Exenatide vs. Biphasic Insulin Aspart for Type 2 Diabetes Glycemic Control
This study aims to compare the effectiveness of Exenatide and Biphasic Insulin Aspart in controlling blood sugar levels, specifically measuring changes in Glycosylated Hemoglobin (HbA1c) over a period of 52 weeks in individuals with Type 2 Diabetes.
exenatide
+ biphasic insulin aspart
Diabetes Mellitus+2
+ Diabetes Mellitus, Type 2
+ Endocrine System Diseases
Treatment Study
Summary
Study start date: November 1, 2003
Actual date on which the first participant was enrolled.This is a Phase 3, multicenter, open-label, comparator-controlled trial comparing the effect of exenatide twice daily to twice daily biphasic insulin aspart on glycemic control, as measured by hemoglobin A1c (HbA1c).
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.505 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 30 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Patients have been treated with a stable dose of the following for at least 3 months prior to screening: 1. \>=1500 mg/day immediate-release metformin or extended-release metformin and at least an optimally effective dose for brand of sulfonylurea, or 2. a fixed-dose sulfonylurea/metformin combination therapy with the same sulfonylurea and metformin requirements as for the individual components * HbA1c between 7.0% and 11.0%, inclusive. * Patients have a body mass index \>25kg/m2 and \<40 kg/m2. * Female patients are not breastfeeding, and female patients of childbearing potential test negative for pregnancy, do not intend to become pregnant during the study, and agree to continue using a reliable method of birth control Exclusion Criteria: * Patients are investigator site personnel directly affiliated with the study, or are immediate family of investigator site personnel directly affiliated with the study. * Patients are employed by Lilly or Amylin. * Patients have previously, in this or any other study, received exenatide or glucagon-like peptide-1 analogs. * Patients have participated in an interventional medical, surgical, or pharmaceutical study within 30 days prior to screening. This criterion includes drugs that have not received regulatory approval for any indication at the time of study entry. * Patients have had greater than three episodes of severe hypoglycemia within 6 months prior to screening. * Patients have less than 5 years of remission history from any malignancy (other than basal cell or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer). * Patients have cardiac disease that is Class III or IV, according to the New York Heart Association criteria. * Patients have a known allergy or hypersensitivity to biphasic insulin aspart, exenatide, or excipients contained in these agents. * Patients have characteristics contraindicating metformin or sulfonylurea use, according to product-specific label. * Patients have a history of renal transplantation or are currently receiving renal dialysis or have serum creatinine \>=1.5 mg/dL for males and \>=1.2 mg/dL for females. * Patients have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or alanine aminotransferase/serum glutamic pyruvic transaminase greater than three times the upper limit of the reference range. * Patients have known hemoglobinopathy or chronic anemia. * Patients have active proliferative retinopathy or macular edema. * Patients are receiving treatment for gastrointestinal disease with a drug directly affecting gastrointestinal motility, including but not limited to metoclopramide, cisapride, and chronic macrolide antibiotics. * Patients are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within 2 weeks immediately prior to screening. * Patients have used any prescription drug to promote weight loss within 3 months prior to screening. * Patients have been treated for longer than 2 weeks with any of the following excluded medications within 3 months prior to screening: insulin, thiazolidinediones, alpha-glucosidase inhibitors, meglitinides. * Patients have any other condition (including known drug or alcohol abuse or psychiatric disorder) that precludes them from following and completing the protocol, in the opinion of the investigator. * Patients fail to satisfy the investigator of suitability to participate for any other reason.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 69 locations
Klinica bolnica Dubrava
Zagreb, CroatiaKlinicki bolnicki centar Zagreb-Rebro
Zagreb, CroatiaOpca bolnica "Sveti Duh"
Zagreb, Croatia