Diabetes Mellitus, Type 2Phase 3NCT01183013

30 Week Parallel Group Comparison Study of Linagliptin + Pioglitazone (5+15, 5+30 and 5+45 mg) qd Versus Respective Monotherapies, Followed by a Comparison of 5mg+30mg and 5mg+45mg Versus Respective Monotherapies in Type 2 Diabetes for up to 54 Weeks

A Phase 3 study testing Pioglitazone 15 mg, Pioglitazone 45 mg and Pioglitazone 30 mg in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 132 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

The primary objective is to demonstrate superior glycaemic control (HbA1c reduction) after 30 weeks of linagliptin/pioglitazone (5/15, 5/30 and 5/45 mg) versus the respective individual monotherapies of pioglitazone (15 mg, 30 mg, or 45 mg, administered orally once daily), and linagliptin (5 mg, administered orally… 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?: Pioglitazone 15 mg, Pioglitazone 45 mg and Pioglitazone 30 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 936 participants
Where: 132 sitesin 6 countries
Study dates: Aug 2010to Feb 2013
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

Diagnosis of type 2 diabetes mellitus prior to informed consent
Male and female patients with insufficient glycaemic control (HbA1c >= 7.0 to <= 10.5% at Visit 2) on diet and exercise alone, without oral antidiabetic drug therapy within 10 weeks prior to start of the run-in period (date of Visit 2)
Age >= 18 and <= 80 years at start date of Visit 1 (Screening)
BMI <= 45 kg/m2 (Body Mass Index) at start date of Visit 1 (Screening)
Signed and dated written informed consent by start date of Visit 1 in accordance with GCP and local legislation

Who cannot join

Uncontrolled hyperglycaemia with a confirmed glucose level > 240 mg/dl (> 13.3 mmol/l) after an overnight fast during screening or placebo run-in period (cf. Section 3.3.4.1)
Myocardial infarction within 6 months, stroke or TIA within 3 months prior to informed consent
Clinical evidence of active liver disease (e.g. jaundice) or the ALT level > 2.5 times the upper limit of normal (according to pioglitazone label)
Bariatric surgery, performed within the past 2 years prior to informed consent or planned at the time of informed consent
Gastrointestinal surgeries prior to informed consent that induce chronic malabsorption
Known hypersensitivity or allergy to the investigational products (linagliptin and/or pioglitazone) or their excipients (including matching placebos)

Show all 24Show fewer

Contraindications to pioglitazone as defined in the local prescribing information (SPC), particularly :
Diagnose of heart failure or history of heart failure
Haemodialysis patients, due to limited experience with pioglitazone
Treatment with gemfibrozil, montelukast, trimethoprim, or rifampicin - according to pioglitazone label and respective restrictions in Section 4.2.2
Treatment with rosiglitazone, pioglitazone, GLP-1 analogues, or insulin within 3 months prior to informed consent
Treatment with anti-obesity drugs (e.g. sibutramine, orlistat) 3 months prior to informed consent
Alcohol or drug abuse within the 3 months prior to informed consent or history of alcoholism
Current treatment with systemic corticosteroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent
Participation in another trial with an investigational drug within 30 days prior to informed consent
Any other clinical condition as judged by the investigator that would not allow the safe completion of the protocol, e.g. inability of patients to comply with study procedures
Pre-menopausal women (last menstruation <= 1 year prior to informed consent) who:
are nursing or pregnant or
are of child-bearing potential (i.e. not permanently sterilised) and are not practicing a highly effective method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial.
A highly effective method of birth control is defined - according to the Note for Guidance on non-clinical safety studies for the conduct of human trials for pharmaceuticals (CPMP/ICH/286/95, modification) - as those which result in a low failure rate (i. e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, hormonal intrauterine devices/systems (IUDs/IUSs), sexual abstinence or vasectomised partner
Symptomatic gallbladder disease in the last six months
Medical history of pancreatitis.
Patients with urinary bladder cancer or a history of urinary bladder cancer or uninvestigated macroscopic haematuria
Any other contraindication or restriction for use of pioglitazone in accordance with the local prescribing information for pioglitazone.

Trial locations and contacts

132 sites in 6 countries.

Country

City, postcode or hospital

132 sites in 6 countries

United States74 sites

1264.3.01008 Boehringer Ingelheim Investigational Site
Atlanta, Georgia
1264.3.01055 Boehringer Ingelheim Investigational Site
Atlanta, Georgia
1264.3.01061 Boehringer Ingelheim Investigational Site
Atlanta, Georgia
1264.3.01026 Boehringer Ingelheim Investigational Site
Birmingham, Alabama
1264.3.01074 Boehringer Ingelheim Investigational Site
Blue Ridge, Georgia
1264.3.01035 Boehringer Ingelheim Investigational Site
Boca Raton, Florida
1264.3.01052 Boehringer Ingelheim Investigational Site
Brownsburg, Indiana
1264.3.01045 Boehringer Ingelheim Investigational Site
Burlington, North Carolina
1264.3.01049 Boehringer Ingelheim Investigational Site
Carmichael, California
1264.3.01084 Boehringer Ingelheim Investigational Site
Cartersville, Georgia
1264.3.01062 Boehringer Ingelheim Investigational Site
Chandler, Arizona
1264.3.01044 Boehringer Ingelheim Investigational Site
Charlotte, North Carolina
1264.3.01077 Boehringer Ingelheim Investigational Site
Chicago, Illinois
1264.3.01078 Boehringer Ingelheim Investigational Site
Chino, California
1264.3.01015 Boehringer Ingelheim Investigational Site
Clearwater, Florida
1264.3.01081 Boehringer Ingelheim Investigational Site
Columbia, South Carolina
1264.3.01031 Boehringer Ingelheim Investigational Site
Concord, California
1264.3.01017 Boehringer Ingelheim Investigational Site
Corpus Christi, Texas
1264.3.01067 Boehringer Ingelheim Investigational Site
Dallas, Texas
1264.3.01027 Boehringer Ingelheim Investigational Site
Denver, Colorado
1264.3.01075 Boehringer Ingelheim Investigational Site
Evansville, Indiana
1264.3.01076 Boehringer Ingelheim Investigational Site
Evansville, Indiana
1264.3.01051 Boehringer Ingelheim Investigational Site
Fleetwood, Pennsylvania
1264.3.01073 Boehringer Ingelheim Investigational Site
Franklin, Indiana
1264.3.01057 Boehringer Ingelheim Investigational Site
Great Falls, Montana
1264.3.01003 Boehringer Ingelheim Investigational Site
Greer, South Carolina
1264.3.01082 Boehringer Ingelheim Investigational Site
Hialeah, Florida
1264.3.01004 Boehringer Ingelheim Investigational Site
Houston, Texas
1264.3.01039 Boehringer Ingelheim Investigational Site
Houston, Texas
1264.3.01041 Boehringer Ingelheim Investigational Site
Houston, Texas
1264.3.01047 Boehringer Ingelheim Investigational Site
Houston, Texas
1264.3.01070 Boehringer Ingelheim Investigational Site
Houston, Texas
1264.3.01069 Boehringer Ingelheim Investigational Site
Hyattsville, Maryland
1264.3.01036 Boehringer Ingelheim Investigational Site
Jacksonville, Florida
1264.3.01040 Boehringer Ingelheim Investigational Site
Killeen, Texas
1264.3.01011 Boehringer Ingelheim Investigational Site
Kingsport, Tennessee
1264.3.01037 Boehringer Ingelheim Investigational Site
Lakewood, California
1264.3.01010 Boehringer Ingelheim Investigational Site
Lexington, Kentucky
1264.3.01013 Boehringer Ingelheim Investigational Site
Longwood, Florida
1264.3.01065 Boehringer Ingelheim Investigational Site
Los Angeles, California
1264.3.01064 Boehringer Ingelheim Investigational Site
Mesa, Arizona
1264.3.01038 Boehringer Ingelheim Investigational Site
Miami, Florida
1264.3.01042 Boehringer Ingelheim Investigational Site
Miami, Florida
1264.3.01079 Boehringer Ingelheim Investigational Site
Miami, Florida
1264.3.01048 Boehringer Ingelheim Investigational Site
Midland, Texas
1264.3.01021 Boehringer Ingelheim Investigational Site
Montgomery, Alabama
1264.3.01020 Boehringer Ingelheim Investigational Site
Muscle Shoals, Alabama
1264.3.01030 Boehringer Ingelheim Investigational Site
New Braunfels, Texas
1264.3.01028 Boehringer Ingelheim Investigational Site
New Orleans, Louisiana
1264.3.01056 Boehringer Ingelheim Investigational Site
Norfolk, Virginia
1264.3.01071 Boehringer Ingelheim Investigational Site
North Richland Hills, Texas
1264.3.01006 Boehringer Ingelheim Investigational Site
Norwalk, California
1264.3.01033 Boehringer Ingelheim Investigational Site
Norwalk, Connecticut
1264.3.01032 Boehringer Ingelheim Investigational Site
Oklahoma City, Oklahoma
1264.3.01060 Boehringer Ingelheim Investigational Site
Perry, Georgia
1264.3.01025 Boehringer Ingelheim Investigational Site
Pittsburgh, Pennsylvania
1264.3.01085 Boehringer Ingelheim Investigational Site
Plano, Texas
1264.3.01019 Boehringer Ingelheim Investigational Site
Port Orange, Florida
1264.3.01001 Boehringer Ingelheim Investigational Site
Rancho Cucamonga, California
1264.3.01018 Boehringer Ingelheim Investigational Site
Saint Cloud, Florida
1264.3.01046 Boehringer Ingelheim Investigational Site
San Antonio, Texas
1264.3.01059 Boehringer Ingelheim Investigational Site
San Diego, California
1264.3.01050 Boehringer Ingelheim Investigational Site
Savannah, Georgia
1264.3.01066 Boehringer Ingelheim Investigational Site
Southfield, Michigan
1264.3.01029 Boehringer Ingelheim Investigational Site
Sunset, Louisiana
1264.3.01009 Boehringer Ingelheim Investigational Site
Tampa, Florida
1264.3.01012 Boehringer Ingelheim Investigational Site
Tampa, Florida
1264.3.01023 Boehringer Ingelheim Investigational Site
Tarzana, California
1264.3.01016 Boehringer Ingelheim Investigational Site
Tustin, California
1264.3.01058 Boehringer Ingelheim Investigational Site
Valencia, California
1264.3.01083 Boehringer Ingelheim Investigational Site
Westlake Village, California
1264.3.01002 Boehringer Ingelheim Investigational Site
Wichita, Kansas
1264.3.01007 Boehringer Ingelheim Investigational Site
Wichita, Kansas
1264.3.01022 Boehringer Ingelheim Investigational Site
Zanesville, Ohio

Other trials in United States

Latvia13 sites

1264.3.37105 Boehringer Ingelheim Investigational Site
Daugavpils
1264.3.37112 Boehringer Ingelheim Investigational Site
Daugavpils
1264.3.37113 Boehringer Ingelheim Investigational Site
Daugavpils
1264.3.37110 Boehringer Ingelheim Investigational Site
Jelgava
1264.3.37101 Boehringer Ingelheim Investigational Site
Liepāja
1264.3.37106 Boehringer Ingelheim Investigational Site
Ogre
1264.3.37104 Boehringer Ingelheim Investigational Site
Riga
1264.3.37108 Boehringer Ingelheim Investigational Site
Riga
1264.3.37109 Boehringer Ingelheim Investigational Site
Riga
1264.3.37111 Boehringer Ingelheim Investigational Site
Riga
1264.3.37107 Boehringer Ingelheim Investigational Site
Talsi
1264.3.37102 Boehringer Ingelheim Investigational Site
Tukums
1264.3.37103 Boehringer Ingelheim Investigational Site
Valmiera

Other trials in Latvia

United Kingdom13 sites

1264.3.44032 Boehringer Ingelheim Investigational Site
Annan
1264.3.44028 Boehringer Ingelheim Investigational Site
Ash Vale, Aldershot
1264.3.44029 Boehringer Ingelheim Investigational Site
Baillieston, Glasgow
1264.3.44008 Boehringer Ingelheim Investigational Site
Balham
1264.3.44021 Boehringer Ingelheim Investigational Site
Bradford on Avon
1264.3.44019 Boehringer Ingelheim Investigational Site
Burbage
1264.3.44012 Boehringer Ingelheim Investigational Site
Chesterfield
1264.3.44027 Boehringer Ingelheim Investigational Site
Chestfield, Whitstable
1264.3.44011 Boehringer Ingelheim Investigational Site
Chippenham
1264.3.44033 Boehringer Ingelheim Investigational Site
Johnstone
1264.3.44007 Boehringer Ingelheim Investigational Site
Midsomer Norton
1264.3.44034 Boehringer Ingelheim Investigational Site
Paisley
1264.3.44031 Boehringer Ingelheim Investigational Site
Warminster

Other trials in United Kingdom

Spain12 sites

1264.3.34013 Boehringer Ingelheim Investigational Site
Badía Del Vallès - Barcelona
1264.3.34001 Boehringer Ingelheim Investigational Site
Barcelona
1264.3.34008 Boehringer Ingelheim Investigational Site
Barcelona
1264.3.34005 Boehringer Ingelheim Investigational Site
Borges Del Camp- Tarragona
1264.3.34006 Boehringer Ingelheim Investigational Site
Canet de Mar - Barcelona
1264.3.34010 Boehringer Ingelheim Investigational Site
Centelles - Barcelona
1264.3.34009 Boehringer Ingelheim Investigational Site
L'Hospitalet de Llobregat
1264.3.34004 Boehringer Ingelheim Investigational Site
L'Hospitalet de Llobregat - Barcelona
1264.3.34002 Boehringer Ingelheim Investigational Site
Sant Adrià Del Besós- Barcelona
1264.3.34007 Boehringer Ingelheim Investigational Site
Tarrega - Lleida
1264.3.34012 Boehringer Ingelheim Investigational Site
Valencia
1264.3.34011 Boehringer Ingelheim Investigational Site
Vic - Barcelona

Other trials in Spain

Estonia10 sites

1264.3.37207 Boehringer Ingelheim Investigational Site
Harju
1264.3.37209 Boehringer Ingelheim Investigational Site
Pärnu
1264.3.37201 Boehringer Ingelheim Investigational Site
Tallinn
1264.3.37202 Boehringer Ingelheim Investigational Site
Tallinn
1264.3.37203 Boehringer Ingelheim Investigational Site
Tallinn
1264.3.37204 Boehringer Ingelheim Investigational Site
Tallinn
1264.3.37205 Boehringer Ingelheim Investigational Site
Tallinn
1264.3.37208 Boehringer Ingelheim Investigational Site
Tallinn
1264.3.37206 Boehringer Ingelheim Investigational Site
Tartu
1264.3.37210 Boehringer Ingelheim Investigational Site
Viljandi County

Other trials in Estonia

Germany10 sites

1264.3.49001 Boehringer Ingelheim Investigational Site
Bad Lauterberg / Harz
1264.3.49007 Boehringer Ingelheim Investigational Site
Dietzenbach
1264.3.49002 Boehringer Ingelheim Investigational Site
Dortmund
1264.3.49009 Boehringer Ingelheim Investigational Site
Essen
1264.3.49003 Boehringer Ingelheim Investigational Site
Hamburg
1264.3.49012 Boehringer Ingelheim Investigational Site
Ingelheim
1264.3.49008 Boehringer Ingelheim Investigational Site
Leipzig
1264.3.49005 Boehringer Ingelheim Investigational Site
Mainz
1264.3.49010 Boehringer Ingelheim Investigational Site
Offenbach
1264.3.49004 Boehringer Ingelheim Investigational Site
Stuhr

Other trials in Germany

About this study

Official title: A Randomised, Double-blind Parallel Group Study to Compare the Efficacy and Safety of Initial Combination Therapy With Linagliptin 5 mg + Pioglitazone 15 mg, 30 mg, or 45 mg, vs. Monotherapy With Pioglitazone (15 mg, 30 mg, or 45 mg) or Linagliptin 5 mg Once Daily for 30 Weeks, Followed by a Blinded Trial Period on Linagliptin 5 mg + Pioglitazone 30 or 45 mg Versus Pioglitazone Monotherapy 30 or 45 mg or Linagliptin 5 mg for up to 54 Weeks in Type 2 Diabetic Patients With Insufficient Glycaemic Control on Diet and Exercise

Conditions: Diabetes Mellitus, Type 2
Being tested: Pioglitazone 15 mg, Pioglitazone 45 mg, Pioglitazone 30 mg, Linagliptin 5mg / Pioglitazone 45 mg FDC, Linagliptin 5mg / Pioglitazone 30 mg FDC
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.

Pioglitazone 15 mgDrug
Pioglitazone Capsules 15 mg once daily for 30 weeks followed by Pioglitazone Capsules 30 mg once daily for up to 54 weeks
Pioglitazone 45 mgDrug
Pioglitazone Capsules 30 mg once daily for 6 weeks followed by Pioglitazone Capsules 45 mg once daily for up to 78 weeks
Pioglitazone 30 mgDrug
Pioglitazone Capsules 30 mg once daily for up to 84 weeks
Linagliptin 5mg / Pioglitazone 45 mg FDCDrug
Linagliptin 5mg low dose / Pioglitazone 30 mg Tablets once daily for 6 weeks followed by Linagliptin 5mg low dose / Pioglitazone 45 mg FDC Tablets once daily for up to 78 weeks
Linagliptin 5mg / Pioglitazone 30 mg FDCDrug
Linagliptin 5mg low dose / Pioglitazone 30 mg FDC Tablets once daily for up to 84 weeks
Linagliptin 5mgDrug
Linagliptin 5mg Tablets low dose once daily for 30 weeks followed by Linagliptin 5mg low dose / Pioglitazone 30 mg FDC Tablets once daily for up to 54 weeks
Linagliptin 5mg / Pioglitazone 15 mg FDCDrug
Linagliptin 5mg low dose / Pioglitazone 15 mg FDC Tablets once daily for 30 weeks followed by Linagliptin 5mg low dose / Pioglitazone 30 mg FDC Tablets once daily for up to 54 weeks

Study groups in NCT01183013
Study group	Role	What they receive
Pioglitazone 15 mg	Active comparator	Pioglitazone Capsules 15 mg once daily Receives: Drug: Pioglitazone 15 mg
Pioglitazone 30 mg	Active comparator	Pioglitazone Capsules 30 mg once daily Receives: Drug: Pioglitazone 30 mg
Pioglitazone 45 mg	Active comparator	Pioglitazone Capsules 45 mg once daily Receives: Drug: Pioglitazone 45 mg
Linagliptin 5mg	Active comparator	Linagliptin 5mg Tablets once daily Receives: Drug: Linagliptin 5mg
Linagliptin 5mg / Pioglitazone 15 mg	Experimental	Linagliptin 5mg / Pioglitazone 15 mg Tablets once daily Receives: Drug: Linagliptin 5mg / Pioglitazone 15 mg FDC
Linagliptin 5mg / Pioglitazone 30 mg	Experimental	Linagliptin 5mg / Pioglitazone 30 mg Tablets once daily Receives: Drug: Linagliptin 5mg / Pioglitazone 30 mg FDC
Linagliptin 5mg / Pioglitazone 45 mg	Experimental	Linagliptin 5mg / Pioglitazone 45 mg Tablets once daily Receives: Drug: Linagliptin 5mg / Pioglitazone 45 mg FDC

What is being measured

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

Change From Baseline in HbA1c After 30 Weeks of Treatment.
HbA1c is measured as a percentage. The change from baseline is the Week 30 HbA1c minus the baseline HbA1c.
Measured: Baseline and 30 weeks

Secondary outcomes (9)

Occurrence of Cumulative Treat to Target Efficacy Response, of HbA1c Under Treatment of < 7.0% After 30 Weeks of Treatment
Glycosylated hemoglobin is reported as a percentage of the total hemoglobin.
Measured: Baseline and 30 weeks
Occurrence of Cumulative Treat to Target Efficacy Response, of HbA1c Under Treatment of < 6.5% After 30 Weeks of Treatment
Glycosylated hemoglobin is reported as a percentage of the total hemoglobin.
Measured: Baseline and 30 weeks
Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5% After 30 Weeks of Treatment)
Glycosylated hemoglobin is reported as a percentage of the total hemoglobin.
Measured: Baseline and 30 weeks
HbA1c Change From Baseline by Visit Over Time
HbA1c is measured as a percentage. The change from baseline is the HbA1c over time minus the baseline HbA1c. The model includes fixed effects for treatment, continuous baseline HbA1c, prior andi-diabetic medication, country, visit and treatment.
by visit interaction.
Measured: Baseline, week 6, week 12, week 18, week 24, week 30
Fasting Plasma Glucose (FPG) Change From Baseline After 30 Weeks of Treatment
The change from baseline is the FPG after 30 weeks minus the baseline FPG.
Measured: Baseline and 30 weeks
Fasting Plasma Glucose (FPG) Change From Baseline by Visit Over Time
The change from baseline is the FPG over time minus the baseline FPG. Model includes fixed effects for treatment, continuous baseline FPG, continuous baseline HbA1c, prior anti-diabetic medication, country, visit and treatment by visit interaction
Measured: Baseline, week 6, week 12, week 18, week 24, week 30
Two-hour Postprandial Glucose (2hPPG) Change From Baseline at Week 30 by Meal Tolerance Test (MTT)
The change from baseline is the 2hPPG after 30 weeks minus the baseline 2hPPG.
Measured: Baseline and 30 weeks
Time to First Use of Rescue Therapy
Proportion of patients at 30 weeks with rescue therapy using Kaplan-Meier analysis.
Measured: 30 weeks
Incidence of Rescue Therapy During the First 30 Weeks of Treatment
Rescue therapy was defined to include any new antidiabetic medication taken for hyperglycemia and introduced on or after the start date of study treatment and before the end date of study treatment.
Measured: 30 weeks

Timeline

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

Aug 2010Feb 2013

First posted17 Aug 2010 (estimated)
Study startAug 2010
Primary completionFeb 2013
Study completionFeb 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Enrolment: 936 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01183013
Sponsor's protocol ID: 1264.3
Other IDs: 2008-008127-15, 2008
Status last verified: Oct 2014
First submitted: 16 Aug 2010
Last updated: 20 Oct 2014
Results posted: Yes, on ClinicalTrials.gov

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 20 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised, Double-blind Parallel Group Study to Compare the Efficacy and Safety of Initial Combination Therapy With Linagliptin 5 mg + Pioglitazone 15 mg, 30 mg, or 45 mg, vs. Monotherapy With Pioglitazone (15 mg, 30 mg, or 45 mg) or Linagliptin 5 mg Once Daily for 30 Weeks, Followed by a Blinded Trial Period on Linagliptin 5 mg + Pioglitazone 30 or 45 mg Versus Pioglitazone Monotherapy 30 or 45 mg or Linagliptin 5 mg for up to 54 Weeks in Type 2 Diabetic Patients With Insufficient Glycaemic Control on Diet and Exercise
ClinicalTrials.gov ID: NCT01183013
Acronym / sponsor ID: 1264.3
Conditions: Diabetes Mellitus, Type 2
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 936 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Collaborators: Eli Lilly and Company
Study start: Aug 2010
Primary completion: Feb 2013 (actual)
Study completion: Feb 2013 (actual)
First posted: 17 Aug 2010 (estimated)
Results: Posted 21 Apr 2014

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: 7

Arm	Type	Receives
Pioglitazone 15 mg	Active comparator	Drug: Pioglitazone 15 mgPioglitazone Capsules 15 mg once daily
Pioglitazone 30 mg	Active comparator	Drug: Pioglitazone 30 mgPioglitazone Capsules 30 mg once daily
Pioglitazone 45 mg	Active comparator	Drug: Pioglitazone 45 mgPioglitazone Capsules 45 mg once daily
Linagliptin 5mg	Active comparator	Drug: Linagliptin 5mgLinagliptin 5mg Tablets once daily
Linagliptin 5mg / Pioglitazone 15 mg	Experimental	Drug: Linagliptin 5mg / Pioglitazone 15 mg FDCLinagliptin 5mg / Pioglitazone 15 mg Tablets once daily
Linagliptin 5mg / Pioglitazone 30 mg	Experimental	Drug: Linagliptin 5mg / Pioglitazone 30 mg FDCLinagliptin 5mg / Pioglitazone 30 mg Tablets once daily
Linagliptin 5mg / Pioglitazone 45 mg	Experimental	Drug: Linagliptin 5mg / Pioglitazone 45 mg FDCLinagliptin 5mg / Pioglitazone 45 mg Tablets once daily

Who may qualify

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

Key inclusion criteria (5 listed)

Diagnosis of type 2 diabetes mellitus prior to informed consent
Male and female patients with insufficient glycaemic control (HbA1c >= 7.0 to <= 10.5% at Visit 2) on diet and exercise alone, without oral antidiabetic drug therapy within 10 weeks prior to start of the run-in period (date of Visit 2)
Age >= 18 and <= 80 years at start date of Visit 1 (Screening)
BMI <= 45 kg/m2 (Body Mass Index) at start date of Visit 1 (Screening)
Signed and dated written informed consent by start date of Visit 1 in accordance with GCP and local legislation

Key exclusion criteria (24 listed)

Uncontrolled hyperglycaemia with a confirmed glucose level > 240 mg/dl (> 13.3 mmol/l) after an overnight fast during screening or placebo run-in period (cf. Section 3.3.4.1)
Myocardial infarction within 6 months, stroke or TIA within 3 months prior to informed consent
Clinical evidence of active liver disease (e.g. jaundice) or the ALT level > 2.5 times the upper limit of normal (according to pioglitazone label)
Bariatric surgery, performed within the past 2 years prior to informed consent or planned at the time of informed consent
Gastrointestinal surgeries prior to informed consent that induce chronic malabsorption

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
Pioglitazone 15 mgPioglitazone Capsules 15 mg once daily for 30 weeks followed by Pioglitazone Capsules 30 mg once daily for up to 54 weeks	Drug	Pioglitazone 15 mg
Pioglitazone 45 mgPioglitazone Capsules 30 mg once daily for 6 weeks followed by Pioglitazone Capsules 45 mg once daily for up to 78 weeks	Drug	Pioglitazone 45 mg
Pioglitazone 30 mgPioglitazone Capsules 30 mg once daily for up to 84 weeks	Drug	Pioglitazone 30 mg
Linagliptin 5mg / Pioglitazone 45 mg FDCLinagliptin 5mg low dose / Pioglitazone 30 mg Tablets once daily for 6 weeks followed by Linagliptin 5mg low dose / Pioglitazone 45 mg FDC Tablets once daily for up to 78 weeks	Drug	Linagliptin 5mg / Pioglitazone 45 mg
Linagliptin 5mg / Pioglitazone 30 mg FDCLinagliptin 5mg low dose / Pioglitazone 30 mg FDC Tablets once daily for up to 84 weeks	Drug	Linagliptin 5mg / Pioglitazone 30 mg
Linagliptin 5mgLinagliptin 5mg Tablets low dose once daily for 30 weeks followed by Linagliptin 5mg low dose / Pioglitazone 30 mg FDC Tablets once daily for up to 54 weeks	Drug	Linagliptin 5mg
Linagliptin 5mg / Pioglitazone 15 mg FDCLinagliptin 5mg low dose / Pioglitazone 15 mg FDC Tablets once daily for 30 weeks followed by Linagliptin 5mg low dose / Pioglitazone 30 mg FDC Tablets once daily for up to 54 weeks	Drug	Linagliptin 5mg / Pioglitazone 15 mg

Primary outcome

Change From Baseline in HbA1c After 30 Weeks of Treatment.
Time frame: Baseline and 30 weeks
HbA1c is measured as a percentage. The change from baseline is the Week 30 HbA1c minus the baseline HbA1c.

9 secondary outcomes

Occurrence of Cumulative Treat to Target Efficacy Response, of HbA1c Under Treatment of < 7.0% After 30 Weeks of Treatment
Time frame: Baseline and 30 weeks
Occurrence of Cumulative Treat to Target Efficacy Response, of HbA1c Under Treatment of < 6.5% After 30 Weeks of Treatment
Time frame: Baseline and 30 weeks
Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5% After 30 Weeks of Treatment)
Time frame: Baseline and 30 weeks
HbA1c Change From Baseline by Visit Over Time
Time frame: Baseline, week 6, week 12, week 18, week 24, week 30
Fasting Plasma Glucose (FPG) Change From Baseline After 30 Weeks of Treatment
Time frame: Baseline and 30 weeks
Fasting Plasma Glucose (FPG) Change From Baseline by Visit Over Time
Time frame: Baseline, week 6, week 12, week 18, week 24, week 30
Two-hour Postprandial Glucose (2hPPG) Change From Baseline at Week 30 by Meal Tolerance Test (MTT)
Time frame: Baseline and 30 weeks
Time to First Use of Rescue Therapy
Time frame: 30 weeks
Incidence of Rescue Therapy During the First 30 Weeks of Treatment
Time frame: 30 weeks

Results and safety

Results posted to the registry on 21 Apr 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pio15/Pio30	131	86
Pio30/Pio30	140	101
Pio45/Pio45	138	97
Lina5/Lina5	135	105
Lina5Pio15/Lina5Pio30	126	90
Lina5Pio30/Lina5Pio30	133	88
Lina5Pio45/Lina5Pio45	133	96

Primary outcome: Change From Baseline in HbA1c After 30 Weeks of Treatment.

Time frame: Baseline and 30 weeks. Mean (Standard Error). Unit: percent

Measure	Pio15 n = 124	Pio30 n = 134	Pio45 n = 134	Lina5 n = 130	Lina5Pio15 n = 120	Lina5Pio30 n = 125	Lina5Pio45 n = 126
Value	-0.66 (0.09)	-0.69 (0.09)	-0.87 (0.09)	-0.39 (0.09)	-0.83 (0.09)	-1.06 (0.09)	-1.28 (0.09)

Pio15 vs Lina5Pio15: Mean Difference (Final Values): -0.17 (95% CI -0.41 to 0.07), p = 0.1571, ANCOVA
Pio30 vs Lina5Pio30: Mean Difference (Final Values): -0.37 (95% CI -0.60 to -0.14), p = 0.0016, ANCOVA
Pio45 vs Lina5Pio45: Mean Difference (Final Values): -0.41 (95% CI -0.64 to -0.18), p = 0.0006, ANCOVA

Population analysed: Patients from Full Analysis Set (FAS) with last observation carried forward (LOCF) used to handle missing values at Week 30. FAS is the patient set which includes all patients who were documented to have taken at least one dose of treatment and who had a baseline HbA1c value at at least one on-treatment HbA1c.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 85 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pio15/Pio30	9 of 131 (6.9%)	57 of 131 (43.5%)	Not reported
Pio30/Pio30	9 of 140 (6.4%)	55 of 140 (39.3%)	Not reported
Pio45/Pio45	5 of 138 (3.6%)	66 of 138 (47.8%)	Not reported
Lina5/Lina5	9 of 135 (6.7%)	57 of 135 (42.2%)	Not reported
Lina5Pio15/Lina5Pio30	9 of 126 (7.1%)	52 of 126 (41.3%)	Not reported
Lina5Pio30/Lina5Pio30	15 of 133 (11.3%)	58 of 133 (43.6%)	Not reported
Lina5Pio45/Lina5Pio45	10 of 133 (7.5%)	56 of 133 (42.1%)	Not reported

Limitations and caveats (from the sponsor): The study (Part B treatment only) was stopped early by protocol amendment #5, although Part A (time frame for all efficacy outcomes) proceeded to completion

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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

132 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 Pioglitazone 15 mg, Pioglitazone 45 mg and Pioglitazone 30 mg in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 132 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 24 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 20 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 132 sites in United States, Latvia, United Kingdom, Spain, Estonia 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 21 Apr 2014). 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 After 30 Weeks of Treatment. (time frame: Baseline and 30 weeks). 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 NCT01183013.

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 20 Oct 2014.