NEWS HIGHLIGHTS
Published Studies Related to Januvia (Sitagliptin)
Anagliptin and sitagliptin as add-ons to metformin for patients with type 2
diabetes: a 24-week, multicentre, randomized, double-blind, active-controlled,
phase III clinical trial with a 28-week extension. [2015]
We conducted a 24-week, multicentre, double-blind, randomized study with a
28-week extension to compare the efficacy and safety of anagliptin and
sitagliptin as an add-on to metformin in patients with type 2 diabetes. Patients
inadequately controlled on metformin were randomized to either anagliptin (100 mg
twice daily, n = 92) or sitagliptin (100 mg once daily, n = 88)...
The impact of weight loss on weight-related quality of life and health
satisfaction: results from a trial comparing canagliflozin with sitagliptin in
triple therapy among people with type 2 diabetes. [2014]
Type 2 diabetes mellitus (T2DM) is primarily a self-managed disease in which
self-care behaviors play an important role in achieving optimal outcomes... Weight loss of an amount demonstrated in
clinical trials of canagliflozin was associated with improvements in
weight-related quality of life and satisfaction with physical and emotional
health, concepts shown to be important to the persistent and consistent
performance of healthy behaviors.
Safety of sitagliptin in elderly patients with type 2 diabetes: a pooled analysis
of 25 clinical studies. [2014]
sitagliptin 100 mg/day in elderly patients with type 2 diabetes... CONCLUSIONS: In this pooled safety analysis of elderly patients with type 2
Rationale, design, and organization of a randomized, controlled Trial Evaluating
Cardiovascular Outcomes with Sitagliptin (TECOS) in patients with type 2 diabetes
and established cardiovascular disease. [2013]
Sitagliptin, an oral dipeptidyl peptidase-4 inhibitor, lowers blood glucose when
administered as monotherapy or in combination with other antihyperglycemic
agents. TECOS will evaluate the effects of adding sitagliptin to usual diabetes
care on cardiovascular outcomes and clinical safety... TECOS is a pragmatic-design
cardiovascular outcome trial assessing the cardiovascular effects of sitagliptin
when added to usual T2DM management.
Efficacy and tolerability of exenatide once weekly versus sitagliptin in patients
with type 2 diabetes mellitus: a retrospective analysis of pooled clinical trial
data. [2013]
and American College of Endocrinology treatment algorithm... CONCLUSION: Significantly greater improvements in HbA1c and FBG levels were
Clinical Trials Related to Januvia (Sitagliptin)
A Study of the Efficacy and Safety of MK-0431D (a Fixed-dose Combination of Sitagliptin and Simvastatin) for the Treatment of Participants With Type 2 Diabetes Mellitus (T2DM) With Inadequate Glycemic Control on Metformin Monotherapy (MK-0431D-266) [Terminated]
The purpose of this study is to assess the efficacy and safety of sitagliptin/simvastatin
fixed-dose combination (FDC) in participants with T2DM who have inadequate glycemic control
while on metformin monotherapy. The primary hypothesis of this study is that after 16 weeks
of therapy, the mean change from baseline in hemoglobin A1C (A1C) in participants treated
with sitagliptin/simvastatin FDC is non-inferior compared to sitagliptin alone.
The Effect of Januvia (Sitagliptin) on Oxidative Stress in Obese Type 2 Diabetic Subjects [Active, not 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 to Assess the Pharmacokinetics, Safety and Tolerability of Sitagliptin in Adolescents (0431-081) [Completed]
This study will assess the safety, tolerability and pharmacokinetics of sitagliptin in 10 to
17 year old diabetic patients.
Sitagliptin Therapy in Hospitalized Patients With Type 2 Diabetes [Recruiting]
High blood glucose levels in hospitalized patients with diabetes are associated with
increased risk of medical complications and death. Improved glucose control with insulin
injections may improve clinical outcome and prevent some of the hospital complications.
Glargine (Lantus®) insulin injection is the most common treatment of diabetes in the
hospital. Sitagliptin (Januvia®)is effective in lowering blood glucose. In a recent pilot
study aiming to determine differences in glycemic control between treatment with sitagliptin
(Januvia®) alone or in combination with basal insulin and basal bolus regimen in general
medicine and surgery patients with type 2 diabetes (T2D). The investigators found that
treatment with sitagliptin alone or in combination with basal insulin resulted in similar
glycemic control compared to basal bolus regimen.
The investigators will conduct a prospective RCT aimed to determine the safety and efficacy
of sitagliptin therapy for in-hospital and post-discharge management of general medicine and
surgical patients with T2D. A total of 280 patients with known history of diabetes will be
randomized to receive sitagliptin plus basal (glargine) insulin once daily (group 1), or
basal bolus regimen with glargine once daily and aspart or lispro insulin before meals
(group 2). If needed, patients in the treatment groups will receive correction doses of
rapid-acting insulin in the presence of hyperglycemia (BG > 140 mg/dl). The overall
hypothesis is that treatment with sitagliptin in combination with basal insulin in patients
with type 2 diabetes will result in a similar improvement in hospital and post-discharge
glycemic control and in a lower frequency of hypoglycemic events than treatment with basal
bolus insulin regimen with glargine once daily and lispro insulin before meals.
Patients will be recruited at Grady Memorial Hospital, Emory University Hospital, University
of Michigan, Ohio State University and Temple University
Vildagliptin vs Sitagliptin add-on to Insulin - Impact on Glycemic Profile and Correlation of Hypoglycemic Episodes and Heart Function [Active, not recruiting]
Vildagliptin and Sitagliptin both belong to the class of DPP-4 inhibitors, but differ in
their pharmacokinetic profile as well as in their approved application (Vildagliptin, 2x 50
mg daily, Sitagliptin, 1x 100 mg daily). This leads to distinct results regarding
postprandial blood-glucose normalization as well as protective properties regarding
hypoglycemic episodes - especially during the night. Additionally, in type 1 diabetic
patients a correlation has been described between hypoglycemia and abnormal heart function
(QTc-elongation), which can have severe consequences for the patients. This study aims for
the evaluation of the potency of both drugs to prevent and/or reduce hypoglycemic events in
insulin-dependent type-2 diabetics and furthermore to evaluate the correlation of
hypoglycemic episodes with changes in heart-function measured by Holter-ECG.
The hypothesis is tested, if vildagliptin leads to a more favourable glycemic profile than
sitagliptin and is more potent in protecting from nocturnal abnormalities in heart-function
caused by undetected hypoglycemic episodes.
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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