Exercise + Liraglutide for Type 2 Diabetes
(ZQL007 Trial)
Recruiting in Palo Alto (17 mi)
Overseen ByZhenqi Liu, MD
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: University of Virginia
Must be taking: Oral hypoglycemics
Must not be taking: Insulin
Disqualifiers: Smoking, Hypertension, Obesity, others
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?The primary objective of this study is to examine whether exercise training alone, liraglutide treatment alone or exercise training plus liraglutide treatment increases cardiac and muscle capillary blood volume, improves vascular function in the larger conduit vessels, and enhances insulin's metabolic action in humans with Type 2 diabetes. Subjects will be randomized to one of the three groups: exercise training, liraglutide treatment, and exercise + liraglutide. They will be studied at the baseline and then after 16 weeks of intervention.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop your current medications, but it requires that you have been on a stable dose of your medications for more than 4 months.
What data supports the effectiveness of the drug liraglutide for managing type 2 diabetes?
Liraglutide, when used with diet and exercise, has been shown to improve blood sugar control and promote weight loss in people with type 2 diabetes. It is effective in reducing hemoglobin A1c levels and is generally well tolerated, with common side effects like nausea decreasing over time.
12345Is the combination of exercise and liraglutide safe for humans?
Liraglutide, used for type 2 diabetes and weight management, is generally safe with a low risk of low blood sugar and common side effects like nausea, which usually decrease over time. It is approved for use with diet and exercise, and safety has been demonstrated in controlled trials for obesity and diabetes.
12345How does the treatment of exercise combined with the drug liraglutide differ from other treatments for type 2 diabetes?
This treatment is unique because it combines exercise with liraglutide, a drug that not only helps control blood sugar levels but also promotes weight loss and improves pancreatic function. Liraglutide is administered as a daily injection and is known for its low risk of causing low blood sugar, making it a safer option for some patients compared to other diabetes medications.
12367Eligibility Criteria
This trial is for adults aged 21-60 with Type 2 diabetes who have an A1C level of ≤8.5% and haven't used GLP-1RA or DPP4I medications. Participants should be on a stable dose of oral diabetes drugs for over four months, not taking insulin, non-smokers, with controlled blood pressure and BMI under 35. They must not have certain heart, lung, liver or kidney diseases, specific family cancer histories, vascular diseases or be pregnant.Inclusion Criteria
I am between 21 and 60 years old.
I have been on the same dose of my medications for over 4 months.
Your A1C level is lower than 8.5%.
+2 more
Exclusion Criteria
My family has a history of thyroid cancer or genetic syndromes affecting multiple glands.
My BMI is over 35.
I have a history of heart, lung, liver, or kidney disease.
+7 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive either exercise training, liraglutide treatment, or a combination of both for 16 weeks
16 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study aims to see if exercise alone, the drug Liraglutide alone, or both combined can improve blood vessel function and insulin sensitivity in people with Type 2 diabetes. Participants will be randomly assigned to one of three groups and evaluated before and after the 16-week intervention period.
3Treatment groups
Experimental Treatment
Group I: Liraglutide aloneExperimental Treatment1 Intervention
16 weeks of treatment
Group II: Exercise AloneExperimental Treatment1 Intervention
16 weeks of treatment
Group III: Exercise + LiraglutideExperimental Treatment2 Interventions
16 weeks of treatment
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of VirginiaCharlottesville, VA
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Who Is Running the Clinical Trial?
University of VirginiaLead Sponsor
American Diabetes AssociationCollaborator
National Institutes of Health (NIH)Collaborator
References
Liraglutide: a review of its use in the management of type 2 diabetes mellitus. [2021]Liraglutide (Victoza®) is a subcutaneously administered glucagon-like peptide-1 (GLP-1) receptor agonist produced by recombinant DNA technology and used as an adjunct to diet and exercise in the treatment of adults with type 2 diabetes mellitus. This article reviews the clinical efficacy and tolerability of liraglutide in adults with type 2 diabetes, and provides a summary of its pharmacological properties. Recently published pharmacoeconomic studies of liraglutide are also reviewed. Administered subcutaneously, liraglutide (usually 1.2 or 1.8 mg once daily) generally produced greater improvements in glycaemic control than active comparators or placebo when administered as monotherapy or in combination with one or two oral antidiabetic drugs (OADs) to adults with type 2 diabetes in numerous randomized, controlled phase III trials. These included six trials in the LEAD trial programme that was designed to evaluate the efficacy and safety of liraglutide across a continuum of antihyperglycaemic management for patients with type 2 diabetes. Liraglutide was generally well tolerated, with a low risk of hypoglycaemia evident, in the phase III trials. The most common adverse events were gastrointestinal and included nausea and diarrhoea; most events were mild to moderate in severity and decreased in incidence over time. In conclusion, liraglutide has an important place in the management of adults with type 2 diabetes across a continuum of care. As well as providing effective glycaemic control, liraglutide improves pancreatic β-cell function and leads to bodyweight loss, thereby addressing some of the unmet needs of patients treated with traditional OADs.
Clinical pearls for initiating and utilizing liraglutide in patients with type 2 diabetes. [2015]This review presents clinical pearls for initiating liraglutide (Victoza®, Novo Nordisk Inc) therapy for the management of type 2 diabetes and selecting patients who will benefit from liraglutide therapy. Liraglutide, a once-daily glucagon-like peptide 1 receptor agonist, is Food and Drug Administration approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Liraglutide is effective for reducing hemoglobin A1c levels by 0.8% to 1.5% in patients with type 2 diabetes as monotherapy or in combination with other diabetic medications (such as metformin, sulfonylureas, rosiglitazone, or basal insulin) when compared with placebo and these other diabetic medications, including exenatide. Overweight or obese patients with type 2 diabetes or those with insulin resistance are good candidates for liraglutide therapy because liraglutide use is associated with weight loss (about 2%-4% of initial body weight) and improved β-cell function. The incidence of hypoglycemia with liraglutide is low; therefore, liraglutide would be a safe therapy choice for patients at risk or with a history of symptomatic or severe hypoglycemia. Nausea seems to be the most problematic adverse effect associated with liraglutide therapy, but it is usually transient and is minimized with dose titration.
Liraglutide: a review of its use in type 2 diabetes mellitus. [2021]Liraglutide (Victoza) is an acylated analogue of glucagon-like peptide-1 (GLP-1) indicated for the treatment of type 2 diabetes mellitus. In phase III studies, once-daily subcutaneous liraglutide improved glycaemic control compared with placebo or active comparator in adult patients with type 2 diabetes, both as monotherapy and in combination with one or two oral antidiabetic drugs such as metformin, sulfonylureas or thiazolidinediones. Liraglutide provided significantly better glycaemic control than rosiglitazone or insulin glargine in combination trials. At appropriate dosages, liraglutide was noninferior to glimepiride with respect to glycaemic control in a combination trial, but provided significantly better control than glimepiride or glibenclamide in monotherapy trials. Liraglutide improved pancreatic beta-cell function, generally led to weight loss, and was associated with a low risk of hypoglycaemia. Liraglutide was generally well tolerated, with the most common adverse events being gastrointestinal events, such as nausea, which decreased over time. Thus, liraglutide is an effective treatment option for use in patients with type 2 diabetes mellitus.
Liraglutide for Type 2 diabetes and obesity: a 2015 update. [2015]Subcutaneous liraglutide (Victoza(®), Novo Nordisk) was approved for the treatment of Type 2 diabetes mellitus (T2DM) in Europe in 2009 and in the USA in 2010. In December 2014, liraglutide 3.0 mg was approved by the Food and Drug Administration (FDA) and in March 2015 by the European Medicines Agency (EMA) for the treatment of chronic weight management under the brand name Saxenda(®) Novo Nordisk. Liraglutide causes a glucose-dependent increase in insulin secretion, decreases glucagon secretion and promotes weight loss by inhibiting appetite. Liraglutide probably induces satiety through activation of different areas in the hind brain and possibly by preserving free leptin levels. Recently, liraglutide has been suggested to protect against prediabetes and seems to prevent bone loss by increasing bone formation following diet-induced weight loss in obesity. This article not only covers the major clinical trials evaluating the effects of liraglutide in obesity and T2DM but also provides novel insights into the pharmacological mechanisms of liraglutide.
[LIRAGUTIDE AT A DOSE OF 3.0 MG (SAXENDA): NEW INDICATION FOR THE TREATMENT OF OBESITY]. [2016]Liraglutide is an analogue of Glucagon-Like Peptide-1 (GLP-1) already indicated under the trade name of Victoza for the treatment of type 2 diabetes, at usual doses of 1.2 or 1.8 mg as once daily subcutaneous injection. It is henceforth indicated at a dose of 3.0 mg, also as once daily subcutaneous injection, for the treatment of obesity or overweight with comorbidities under the trade name of Saxenda, in combination with diet and exercise. Besides a specific action on the endocrine pancreas, mainly responsible for the antihyperglycaemic effect, liraglutide helps controlling appetite at the hypothamalic level. A specific programme of controlled trials (especially SCALE studies) demonstrated both efficacy and safety of the 3.0 mg dose of liraglutide in obese or overweight patients with various comorbidities.
Liraglutide (Victoza) for type 2 diabetes. [2015]Liraglutide (Victoza-Novo Nordisk), a glucagon-like peptide-1 (GLP-1) receptor agonist given by subcutaneous injection, has been approved by the FDA for treatment of patients with type 2 diabetes. It can be used alone or in addition to oral antidiabetic drugs such as metformin (Glucophage, and others) or glimepiride (Amaryl, and others). Liraglutide is not recommended for first-line therapy and is not approved for use with insulin.
Liraglutide in type 2 diabetes mellitus. [2018]Liraglutide (victoza, Novo Nordisk A/S) is human GLP-1 analogue developed by recombinant DNA technology. It is indicated along with diet and exercise in management of type 2 diabetes (T2DM) in adults. Liraglutide has been made available in India recently. Present review evaluates the efficacy and safety of liraglutide in T2DM and its comparison with other incretin based therapies. Liraglutide has been evaluated as monotherapy, in combination with one, two and three oral antidiabetic drugs similarly to routine clinical practice. These studies reported greater improvement in glycaemic control with liraglutide compared with comparators. Evaluation up to 2 years revealed sustained improvement in glycaemic control with liraglutide use. Liraglutide was well tolerated except for mild to moderate gastro-intestinal adverse events, which declined after continuation of therapy. Low risk of hypoglycaemia was reported with liraglutide therapy. Greater efficacy than other incretin based therapies was noted with liraglutide. Liraglutide has an important place in the management of T2DM. Apart from glycaemic control it also provides some important non-glycaemic benefits in terms of improving beta-cell function, weight reduction, and reduction in systolic blood pressure thereby overcoming the present therapeutic gap.