NEWS HIGHLIGHTS
Published Studies Related to Januvia (Sitagliptin)
A treatment strategy implementing combination therapy with sitagliptin and metformin results in superior glycaemic control versus metformin monotherapy due to a low rate of addition of antihyperglycaemic agents. [2011.09]
AIMS: Combination therapy with sitagliptin and metformin has shown superior efficacy compared with metformin monotherapy. In this study, we compare two strategies: initial combination therapy with sitagliptin/metformin as a fixed-dose combination (FDC) and initial metformin monotherapy, with the option to add additional antihyperglycaemic agents (AHAs) in either treatment arm during the second phase of the study in order to reach adequate glycaemic control... CONCLUSIONS: A strategy initially implementing combination therapy with sitagliptin/metformin FDC was superior to a strategy initially implementing metformin monotherapy, even when accounting for the later addition of supplemental AHAs. Sitagliptin/metformin FDC was generally well tolerated. (c) 2011 Blackwell Publishing Ltd.
The effect of initial therapy with the fixed-dose combination of sitagliptin and metformin compared with metformin monotherapy in patients with type 2 diabetes mellitus. [2011.07]
AIMS: This study was conducted to compare the glycaemic efficacy and safety of initial combination therapy with the fixed-dose combination of sitagliptin and metformin versus metformin monotherapy in drug-naive patients with type 2 diabetes... CONCLUSION: Compared with metformin monotherapy, initial treatment with sitagliptin/metformin FDC provided superior glycaemic improvement with a similar degree of weight loss and lower incidences of abdominal pain and diarrhoea. (c) 2011 Blackwell Publishing Ltd.
DURATION-2: efficacy and safety of switching from maximum daily sitagliptin or pioglitazone to once-weekly exenatide. [2011.06]
AIMS: In the initial 26-week, double-blind, double-dummy assessment period of the DURATION-2 trial in patients with Type 2 diabetes on metformin, the once-weekly glucagon-like peptide 1 (GLP-1) receptor agonist exenatide once-weekly resulted in greater HbA(1c) improvement and weight reduction compared with maximum approved daily doses of sitagliptin or pioglitazone. This subsequent, 26-week, open-label, uncontrolled assessment period evaluated the safety and efficacy of (i) continued exenatide once-weekly treatment and (ii) switching from sitagliptin or pioglitazone to exenatide once-weekly... CONCLUSIONS: Patients who switched to once-weekly exenatide from daily sitagliptin or pioglitazone had improved or sustained glycaemic control, with weight loss. (c) 2011 Amylin Pharmaceuticals, Inc. Diabetic Medicine (c) 2011 Diabetes UK.
Efficacy and tolerability of sitagliptin monotherapy in elderly patients with type 2 diabetes: a randomized, double-blind, placebo-controlled trial. [2011.05]
CONCLUSION: In this study, sitagliptin treatment significantly and rapidly improved glycemic measures and was well tolerated in patients aged >/= 65 years with type 2 diabetes.
Liraglutide improves treatment satisfaction in people with Type 2 diabetes compared with sitagliptin, each as an add on to metformin. [2011.03]
AIMS: Patient-reported outcomes from clinical trials offer insight into the impact of disease on health-related quality of life, including treatment satisfaction. This patient-reported outcomes evaluation was a substudy of a 26-week randomized, open-label trial comparing the once-daily injectable human GLP-1 analogue liraglutide with once-daily oral sitagliptin, both added to metformin. The patient reported outcomes substudy aimed to evaluate treatment satisfaction using the Diabetes Treatment Satisfaction Questionnaire (DTSQ) at baseline and 26 weeks... CONCLUSIONS: Injectable liraglutide may lead to greater treatment satisfaction than oral sitagliptin, potentially by facilitating greater improvement in glycaemic control, weight loss and/ or perception of greater treatment efficacy. (c) 2011 The Authors. Diabetic Medicine (c) 2011 Diabetes UK.
Clinical Trials Related to Januvia (Sitagliptin)
Assessment of the Effects of a DPP-4 Inhibitor (Sitagliptin) Januvia on Immune Function in Healthy Individuals [Recruiting]
Patients with diabetes have high blood sugar levels (hyperglycemia) because pancreatic
beta-cells no longer produce sufficient insulin. Insufficient beta-cell function can be
caused by an autoimmune killing of the beta-cells in type 1 diabetes (T1D), or by poorly
understood mechanisms in type 2 diabetes (T2D). Glucagon-like peptide-1 (GLP-1) improves
function of the insulin-producing beta cells, but GLP-1 has a very short circulating
half-life because it is cleaved by the enzyme dipeptidyl peptidase IV (DPP-4). One current
treatment being used to improve glycemia control in patients with T2D is sitagliptin, an
inhibitor of DPP-4. By inhibiting DPP-4, sitagliptin increases GLP-1 levels, resulting in
improved beta cell function. Sitagliptin is now being tested in individuals with new-onset
T1D to determine whether it may help to preserve beta cell function. Because T1D is a
disease in which the immune system destroys the insulin-producing beta cells in the
pancreas, we wish to determine if and how sitagliptin alters immune function. Sitagliptin
has been shown by Merck to be safe and effective with no overt immuno-toxicities. However,
several lines of evidence suggest that DPP-4 inhibitors such as sitagliptin could be
immunomodulatory.
This randomized clinical trial will study immune function in healthy volunteers given
short-term (4 week) treatment with either sitagliptin or placebo. During the study, we will
take blood samples at various time intervals before, during and after treatment. We will
compare the immune response with and without sitagliptin treatment using blood samples from
healthy individuals. We will measure changes in the magnitude and type of immune responses.
The study period is nine weeks. The study's primary outcome will be changes in blood plasma
levels of a protein marker associated with decreased inflammation: Transforming Growth
Factor Beta 1 (TGF beta 1). In addition, we plan to use these blood samples to measure
sitagliptin's effect on expression levels of several cytokines (immune proteins). We will
also measure the level of proliferation in stimulated PBMCs (blood immune cells) and gene
expression in whole blood after sitagliptin treatment.
The Effect of Januvia (Sitagliptin) on Oxidative Stress in Obese Type 2 Diabetic Subjects [Recruiting]
Sitagliptin is a new oral hypoglycemic anti-diabetic drug used either alone or in
combination with metformin or a thiazolidinedione for control of type 2 diabetes mellitus.
Sitagliptin has been shown to have fewer side effects in the control of blood glucose
values.
Obesity and diabetes are states of increased inflammation and can influence the free
radicals and inflammatory markers (chemicals in the blood which increase due to inflammation
in the body) and are also major risk factors for atherosclerotic disease. In this study we
want to see the effect of sitagliptin on these markers. We believe that Sitagliptin may
exert an anti-inflammatory effect in the human. The purpose of this study is to determine if
the addition of sitagliptin to diabetic patients will provide added benefit. We believe that
sitagliptin provides these added benefits by suppressing free radicals (charged substances
that cause damage to the body) and inflammation.
A Study of the Co-administration of Sitagliptin and Atorvastatin in Inadequately Controlled Type 2 Diabetes Mellitus (MK-0431E-211) [Not yet recruiting]
This 2 phase study will examine if 16 weeks of treatment with sitagliptin in combination
with atorvastatin reduces hemoglobin A1C (A1C) and low density lipoprotein cholesterol
(LDL-C) from baseline more than atorvastatin alone and sitagliptin alone, respectively.
Following a single-blind placebo run-in period, participants were randomized to one of three
treatment arms (sitagliptin monotherapy with placebo to atorvastatin, atorvastatin
monotherapy with placebo to sitagliptin, or sitagliptin plus atorvastatin) for 16 weeks
(Phase A). During Phase B of the study (Weeks 16 through 54), participants received either
sitagliptin plus atorvastatin with placebo to glimepiride or glimepiride plus atorvastatin
with placebo to sitagliptin.
Combination Therapy With Sitagliptin and Lansoprazole to Restore Pancreatic Beta Cell Function in Recent-Onset Type 1 Diabetes [Recruiting]
Sanford Research/USD proposes to study the combination therapy of oral administration of
sitagliptin and lansoprazole versus placebo for the preservation of pancreatic beta cells
still present in patients with recent-onset diabetes and possibly regenerating their beta
cells, while safely down-regulating the autoimmune response directed against the beta cells.
Dose Response Finding Study of MK-0431/ONO-5435 in Japanese Subjects With Impaired Glucose Tolerance (MK-0431-105) [Recruiting]
This study is being done to evaluate the safety, efficacy, and dose level of sitagliptin
(MK-0431/ONO-5435) used once daily (qd) for Japanese subjects with impaired glucose
tolerance who have inadequate glycemic control using diet and exercise therapy.
Reports of Suspected Januvia (Sitagliptin) Side Effects
Pancreatitis (192),
Hypoglycaemia (93),
Interstitial Lung Disease (67),
Pancreatic Carcinoma (63),
Blood Glucose Increased (58),
Nausea (48),
Diarrhoea (39),
Pancreatitis Acute (35),
Renal Failure (34),
Renal Failure Acute (33), more >>
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