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81. Safety and Efficacy of Technosphere® Insulin Inhalation Powder (TI Inhalation Powder)When an Optimal Dose is Taken With Varied Carbohydrate Intake

of Symlin (pramlintide acetate) and/or Byetta (exenatide) within the past 12 weeks Unstable diabetes control and evidence of severe complications of diabetes mellitus (ie, autonomic neuropathy) Exposure to any investigational product(s) in the past 12 weeks For subjects with type 2 diabetes mellitus: In subjects taking metformin, serum creatinine > 1.4 mg/dL in female subjects and > 1.5 mg/dL in male subjects Contacts and Locations Go to Information from the National Library of Medicine To learn more

2008 Clinical Trials

82. Efficacy of Pramlintide on Prevention of Weight Gain Early Onset of Type 1 Diabetes

mcg dose is not tolerated, investigator will evaluate for possibility of withdrawing the pramlintide. The dose of preprandial short acting insulin (eg: Novolog/Humalog) will be reduced by 30 to 50% at the start of pramlintide 15 mcg (2.5 units) and then will be adjusted every time the dose of pramlintide is increased by 15 mcg (2.5 units) as needed based on blood glucose readings. Other Name: Symlin Drug: Glargine Drug: Lispro Drug: Aspart Outcome Measures Go to Primary Outcome Measures

2007 Clinical Trials

83. The Effect of Pramlintide on Meal Time Insulin Bolus

using the contact information provided by the sponsor. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00460304 Sponsors and Collaborators Diabetes Care Center Amylin Pharmaceuticals, LLC. Investigators Layout table for investigator information Principal Investigator: Allen B King, MD Diabetes Care Center Study Director: Gary S Wolfe, RN, CCM Diabetes Care Center More Information Go to Publications: Symlin (package insert) San Diego, CA Amylin Pharmacetucials. 2005

2007 Clinical Trials

84. A Study to Characterize Regimens of Basal Insulin Intensified With Either Symlin® or Rapid Acting Insulin in Patients With Type 2 Diabetes

A Study to Characterize Regimens of Basal Insulin Intensified With Either Symlin® or Rapid Acting Insulin in Patients With Type 2 Diabetes A Study to Characterize Regimens of Basal Insulin Intensified With Either Symlin® or Rapid Acting Insulin in Patients With Type 2 Diabetes - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study (...) Warning You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more. A Study to Characterize Regimens of Basal Insulin Intensified With Either Symlin® or Rapid Acting Insulin in Patients With Type 2 Diabetes 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

2007 Clinical Trials

85. A Pilot Study of Continuous Subcutaneous Pramlintide Infusion Therapy in Patients With Type 1 Diabetes

, 2013 Sponsor: University Diabetes & Endocrine Consultants Collaborator: Amylin Pharmaceuticals, LLC. Information provided by (Responsible Party): David M. Huffman MD, University Diabetes & Endocrine Consultants Study Details Study Description Go to Brief Summary: This research project will investigate the effects of pramlintide (Symlin) given by continuous subcutaneous (under the skin) infusion throughout the day and night, along with meal doses similar to those injected during conventional (...) pramlintide (Symlin) treatment, delivered using a second insulin pump, in subjects with inadequately controlled type I diabetes mellitus who are already using insulin pump therapy. Study participants will wear two pumps for a four month period, taking insulin in their usual manner and pramlintide (Symlin) in a similar basal/bolus fashion. Continuous glucose monitors will be worn on three occasions during the study to assess blood glucose responses to continuous pramlintide (Symlin) treatment. Condition

2007 Clinical Trials

86. A Study to Compare the Effects of Exenatide and Sitagliptin on Postprandial Glucose in Subjects With Type 2 Diabetes Mellitus

-4 inhibitor prior to screening Received any study medication or participated in any type of clinical trial within 30 days prior to screening Has donated blood within 60 days of screening visit or is planning to donate blood during the study Treated with any of the following medications: Sulfonylurea or Thiazolidinedione within 3 months of screening; Alpha-glucosidase inhibitor, meglitinide, nateglinide, or pramlintide (SYMLIN®)within 30 days of screening; Insulin within 2 weeks prior

2007 Clinical Trials

87. A Study Comparing Subcutaneous Rapid Acting Insulin and One Formulation of Inhaled Insulin in Subjects With Type 2 Diabetes

(BMI) of ≤ 34 kg/m2 and ≥ 25 kg/m2 HbA1c ≤ 8.5% based upon results from a central laboratory Non-smoking Males and females ≥ 18 and ≤ 70 years of age A clinical diagnosis of type 2 diabetes mellitus for ≥ 12 months Exclusion Criteria: Total daily insulin requirement of ≥ 1.2 U/kg body weight Use of Symlin® (pramlintide acetate) and/or Byetta® (exenatide) within the preceding 8 weeks Two or more severe hypoglycemic episodes within 6 months of screening Any hospitalization or emergency room visit due

2007 Clinical Trials

88. Effect on Weight Loss of Exenatide Versus Placebo

Criteria: Are treated with any of the following excluded medications: *exogenous insulin, thiazolidinedione, or alpha-glucosidase inhibitor for more than 1 week within 6 weeks of screening; *Symlin injection at any time; * Byetta injection within 3 months of screening or discontinuation of therapy at any time due to adverse reaction; *drugs that directly affect gastrointestinal motility; *use of a weight loss drug (including those available over the counter) within 3 months of screening; *chronic

2006 Clinical Trials

89. Efficacy and Safety in Subjects With Type 2 Diabetes Receiving Subcutaneous Basal Insulin and Prandial Inhalation of Technosphere/Insulin Versus Subcutaneous Premixed Insulin Therapy Over a 52-Week Treatment Period and a 4-Week Follow-up

. FEV1 ≥ 70% of NHANES III predicted; TLC) ≥ 80% of predicted (Intermountain Thoracic Society); DLCO uncorrected ≥ 70% of predicted Exclusion Criteria: Total daily dose of insulin ≥1.4 IU/kg body weight Treatment with any sulfonylureas and/or meglitinides and/or alpha-glucosidase inhibitors within the preceding 8 weeks Treatment with pramlintide acetate (Symlin®), and/or any incretins (e.g., exenatide [Byetta®]) within the preceding 8 weeks Unstable diabetes mellitus control, defined as 2 or more

2006 Clinical Trials

90. Continuous Subcutaneous Infusion of Pramlintide and Insulin

2006 Actual Primary Completion Date : November 2007 Actual Study Completion Date : November 2007 Resource links provided by the National Library of Medicine related topics: available for: Arms and Interventions Go to Intervention Details: Drug: Pramlintide Basal and bolus pramlintide subcutaneous infusion Other Name: Symlin Outcome Measures Go to Primary Outcome Measures : Area under the curve for glucose [ Time Frame: 4 hrs ] Secondary Outcome Measures : glucagon and gastric emptying [ Time Frame

2006 Clinical Trials

91. A Study to Evaluate the Effect on Body Weight of Leptin Administered in Conjunction With Pramlintide in Overweight and Obese Subjects

-metreleptin 1 mL BID, 20 weeks Drug: pramlintide acetate 360 mcg subcutaneous injection, twice a day, 360mcg Other Name: SYMLIN® Drug: placebo-metreleptin 1 mL twice a day Experimental: Pramlintide Acetate and Metreleptin Lead-in period: 2 weeks pramlintide acetate 180 mcg BID, then 2 weeks pramlintide acetate 360 mcg BID Study period: Pramlintide acetate 360 mcg BID and metreleptin (recombinant-methionyl human leptin) 5 mg BID, 20 weeks Drug: pramlintide acetate 360 mcg subcutaneous injection, twice (...) a day, 360mcg Other Name: SYMLIN® Drug: metreleptin subcutaneous injection, twice a day, 5mg Other Name: recombinant-methionyl human leptin Lead-In Period During the Lead-In Period before a participant was randomized to a study arm, the participant received 180 mcg pramlintide acetate twice a day (BID) for 2 weeks, followed by 360 mcg pramlintide acetate BID for 2 weeks (total of 4 weeks in the Lead-In Period). Drug: pramlintide acetate 360 mcg subcutaneous injection, twice a day, 360mcg Other Name

2006 Clinical Trials

92. Exploratory Study to Evaluate Various Pharmacodynamic Effects of Subcutaneously Infused or Injected Pramlintide in Obese Subjects

Information Go to Layout table for additonal information Responsible Party: AstraZeneca ClinicalTrials.gov Identifier: Other Study ID Numbers: 137-160 First Posted: March 8, 2007 Last Update Posted: June 11, 2015 Last Verified: May 2015 Keywords provided by AstraZeneca: pramlintide Symlin Amylin Additional relevant MeSH terms: Layout table for MeSH terms Overweight Body Weight Signs and Symptoms Pramlintide Islet Amyloid Polypeptide Hypoglycemic Agents Physiological Effects of Drugs Appetite Depressants

2007 Clinical Trials

93. A Study to Examine the Safety, Tolerability, and Body Weight Effect of Pramlintide Alone and in Combination With Oral Antiobesity Agents in Overweight and Obese Subjects

Experimental: 1 Drug: pramlintide acetate subcutaneous injection, three times a day, 120mcg Other Name: Symlin Experimental: 2 Drug: pramlintide acetate subcutaneous injection, three times a day, 120mcg Other Name: Symlin Drug: sibutramine oral tablet, once a day, 10mg Other Name: Meridia Experimental: 3 Drug: pramlintide acetate subcutaneous injection, three times a day, 120mcg Other Name: Symlin Drug: phentermine oral tablet, once a day, 37.5mg Other Names: Adipex-P Fastin Obenix Oby-Trim Placebo (...) , United States Sponsors and Collaborators AstraZeneca Investigators Layout table for investigator information Study Director: Lisa Porter, MD Amylin Pharmaceuticals, LLC. More Information Go to Layout table for additonal information Responsible Party: AstraZeneca ClinicalTrials.gov Identifier: Other Study ID Numbers: AFA203 First Posted: November 22, 2006 Last Update Posted: March 6, 2015 Last Verified: February 2015 Keywords provided by AstraZeneca: overweight obesity pramlintide Symlin sibutramine

2006 Clinical Trials

94. A Study Evaluating the Efficacy and Safety of Adding Symlin® to Lantus® (Insulin Glargine) in Subjects With Type 2 Diabetes

A Study Evaluating the Efficacy and Safety of Adding Symlin® to Lantus® (Insulin Glargine) in Subjects With Type 2 Diabetes A Study Evaluating the Efficacy and Safety of Adding Symlin® to Lantus® (Insulin Glargine) in Subjects With Type 2 Diabetes - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached (...) the maximum number of saved studies (100). Please remove one or more studies before adding more. A Study Evaluating the Efficacy and Safety of Adding Symlin® to Lantus® (Insulin Glargine) in Subjects With Type 2 Diabetes 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: NCT00240253 Recruitment Status

2005 Clinical Trials

95. An Observational Study Evaluating SYMLIN® (Pramlintide Acetate) Injection Use in Insulin Using Patients With Type 2 and Type 1 Diabetes

An Observational Study Evaluating SYMLIN® (Pramlintide Acetate) Injection Use in Insulin Using Patients With Type 2 and Type 1 Diabetes An Observational Study Evaluating SYMLIN® (Pramlintide Acetate) Injection Use in Insulin Using Patients With Type 2 and Type 1 Diabetes - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning (...) You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more. An Observational Study Evaluating SYMLIN® (Pramlintide Acetate) Injection Use in Insulin Using Patients With Type 2 and Type 1 Diabetes 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

2005 Clinical Trials

96. Pilot Study Assessing Insulin Pump Therapy in Type 2 Diabetes

insulin ± OA(s) for at least 3 months (Subjects may also be treated with exenatide [Byetta] or pramlintide [Symlin]. If on concomitant metformin, has serum creatinine < 1.5 mg/dL (male) or <1.4 mg/dL (female); If female, has a negative urine pregnancy test Exclusion Criteria: Has experienced recurrent severe hypoglycemia (> 2 episodes) requiring assistance during the past 6 months; Has clinical cardiovascular disease (CVD) as evidenced by prior myocardial infarction, stroke, arterial revascularization

2008 Clinical Trials

97. A Study to Examine the Long Term Effect of Pramlintide on Body Weight and Its Safety and Tolerability in Obese Subjects

Date : June 2007 Resource links provided by the National Library of Medicine related topics: available for: Arms and Interventions Go to Arm Intervention/treatment Experimental: 1 Drug: pramlintide acetate Subcutaneous injection, twice a day or three times a day, at doses of 120mcg, 240mcg, or 360mcg Other Name: Symlin Experimental: 2 Drug: pramlintide acetate Subcutaneous injection, twice a day or three times a day, at doses of 120mcg, 240mcg, or 360mcg Other Name: Symlin Experimental: 3 Drug (...) : pramlintide acetate Subcutaneous injection, twice a day or three times a day, at doses of 120mcg, 240mcg, or 360mcg Other Name: Symlin Placebo Comparator: 4 Drug: placebo subcutaneous injection, three times a day, volumes equivalent to 120mcg, 240mcg, or 360mcg of pramlintide acetate Outcome Measures Go to Primary Outcome Measures : Examine the long-term effect of subcutaneously (SC) injected pramlintide on body weight in obese subjects. [ Time Frame: open ended ] Examine the long-term safety

2005 Clinical Trials

98. Evaluation of the Bioavailability of Pramlintide

. The strength of pramlintide is 1.0 mg/mL for SC injection and 0.6 mg/mL for IV bolus injection. Other Name: Symlin (pramlintide acetate) Outcome Measures Go to Primary Outcome Measures : Effect of varying needle length on bioavailability of Pramlintide [ Time Frame: approximately 6days but not to exceed 14days ] To determine the effect of various anatomical injection sites and varying needle lengths upon the absolute bioavailability of pramlintide when injected subcutaneously (SC) in non-obese and obese

2002 Clinical Trials

99. Safety Study of Using Symlin Alongside Insulin in a Multiple Injection Port

Safety Study of Using Symlin Alongside Insulin in a Multiple Injection Port Safety Study of Using Symlin Alongside Insulin in a Multiple Injection Port - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more. Safety (...) Study of Using Symlin Alongside Insulin in a Multiple Injection Port 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: NCT00790699 Recruitment Status : Terminated (Lack of patient population) First Posted : November 13, 2008 Last Update Posted : November 17, 2011 Sponsor: Texas Diabetes & Endocrinology

2008 Clinical Trials

100. A Study to Evaluate Symlin in Adolescent Subjects With Type 1 Diabetes Mellitus

A Study to Evaluate Symlin in Adolescent Subjects With Type 1 Diabetes Mellitus A Study to Evaluate Symlin in Adolescent Subjects With Type 1 Diabetes Mellitus - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more (...) . A Study to Evaluate Symlin in Adolescent Subjects With Type 1 Diabetes Mellitus 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: NCT00313183 Recruitment Status : Completed First Posted : April 12, 2006 Last Update Posted : March 6, 2015 Sponsor: AstraZeneca Information provided by (Responsible Party

2006 Clinical Trials

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