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

NCT01690091 | Completed Phase 2 DMC

• 1 other identifier: NT13034
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Insulin Resistance; Chronic Heart Failure

Keywords

chronic heart failure; type 2 diabetes; metformin; insulin resistance

Outcome Measures

Primary Outcomes (1)

• insulin sensitivity

  change of glucose disposal during clamp

  at baseline and after 3 months

Secondary Outcomes (3)

• energy expenditure

  at baseline and after 3 months

• endothelial function

  at baseline and after 3 months

• heart function

  at baseline and after 3 months

Study Arms (2)

Metformin

EXPERIMENTAL

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), duration: 3 months

Drug: Metformini hydrochloridum (Siofor 1000 tbl, Berlin); Drug: placebo

Placebo

PLACEBO COMPARATOR

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), duration:3 months

Drug: Metformini hydrochloridum (Siofor 1000 tbl, Berlin); Drug: placebo

Interventions

Metformini hydrochloridum (Siofor 1000 tbl, Berlin) DRUG

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)

Also known as: A10BA02 Metformin

Metformin; Placebo

placebo DRUG

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

Metformin; Placebo

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute for Clinical and Experimental Medicine: lead

Study Sites (1)

Diabetes Center, Institute of Clinical and Experimental Medicine

Prague, Czechia

Location

MeSH Terms

Conditions

Insulin Resistance; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Terezie Pelikanova, Prof., MD

  Diabetes Center, Institute of Clinical and Experimental Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.MUDr.Terezie Pelikanova DrSc.

Study Record Dates

• First Submitted: March 12, 2012
• First Posted: September 21, 2012
• Study Start: November 1, 2012
• Primary Completion: May 1, 2016
• Study Completion: December 1, 2016
• Last Updated: March 29, 2018

Record last verified: 2018-03

Locations

CZ (1)