Type 2 diabetes mellitus
Conditions
Interventions
Trade Name: BYETTA
Product Name: Exenatide
Product Code: AC2993,LY2148568
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Exenatide
CAS Number: 141732-76-5
Current Sponsor code: AC299
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All individuals must satisfy all inclusion criteria unless appropriate approval is obtained. 1.Is between 30 and 75 years of age, inclusive. 2.Has an HbA1c of 6.6% to 9.5%, inclusive. 3.Has a body mass index of 25 kg/m2 to 40 kg/m2, inclusive. 4.Is male or if female, has a negative pregnancy test (human chorionic gonadotropin, ß subunit [ß hCG]) regardless of birth control method used and agrees to continue using birth control throughout the study to prevent pregnancy. 5.Has a diagnosis of type 2 diabetes and is otherwise healthy. 6.Has fasting (at least 8 h) plasma glucose 10% for at least 3 months prior to screening). Open ended extension: completed initial study, off study drug for at least 8 weeks before starting extension. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Clinical significant history (organ transplant, hepatic, renal, CNS, GI, pulmonary, hematologic diseases including anemia, blood transplant, recent surgery, donated blood, low hemoglobin, CV problems) More than 3 episodes of severe hypoglycaemia within 6 months before screen Less than 2 years remission from clinical significant malignancy. Expresses apoE2 allele Known hypersensitivity to components of treatment Been in a previous exenatide study Taking excluded medications (insulin, SU, TZD, meglitinides, alpha glucosidase, gastrointestinal motility products, antineoplastics, weight loss agents, transplant medications, lipid lowering or b blockers, HRT) or any investigational drug. Received chronic systemic glucocorticoid therapy Relative to person affiliated with study Employee of Amylin or Lilly
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare beta function (as measured by arginine stimulated insulin secretion during a hyperglycemic clamp) after 52 weeks of intensified therapy with exenatide or insulin glargine in subjects with type 2 diabetes treated with metformin. Open ended extension to compare the beta cell function after longer term therapy with exenatide or glargine in subjects with type 2 diabetes.;Secondary Objective: At 52 weeks compare 1st phase, sustained insulin release, glucose measures, insulin, c-peptide, lipids, lipoproteins and markers of inflammation, coag and endothelial function. Insulin sensitivity in euglycaemic clamp test. Weight and composition. Safety and tolerability, (hypoglycemic events, bp and urinary albumin excretion rate). HOMA (insulin sensitivity and beta cell function). At cessation ; b- cell function after 4 weeks, glucose measures, insulin, lipids, lipoproteins and circulating markers at 5 weeks. HbA1c and fasting plasma glucose at 4, 8 and 12 weeks. Time before withdrawal due to loss of glucose control followed for 12 weeks. Open ended extension. HbA1c, fasting glucose, insulin, proinsulin, c-peptide. Postprandial glucose, insulin C-peptide. Lipids, weight, HOMA. To assess the effect of treatment interruption of exenatide on safety, tolerability and anti exenatide antibodies. ;Primary end point(s): The primary efficacy endpoint is the treatment effect on beta-cell function as measured by the ratio of week 52 arginine-stimulated insulin secretion during a hyperglycaemic clamp, specifically the incremental AUC of insulin with respect to basal value over a 10 minute period (i.e. clamp time 290 min to 300 min) to that at baseline week -2. Open ended extension: Stimulated beta cell function, proinsulin/insulin ratio and HOMA B. | — |
Countries
Finland
Outcome results
None listed