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Diabetes Mellitus, Type 2Phase 3NCT01106677

The CANTATA-D Trial (CANagliflozin Treatment and Trial Analysis - DPP-4 Inhibitor Comparator Trial)

A Phase 3 study testing Canagliflozin, Sitagliptin and Metformin immediate release in people with Diabetes Mellitus, Type 2, run by Janssen Research & Development, LLC at 125 sites in 22 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 purpose of this study is to evaluate the efficacy and safety of canagliflozin compared with sitagliptin and placebo in patients with type 2 diabetes mellitus who are receiving treatment with metformin monotherapy (i.e., treatment with a single drug) and have inadequate glycemic (blood sugar) 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?
Canagliflozin, Sitagliptin and Metformin immediate release
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,284 participants
Where
125 sitesin 22 countries
Study dates
May 2010to May 2012
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All patients must have a diagnosis of T2DM and be currently treated with metformin IR
  • Patients in the study must have a HbA1c between >=7 and <=10.5%
  • Patients must have a fasting plasma glucose (FPG) <270 mg/dL (15 mmol/L)

Who cannot join

  • History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta cell transplantation, diabetes secondary to pancreatitis or pancreatectomy, or a severe hypoglycemic episode within 6 months before screening

Trial locations and contacts

125 sites in 22 countries.

125 sites in 22 countries

United States45 sites

  • Study site

    Altoona, Pennsylvania

  • Study site

    Asheboro, North Carolina

  • Study site

    Atlanta, Georgia

  • Study site

    Avon, Indiana

  • Study site

    Benzonia, Michigan

  • Study site

    Bountiful, Utah

  • Study site

    Bradenton, Florida

  • Study site

    Brooksville, Florida

  • Study site

    Champaign, Illinois

  • Study site

    Charlotte, North Carolina

  • Study site

    Colorado Springs, Colorado

  • Study site

    DeFuniak Springs, Florida

  • Study site

    Denver, Colorado

  • Study site

    East Providence, Rhode Island

  • Study site

    Fishers, Indiana

  • Study site

    Florissant, Missouri

  • Study site

    Fountain Valley, California

  • Study site

    Franklin, Indiana

  • Study site

    Greer, South Carolina

  • Study site

    Hialeah, Florida

  • Study site

    Interlochen, Michigan

  • Study site

    Kettering, Ohio

  • Study site

    Las Vegas, Nevada

  • Study site

    Little Rock, Arkansas

  • Study site

    Mansfield, New Jersey

  • Study site

    Mt. Pleasant, South Carolina

  • Study site

    Munfordville, Kentucky

  • Study site

    Nashville, Tennessee

  • Study site

    National City, California

  • Study site

    New Braunfels, Texas

  • Study site

    New Hyde Park, New York

  • Study site

    Niceville, Florida

  • Study site

    Northridge, California

  • Study site

    Oregon City, Oregon

  • Study site

    Picayune, Mississippi

  • Study site

    Portland, Maine

  • Study site

    San Antonio, Texas

  • Study site

    Savannah, Georgia

  • Study site

    Spokane, Washington

  • Study site

    St Louis, Missouri

  • Study site

    Tampa, Florida

  • Study site

    Tipton, Pennsylvania

  • Study site

    Troy, Michigan

  • Study site

    West Des Moines, Iowa

  • Study site

    Wichita, Kansas

Other trials in United States

India10 sites

  • Study site

    Ahmedabad, Gujarat

  • Study site

    Bangalore

  • Study site

    Bangalore, Karnataka

  • Study site

    Belagavi

  • Study site

    Chhatrapati Sambhajinagar

  • Study site

    Coimbatore

  • Study site

    Mumbai

  • Study site

    Nagpur

  • Study site

    Pune

  • Study site

    Trivandrum

Other trials in India

Russia6 sites

  • Study site

    Chelyabinsk

  • Study site

    Dzerzhinsky Moscow Region

  • Study site

    Kemerovo

  • Study site

    Penza

  • Study site

    Saint Petersburg

  • Study site

    Yekaterinburg

Other trials in Russia

Ukraine6 sites

  • Study site

    Donetsk

  • Study site

    Ivano-Frankivsk

  • Study site

    Kiev

  • Study site

    Sumy

  • Study site

    Vinnitsa

  • Study site

    Zaporizhzhya

Other trials in Ukraine

Czechia5 sites

  • Study site

    Beroun

  • Study site

    Pardubice

  • Study site

    Pilsen

  • Study site

    Rychnov nad Kněžnou

  • Study site

    Tábor

Other trials in Czechia

Mexico5 sites

  • Study site

    Culiacán

  • Study site

    Guadalajara

  • Study site

    Monterrey

  • Study site

    Querétaro

  • Study site

    Tampico

Other trials in Mexico

Poland5 sites

  • Study site

    Łęczyca

  • Study site

    Lodz

  • Study site

    Lublin

  • Study site

    Wroclaw

  • Study site

    Zgierz

Other trials in Poland

Slovakia5 sites

  • Study site

    Banská Bystrica

  • Study site

    Bratislava

  • Study site

    Košice

  • Study site

    Šahy

  • Study site

    Trebišov

Other trials in Slovakia

Turkey (Türkiye)5 sites

  • Study site

    Ankara

  • Study site

    Antalya

  • Study site

    Istanbul

  • Study site

    Izmir

  • Study site

    Konya

Other trials in Turkey (Türkiye)

Bulgaria4 sites

  • Study site

    Pleven

  • Study site

    Plovdiv

  • Study site

    Sevlievo

  • Study site

    Sofia

Other trials in Bulgaria

Latvia4 sites

  • Study site

    Daugavpils

  • Study site

    Limbaži

  • Study site

    Riga

  • Study site

    Talsi

Other trials in Latvia

Malaysia4 sites

  • Study site

    Kelantan

  • Study site

    Kuala Lumpur

  • Study site

    Kuala Selangor

  • Study site

    Pulau Pinang

Other trials in Malaysia

Portugal4 sites

  • Study site

    Aveiro

  • Study site

    Leiria

  • Study site

    Lisbon

  • Study site

    Portalegre

Other trials in Portugal

Argentina3 sites

  • Study site

    Buenos Aires

  • Study site

    Mendoza

  • Study site

    San Juan

Other trials in Argentina

Colombia3 sites

  • Study site

    Barranquilla

  • Study site

    Bogotá

  • Study site

    Medellín

Other trials in Colombia

Thailand3 sites

  • Study site

    Bangkok

  • Study site

    Chiang Mai

  • Study site

    Khon Kaen

Other trials in Thailand

Greece2 sites

  • Study site

    Piraeus

  • Study site

    Thessalonikis

Other trials in Greece

Sweden2 sites

  • Study site

    Gothenburg

  • Study site

    Stockholm

Other trials in Sweden

Estonia1 site

  • Study site

    Tallinn

Other trials in Estonia

Peru1 site

  • Study site

    Lima 1 Lima Lima

Other trials in Peru

Puerto Rico1 site

  • Study site

    San Juan

Other trials in Puerto Rico

Singapore1 site

  • Study site

    Singapore

Other trials in Singapore

About this study

Official title: A Randomized, Double-Blind, Placebo and Active-Controlled, 4-Arm, Parallel Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin in the Treatment of Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Monotherapy

The purpose of this study is to evaluate the efficacy and safety of canagliflozin compared with sitagliptin and placebo in patients with type 2 diabetes mellitus who are receiving treatment with metformin monotherapy (i.e., treatment with a single drug) and have inadequate glycemic (blood sugar) control.

Read the detailed description

Canagliflozin is a drug that is being tested to see if it may be useful in treating patients diagnosed with type 2 diabetes mellitus (T2DM). This is a randomized (study drug assigned by chance), double-blind (neither the patient nor the study doctor will know the identity of assigned study drug), placebo- and active-controlled, parallel-group, 4-arm (4 treatment groups) multicenter study to determine the efficacy, safety, and tolerability of canagliflozin (100 mg and 300 mg) compared to placebo (a capsule that looks like all the other treatments but has no real medicine) and an active-control (sitagliptin 100 mg, an antihyperglycemic agent) in patients with T2DM who are not achieving an adequate response from current antihyperglycemic therapy with metformin Immediate Release (IR) to control their diabetes. Approximately 1,260 patients with T2DM who are receiving treatment with metformin IR and have inadequate glycemic (blood sugar) will receive once-daily treatment with canagliflozin (100 mg or 300 mg), sitagliptin 100 mg, or placebo capsules for 26 weeks (Period I) followed by another 26-weeks where patients treated with canagliflozin (100 mg or 300 mg) or sitagliptin 100 mg will continue treatment for an additional 26 weeks and patients treated with placebo will be switched to active double-blind treatment with sitagliptin 100 mg capsules administered once-daily for 26 weeks (Period II). In addition, all patients will take protocol specified stable doses of metformin IR along with assigned study drug for the duration of the study. Patients will participate in the study for approximately 59 to 71 weeks. During the study, if a patient's fasting blood sugar remains high despite treatment with study drug, metformin IR, and reinforcement with diet and exercise, the patient will receive treatment with glimepiride (rescue therapy) consistent with local prescribing information. During treatment, patients will be monitored for safety by review of adverse events, results from laboratory tests, 12-lead electrocardiograms (ECGs), vital sign measurements, body weight, physical examinations, and self-monitored blood glucose (SMGB) measurements. The primary outcome measure in the study is to assess the effect of canagliflozin relative to placebo on hemoglobin A1c (HbA1c) after 26 weeks of treatment. Study drug will be taken orally (by mouth) once daily before the first meal each day unless otherwise specified. Patients will take single-blind placebo for 2 weeks before randomization. After randomization, patients in the study will take double-blind canagliflozin (100 mg or 300 mg) or sitagliptin 100 mg for 52 weeks OR placebo for 26 weeks switched to double-blind treatment with sitaliptin 100 mg for 26 weeks.

Being tested
Placebo, Canagliflozin, Sitagliptin, Metformin immediate release
Keywords
Type 2 diabetes mellitus, Canagliflozin, Placebo, Sitagliptin, Januvia, Metformin Immediate Release (IR), Hemoglobin A1c
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.

  • PlaceboDrug

    One matching placebo capsule orally (by mouth) once daily for 26 weeks with protocol-specified doses of metformin immediate release.

  • CanagliflozinDrug

    One 100 mg or 300 mg over-encapsulated tablet orally once daily for 52 weeks with protocol-specified doses of metformin immediate release.

  • SitagliptinDrug

    One 100 mg over-encapsulated tablet orally once daily for 52 weeks (sitagliptin 100 mg arm) or once daily beginning at Week 26 until Week 52 (placebo/sitagliptin arm). Sitagliptin will be given with protocol-specified doses of metformin immediate release.

  • Metformin immediate releaseDrug

    The patient's stable dose of metformin immediate release background therapy should be continued throughout the study.

Study groups in NCT01106677
Study groupRoleWhat they receive
Canagliflozin 100 mgExperimentalEach patient will receive 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
Receives: Drug: Canagliflozin; Drug: Metformin immediate release
Canagliflozin 300 mgExperimentalEach patient will receive 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
Receives: Drug: Canagliflozin; Drug: Metformin immediate release
Sitagliptin 100 mgActive comparatorEach patient will receive 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
Receives: Drug: Sitagliptin; Drug: Metformin immediate release
Placebo/SitagliptinOtherEach patient will receive matching placebo once daily for 26 weeks and will then switch from placebo to 100 mg of sitagliptin once daily until Week 52. Placebo and sitagliptin will be given with protocol-specified doses of metformin immediate release.
Receives: Drug: Placebo; Drug: Sitagliptin; Drug: Metformin immediate release

What is being measured

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

  1. Change in HbA1c From Baseline to Week 26

    The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the LS mean change.

    Measured: Day 1 (Baseline) and Week 26

Secondary outcomes (13)

  1. Percentage of Patients With HbA1c <7% at Week 26

    The table below shows the percentage of patients with HbA1c <7% at Week 26 in each treatment group. The statistical analyses show the treatment differences between each canagliflozin or sitagliptin group and placebo.

    Measured: Week 26

  2. Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26

    The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the LS mean change.

    Measured: Day 1 (Baseline) and Week 26

  3. Change in 2-hour Post-prandial Glucose From Baseline to Week 26

    The table below shows the least-squares (LS) mean change in 2-hour post-prandial glucose from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the LS mean change.

    Measured: Day 1 (Baseline) and Week 26

  4. Percent Change in Body Weight From Baseline to Week 26

    The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the LS mean percent change.

    Measured: Day 1 (Baseline) and Week 26

  5. Change in Systolic Blood Pressure (SBP) From Baseline to Week 26

    The table below shows the least-squares (LS) mean change in SBP from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the LS mean change.

    Measured: Day 1 (Baseline) and Week 26

  6. Percent Change in Triglycerides From Baseline to Week 26

    The table below shows the least-squares (LS) mean percent change in triglycerides from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the LS mean percent change.

    Measured: Day 1 (Baseline) and Week 26

  7. Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26

    The table below shows the least-squares (LS) mean percent change in HDL-C from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the LS mean percent change.

    Measured: Day 1 (Baseline) and Week 26

  8. Change in HbA1c From Baseline to Week 52

    The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 52 for each active treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus sitagliptin) in the LS mean change.

    Measured: Day 1 (Baseline) and Week 52

  9. Change in Fasting Plasma Glucose (FPG) From Baseline to Week 52

    The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 52 for each active treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus sitagliptin) in the LS mean change.

    Measured: Day 1 (Baseline) and Week 52

  10. Percent Change in Body Weight From Baseline to Week 52

    The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 52 for each active treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus sitagliptin) in the LS mean percent change.

    Measured: Day 1 (Baseline) and Week 52

  11. Change in Systolic Blood Pressure (SBP) From Baseline to Week 52

    The table below shows the least-squares (LS) mean change in SBP from Baseline to Week 52 for each active treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus sitagliptin) in the LS mean change.

    Measured: Day 1 (Baseline) and Week 52

  12. Percent Change in Triglycerides From Baseline to Week 52

    The table below shows the least-squares (LS) mean percent change in triglycerides from Baseline to Week 52 for each active treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus sitagliptin) in the LS mean percent change.

    Measured: Day 1 (Baseline) and Week 52

  13. Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 52

    The table below shows the least-squares (LS) mean percent change in HDL-C from Baseline to Week 52 for each active treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus sitagliptin) in the LS mean percent change.

    Measured: Day 1 (Baseline) and Week 52

Timeline

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

  1. First posted20 Apr 2010 (estimated)
  2. Study startMay 2010
  3. Primary completionOct 2011
  4. Study completionMay 2012

Resources

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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
1,284 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01106677
Sponsor's protocol ID
CR017023
Other IDs
28431754DIA3006
Status last verified
Jul 2013
First submitted
1 Apr 2010
Last updated
30 Jul 2013
Data monitoring committee
Yes

Publications

  • Cai J, Delahanty LM, Akapame S, Slee A, Traina S. Impact of Canagliflozin Treatment on Health-Related Quality of Life among People with Type 2 Diabetes Mellitus: A Pooled Analysis of Patient-Reported Outcomes from Randomized Controlled Trials. Patient. 2018 Jun;11(3):341-352. doi: 10.1007/s40271-017-0290-4.

    PubMed 29313267

  • Davies MJ, Merton K, Vijapurkar U, Yee J, Qiu R. Efficacy and safety of canagliflozin in patients with type 2 diabetes based on history of cardiovascular disease or cardiovascular risk factors: a post hoc analysis of pooled data. Cardiovasc Diabetol. 2017 Mar 21;16(1):40. doi: 10.1186/s12933-017-0517-7.

    PubMed 28327140

  • Pfeifer M, Townsend RR, Davies MJ, Vijapurkar U, Ren J. Effects of canagliflozin, a sodium glucose co-transporter 2 inhibitor, on blood pressure and markers of arterial stiffness in patients with type 2 diabetes mellitus: a post hoc analysis. Cardiovasc Diabetol. 2017 Feb 27;16(1):29. doi: 10.1186/s12933-017-0511-0.

    PubMed 28241822

  • Gilbert RE, Mende C, Vijapurkar U, Sha S, Davies MJ, Desai M. Effects of Canagliflozin on Serum Magnesium in Patients With Type 2 Diabetes Mellitus: A Post Hoc Analysis of Randomized Controlled Trials. Diabetes Ther. 2017 Apr;8(2):451-458. doi: 10.1007/s13300-017-0232-0. Epub 2017 Feb 14.

    PubMed 28197834

  • Qiu R, Balis D, Xie J, Davies MJ, Desai M, Meininger G. Longer-term safety and tolerability of canagliflozin in patients with type 2 diabetes: a pooled analysis. Curr Med Res Opin. 2017 Mar;33(3):553-562. doi: 10.1080/03007995.2016.1271780. Epub 2017 Jan 4.

    PubMed 27977934

  • John M, Cerdas S, Violante R, Deerochanawong C, Hassanein M, Slee A, Canovatchel W, Hamilton G. Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus living in hot climates. Int J Clin Pract. 2016 Sep;70(9):775-85. doi: 10.1111/ijcp.12868.

    PubMed 27600862

  • Schernthaner G, Lavalle-Gonzalez FJ, Davidson JA, Jodon H, Vijapurkar U, Qiu R, Canovatchel W. Canagliflozin provides greater attainment of both HbA1c and body weight reduction versus sitagliptin in patients with type 2 diabetes. Postgrad Med. 2016 Nov;128(8):725-730. doi: 10.1080/00325481.2016.1210988. Epub 2016 Jul 26.

    PubMed 27391951

  • Watts NB, Bilezikian JP, Usiskin K, Edwards R, Desai M, Law G, Meininger G. Effects of Canagliflozin on Fracture Risk in Patients With Type 2 Diabetes Mellitus. J Clin Endocrinol Metab. 2016 Jan;101(1):157-66. doi: 10.1210/jc.2015-3167. Epub 2015 Nov 18.

    PubMed 26580237

  • Lavalle-Gonzalez FJ, Eliaschewitz FG, Cerdas S, Chacon Mdel P, Tong C, Alba M. Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus from Latin America. Curr Med Res Opin. 2016;32(3):427-39. doi: 10.1185/03007995.2015.1121865. Epub 2016 Jan 14.

    PubMed 26579834

  • Blonde L, Woo V, Mathieu C, Yee J, Vijapurkar U, Canovatchel W, Meininger G. Achievement of treatment goals with canagliflozin in patients with type 2 diabetes mellitus: a pooled analysis of randomized controlled trials. Curr Med Res Opin. 2015 Nov;31(11):1993-2000. doi: 10.1185/03007995.2015.1082991. Epub 2015 Sep 28.

    PubMed 26373629

  • Gavin JR 3rd, Davies MJ, Davies M, Vijapurkar U, Alba M, Meininger G. The efficacy and safety of canagliflozin across racial groups in patients with type 2 diabetes mellitus. Curr Med Res Opin. 2015;31(9):1693-702. doi: 10.1185/03007995.2015.1067192. Epub 2015 Sep 4.

    PubMed 26121561

  • Cefalu WT, Stenlof K, Leiter LA, Wilding JP, Blonde L, Polidori D, Xie J, Sullivan D, Usiskin K, Canovatchel W, Meininger G. Effects of canagliflozin on body weight and relationship to HbA1c and blood pressure changes in patients with type 2 diabetes. Diabetologia. 2015 Jun;58(6):1183-7. doi: 10.1007/s00125-015-3547-2. Epub 2015 Mar 27.

    PubMed 25813214

  • Bailey RA, Vijapurkar U, Meininger G, Rupnow MF, Blonde L. Diabetes-Related Composite Quality End Point Attainment: Canagliflozin Versus Sitagliptin Based on a Pooled Analysis of 2 Clinical Trials. Clin Ther. 2015 May 1;37(5):1045-54. doi: 10.1016/j.clinthera.2015.02.020. Epub 2015 Mar 18.

    PubMed 25795432

  • Weir MR, Januszewicz A, Gilbert RE, Vijapurkar U, Kline I, Fung A, Meininger G. Effect of canagliflozin on blood pressure and adverse events related to osmotic diuresis and reduced intravascular volume in patients with type 2 diabetes mellitus. J Clin Hypertens (Greenwich). 2014 Dec;16(12):875-82. doi: 10.1111/jch.12425. Epub 2014 Oct 20.

    PubMed 25329038

  • Usiskin K, Kline I, Fung A, Mayer C, Meininger G. Safety and tolerability of canagliflozin in patients with type 2 diabetes mellitus: pooled analysis of phase 3 study results. Postgrad Med. 2014 May;126(3):16-34. doi: 10.3810/pgm.2014.05.2753.

    PubMed 24918789

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Canagliflozin, Sitagliptin and Metformin immediate release in people with Diabetes Mellitus, Type 2, run by Janssen Research & Development, LLC at 125 sites in 22 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 3 inclusion and 1 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 30 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 125 sites in United States, India, Russia, Ukraine, Czechia and 17 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. 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 30 Jul 2013). 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 to Week 26 (time frame: Day 1 (Baseline) and 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 NCT01106677, which also lists 19 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 30 Jul 2013.

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