Pioglitazone vs Empagliflozin for Diabetes
(PEP-DM Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Mayo Clinic
Must be taking: Metformin
Disqualifiers: Type 1 diabetes, Pregnancy, Bleeding disorders, Hepatic impairment, others
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?The purpose of this study is to evaluate efficacy of pioglitazone (PIO) versus empagliflozin (EMPA) to improve glycemic control in people with Chronic Pancreatitis (CP) or Recurrent Acute Pancreatitis (RAP) associated with Diabetes Mellitus (DM). To evaluate mixed meal response in PIO versus EMPA group to better understand physiology of both therapies in CP-DM.
Will I have to stop taking my current medications?
The trial requires that participants are not on any antihyperglycemic medication except Metformin. If you are taking other diabetes medications, you may need to stop them to join the study.
What data supports the effectiveness of the drug empagliflozin for diabetes?
Empagliflozin, also known as Jardiance, is effective in treating type-2 diabetes by improving blood sugar control, and it has also been shown to reduce the risk of hospitalization in people with heart failure, even if they do not have diabetes.
12345Is empagliflozin safe for humans?
Empagliflozin (Jardiance) is generally considered safe for humans and is used to treat type 2 diabetes and heart failure. However, it may cause side effects like fluid deficits, so patients should be monitored for these.
34567How does the drug combination of Pioglitazone and Empagliflozin differ from other diabetes treatments?
The combination of Pioglitazone and Empagliflozin is unique because it combines two different mechanisms: Pioglitazone reduces insulin resistance and improves lipid profiles, while Empagliflozin helps lower blood sugar by preventing glucose reabsorption in the kidneys, leading to glucose excretion and weight loss. This dual approach may offer enhanced glycemic control and additional benefits like reduced cardiovascular risk and slight blood pressure reduction.
2891011Eligibility Criteria
This trial is for individuals with diabetes that's related to chronic or recurrent acute pancreatitis. Participants should have a history of these conditions and need better blood sugar control.Inclusion Criteria
I am between 18 and 70 years old.
Able to provide written informed consent and participate in longitudinal follow-up
Fasting plasma glucose <220 mg/dL at screening visit
+5 more
Exclusion Criteria
I am not on any systemic treatment for cancer, except for non-melanoma skin cancers.
I have a history of bleeding disorders like Hemophilia or von Willebrand disease.
My kidney function is very low.
+13 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive either Pioglitazone or Empagliflozin to improve glycemic control in CP-DM
24 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study aims to compare the effectiveness of two diabetes medications, Pioglitazone (PIO) and Empagliflozin (EMPA), in managing blood sugar levels in patients with pancreatitis-associated diabetes.
2Treatment groups
Experimental Treatment
Group I: Pioglitazone (PIO)Experimental Treatment1 Intervention
PIO (Actos) is a thiazolidinedione and an agonist for peroxisome proliferator activated receptor (PPAR) gamma indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 DM in multiple clinical settings. Its use has limitation for type 1 DM or for treatment of diabetic ketoacidosis. It is contraindicated to use in established NYHA class III or IV heart failure.
Group II: Empagliflozin (EMPA)Experimental Treatment1 Intervention
EMPA is a sodium-glucose co-transporter 2 inhibitor, FDA approved drug. It is indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure, to reduce the risk of cardiovascular death in adults with type 2 DM and established cardiovascular disease and as an adjunct to diet and exercise to improve glycemic control in adults with type 2 DM. It is not recommended in patients with type 1 DM. It may increase the risk of diabetic ketoacidosis. Not recommended for use to improve glycemic control in adults with type 2 DM with an eGFR less than 30mL/min/1.73m2.
Empagliflozin is already approved in European Union, United States, Canada, Japan for the following indications:
🇪🇺 Approved in European Union as Jardiance for:
- Type 2 diabetes mellitus
- Heart failure with reduced ejection fraction
- Chronic kidney disease
🇺🇸 Approved in United States as Jardiance for:
- Type 2 diabetes mellitus
- Heart failure with reduced ejection fraction
- Chronic kidney disease
- Cardiovascular risk reduction
🇨🇦 Approved in Canada as Jardiance for:
- Type 2 diabetes mellitus
- Heart failure with reduced ejection fraction
- Chronic kidney disease
🇯🇵 Approved in Japan as Jardiance for:
- Type 2 diabetes mellitus
- Heart failure with reduced ejection fraction
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Pittsburgh Medical CenterPittsburgh, PA
Mayo ClinicRochester, MN
Loading ...
Who Is Running the Clinical Trial?
Mayo ClinicLead Sponsor
University of Pittsburgh Medical CenterCollaborator
References
Pharmacokinetics and bioequivalence of a generic empagliflozin tablet versus a brand-named product and the food effects in healthy Chinese subjects. [2021]Label="OBJECTIVE" NlmCategory="OBJECTIVE">The aim of the present study was to assess the bioequivalence of a generic empagliflozin tablet versus a brand-named empagliflozin tablet (Jardiance®) and evaluate the food effects on the pharmacokinetics (PK) of empagliflozin in healthy Chinese subjects.
Design expert software assisted development and evaluation of empagliflozin and sitagliptin combination tablet with improved in-vivo anti-diabetic activities. [2023]The combination of empagliflozin and sitagliptin to treat type-2 diabetes might be more economical and patient compliance with an additive improvement in glycemic control due to complementary modes of action.
Drug treatment with empagliflozin lowered risk for hospitalization in people with heart failure with reduced ejection fraction: plain language summary of the EMPEROR-Reduced study. [2023]Label="WHAT IS THIS SUMMARY ABOUT?" NlmCategory="UNASSIGNED">This is a summary of the article describing the EMPEROR-Reduced study of empagliflozin, which was published in the New England Journal of Medicine. Empagliflozin (brand name Jardiance®) is a new drug therapy for the treatment of chronic heart failure. Chronic heart failure is a long-term condition where the heart cannot pump enough blood around the body, leading to symptoms such as shortness of breath, fatigue and build-up of too much water in the body (fluid retention). It also increases the risk for premature death.
Pharmacokinetics, Safety, and Bioequivalence of Two Empagliflozin Formulations after Single Oral Administration under Fasting and Fed Conditions in Healthy Chinese Subjects: An Open-label Randomized Single-dose Two-sequence, Two-treatment, Two-period Crossover Study. [2021]To evaluate the pharmacokinetic properties and safety of empagliflozin, and the bioequivalence of test formulation empagliflozin tablet compared with the brand-name drug Jardiance (reference formulation) after single oral administration under fasting and fed conditions in healthy Chinese subjects.
Diabetes Drug Now Approved for Heart Failure. [2023]The diabetes drug empagliflozin (Jardiance) is now approved to reduce the risk of cardiovascular death and hospitalization in adults with heart failure, even if they do not have diabetes.Nurses and NPs should monitor patients for adverse effects, especially fluid deficits.
▼ Empagliflozin, diabetes and outcomes. [2017]The prevalence of type 2 diabetes is rising, and in 2015 more than 5% of adults in the UK were affected by this condition.(1,2) Management of type 2 diabetes includes encouraging lifestyle changes (increased exercise, modification of diet and smoking cessation) alongside the provision of medication to minimise long-term complications and manage blood sugar control while avoiding unwanted effects of drug treatment.(3) Of particular importance, people with type 2 diabetes are at increased risk of cardiovascular disease, and therefore the aims of treatment also include modification of associated risk factors.(2-5)▼ Empagliflozin (Jardiance-Boehringer Ingelheim) is the third sodium-glucose co-transporter-2 (SGLT2) inhibitor licensed for use in the UK. It was launched in August 2014, and acts in a similar way to the other SGLT2 inhibitors, ▼ dapagliflozin and ▼ canagliflozin, by inhibiting renal glucose resorption and promoting glycosuria.(6) It is indicated for the treatment of type 2 diabetes in adults to improve glycaemic control, as monotherapy when metformin cannot be used, and in combination with other glucose-lowering drugs including insulin. Here we review the evidence for empagliflozin and discuss the results of a recent study that assessed cardiovascular outcomes.
Effectiveness and safety of empagliflozin-based quadruple therapy compared with insulin glargine-based therapy in patients with inadequately controlled type 2 diabetes: An observational study in clinical practice. [2022]This open-label, prospective study evaluated the effectiveness and safety of empagliflozin as add-on therapy in inadequately controlled type 2 diabetes (T2D) patients (glycated haemoglobin [HbA1c], 7.5-12%) who were already using three other types of orally active antidiabetic agents. A total of 268 T2D patients were enrolled and divided into two groups, empagliflozin (EMPA 25 mg/d, n = 142) or insulin glargine (INS, n = 126), respectively. After the treatment period of 24 weeks, HbA1c and fasting plasma glucose (FPG) were significantly reduced (HbA1c, P = 0.004; FPG, P = 0.008, respectively) in the EMPA group compared to the INS group. Also, EMPA treatment evoked a significant reduction in body weight (P
[Empagliflozin - the new representative of SGLT2 transporter inhibitors for the treatment of patients with diabetes 2 type]. [2018]Empagliflozin is a new medicine used to reduce hyperglycemia in patients with type 2 diabetes. It belongs to the most advanced class of antidiabetic drugs, known as gliflozins, which prevent reabsorption of glucose through inhibiting SGLT2 sodium-glucose cotransporter. Thereby they cause therapeutic glycosuria, thanks to which a loss of approximately 70 g of glucose per day occurs. This not only effects the decrease in glycemia, but also the loss of body mass, since this excreted glucose cannot be used as an energetic substrate. The studies within phase 3 have proven the therapeutic efficacy of empagliflozin in monotherapy, in combination with the other oral antidiabec drugs and insulin. Another favourable effect of empagliflozin is a slight decrease in blood pressure. In May 2014, empagliflozin was approved for the treatment of patients with type 2 diabetes within the European Union 2014, since October 2014 it has been available in the Czech Republic and since 1 February 2015 empagliflozin (under the trade name Jardiance®) has been partially covered by the health insurance for the treatment of patients with type 2 diabetes either in combination with metformin or in combination with insulin (with or without metformin).
Comparison of therapeutic efficacy and safety of sitagliptin, dapagliflozin, or lobeglitazone adjunct therapy in patients with type 2 diabetes mellitus inadequately controlled on sulfonylurea and metformin: Third agent study. [2023]Compare the efficacy and safety of sitagliptin, dapagliflozin, and lobeglitazone in patients with uncontrolled type 2 diabetes, despite metformin and sulfonylurea therapy.
Competact, a fixed combination of pioglitazone and metformin, improves metabolic markers in type 2 diabetes patients with insufficient glycemic control by metformin alone--results from a post-marketing surveillance trial under daily routine conditions. [2022]In patients with type 2 diabetes, glycemic control to target goals can only be achieved for a while by single-drug treatment. Antidiabetes therapy has to be adapted according to the individual course of the disease. This trial investigates the impact of Competact (Takeda Pharma, Aachen, Germany) (marketed as ActoplusMet in the United States)-a fixed combination of 850 mg of metformin with 15 mg of pioglitazone-for diabetes treatment in patients with insufficient glycemic control by metformin alone.
Comparative analysis of therapeutic efficiency and costs (experience in Bulgaria) of oral antidiabetic therapies based on glitazones and gliptins. [2022]Type 2 diabetes mellitus is a serious, chronic, progressive and widespread disease. Metformin is the most commonly prescribed initial therapy, but combination with other antidiabetic agents usually becomes necessary due to the progression of the disease. Pioglitazone is recommended as a second-line therapy because of its strong antihyperglycemic effect and its ability to reduce insulin resistance. Treatment with pioglitazone is associated with a significantly lower risk of cardiovascular complications and hypoglycemia, while simultaneously improving the lipid profile and the symptomatic and histological changes in the liver. Gliptins (sitagliptin and vildagliptin) are a new class of oral antidiabetic drugs which reduce glycated hemoglobin by a different mechanism. Although the efficacy of sitagliptin and vildagliptin is close to that of pioglitazone, the lack of long-term safety data and the higher price question their predominant use. The objective of this review is to highlight the advantages of mono- and combination therapy with pioglitazone in comparison with gliptins and to underline the inconsistencies in the medicinal and reimbursement policy in Bulgaria.