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First Generation Sulfonylurea

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141. Tenelia (teneligliptin hydrobromide hydrate)

Tenelia (teneligliptin hydrobromide hydrate) Report on the Deliberation Results April 27, 2012 Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare [Brand name] Tenelia Tablets 20 mg [Non-proprietary name] Teneligliptin Hydrobromide Hydrate (JAN*) [Applicant] Mitsubishi Tanabe Pharma Corporation [Date of application] August 26, 2011 [Results of deliberation] In the meeting held on April 27, 2012, the First Committee on New Drugs (...) ] Type 2 diabetes mellitus; The drug product should be used only in patients who have not sufficiently responded to either of the following treatments. (a) Diet and/or exercise therapy alone (b) Use of sulfonylureas in addition to diet and/or exercise therapy (c) Use of thiazolidinediones in addition to diet and/or exercise therapy [Dosage and administration] The usual adult dosage is 20 mg of teneligliptin administered orally once daily. If efficacy is insufficient, the dose may be increased up

2012 Pharmaceuticals and Medical Devices Agency, Japan

142. Evaluation of a Mixed Meal Test for Diagnosis and Characterization and Type 3c Diabetes Mellitus Secondary to Pancreatic Cancer and Chronic Pancreatitis (DETECT)

. Federal Government. of clinical studies and talk to your health care provider before participating. Read our for details. ClinicalTrials.gov Identifier: NCT03460769 Recruitment Status : Recruiting First Posted : March 9, 2018 Last Update Posted : October 5, 2018 See Sponsor: M.D. Anderson Cancer Center Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Information provided by (Responsible Party): M.D. Anderson Cancer Center Study Details Study Description Go (...) Criteria Go to Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Layout table for eligibility information Ages Eligible for Study: 40 Years to 84 Years (Adult, Older Adult) Sexes Eligible for Study: All

2018 Clinical Trials

143. A Comparative Study of the Effects of QS-M Needle Free Injector and Glargine Pen Subcutaneous Injection of Insulin Glargine on Insulin Use

Identifier: NCT03420040 Recruitment Status : Enrolling by invitation First Posted : February 2, 2018 Last Update Posted : February 2, 2018 Sponsor: Xijing Hospital Information provided by (Responsible Party): Xijing Hospital Study Details Study Description Go to Brief Summary: A clinical study of the use of glargine insulin in 2 subjects with type two diabetes in China was carried out. The two kinds of injection methods were evaluated as subcutaneous injection of insulin glargine. Condition or disease (...) glucose between baseline to week 4 [ Time Frame: baseline and week 4 ] fasting blood glucose are measured at baseline and week 4 Eligibility Criteria Go to Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information

2018 Clinical Trials

144. Comparing Efficacy and Safety of CinnaGen-liraglutide Versus Victoza® in Patients With Type II Diabetes

and Interventions Go to Arm Intervention/treatment Experimental: CinnaGen-liraglutide CinnaGen-liraglutide (Liraglutide 6 MG/ML Pen Injector by CinnaGen Company) will be administered 1.8 mg/day subcutaneously. Doses of CinnaGen-liraglutide will be up-titrated from 0.6 mg/day in the first week to 1.2 mg/day in the second, third and fourth weeks, up to 1.8 mg/day from the start of the fifth week to the end of 26th week. Patients in this group will continue to receive metformin along with a Sulfonylurea/non (...) Patients who were receiving Sulfonylurea/non-sulfonylurea insulin secretagogues with maximum tolerable dose prior to study will continue to receive it during the study. Other Name: Sulfonylurea or non-sulfonylurea insulin secretagogues Active Comparator: Victoza® Victoza® (Liraglutide 6 MG/ML Pen Injector by Novo Nordisk Company) will be administered 1.8 mg/day subcutaneously. Doses of Victoza® will be up-titrated from 0.6 mg/day in the first week to 1.2 mg/day in the second, third and fourth weeks, up

2018 Clinical Trials

145. Lanifibranor in Patients With Type 2 Diabetes & Nonalcoholic Fatty Liver Disease

medications, the dose of these medications will be kept stable throughout the study and baseline studies performed as outlined below. If the HbA1c is > 8.0% but ≤ 9.5%, metformin (minimum dose required: 1,000 mg/day for metformin) and/or a sulfonylurea (minimum dose required: glimepiride 2 mg once daily) will be added, or doses maximized, during the first 2 weeks of the lead-in period. Afterwards, patient's metformin or sulfonylurea dose will be maintained at the new dose stable for 4 weeks before (...) more. Lanifibranor in Patients With Type 2 Diabetes & Nonalcoholic Fatty Liver Disease The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. of clinical studies and talk to your health care provider before participating. Read our for details. ClinicalTrials.gov Identifier: NCT03459079 Recruitment Status : Recruiting First Posted : March 8, 2018 Last Update

2018 Clinical Trials

146. Hypoglycemia and Autonomic Nervous System Function- B2

contact the study research staff using the contacts provided below. For general information, Layout table for eligibility information Ages Eligible for Study: 18 Years to 55 Years (Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No Criteria Inclusion Criteria: Males and females age 18 to 55 years Type 2 Diabetes Mellitus controlled by diet, exercise and non-insulin glycemic control agents (metformin, thiazolidinediones, sulfonylureas, dipeptidyl peptidase-4 inhibitors, sodium-glucose (...) Function- B2 (HypoANS-B2) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. of clinical studies and talk to your health care provider before participating. Read our for details. ClinicalTrials.gov Identifier: NCT03422471 Recruitment Status : Recruiting First Posted : February 5, 2018 Last Update Posted : February 5, 2018 See Sponsor: Brigham and Women's

2018 Clinical Trials

147. Once-Weekly Oral Aminopterin for the Treatment of Subjects With Moderate-To-Severe Psoriasis

studies before adding more. Once-Weekly Oral Aminopterin for the Treatment of Subjects With Moderate-To-Severe Psoriasis The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. of clinical studies and talk to your health care provider before participating. Read our for details. ClinicalTrials.gov Identifier: NCT03431974 Recruitment Status : Recruiting First Posted (...) to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Layout table for eligibility information Ages Eligible for Study: 18 Years and older (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No Criteria Inclusion Criteria: Be 18 years of age or older. Have a diagnosis of moderate-to-severe psoriasis for at least 6 months confirmed by a dermatologist, defined here

2018 Clinical Trials

148. Multifactorial Intervention on Diabetes (MIDiab Study)

Study) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. of clinical studies and talk to your health care provider before participating. Read our for details. ClinicalTrials.gov Identifier: NCT03430284 Recruitment Status : Recruiting First Posted : February 12, 2018 Last Update Posted : September 5, 2018 See Sponsor: Shandong Provincial Hospital Information (...) guidelines recommend an integrated multifactorial treatment approach. In this study, we aim to evaluate the effect on diabetic vascular complications of a multifactorial intervention comprising behavior modification, polypharmacological therapy and periodical monitoring in patients with type 2 diabetes. Condition or disease Intervention/treatment Phase Diabetes Mellitus, Type 2 Behavioral: Lifestyle therapy Drug: Pharmacotherapy Other: Monitoring and management Other: General treatment Phase 4 Study

2018 Clinical Trials

149. CloudConnect: Predictive And Retrospective Clinical Decision Support For Chronic Disease Management

: Recruiting First Posted : September 18, 2018 Last Update Posted : January 11, 2019 See Sponsor: University of Virginia Collaborator: National Library of Medicine (NLM) Information provided by (Responsible Party): Daniel Chernavvsky, MD, CRC, University of Virginia Study Details Study Description Go to Brief Summary: This study is to assess an approach of self-management called CloudConnect, evaluating the impact of CloudConnect Reports on patient engagement, adolescent/parent discussion, and clinical (...) - and post-study Family Communication Inventory questionnaire and the weekly communication assessments. Eligibility Criteria Go to Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Layout table

2018 Clinical Trials

150. Personalized Glucose Optimization Through Nutritional Intervention

Optimization Through Nutritional Intervention (PERSON) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. of clinical studies and talk to your health care provider before participating. Read our for details. ClinicalTrials.gov Identifier: NCT03708419 Recruitment Status : Recruiting First Posted : October 17, 2018 Last Update Posted : October 17, 2018 See Sponsor (...) of first phase insulin secretion and insulin sensitivity during a 2-hour 7-points oral glucose tolerance test (OGTT). Disposition index will be calculated as follows: [Insulin sensitivity index (ISI) * (AUC30 min insulin / AUC30 min glucose)], where AUC30 min is the area under the curve between 0 and 30 minutes of the OGTT for insulin (pmol/l) and glucose (mmol/l), respectively, and ISI is defined as: [10,000 ÷ square root of (fasting plasma glucose (mmol/l) x fasting insulin (pmol/l)) x (mean glucose

2018 Clinical Trials

151. Glibenclamide Advantage in Treating Edema After Intracerebral Hemorrhage

. Glibenclamide Advantage in Treating Edema After Intracerebral Hemorrhage (GATE-ICH) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our for details. ClinicalTrials.gov Identifier: NCT03741530 Recruitment Status : Enrolling by invitation First Posted : November 15, 2018 Last Update Posted : December 3, 2018 Sponsor: Xijing Hospital Information provided (...) ] Eligibility Criteria Go to Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Layout table for eligibility information Ages Eligible for Study: 18 Years and older (Adult, Older Adult) Sexes Eligible for Study

2018 Clinical Trials

152. IDegLira HIGH Trial

and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. of clinical studies and talk to your health care provider before participating. Read our for details. ClinicalTrials.gov Identifier: NCT03737240 Recruitment Status : Recruiting First Posted : November 9, 2018 Last Update Posted : January 25, 2019 See Sponsor: Emory University Collaborator: Novo Nordisk A/S Information provided by (Responsible Party): Rodolfo Galindo, Emory University Study Details Study (...) will be compared between study groups. Eligibility Criteria Go to Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Layout table for eligibility information Ages Eligible for Study: 18 Years to 80 Years (Adult

2018 Clinical Trials

153. Clinical Impact of ITCA 650, a Novel Drug-Device GLP-1 Receptor Agonist, in Uncontrolled Type 2 Diabetes and Very High Baseline HbA<sub>1c</sub>: The FREEDOM-1 HBL Study. (PubMed)

Clinical Impact of ITCA 650, a Novel Drug-Device GLP-1 Receptor Agonist, in Uncontrolled Type 2 Diabetes and Very High Baseline HbA1c: The FREEDOM-1 HBL Study. ITCA 650 is a subdermal osmotic mini-pump that continuously delivers exenatide subcutaneously for 3-6 months. The efficacy, safety, and tolerability of ITCA 650 added to diet and exercise alone or combined with metformin, sulfonylurea, or thiazolidinedione monotherapy or a combination of these drugs was evaluated in poorly (...) HbA1c was 10.8% (94.7 mmol/mol) and mean (± SD) duration of diabetes was 8.6 (± 5.3) years. At week 39, there was a mean reduction in HbA1c of -2.8% (-30.3 mmol/mol; P < 0.001 vs. baseline) and in body weight of -1.2 kg (P = 0.105), and 25% of patients achieved HbA1c <7% (53 mmol/mol). A reduction in HbA1c of ≥1% (≥10.9 mmol/mol) occurred in 90% of patients. The most common adverse events were nausea, vomiting, diarrhea, and headache. Gastrointestinal adverse events were generally transient

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2018 Diabetes Care

154. Take a pill and stop aging. Really?

lifetime. Hence, rapamycin is being evaluated for its effect on lifespan, cardiac function and perhaps cancer onset and immune function. Drug companies have not put a lot of interest into anti-aging drugs for three possible reasons. First, the knowledge base upon which to develop such drugs has just not been available. Second, natural compounds, such as antioxidants and generic drugs like metformin, don’t offer much opportunity for profit. Third, it has been unclear if the FDA would approve (...) longer than normal. So it was interesting that a of a U.K. Registry of 180,000 people showed that individuals with diabetes mellitus who took metformin lived longer than those treated with another diabetes drug, a sulfonylurea. Of course, there may have been variations unappreciated in the two groups leading their doctors to prescribe one drug versus another. Still, the difference in lifespan was unexpected and intriguing. Further, the older diabetic patients on metformin also lived longer than older

2018 KevinMD blog

155. Placebo-Controlled, Randomized, SAD Study to Evaluate the Safety, Tolerability, and PK of TBI-223 in Healthy Adults

First Posted : November 29, 2018 Last Update Posted : January 31, 2019 See Sponsor: Global Alliance for TB Drug Development Information provided by (Responsible Party): Global Alliance for TB Drug Development Study Details Study Description Go to Brief Summary: Partially-Blinded, Placebo-Controlled, Randomized, Single Ascending Dose (SAD) with a Food Effect Cohort to Evaluate the Safety, Tolerability, and Pharmacokinetics of TBI-223 in Healthy Adults. Condition or disease Intervention/treatment (...) -life. Eligibility Criteria Go to Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Layout table for eligibility information Ages Eligible for Study: 19 Years to 50 Years (Adult) Sexes Eligible

2018 Clinical Trials

156. Durvalumab With or Without Metformin in Treating Participants With Head and Neck Squamous Cell Carcinoma

Recruitment Status : Recruiting First Posted : August 7, 2018 Last Update Posted : January 15, 2019 See Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University Information provided by (Responsible Party): Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University ) Study Details Study Description Go to Brief Summary: This pilot phase I trial studies how well durvalumab given with or without metformin works in treating participants with head and neck squamous cell (...) this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Layout table for eligibility information Ages Eligible for Study: 18 Years and older (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No Criteria Inclusion Criteria: Pathologically confirmed head and neck squamous cell carcinoma (HNSCC), with measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Any stage HNSCC of the 1

2018 Clinical Trials

157. A Trial of Personalized Acupuncture, Standardized Acupuncture, Letrozole and Placebo on Live Birth in Women With PCOS

. ClinicalTrials.gov Identifier: NCT03625531 Recruitment Status : Not yet recruiting First Posted : August 10, 2018 Last Update Posted : August 14, 2018 See Sponsor: Hongxia Ma Information provided by (Responsible Party): Hongxia Ma, The First Affiliated Hospital of Guangzhou Medical University Study Details Study Description Go to Brief Summary: This study is a parallel, assessor-blind controlled trial. A total of 1,100 women with PCOS will be recruited from 10 hospitals and randomly allocated into four groups (...) session will last for 30 min, with a maximum of 48 treatment sessions over 16 weeks. Experimental: Standardized acupuncture Two sets of acupuncture points will be alternated every second treatment. The first set consists of CV 3, CV 6, ST 29 bilaterally, SP 6 bilaterally, SP 9 bilaterally, GV 20 and LI 4 bilaterally. The second set consists of 13 needles: ST 25 bilaterally, ST 29 bilaterally, CV 3, CV 6, SP 6 bilaterally, LR 3 bilaterally, PC 6 bilaterally and GV 20. The following points

2018 Clinical Trials

158. DAPA

aged 20-79 are living with Diabetes in MENA region in 2017, Egypt is number 8 in the top 10 countries in number of adults with Diabetes (8.2 million), where Egypt represents 21% of the Diabetics in MENA region. Metformin is used as 1st line oral anti-diabetic drug in most cases. Sulfonylureas (SU) are used as frequent first add-on after failure of metformin monotherapy. Sodium Glucose Co-transporter 2 (SGLT2) inhibitors are a newer class of therapy which has a lower incidence of hypoglycemia (...) . Listing a study does not mean it has been evaluated by the U.S. Federal Government. of clinical studies and talk to your health care provider before participating. Read our for details. ClinicalTrials.gov Identifier: NCT03624803 Recruitment Status : Recruiting First Posted : August 10, 2018 Last Update Posted : March 20, 2019 See Sponsor: AstraZeneca Information provided by (Responsible Party): AstraZeneca Study Details Study Description Go to Brief Summary: Approximately 39 million people of adults

2018 Clinical Trials

159. 5-ALA Patch-PDT of Actinic Keratosis on the Upper Extremities

Keratosis on the Upper Extremities The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. of clinical studies and talk to your health care provider before participating. Read our for details. ClinicalTrials.gov Identifier: NCT03606122 Recruitment Status : Recruiting First Posted : July 30, 2018 Last Update Posted : December 5, 2018 See Sponsor: photonamic GmbH & Co (...) . KG Information provided by (Responsible Party): photonamic GmbH & Co. KG Study Details Study Description Go to Brief Summary: This study evaluates the potential usefulness of photodynamic therapy with PD P 506 A in patients with actinic keratosis on the upper extremities for the first time. Condition or disease Intervention/treatment Phase Actinic Keratoses Drug: PD P 506 A Phase 2 Detailed Description: Patients will receive a second PD P 506 A-PDT on all AK lesions 1-2 weeks after the first PDT

2018 Clinical Trials

160. Effect of Drinks Containing Fruit Polyphenol Extracts and Fibre on Postprandial Glycaemia. (Glu-MIX)

remove one or more studies before adding more. Effect of Drinks Containing Fruit Polyphenol Extracts and Fibre on Postprandial Glycaemia. (Glu-MIX) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our for details. ClinicalTrials.gov Identifier: NCT03572296 Recruitment Status : Completed First Posted : June 28, 2018 Last Update Posted : January 31, 2019 (...) min following the ad libitum meal ] For each VAS, a numerical score between 0 (not at all) and 100 (extremely) mm was obtained. Buccal mouth swab [ Time Frame: One off sample, collected at the first 1 day of study visit ] Future exploratory analysis of lactase activity via the derived allele at the European Eligibility Criteria Go to Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Talk with your doctor and family members

2018 Clinical Trials

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