Type 2 Diabetes MellitusNCT02694289
Effects of Metformin in Heart Failure Patients
A study testing Metformin and Subcutaneous (sliding scale) Insulin in people with Type 2 Diabetes Mellitus, run by Maya Guglin.
Trial summary
Hypothesis: In patients, who have diabetes type 2, are treated with metformin, and are admitted for HF, leads to reduced insulin requirements, as measured in units of insulin, with no negative impact on patient safety. This is a single center, prospective trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Metformin and Subcutaneous (sliding scale) Insulin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to 10 Sep 2018
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients > / = 18 years of age
- Admitted to the Medicine / Cardiology Advanced Heart Failure at UK Hospital
- Carry a diagnosis of heart failure with or without preserved ejection fraction
- Carry a diagnosis of type 2 diabetes mellitus
Who cannot join
- Patients <18 years of age
- Prisoners
- Terminal state
- Known adverse reaction or hypersensitivity to metformin administration
- Pregnancy
- Pathological conditions in which metformin administration is clinically contraindicated (Patients with acute or chronic metabolic acidosis, serum creatinine > 1.4 mg/dL in females, serum creatinine > 1.5 mg/dL in males)
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- Patients with acute cardiovascular collapse, acute myocardial infarction, septicemia
- Patients carrying a diagnosis of type 1 diabetes mellitus
- Patients admitted with diabetic ketoacidosis or hyperosmotic hyperosmolar state.
- Patients who experience diabetic ketoacidosis or hyperosmotic hyperosmolar state at any point during their hospital admission.
- Patients admitted with a subcutaneous insulin pump
- Patients who, at the discretion of the Medicine / Cardiology Advanced Heart Failure service, required an endocrinology consult during their hospitalization where the endocrine consult service is opposed to utilizing metformin in a particular patient
About this study
Hypothesis: In patients, who have diabetes type 2, are treated with metformin, and are admitted for HF, leads to reduced insulin requirements, as measured in units of insulin, with no negative impact on patient safety.
This is a single center, prospective trial. Subjects will be randomized to initiate metformin (starting dose 500mg orally once daily up to a maximum dose of 2,500mg daily) OR be placed on insulin products for management of their type 2 diabetes mellitus.
Read the detailed description
Because of the state of insulin resistance in heart failure (HF), metformin, with its ability to sensitize tissues to insulin, seems to be an ideal agent for managing type 2 diabetes mellitus (DM) in HF. It reduces the concentration of glucose in blood by enhancing insulin sensitivity, inducing greater peripheral uptake of glucose, and decreasing hepatic glucose output. However, according to the package insert, it is contraindicated in all patients with HF requiring pharmacologic treatment because of increased risk of lactic acidosis. The FDA has now de-escalated this contraindication to a warning as the evidence is lacking regarding an increased risk of lactic acidosis in patients with type 2 DM and HF who take metformin.
Hypothesis: In patients, who have diabetes type 2, are treated with metformin, and are admitted for HF, metformin leads to reduced insulin requirements, as measured in units of insulin, with no negative impact on patient safety.
Primary Objective: To test the hypothesis that continuing a patient's home metformin for diabetes management while admitted to UK hospital will result in decreased utilization of insulin as denoted by total units given.
Secondary Objectives: To test the hypothesis that administering metformin in HF patients admitted to UK Hospital:
- Results in similar glycemic control (targeting a blood glucose < 200mg/dL) when compared with placebo along on the basis of basic metabolic panel glucose values. Both groups may receive conventional inpatient hyperglycemia management with insulin products
- Reduces drug and laboratory costs
- Reduces hospital length of stay
- Does not result in hypoglycemia (blood glucose < 60 mg/dL)
- Reduced discharge medication errors related to diabetic medications
- No observed increase in metabolic acidosis due to elevated lactate levels
- Does not impact heart failure status (as indicated by trending NT-pro BNP levels)
Both the diagnosis and clinical management of patients with heart failure and type 2 diabetes mellitus will be guaranteed by the application of standard guidelines internationally recognized. All patients admitted to the Medicine / Cardiology Advanced Heart Failure at UK Hospital will be evaluated for inclusion and exclusion criteria. Based on our power analysis we plan to enroll 100 subjects total. Subjects will be enrolled from January 1, 2016 - December 31, 2018 until 120 patients are enrolled, estimated study time frame is two years.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Metformin, Subcutaneous (sliding scale) Insulin
- 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.
MetforminDrug
Also called no other names
Treatment/continuation of metformin therapy during admission
Subcutaneous (sliding scale) InsulinDrug
Also called eg. Humulin, Lantus, Novalin
Discontinue Metformin and be placed on subcutaneous sliding scale insulin during admission
| Study group | Role | What they receive |
|---|---|---|
| Metformin | Other | Continue Metformin while admitted to hospital Receives: Drug: Metformin |
| Subcutaneous (sliding scale) Insulin | Other | Discontinue Metformin upon admission and be placed on sliding scale subcutaneous insulin treatment while admitted to hospital Receives: Drug: Subcutaneous (sliding scale) Insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Units of Insulin used
doses and amounts on insulin needed
Measured: from time of hospital admission to hospital discharge, up to one year
Secondary outcomes (4)
Blood glucose levels
patient's glycemic control will be evaluated based on blood glucose levels
Measured: from time of hospital admission to hospital discharge, up to one year
Length of stay
Measured: time from hospital admission to hospital discharge, up to one year
Lactate levels, mmol/L
Measured: from time of hospital admission to hospital discharge, up to one year
pro-BNP levels, pg/mL
Measured: from time of hospital admission to hospital discharge, up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2016 (estimated)
- Study startNov 2016
- Primary completion10 Sep 2018
- Study completion10 Sep 2018
Why it stopped: failure to enroll participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maya Guglin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Maya Guglin, University of Kentucky
- Investigators
- Maya Guglin, MD, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02694289
- Sponsor's protocol ID
- 15-0797-F6A
- Status last verified
- Nov 2018
- First submitted
- 5 Feb 2016
- Last updated
- 23 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Metformin in Heart Failure Patients
- ClinicalTrials.gov ID
- NCT02694289
- Acronym / sponsor ID
- 15-0797-F6A
- Conditions
- Type 2 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: failure to enroll participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Maya GuglinUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- 10 Sep 2018 (actual)
- Study completion
- 10 Sep 2018 (actual)
- First posted
- 29 Feb 2016 (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.
Hypothesis: In patients, who have diabetes type 2, are treated with metformin, and are admitted for HF, leads to reduced insulin requirements, as measured in units of insulin, with no negative impact on patient safety.
This is a single center, prospective trial. Subjects will be randomized to initiate metformin (starting dose 500mg orally once daily up to a maximum dose of 2,500mg daily) OR be placed on insulin products for management of their type 2 diabetes mellitus.
Detailed description
Because of the state of insulin resistance in heart failure (HF), metformin, with its ability to sensitize tissues to insulin, seems to be an ideal agent for managing type 2 diabetes mellitus (DM) in HF. It reduces the concentration of glucose in blood by enhancing insulin sensitivity, inducing greater peripheral uptake of glucose, and decreasing hepatic glucose output. However, according to the package insert, it is contraindicated in all patients with HF requiring pharmacologic treatment because of increased risk of lactic acidosis. The FDA has now de-escalated this contraindication to a warning as the evidence is lacking regarding an increased risk of lactic acidosis in patients with type 2 DM and HF who take metformin.
Hypothesis: In patients, who have diabetes type 2, are treated with metformin, and are admitted for HF, metformin leads to reduced insulin requirements, as measured in units of insulin, with no negative impact on patient safety.
Primary Objective: To test the hypothesis that continuing a patient's home metformin for diabetes management while admitted to UK hospital will result in decreased utilization of insulin as denoted by total units given.
Secondary Objectives: To test the hypothesis that administering metformin in HF patients admitted to UK Hospital:
- Results in similar glycemic control (targeting a blood glucose < 200mg/dL) when compared with placebo along on the basis of basic metabolic panel glucose values. Both groups may receive conventional inpatient hyperglycemia management with insulin products
- Reduces drug and laboratory costs
- Reduces hospital length of stay
- Does not result in hypoglycemia (blood glucose < 60 mg/dL)
- Reduced discharge medication errors related to diabetic medications
- No observed increase in metabolic acidosis due to elevated lactate levels
- Does not impact heart failure status (as indicated by trending NT-pro BNP levels)
Both the diagnosis and clinical management of patients with heart failure and type 2 diabetes mellitus will be guaranteed by the application of standard guidelines internationally recognized. All patients admitted to the Medicine / Cardiology Advanced Heart Failure at UK Hospital will be evaluated for inclusion and exclusion criteria. Based on our power analysis we plan to enroll 100 subjects total. Subjects will be enrolled from January 1, 2016 - December 31, 2018 until 120 patients are enrolled, estimated study time frame is two years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metformin | Other | Drug: MetforminContinue Metformin while admitted to hospital |
| Subcutaneous (sliding scale) Insulin | Other | Drug: Subcutaneous (sliding scale) InsulinDiscontinue Metformin upon admission and be placed on sliding scale subcutaneous insulin treatment while admitted to hospital |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients > / = 18 years of age
- Admitted to the Medicine / Cardiology Advanced Heart Failure at UK Hospital
- Carry a diagnosis of heart failure with or without preserved ejection fraction
- Carry a diagnosis of type 2 diabetes mellitus
Key exclusion criteria (12 listed)
- Patients <18 years of age
- Prisoners
- Terminal state
- Known adverse reaction or hypersensitivity to metformin administration
- Pregnancy
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 |
|---|---|---|
| MetforminAlso: no other namesTreatment/continuation of metformin therapy during admission | Drug | Metformin |
| Subcutaneous (sliding scale) InsulinAlso: eg. Humulin, Lantus, NovalinDiscontinue Metformin and be placed on subcutaneous sliding scale insulin during admission | Drug | Subcutaneous (sliding scale) Insulin |
Primary outcome
Units of Insulin used
Time frame: from time of hospital admission to hospital discharge, up to one year
doses and amounts on insulin needed
4 secondary outcomes
Blood glucose levels
Time frame: from time of hospital admission to hospital discharge, up to one year
Length of stay
Time frame: time from hospital admission to hospital discharge, up to one year
Lactate levels, mmol/L
Time frame: from time of hospital admission to hospital discharge, up to one year
pro-BNP levels, pg/mL
Time frame: from time of hospital admission to hospital discharge, up to one year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2018.
- Individual participant dataSharing planned: No
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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.
Maya Guglin, MD, PhD principal investigator
University of Kentucky
Questions about this trial
What is this clinical trial studying?
A study testing Metformin and Subcutaneous (sliding scale) Insulin in people with Type 2 Diabetes Mellitus, run by Maya Guglin.
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 4 inclusion and 12 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: withdrawn, as of the sponsor's last update on 23 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Units of Insulin used (time frame: from time of hospital admission to hospital discharge, up to one year). 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 23 Nov 2018.