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Insulin ResistancePhase 2/3CARMETNCT01690091

Cardioprotective and Metabolic Effects of Metformin in Patients With Heart Failure and Diabetes

A Phase 2/3 study testing Metformini hydrochloridum (Siofor 1000 tbl, Berlin) in people with Insulin Resistance and Chronic Heart Failure, run by Institute for Clinical and Experimental Medicine at 1 site in Czechia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of the study is to evaluate the effect of metformin on myocardial function, insulin resistance and selected metabolic markers in patients with type 2 diabetes and heart failure (HF+DM+) in a cross-over, randomized, placebo controlled trial. Read more about this study

Who is it for?
Ages 40 to 70 years
Conditions the study is for
Insulin Resistance, Chronic Heart Failure
What is being tested?
Metformini hydrochloridum (Siofor 1000 tbl, Berlin)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteCzechia
Study dates
Nov 2012to Dec 2016
Phase
Phase 2/3
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 40 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • chronic heart failure will be defined by the following criteria (all must be included):
  • diagnosis of HF known for at least 6 months
  • medical history of hospitalization for cardiac decompensation with need for parenteral therapy for congestion - X-ray findings or swelling of lower extremities
  • stable drug therapy at least 1 month
  • treatment with diuretics (thiazide or furosemide)
  • LVEF below 50%
Show all 17Show fewer
  • the presence of diabetes will be defined by:
  • diagnosis and treatment of type 2 diabetes in the medical history
  • screening blood sample:
  • the value of HbA1c(according to IFCC)≥ 4.8% + fasting glucose ≥ 7.0 mmol / l in venous plasma or
  • the value of HbA1c ≥ 4.8%(according to IFCC) + random blood glucose ≥ 11.1 mmol/l in venous plasma
  • or OGTT - blood glucose level at 120 min ≥ 11.1 mmol/l OGTT is indicated just in case of positivity of one of the criteria (fasting glucose + HbA1c or HbA1c + random blood glucose)
  • treatment of diabetes - by diet only
  • women and men aged 40-70 years
  • body mass index (kg/m2) in the range of 20-35
  • the range of HbA1c between 4-6,5% IFCC
  • signed informed consent

Who cannot join

  • the planned cardiac intervention during the study that affect the function of the heart (revascularization including PCI, heart surgery, implantation of pacemaker, RF ablation; urgent candidate for OTS
  • metabolic disease, including: 1 type diabetes, decompensated thyreopathy (Note: patients with hypothyroidism and stable substitution (the last 3 months) of normal TSH levels may participate in the study
  • treatment with insulin or PAD one month before the recruitment(patients who were temporarily treated with insulin during hospitalization may participate in the study)
  • pregnancy (positive β-HCG test), breast feeding, trying to become pregnant
  • clinically significant anemia with hemoglobin below 100 g/l
  • renal insufficiency with eGF below 0.7 ml/s
  • atrial fibrillation - present during screening test
  • the presence of other medical condition, which occurs during physical examination, laboratory tests, ECG, including pulmonary, neurological or inflammatory disease, which would be considered by the examiner to distort the consistency of data

Trial locations and contacts

1 site in 1 country.

Czechia1 site

  • Diabetes Center, Institute of Clinical and Experimental Medicine

    Prague

Other trials in Czechia

About this study

The aim of the study is to evaluate the effect of metformin on myocardial function, insulin resistance and selected metabolic markers in patients with type 2 diabetes and heart failure (HF+DM+) in a cross-over, randomized, placebo controlled trial.

Hypothesis:

Metformin treatment in HF+DM+ group will lead to better myocardial function and load tolerance in comparison to placebo. The degree of improvement will be linked to selected metabolic parameters.

Read the detailed description

40 patients with HF and DM without previous diabetes treatment will be randomized into 2 groups (A succession: MET-placebo, B succession: placebo-MET) - stratified randomization with following parameters weighted: HF etiology (ischemic /non-ischemic), diabetes duration, gender, BMI, age, NYHA, smoker/non-smoker). After 3 months the treatment will be switched. All participants will undergo standardized selection of metabolic and cardiovascular tests (hyperinsulinemic euglycemic clamp with indirect calorimetry, measurement of endothelial function, echocardiography, spiroergometry, proton/phosphor MR spectroscopy, adipose tissue biopsy, selected cytokines in plasma and adipose tissue at the beginning and the end of each intervention period (3 times in total).

Being tested
Metformini hydrochloridum (Siofor 1000 tbl, Berlin), placebo
Keywords
chronic heart failure, type 2 diabetes, metformin, insulin resistance
Medical subject headings
Insulin Resistance, Diabetes Mellitus, Type 2

What participants receive

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

  • Metformini hydrochloridum (Siofor 1000 tbl, Berlin)Drug

    Also called A10BA02 Metformin

    Patients will be randomized into 2 groups (A succession: MET-placebo, B succession: placebo-MET. After 3 months the treatment will be switched.

    Titration:

    500 mg per day(1/2 tbl 1000 mg once a day - in the morning) after a week increase the dose to 1 tbl á 1000 mg after two weeks increase the dose to 2 x tbl 1000 mg (in the morning and in the evening)

  • placeboDrug

    Patients will be randomized into 2 groups (A succession: MET-placebo, B succession: placebo-MET. After 3 months the treatment will be switched.

Study groups in NCT01690091
Study groupRoleWhat they receive
MetforminExperimental500 mg per day(1/2 tbl 1000 mg once a day - in the morning) after a week increase the dose to 1 tbl á 1000 mg after two weeks increase the dose to 2 x tbl 1000 mg (in the morning and in the evening), duration: 3 months
Receives: Drug: Metformini hydrochloridum (Siofor 1000 tbl, Berlin); Drug: placebo
PlaceboPlacebo comparator500 mg per day(1/2 tbl 1000 mg once a day - in the morning) after a week increase the dose to 1 tbl á 1000 mg after two weeks increase the dose to 2 x tbl 1000 mg (in the morning and in the evening), duration:3 months
Receives: Drug: Metformini hydrochloridum (Siofor 1000 tbl, Berlin); Drug: placebo

What is being measured

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

  1. insulin sensitivity

    change of glucose disposal during clamp

    Measured: at baseline and after 3 months

Secondary outcomes (3)

  1. energy expenditure

    change of energy expenditure measured by indirect calorimetry

    Measured: at baseline and after 3 months

  2. endothelial function

    change in digital pulse amplitude tonometry

    Measured: at baseline and after 3 months

  3. heart function

    change measured by echocardiography and spiroergometry

    Measured: at baseline and after 3 months

Timeline

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

  1. First posted21 Sep 2012 (estimated)
  2. Study startNov 2012
  3. Primary completionMay 2016
  4. Study completionDec 2016

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01690091
Sponsor's protocol ID
NT13034
Acronym
CARMET
Status last verified
Mar 2018
First submitted
12 Mar 2012
Last updated
29 Mar 2018
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Metformini hydrochloridum (Siofor 1000 tbl, Berlin) in people with Insulin Resistance and Chronic Heart Failure, run by Institute for Clinical and Experimental Medicine at 1 site in Czechia.

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 17 inclusion and 8 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 29 Mar 2018. 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 Czechia. 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 combined 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.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

insulin sensitivity (time frame: at baseline and after 3 months). 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 NCT01690091.

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 29 Mar 2018.

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