Madrid
1218.62.34007 Boehringer Ingelheim Investigational Site
Madrid
1218.62.34001 Boehringer Ingelheim Investigational Site
Palma (Mallorca)
1218.62.34008 Boehringer Ingelheim Investigational Site
Palma de Mallorca

Other trials in Spain

South Korea6 sites

1218.62.82005 Boehringer Ingelheim Investigational Site
Goyang
1218.62.82006 Boehringer Ingelheim Investigational Site
Goyang
1218.62.82003 Boehringer Ingelheim Investigational Site
Incheon
1218.62.82004 Boehringer Ingelheim Investigational Site
Pucheon
1218.62.82002 Boehringer Ingelheim Investigational Site
Seoul
1218.62.82001 Boehringer Ingelheim Investigational Site
Suwon

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India5 sites

1218.62.91001 Boehringer Ingelheim Investigational Site
Bangalore
1218.62.91004 Boehringer Ingelheim Investigational Site
Bangalore
1218.62.91003 Boehringer Ingelheim Investigational Site
Hyderabad, Andra Pradesh
1218.62.91005 Boehringer Ingelheim Investigational Site
Nagpru
1218.62.91002 Boehringer Ingelheim Investigational Site
Trivandrum

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Malaysia5 sites

1218.62.60002 Boehringer Ingelheim Investigational Site
George Town
1218.62.60001 Boehringer Ingelheim Investigational Site
Kelantan Kota Bahru
1218.62.60005 Boehringer Ingelheim Investigational Site
Kuala Lumpur
1218.62.60003 Boehringer Ingelheim Investigational Site
Putrajaya
1218.62.60004 Boehringer Ingelheim Investigational Site
Seremban

Other trials in Malaysia

About this study

Official title: 12 Week Randomised Double-blind BI 1356 2.5 mg Bid vs 5 mg qd add-on to Metformin

Conditions: Diabetes Mellitus, Type 2
Being tested: linagliptin low dose, placebo, linagliptin medium dose
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

linagliptin low doseDrug
patient to receive tablets containing low dose linagliptin twice daily
placeboDrug
patient to receive placebo tablet(s) matching linagliptin
linagliptin medium doseDrug
patient to receive a tablet containing medium dose linagliptin once daily

Study groups in NCT01012037
Study group	Role	What they receive
linagliptin low dose	Experimental	linagliptin low dose twice daily Receives: Drug: linagliptin low dose
placebo	Placebo comparator	placebo matching linagliptin Receives: Drug: placebo
linagliptin medium dose	Experimental	linagliptin medium dose once daily Receives: Drug: linagliptin medium dose

What is being measured

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

HbA1c Change From Baseline at Week 12
HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the baseline HbA1c percent. Treatment means are adjusted for baseline HbA1c and use of prior oral antidiabetics (OADs) in addition to background metformin.
Measured: Baseline and week 12

Secondary outcomes (9)

HbA1c Change From Baseline at Week 6 From Mixed Model Repeated Measures (MMRM) Analysis
Mixed model includes treatment, baseline HbA1c, use of prior oral antidiabetics (OADs) in addition to background metformin, week repeated within patient, week by treatment interaction.
Measured: Baseline and week 6
HbA1c Change From Baseline at Week 12 From Mixed Model Repeated Measures (MMRM) Analysis
Mixed model includes treatment, baseline HbA1c, use of prior oral antidiabetics (OADs) in addition to background metformin, week repeated within patient, week by treatment interaction.
Measured: Baseline and week 12
FPG Change From Baseline at Week 12
Change from baseline reflects the Week 12 FPG minus the baseline FPG. Treatment means are adjusted for baseline HbA1c, baseline fasting plasma glucose and use of prior oral antidiabetics (OADs) in addition to background metformin.
Measured: Baseline and week 12
FPG Change From Baseline at Week 6 From Mixed Model Repeated Measures (MMRM) Analysis
Mixed model includes treatment, baseline HbA1c, baseline FPG, use of prior oral antidiabetics (OADs) in addition to background metformin, week repeated within patient, week by treatment interaction.
Measured: Baseline and week 6
FPG Change From Baseline at Week 12 From Mixed Model Repeated Measures (MMRM) Analysis
Mixed model includes treatment, baseline HbA1c, baseline FPG, use of prior oral antidiabetics (OADs) in addition to background metformin, week repeated within patient, week by treatment interaction.
Measured: Baseline and week 12
Percentage of Patients With HbA1c Lowering by 0.5% or More at Week 12
Percentage of patients with HbA1c lowering by at least 0.5% after 12 weeks. The analysis was performed on the full analysis set (FAS) using NCF.
Measured: Week 12
Percentage of Patients With Rescue Therapy
Percentage of patients with rescue therapy at Week 12. The analysis was performed on the full analysis set (FAS) using OC.
Measured: 12 weeks
The Occurrence of a Treat to Target Efficacy Response (HbA1c <7.0%) After 12 Weeks of Treatment
Percentage of those patients with baseline HbA1c >= 7.0% who had HbA1c < 7% at Week 12. The analysis was performed on the full analysis set (FAS) using NCF.
Measured: 12 weeks
The Occurrence of a Treat to Target Efficacy Response (HbA1c <6.5 %) After 12 Weeks of Treatment
Percentage of those patients with baseline HbA1c >= 6.5% who had HbA1c < 6.5% at Week 12. The analysis was performed on the full analysis set (FAS) using NCF.
Measured: 12 weeks

Timeline

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

Nov 2009Sep 2010

First posted11 Nov 2009 (estimated)
Study startNov 2009
Primary completionSep 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 Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe 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: Double blind
Enrolment: 491 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01012037
Sponsor's protocol ID: 1218.62
Other IDs: 2009-013549-27, 2009
Status last verified: Dec 2013
First submitted: 10 Nov 2009
Last updated: 27 Jun 2014
Results posted: Yes, on ClinicalTrials.gov

Publications

Ross SA, Rafeiro E, Meinicke T, Toorawa R, Weber-Born S, Woerle HJ. Efficacy and safety of linagliptin 2.5 mg twice daily versus 5 mg once daily in patients with type 2 diabetes inadequately controlled on metformin: a randomised, double-blind, placebo-controlled trial. Curr Med Res Opin. 2012 Sep;28(9):1465-74. doi: 10.1185/03007995.2012.714360. Epub 2012 Aug 13.
PubMed 22816729

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 27 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 12 Week Randomised Double-blind BI 1356 2.5 mg Bid vs 5 mg qd add-on to Metformin
ClinicalTrials.gov ID: NCT01012037
Acronym / sponsor ID: 1218.62
Conditions: Diabetes Mellitus, Type 2
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 491 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Nov 2009
Primary completion: Sep 2010 (actual)
First posted: 11 Nov 2009 (estimated)
Results: Posted 31 Oct 2011

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: Double blind
Number of arms: 3

Arm	Type	Receives
linagliptin low dose	Experimental	Drug: linagliptin low doselinagliptin low dose twice daily
placebo	Placebo comparator	Drug: placeboplacebo matching linagliptin
linagliptin medium dose	Experimental	Drug: linagliptin medium doselinagliptin medium dose once daily

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Diagnosis of type 2 diabetes mellitus.
Current treatment with metformin alone (>/= 1500 mg or maximally tolerated dose) or metformin plus 1 other antidiabetic drug. Metformin must be administered in twice daily dosing regimen. Patients taking metformin three times daily can be included if posology is switched to twice daily and total daily dose is maintained.
Glycosylated haemoglobin (HbA1c) is between 7.0% - 10.0%.
Body Mass Index (BMI) </=45 kg/m2.

Key exclusion criteria (9 listed)

Treatment with extended release metformin.
Uncontrolled hyperglycaemia (fasting plasma glucose > 240 mg/dL or 13.3 mmol/L).
Myocardial infarction (MI), stroke or transient ischaemic attack (TIA) within 6 months prior to informed consent.
Impaired hepatic or renal function, or gastric bypass surgery.
Treatment with glitazones, glucagon like peptide-1 (GLP-1) analogues/mimetics, antiobesity agents, or insulin within 3 months of informed consent.

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
linagliptin low dosepatient to receive tablets containing low dose linagliptin twice daily	Drug	linagliptin low dose
placebopatient to receive placebo tablet(s) matching linagliptin	Drug	placebo
linagliptin medium dosepatient to receive a tablet containing medium dose linagliptin once daily	Drug	linagliptin medium dose

Primary outcome

HbA1c Change From Baseline at Week 12
Time frame: Baseline and week 12
HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the baseline HbA1c percent. Treatment means are adjusted for baseline HbA1c and use of prior oral antidiabetics (OADs) in addition to background metformin.

9 secondary outcomes

HbA1c Change From Baseline at Week 6 From Mixed Model Repeated Measures (MMRM) Analysis
Time frame: Baseline and week 6
HbA1c Change From Baseline at Week 12 From Mixed Model Repeated Measures (MMRM) Analysis
Time frame: Baseline and week 12
FPG Change From Baseline at Week 12
Time frame: Baseline and week 12
FPG Change From Baseline at Week 6 From Mixed Model Repeated Measures (MMRM) Analysis
Time frame: Baseline and week 6
FPG Change From Baseline at Week 12 From Mixed Model Repeated Measures (MMRM) Analysis
Time frame: Baseline and week 12
Percentage of Patients With HbA1c Lowering by 0.5% or More at Week 12
Time frame: Week 12
Percentage of Patients With Rescue Therapy
Time frame: 12 weeks
The Occurrence of a Treat to Target Efficacy Response (HbA1c <7.0%) After 12 Weeks of Treatment
Time frame: 12 weeks
The Occurrence of a Treat to Target Efficacy Response (HbA1c <6.5 %) After 12 Weeks of Treatment
Time frame: 12 weeks

Results and safety

Results posted to the registry on 31 Oct 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
Placebo	44	43
Lina 2.5 Twice Daily (Bid)	223	207
Lina 5 Once Daily (qd)	224	214

Primary outcome: HbA1c Change From Baseline at Week 12

Time frame: Baseline and week 12. Mean (Standard Error). Unit: percent

Measure	Placebo n = 43	Lina 2.5 Twice Daily (Bid) n = 214	Lina 5 Once Daily (qd) n = 221
Value	0.28 (0.11)	-0.46 (0.05)	-0.52 (0.05)

Placebo vs Lina 2.5 Twice Daily (Bid): Mean Difference (Final Values): -0.74 (95% CI -0.97 to -0.52), p <0.0001, ANCOVA
Placebo vs Lina 5 Once Daily (qd): Mean Difference (Final Values): -0.80 (95% CI -1.02 to -0.58), p <0.0001, ANCOVA
Lina 2.5 Twice Daily (Bid) vs Lina 5 Once Daily (qd): Mean Difference (Final Values): 0.06 (95% CI -0.07 to 0.19), ANCOVA

Population analysed: The Full Analysis Set (FAS) included all treated patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: up to 12 weeks (drug stop) + 7 days (follow-up). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 44 (0%)	0 of 44 (0%)	Not reported
Lina 2.5 Twice Daily (Bid)	9 of 223 (4%)	0 of 223 (0%)	Not reported
Lina 5 Once Daily (qd)	5 of 224 (2.2%)	0 of 224 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 22816729Ross SA, Rafeiro E, Meinicke T, Toorawa R, Weber-Born S, Woerle HJ. Efficacy and safety of linagliptin 2.5 mg twice daily versus 5 mg once daily in patients with type 2 diabetes inadequately controlled on metformin: a randomised, double-blind, placebo-controlled trial. Curr Med Res Opin. 2012 Sep;28(9):1465-74. doi: 10.1185/03007995.2012.714360. Epub 2012 Aug 13.
Related InfoLink 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.

Boehringer Ingelheim study chair

Boehringer Ingelheim

84 sites in 9 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing linagliptin low dose and linagliptin medium dose in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 84 sites in 9 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 4 inclusion and 9 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 27 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 84 sites in France, Canada, Italy, Belgium, Netherlands and 4 more countries. 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. Some participants in this study may receive a placebo. 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 31 Oct 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?

HbA1c Change From Baseline at Week 12 (time frame: Baseline and week 12). 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 NCT01012037, 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 27 Jun 2014; AzTrials last refreshed its copy on 6 Nov 2026.