Dulaglutide for Type 2 Diabetes
Recruiting in Palo Alto (17 mi)
+2 other locations
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Eli Lilly and Company
Must be taking: Metformin, Basal insulin
Must not be taking: Weight loss drugs
Disqualifiers: Type 1 diabetes, Severe hypoglycemia, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?The main purpose of this study is to evaluate additional dosing options for dulaglutide in pediatric participants with Type 2 Diabetes. Participation in this study will last about 8 months.
Will I have to stop taking my current medications?
You can continue taking metformin and/or basal insulin as long as your dose has been stable for at least 8 weeks before the trial. However, you should not have taken any other glucose-lowering medications or weight loss drugs in the 90 days before the trial.
Is Dulaglutide (Trulicity) safe for humans?
Dulaglutide (Trulicity) is generally well tolerated in adults with type 2 diabetes, with a low risk of low blood sugar. The most common side effects are related to the stomach, like nausea, vomiting, and diarrhea.
12345How is the drug Dulaglutide different from other treatments for type 2 diabetes?
Dulaglutide (Trulicity) is unique because it is a once-weekly injection that mimics a hormone called GLP-1, which helps regulate blood sugar levels by enhancing insulin release and slowing stomach emptying. This makes it different from many other diabetes treatments that require daily dosing or work through different mechanisms.
678910Eligibility Criteria
This trial is for children with Type 2 Diabetes. The study will last approximately 8 months, but specific eligibility criteria are not provided.Inclusion Criteria
I manage my Type 2 diabetes with diet, exercise, and stable doses of metformin or insulin.
I weigh at least 50 kg and my BMI is above the 85th percentile.
Exclusion Criteria
I have taken diabetes medication other than metformin or basal insulin in the last 3 months.
I have had chronic pancreatitis or issues with my gallbladder.
I have not used weight loss drugs in the last 90 days.
+4 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive dulaglutide subcutaneously for Type 2 Diabetes management
26 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study is testing two higher doses of Dulaglutide (3.0 mg and 4.5 mg) to see how well they work in young patients with Type 2 Diabetes.
1Treatment groups
Experimental Treatment
Group I: DulaglutideExperimental Treatment1 Intervention
Participants will receive dulaglutide subcutaneously (SC)
Dulaglutide is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Trulicity for:
- Type 2 diabetes mellitus
- Cardiovascular risk reduction in adults with established cardiovascular disease or multiple cardiovascular risk factors
🇪🇺 Approved in European Union as Trulicity for:
- Type 2 diabetes mellitus
- Cardiovascular risk reduction in adults with established cardiovascular disease or multiple cardiovascular risk factors
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
D&H Tamarac Research Center, LLCTamarac, FL
D&H National Research Centers, IncMiami, FL
Centricity Research Columbus EndocrinologyColumbus, GA
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Who Is Running the Clinical Trial?
Eli Lilly and CompanyLead Sponsor
References
Dulaglutide: first global approval. [2021]Dulaglutide (Trulicity™) is a long-acting, glucagon-like peptide-1 (GLP-1) receptor agonist that has been developed by Eli Lilly and Company for the treatment of type 2 diabetes mellitus. It consists of a dipeptidyl peptidase-IV-protected GLP-1 analogue covalently linked to a human IgG4-Fc heavy chain by a small peptide linker. The subcutaneous formulation is approved for use in type 2 diabetes in the US, has been recommended for approval in the EU in this indication, and is under regulatory review in other countries. This article summarizes the milestones in the development of subcutaneous dulaglutide leading to this first approval for type 2 diabetes.
Dulaglutide: A Review in Type 2 Diabetes. [2021]Subcutaneous dulaglutide (Trulicity®) is a once-weekly glucagon-like peptide-1 receptor agonist that is approved in numerous countries as an adjunct to diet and exercise for the treatment of adults with type 2 diabetes (T2D). In the clinical trial and real-world settings, once-weekly subcutaneous dulaglutide, as monotherapy or add-on therapy to other antihyperglycaemic agents (including oral antihyperglycaemic drugs and insulin), was an effective and generally well tolerated treatment in adults with inadequately controlled T2D, including in high-risk patients [e.g. obese and elderly patients, those with stage 3 or 4 chronic kidney disease (CKD) and/or cardiovascular (CV) disease]. In the REWIND CV outcomes trial in patients with T2D with or without CV disease, dulaglutide was associated with a significant reduction in the risk of a major adverse cardiac event (MACE; primary composite outcome comprising CV death, nonfatal myocardial infarction or nonfatal stroke) at a median of 5.4 years' follow-up. Given its durable glycaemic efficacy, beneficial effects on bodyweight and MACE outcomes, low inherent risk of hypoglycaemia and convenient once-weekly regimen, dulaglutide remains an important option in the management of T2D.
Dulaglutide: A Review in Type 2 Diabetes. [2015]Dulaglutide (Trulicity™) is a once-weekly subcutaneously administered glucagon-like peptide-1 (GLP-1) receptor agonist produced by recombinant DNA technology and approved in numerous countries as an adjunct to diet and exercise for the treatment of adults with type 2 diabetes (T2DM). In randomized controlled trials in patients with T2DM, dulaglutide monotherapy was noninferior to once-daily subcutaneous liraglutide monotherapy and significantly more effective than oral metformin monotherapy in improving glycemic control at 26 weeks. When used in combination with other agents (including metformin, metformin and a sulfonylurea, metformin and oral pioglitazone, and prandial insulin ± metformin), dulaglutide was noninferior to once-daily liraglutide and significantly more effective than once-daily oral sitagliptin, twice-daily subcutaneous exenatide, and once-daily subcutaneous insulin glargine in terms of improvements in glycated hemoglobin from baseline at 26 or 52 weeks, in trials of 26-104 weeks' duration. Moreover, dulaglutide 1.5 mg once weekly, but not 0.75 mg once weekly, was associated with consistent reductions form baseline in bodyweight. Improvements in glycemic control and bodyweight were maintained during long-term treatment (up to 2 years). Dulaglutide was generally well tolerated, with a low inherent risk of hypoglycemia. The most frequently reported adverse events in clinical trials were gastrointestinal-related (e.g., nausea, vomiting, and diarrhea). Thus, dulaglutide is a useful option for the treatment of adult patients with T2DM.
Dulaglutide (Trulicity): The Third Once-Weekly GLP-1 Agonist. [2020]Dulaglutide (Trulicity): the third once-weekly GLP-1 agonist for type-2 diabetes.
[Dulaglutide (Trulicity®), a new once-weekly agonist of glucagon-like peptide-1 receptors for type 2 diabetes]. [2016]Dulaglutide (Trulicity®) is a new once-weekly agonist of Glucagon-Like Peptide-1 (GLP-1) receptors indicated in the treatment of type 2 diabetes. Phase III clinical trials in AWARD programme demonstrated the efficacy and safety of dulaglutide in patients with type 2 diabetes treated by diet and exercise, metformin, a combination of metformin and a sulfonylurea or metformin and pioglitazone or even by supplements of prandial insulin. In the AWARD programme, dulaglutide (subcutaneous 0.75 or 1.5 mg once weekly) exerted a greater glucose-lowering activity than metformin, sitagliptin, exenatide or insulin glargine, and was non-inferior to liraglutide 1.8 mg once daily. Dulaglutide is currently reimbursed in Belgium after failure of and in combination with a dual oral therapy with metformin and a sulfonylurea or metformin and pioglitazone.
Efficacy and safety of tofacitinib in the treatment of rheumatoid arthritis: a systematic review and meta-analysis. [2023]Tofacitinib is a disease-modifying antirheumatic drug (DMARD) which was recently approved by US Food and Drug Administration (FDA). There are several randomised clinical trials (RCTs) that have investigated the efficacy and safety of tofacitinib in adult patients with rheumatoid arthritis (RA). A systematic review with a meta-analysis of RCTs was undertaken to determine the efficacy and safety of tofacitinib in treating patients with RA.
Is there a role for everolimus in the treatment of RA? [2021]The past decade has seen remarkable advances in the treatment of rheumatoid arthritis. Although this is good news for the majority of patients, one consequence is that the environment for the development of new drugs has become difficult as a result of high expectations for efficacy. Nevertheless, there remains a subgroup of patients with rheumatoid arthritis who are not candidates for treatment with the newer biologic agents and in whom oral DMARDs have certain advantages. A recent report by Bruyn et al. suggests that the proliferation-signal inhibitor everolimus could have unique properties, in addition to a convenient once-daily oral dosing schedule, that might fit this niche in the therapeutic armamentarium. Further studies are required, however, to confirm the disease-modifying effects and adverse event profile of this drug.
Successful novel use of tofacitinib for type II refractory coeliac disease. [2022]Refractory coeliac disease (RCD) occurs when patients with confirmed CD have continuous or recurrent malabsorption and enteropathy after at least 12 months on a gluten-free diet. Differentiating between type I and type II RCD is key as the latter is associated with T-cell aberrancy and considered prelymphoma, with high mortality rates. Current treatment regimens for type II RCD include corticosteroids, biologics and chemotherapy, but there are no proven therapies for this serious condition. Our patient is a middle-aged woman who developed postpartum type II RCD. When she failed multiple drug classes, we did a trial of tofacitinib. Our clinical experience with use of a janus kinase inhibitor was successful, with no associated adverse events. This is the first report in the literature of RCD remission in response to tofacitinib. The use of this novel agent shows promise in reversing this potentially fatal condition.
Efficacy and safety of tofacitinib for treatment of rheumatoid arthritis. [2022]Tofacitinib is the first in a new class of nonbiologic disease-modifying antirheumatic drugs (DMARDs), a targeted, synthetic DMARD, approved for the treatment of rheumatoid arthritis (RA) as monotherapy or in combination with methotrexate or other non-biologic DMARD. Tofacitinib, an orally administered Janus kinase (JAK) inhibitor, decreases T-cell activation, pro-inflammatory cytokine production, and cytokine signaling by inhibiting binding of type I cytokine receptors family and γ-chain cytokines to paired JAK1/JAK3 receptors. The net effect of tofacitinb's mechanism of action is decreased synovial inflammation and structural joint damage in RA patients. To date, six phase 3 trials have been conducted to evaluate the safety and efficacy of tofacitinib under the oral rheumatoid arthritis triaLs (ORAL) series. This review describes the pharmacology of the novel agent, tofacitinib, and details the safety and efficacy data of the ORAL trials.
[A short history of anti-rheumatic therapy - VI. Rheumatoid arthritis drugs]. [2019]The treatment of rheumatoid arthritis traditionally includes symptomatic drugs, showing a prompt action on pain and inflammation, but without any influence on disease progression, and other drugs that could modify the disease course and occasionally induce clinical remission (DMARDs or disease modifying anti-rheumatic drugs). This review describes the historical steps that led to the use of the main DMARDs in rheumatoid arthritis, such as gold salts, sulphasalazine, chloroquine and hydroxychloroquine, D-penicillamine, and other immunoactive drugs, including methotrexate, azathioprine, cyclosporin and leflunomide. The historical evolution of use of these drugs is then discussed, including the strategy of progressive ("therapeutic pyramid") or of more aggressive treatment, through the simultaneous use of two or more DMARDs ("combination therapy").