Diabetes Mellitus Type 2 (T2DM)Phase 3Diast DysfktNCT01888796
Diastolic Dysfunction in Patients With Type 2 Diabetes Mellitus
A Phase 3 study testing Linagliptin in people with Diabetes Mellitus Type 2 (T2DM) and Left Ventricular Diastolic Dysfunction, run by RWTH Aachen University at 1 site in Germany.
Trial summary
Examination of the effect of Linagliptin versus placebo on diastolic function in patients with type 2 diabetes mellitus and diastolic dysfunction as assessed by transthoracic echocardiography. Furthermore the effect on serum levels of NT-pro BNP as a biomarker of heart failure will be investigated. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Diabetes Mellitus Type 2 (T2DM), Left Ventricular Diastolic Dysfunction
- What is being tested?
- Linagliptin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2013to Dec 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diabetes mellitus Type 2
- Age > 50 years
- HbA1c > 7%
- Left ventricular diastolic dysfunction determined by echocardiography as average E/é ≥13 or average E/é≥8 and LA volume ≥34ml/m2
- Stable anti-diabetic medication for the last 6 weeks which should include a maximal tolerated dose of metformin (unless contraindication or intolerance to metformin does exist).
- Indication to increase anti-diabetic medication as judged by the investigator
- Written informed consent prior to study participation
Who cannot join
- Diabetes mellitus type 1
- Echocardiography:
- decreased left ventricular systolic function, ejection fraction (EF) <45%
- regional wall motion abnormalities
- hypertrophic cardiomyopathy (septum >15mm)
- severe valvular dysfunction
Show all 22Show fewer
- Uncontrolled hypertension
- Atrial fibrillation
- Obstructive sleep apnea syndrome
- Use of DPP-4 Inhibitor (Dipeptidyl-peptidase IV Inhibitor), GLP 1 agonists, Thiazolindinedione
- Kidney disease CKD 4 and more (GFR < 30 ml/min/1.73)
- Liver disease (ALT or AST > 3 times the upper limit of norm) or known liver cirrhosis
- Active malignant disease
- HbA1c > 8.5%
- Recent (<3 months) clinically significant coronary or cerebral vascular event
- Pregnant females as determined by positive [serum or urine] hCG test at Screening or prior to dosing. Participants of child-bearing age should use adequate contraception as defined in the study protocol.
- Lactating females
- The subject has a history of any other illness, which, in the opinion of the Investigator, might pose an unacceptable risk by administering study medication.
- The subject received an investigational drug within 30 days prior to inclusion into this study
- The subject has any current or past medical condition and/or required medication to treat a condition that could affect the evaluation of the study
- The subject is unwilling or unable to follow the procedures outlined in the protocol
- The subject is mentally or legally incapacitated
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Internal Medicine I, University Hospital
Aachen, 52074
About this study
Official title: Effect of Linagliptin Therapy on Myocardial Diastolic Function in Patients With Type 2 Diabetes Mellitus
Examination of the effect of Linagliptin versus placebo on diastolic function in patients with type 2 diabetes mellitus and diastolic dysfunction as assessed by transthoracic echocardiography.
Furthermore the effect on serum levels of NT-pro BNP as a biomarker of heart failure will be investigated.
Read the detailed description
Treatment:
The Patients will receive Linagliptin 5 mg QD or placebo for a period of 6 months.
The echocardiography and 24h RR measurement will be performed at baseline and 6 months after initiation of the therapy.
The blood chemistry (Glucose, HbA1c, BNP) will be evaluated at baseline as well as 3 and 6 months after initiation of the therapy.
- Being tested
- Linagliptin, placebo
- Keywords
- T2DM, diastolic dysfunction
- Medical subject headings
- Diabetes Mellitus, Type 2, Ventricular Dysfunction, Left
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LinagliptinDrug
Also called Trade name Trajenta® by Boehringer Ingelheim (BI) Pharma GmbH & Co KG, Biberach, Germany
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| Linagliptin | Active comparator | Linagliptin 5 mg (tablets) once daily for 6 month Receives: Drug: Linagliptin |
| Placebo | Placebo comparator | Placebo (tablets) once daily for 6 month Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in left ventricular diastolic function
Change in left ventricular diastolic function between baseline and after 6 month as determined by 2D and novel 3D parameter global Strain Rate E Change in left ventricular diastolic function between baseline and after 6 month as determined by standardized parameter E/é and left atrial (LA) volume
Measured: baseline and 6 months
Secondary outcomes (1)
Change in serum NT-pro BNP levels
Change in serum NT-pro BNP levels
Measured: baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2013 (estimated)
- Study startSep 2013
- Primary completionDec 2014
- Study completionDec 2014
Why it stopped: bad recruitment of suitable participants, just 8 patients in one year
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type 2 (T2DM)Studies of the same condition, open and under way.
- 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
- Who is masked
- Participant, Investigator
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nikolaus Marx, Univ.-Prof., Principal investigator, Department of Internal Medicine I, RWTH Aachen University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01888796
- Sponsor's protocol ID
- 12-025
- Other IDs
- 2012-003858-81, EK 113/13
- Acronym
- Diast Dysfkt
- Status last verified
- Feb 2015
- First submitted
- 20 Jun 2013
- Last updated
- 12 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Linagliptin Therapy on Myocardial Diastolic Function in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01888796
- Acronym / sponsor ID
- Diast Dysfkt / 12-025
- Keywords
- T2DM, diastolic dysfunction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: bad recruitment of suitable participants, just 8 patients in one year
- Enrolment
- 8 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 28 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Examination of the effect of Linagliptin versus placebo on diastolic function in patients with type 2 diabetes mellitus and diastolic dysfunction as assessed by transthoracic echocardiography.
Furthermore the effect on serum levels of NT-pro BNP as a biomarker of heart failure will be investigated.
Detailed description
Treatment:
The Patients will receive Linagliptin 5 mg QD or placebo for a period of 6 months.
The echocardiography and 24h RR measurement will be performed at baseline and 6 months after initiation of the therapy.
The blood chemistry (Glucose, HbA1c, BNP) will be evaluated at baseline as well as 3 and 6 months after initiation of the therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Linagliptin | Active comparator | Drug: LinagliptinLinagliptin 5 mg (tablets) once daily for 6 month |
| Placebo | Placebo comparator | Drug: placeboPlacebo (tablets) once daily for 6 month |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diabetes mellitus Type 2
- Age > 50 years
- HbA1c > 7%
- Left ventricular diastolic dysfunction determined by echocardiography as average E/é ≥13 or average E/é≥8 and LA volume ≥34ml/m2
- Stable anti-diabetic medication for the last 6 weeks which should include a maximal tolerated dose of metformin (unless contraindication or intolerance to metformin does exist).
Key exclusion criteria (22 listed)
- Diabetes mellitus type 1
- Echocardiography:
- Uncontrolled hypertension
- Atrial fibrillation
- Obstructive sleep apnea syndrome
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 |
|---|---|---|
| LinagliptinAlso: Trade name Trajenta® by Boehringer Ingelheim (BI) Pharma GmbH & Co KG, Biberach, Germany | Drug | Linagliptin |
| placebo | Drug | Placebo |
Primary outcome
Change in left ventricular diastolic function
Time frame: baseline and 6 months
Change in left ventricular diastolic function between baseline and after 6 month as determined by 2D and novel 3D parameter global Strain Rate E Change in left ventricular diastolic function between baseline and after 6 month as determined by standardized parameter E/é and left atrial (LA) volume
1 secondary outcome
Change in serum NT-pro BNP levels
Time frame: baseline and 6 months
Results and safety
The study was stopped early (reason given: bad recruitment of suitable participants, just 8 patients in one year). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2017.
Related trials for Diabetes Mellitus Type 2 (T2DM)
Not yet recruiting
Role of Endothelial Dysfunction on Exercise Pressor Reflex in Type 2 Diabetes
Type 2 Diabetes (T2DM), Endothelial Dysfunction
Not yet recruiting
Physiologic Insulin Resensitization (PIR) Treatment in Patients With a Diagnosis of Type 2 Diabetes Mellitus (T2DM)
Type 2 Diabetes Mellitus
Active, not recruiting
Community-Empowerment and Environmental Enrichment-based Co-management (CEEEC) Model and Mechanisms for Improving Health of Older Stroke Patients With Multimorbidity
Hypertension, Type 2 Diabetes Mellitus (T2DM)
Not yet recruiting
Efficacy, Safety, and Treatment Satisfaction of Once-Weekly Tirzepatide in Obese Type 2 Diabetic Patients
Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Active, not recruiting
Helping Adults With Type 2 Diabetes Use Their Health Data for Healthy Diabetes Self-Management
Type 2 Diabetes Mellitus (T2DM)
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.
Nikolaus Marx, Univ.-Prof. principal investigator
Department of Internal Medicine I, RWTH Aachen University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Linagliptin in people with Diabetes Mellitus Type 2 (T2DM) and Left Ventricular Diastolic Dysfunction, run by RWTH Aachen University at 1 site in Germany.
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 7 inclusion and 22 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: stopped early, as of the sponsor's last update on 12 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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 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?
The study was stopped early (reason given: bad recruitment of suitable participants, just 8 patients in one year). Results are not available in the source record.
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 left ventricular diastolic function (time frame: baseline and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2017.