NNC0487-0111 for Type 2 Diabetes
Recruiting in Palo Alto (17 mi)
+94 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Novo Nordisk A/S
Must be taking: Metformin, SGLT2 inhibitors
Must not be taking: Diabetes, obesity medications
Disqualifiers: Uncontrolled diabetic retinopathy, hypoglycaemic unawareness, others
Prior Safety Data
Trial Summary
What is the purpose of this trial?The study will look at how well different doses of a new medicine called NNC0487-0111 help lower the blood sugar and body weight in people with type 2 diabetes. NNC0487-0111 is a new medicine which cannot be prescribed by doctors but has previously been tested in humans. Participants will either get NNC0487-0111, which is given as tablets or as injections, or placebo. Which treatment the participant get is decided by chance.The study will last for about 43 weeks.
Will I have to stop taking my current medications?
The trial does not specify if you must stop taking your current medications, but it requires that you have been on a stable dose of metformin, with or without an SGLT2 inhibitor, for at least 90 days before joining. Other diabetes or obesity medications are not allowed within 90 days before the trial.
What data supports the effectiveness of the drug NNC0487-0111 for Type 2 Diabetes?
Incretin-based therapies, which include drugs similar to NNC0487-0111, have shown to improve blood sugar control and help with weight management in people with Type 2 Diabetes. These therapies work by enhancing the body's natural response to food intake, and they have additional benefits like reducing inflammation and supporting heart and liver health.
12345What makes the drug NNC0487-0111 unique for treating Type 2 Diabetes?
NNC0487-0111, also known as Amycretin, is unique because it is a long-acting glucagon-like peptide-1 (GLP-1) derivative designed for once-daily administration, which helps lower blood sugar levels and potentially increases beta-cell mass in the pancreas, offering a longer duration of action compared to other GLP-1 treatments.
56789Eligibility Criteria
This trial is for individuals with type 2 diabetes who are interested in testing a new medication, NNC0487-0111. Participants will be involved in the study for approximately 43 weeks and must meet specific health criteria to join.Inclusion Criteria
Body mass index between greater or equal to 23.0 and below 50.0 kg/m^2
I was diagnosed with type 2 diabetes more than 6 months ago.
Able and willing to adhere to the protocol including wearing a continuous glucose monitoring (CGM) device provided for the study
+3 more
Exclusion Criteria
I have severe diabetic eye problems that are not under control.
I haven't taken diabetes or obesity drugs not listed in the criteria in the last 90 days.
Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's questionnaire question
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive either NNC0487-0111 or placebo, administered as tablets or injections, to evaluate the effect on blood sugar and body weight
36 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study tests how well different doses of NNC0487-0111 lower blood sugar and body weight when administered orally or by injection compared to a placebo. Treatment assignments are randomized.
11Treatment groups
Experimental Treatment
Placebo Group
Group I: NNC0487-0111 subcutaneous dose 6Experimental Treatment1 Intervention
NNC0487-0111 subcutaneous dose 6 treatment
Group II: NNC0487-0111 subcutaneous dose 5Experimental Treatment1 Intervention
NNC0487-0111 subcutaneous dose 5 treatment
Group III: NNC0487-0111 subcutaneous dose 4Experimental Treatment1 Intervention
NNC0487-0111 subcutaneous dose 4 treatment
Group IV: NNC0487-0111 subcutaneous dose 3Experimental Treatment1 Intervention
NNC0487-0111 subcutaneous dose 3 treatment
Group V: NNC0487-0111 subcutaneous dose 2Experimental Treatment1 Intervention
NNC0487-0111 subcutaneous dose 2 treatment
Group VI: NNC0487-0111 subcutaneous dose 1Experimental Treatment1 Intervention
NNC0487-0111 subcutaneous dose 1 treatment
Group VII: NNC0487-0111 oral dose 3Experimental Treatment1 Intervention
NNC0487-0111 oral dose 3 treatment
Group VIII: NNC0487-0111 oral dose 2Experimental Treatment1 Intervention
NNC0487-0111 oral dose 2 treatment
Group IX: NNC0487-0111 oral dose 1Experimental Treatment1 Intervention
NNC0487-0111 oral dose 1 treatment
Group X: Placebo oralPlacebo Group1 Intervention
Placebo for oral treatment
Group XI: Placebo subcutaneousPlacebo Group1 Intervention
Placebo for subcutaneous treatment
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Southern California DermatologySanta Ana, CA
Southern Cal Clinical ResearchSanta Ana, CA
PrimeCare Medical GroupHouston, TX
Fmc Science, LlcLampasas, TX
More Trial Locations
Loading ...
Who Is Running the Clinical Trial?
Novo Nordisk A/SLead Sponsor
References
Incretin-based therapies. [2022]Incretin-based therapies have established a foothold in the diabetes armamentarium through the introduction of oral dipeptidyl peptidase-4 inhibitors and the injectable class, the glucagon-like peptide-1 receptor agonists. In 2009, the American Diabetes Association and European Association for the Study of Diabetes authored a revised consensus algorithm for the initiation and adjustment of therapy in Type 2 diabetes (T2D). The revised algorithm accounts for the entry of incretin-based therapies into common clinical practice, especially where control of body weight and hypoglycemia are concerns. The gut-borne incretin hormones have powerful effects on glucose homeostasis, particularly in the postprandial period, when approximately two-thirds of the β-cell response to a given meal is due to the incretin effect. There is also evidence that the incretin effect is attenuated in patients with T2D, whereby the β-cell becomes less responsive to incretin signals. The foundation of incretin-based therapies is to target this previously unrecognized feature of diabetes pathophysiology, resulting in sustained improvements in glycemic control and improved body weight control. In addition, emerging evidence suggests that incretin-based therapies may have a positive impact on inflammation, cardiovascular and hepatic health, sleep, and the central nervous system. In the present article, we discuss the attributes of current and near-future incretin-based therapies.
Incretin-based therapies for type 2 diabetes: a nurse's perspective. [2011]Type 2 diabetes (T2D) is a serious and increasing problem in the UK. Large numbers of people are suffering from the disease, and its onset is occurring at younger ages, requiring prolonged treatment. Current therapies pose challenges for patients and health professionals, and new methods of treatment are therefore needed. This article examines a group of treatments--the incretin therapies--which have recently become available. It considers the clinical evidence for these therapies relevant to UK-based prescribing, and their potential benefits for patients with T2D. Awareness of these therapies, the evidence supporting them, and the clinical recommendations for their use will allow diabetes nurses to expand treatment options for patients with T2D.
Incretin manipulation in diabetes management. [2020]Incretin-based therapies have revolutionized the medical management of type 2 diabetes mellitus (T2DM) in the 21(st) century. Glucagon-like peptide-1 (GLP-1) suppresses appetite and gastric motility, and has trophic effects on pancreas, cardio-protective and renal effects. GLP-1 analogues and dipeptidyl peptidase-4 inhibitors form the incretin-based therapies. Significant reduction of hemoglobin A1c when used as monotherapy and in combination regimens, favorable effects on body weight, and low risk of hypoglycemia are their unique therapeutic benefits. Their safety and tolerability are comparable to other anti-diabetic medications. Concern about elevated risk of pancreatitis has been discarded by two recent meta-analyses. This article discusses the therapeutic manipulation of incretin system for the management of T2DM.
Management of type 2 diabetes: new and future developments in treatment. [2022]To date, six classes of oral medication have been approved by the U.S. Food and Drug Administration for the treatment of type 2 diabetes and several new agents are in the pipeline. In 2009, the American Diabetes Association and the European Association for the Study of Diabetes developed a consensus statement regarding the treatment of type 2 diabetes, citing lifestyle modification and metformin as the preferred first line therapies. In addition to the currently available drugs, several new agents have recently been introduced or are in the development pipeline. Incretin therapies include both glucagon-like peptide-1 (GLP-1) inhibitors and dipeptidyl peptidase 4 (DPP-4) inhibitors. Non-incretin beta cell stimulants still in development include glucokinase activators, G-protein-coupled receptors, and anti-inflammatory and anti-oxidant therapies. Additional agents that target glucose synthesis include glucose-6-phosphatase and glycogen phosphorylase. Other new agents target metabolic syndrome, which is often the first clinical condition that presents in patients at risk for type 2 diabetes. Finally, for obese patients who are unable to lose weight through diet and exercise, weight-loss surgery is an option that should be discussed with their physicians. This CME multimedia activity, which is part of a 2-part multimedia activity on the management and treatment of diabetes, contains a video presentation and is available through the website of The American Journal of Medicine at http://amjmed.com/content/multimedia. Click on "Management of Type 2 Diabetes: New and Future Developments in Treatment" to access this part of this multimedia program.
Effects of liraglutide (NN2211), a long-acting GLP-1 analogue, on glycaemic control and bodyweight in subjects with Type 2 diabetes. [2022]Liraglutide (NN2211) is a long-acting GLP-1 analogue, with a pharmacokinetic profile suitable for once-daily administration. This multicentre, double-blind, parallel-group, double-dummy study explored the dose-response relationship of liraglutide effects on bodyweight and glycaemic control in subjects with Type 2 diabetes.
The long-acting GLP-1 derivative NN2211 ameliorates glycemia and increases beta-cell mass in diabetic mice. [2018]NN2211 is a long-acting, metabolically stable glucagon-like peptide-1 (GLP-1) derivative designed for once daily administration in humans. NN2211 dose dependently reduced the glycemic levels in ob/ob mice, with antihyperglycemic activity still evident 24 h postdose. Apart from an initial reduction in food intake, there were no significant differences between NN2211 and vehicle treatment, and body weight was not affected. Histological examination revealed that beta-cell proliferation and mass were not increased significantly in ob/ob mice with NN2211, although there was a strong tendency for increased proliferation. In db/db mice, exendin-4 and NN2211 decreased blood glucose compared with vehicle, but NN2211 had a longer duration of action. Food intake was lowered only on day 1 with both compounds, and body weight was unaffected. beta-Cell proliferation rate and mass were significantly increased with NN2211, but with exendin-4, only the beta-cell proliferation rate was significantly increased. In conclusion, NN2211 reduced blood glucose after acute and chronic treatment in ob/ob and db/db mice and was associated with increased beta-cell mass and proliferation in db/db mice. NN2211 is currently in phase 2 clinical development.
The GLP-1 derivative NN2211 restores beta-cell sensitivity to glucose in type 2 diabetic patients after a single dose. [2019]Glucagon-like peptide 1 (GLP-1) stimulates insulin secretion in a glucose-dependent manner, but its short half-life limits its therapeutic potential. We tested NN2211, a long-acting GLP-1 derivative, in 10 subjects with type 2 diabetes (means +/- SD: age 63 +/- 8 years, BMI 30.1 +/- 4.2 kg/m(2), HbA(1c) 6.5 +/- 0.8%) in a randomized, double-blind, placebo-controlled, crossover study. A single injection (7.5 micro g/kg) of NN2211 or placebo was administered 9 h before the study. beta-cell sensitivity was assessed by a graded glucose infusion protocol, with glucose levels matched over the 5-12 mmol/l range. Insulin secretion rates (ISRs) were estimated by deconvolution of C-peptide levels. Findings were compared with those in 10 nondiabetic volunteers during the same glucose infusion protocol. In type 2 diabetic subjects, NN2211, in comparison with placebo, increased insulin and C-peptide levels, the ISR area under the curve (AUC) (1,130 +/- 150 vs. 668 +/- 106 pmol/kg; P
Effect of liraglutide vs. NPH in combination with metformin on blood glucose fluctuations assessed using continuous glucose monitoring in patients with newly diagnosed type 2 diabetes. [2022]To evaluate the effect of liraglutide and NPH on blood glucose fluctuations in patients with newly diagnosed type 2 diabetes mellitus (T2DM).
Bedtime administration of NN2211, a long-acting GLP-1 derivative, substantially reduces fasting and postprandial glycemia in type 2 diabetes. [2022]Glucagon-like peptide 1 (GLP-1) is a potent glucose-lowering agent of potential interest for the treatment of type 2 diabetes. To evaluate actions of NN2211, a long-acting GLP-1 derivative, we examined 11 patients with type 2 diabetes, age 59 +/- 7 years (mean +/- SD), BMI 28.9 +/- 3.0 kg/m(2), HbA(1c) 6.5 +/- 0.6%, in a double-blind, placebo-controlled, crossover design. A single injection (10 microg/kg) of NN2211 was administered at 2300 h, and profiles of circulating insulin, C-peptide, glucose, and glucagon were monitored during the next 16.5 h. A standardized mixed meal was served at 1130 h. Efficacy analyses were performed for the fasting (7-8 h) and mealtime (1130-1530 h) periods. Insulin secretory rates (ISR) were estimated by C-peptide deconvolution analysis. Glucose pulse entrainment (6 mg x kg(-1) x min(-1) every 10 min) was evaluated by 1-min sampled measurements of insulin concentrations from 0930 to 1030 h and subsequent time series analysis of the insulin concentration profiles. All results are given as NN2211 versus placebo; statistical analyses were performed by analysis of variance. In the fasting state, plasma glucose was significantly reduced (6.9 +/- 1.0 vs. 8.1 +/- 1.0 mmol/l; P = 0.004), ISR was increased (179 +/- 70 vs. 163 +/- 66 pmol/min; P = 0.03), and plasma glucagon was unaltered (19 +/- 4 vs. 20 +/- 4 pg/ml; P = 0.17) by NN2211. Meal-related area under the curve (AUC)(1130-1530 h) for glucose was markedly reduced (30.6 +/- 2.4 vs. 39.9 +/- 7.3 mmol x l(-1) x h(-1); P