Diabetes MedDRA version: 14.0 Level: LLT Classification code 10012594 Term: Diabetes System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Product Name: Exenatide
Product Code: LY2148568, AC2993
Pharmaceutical Form: Powder and solvent for suspension for injection
INN or Proposed INN: Exenat
Sponsors
Eli Lilly and Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1]Present with type 2 diabetes based on the disease diagnostic criteria as described by the World Health Organization (WHO) (refer to Attachment GWDL.3). [2]Are at least 18 years of age at screening. [3]Have suboptimal glycaemic control as evidenced by an HbA1c 7.1% to 10.0%, inclusive. [4]Have a history of stable body weight (not varying by >5% for at least 3 months prior to screening). [5]Have a body mass index (BMI) of 25 kg/m2 to 45 kg/m2, inclusive. [6]Are receiving metformin at a stable dose (consistent with country specific requirements) of a minimum of 1000mg for at least 3 months prior to visit 3 Or Are receiving metformin at a minimum dose (consistent with country specific requirements) of 1000mg and sulphonylurea (as separate medications not as a fixed dose combination) at stable doses for 3 months prior to visit 3. [7]For females of child-bearing potential (not surgically sterilised and between menarche and 1-year postmenopause) only: •Are not breastfeeding •Test negative for pregnancy at the time of screening based on a urine pregnancy test •Intend not to become pregnant during the study •Have practiced a reliable method of birth control (e.g. use of oral contraceptives or Norplant®; diaphragms with contraceptive jelly; cervical caps with contraceptive jelly; condoms with contraceptive foam; intrauterine devices; partner with vasectomy for at least 6 weeks prior to screening) •Agree to continue to use a reliable method of birth control (as above) during the study, as determined by the investigator. 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: [8] Are Lilly, Amylin, or Alkermes employees. [9] Are investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child or sibling, whether biological or legally adopted. [10] Have had a clinically significant history of cardiac disease or presence of active cardiac disease within the year prior to inclusion in the study, including myocardial infarction, clinically significant arrhythmia, unstable angina, moderate to severe congestive heart failure (New York Heart Association Class III or IV), coronary artery bypass surgery or angioplasty; or are expected to require coronary artery bypass surgery or angioplasty during the course of the study. [11] Have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, alanine aminotransaminase (ALT), or serum glutamic pyruvic transaminase (SGPT), greater than three times the upper limit of the reference range. [12] Have a history of renal transplantation or are currently receiving renal dialysis or have a creatinine clearance of 500mg/dL (>5.64mmol/L) [21] Have been treated within 4 weeks of screening with systemic glucocorticoid therapy by oral, intravenous (IV) or intramuscular (IM) route, or are regularly treated with potent, inhaled intranasal steroids that are known to have a high rate of systemic absorption. Exceptions to this criterion include patients who are receiving glucocorticoid therapy for corticotropic hypopituitary deficiency (e.g. Addison disease). [22] Have been treated with drugs that promote weight loss, within 3 months of screening. [23] Have been treated for longer than 2 weeks with any of the following excluded medications within 3 months prior to screening: • insulin • alpha-glucosidase • meglitinides • Byetta® (exenatide BID formulation) • thiazolidinediones (TZD) • dipeptidyl peptidase (DPP)-4 inhibitors. [24] Have had an organ transplant. [25] Have donated blood within 30 days of screening. [26] Have previously completed or withdrawn from this s
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to test the hypothesis that exenatide QW given once weekly for 26 weeks is superior to a titration of insulin detemir, given once or twice daily (titrated to reach a target of pre-breakfast and pre-dinner glucose concentrations of <5.5 mmol/L) when given for 26 weeks in the treatment of patients with type 2 diabetes not adequately controlled using OAD therapy. The primary efficacy measure will be assessed by the proportion of patients on each therapy who have achieved HbA1c concentration =7.0% with weight loss (=1.0 kg) at endpoint.; Secondary Objective: The secondary efficacy measure of the study are to compare exenatide QW with insulin detemir over 26 weeks with respect to: •the proportion of patients who have achieved HbA1c =7.0% with weight loss (=1.0 kg) at 12 weeks. •the proportion of patients who have achieved HbA1c =7.4% with weight loss (=1.0 kg) at endpoint •the proportion of patients who have achieved HbA1c =7.0% and =7.4%, with minimal weight gain (=1 kg) at endpoint •HbA1c change from baseline •change in body weight •the proportion of patients achieving HbA1c =7.4%, =7.0% and =6.5% •change in fasting serum glucose •7-point self-monitored blood glucose (SMBG) profile (blood glucose measurements before and 2 hours after the start of the morning, midday, and evening meals, and at bedtime) •changes in cardiovascular risk parameters: •incidence and rate of hypoglycaemic events •resource utilisation •safety and tolerability •health outcomes. safety and tolerability (including anti exenatide antibodies) ;Primary end point(s): The primary efficacy measure will be assessed by the proportion of patients on each therapy who have achieved HbA1c concentration =7 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary efficacy measure of the study are to compare exenatide QW with insulin detemir over 26 weeks with respect to: •the proportion of patients who have achieved HbA1c =7.0% with weight loss (=1.0 kg) at 12 weeks. •the proportion of patients who have achieved HbA1c =7.4% with weight loss (=1.0 kg) at endpoint •the proportion of patients who have achieved HbA1c =7.0% and =7.4%, with minimal weight gain (=1 kg) at endpoint •HbA1c change from baseline •change in body weight •the proportion of patients achieving HbA1c =7.4%, =7.0% and =6.5% •change in fasting serum glucose •7-point self-monitored blood glucose (SMBG) profile (blood glucose measurements before and 2 hours after the start of the morning, midday, and evening meals, and at bedtime) •changes in cardiovascular risk parameters: oBMI (body mass index) owaist circumference osystolic and diastolic blood pressure (SBP and DBP) olipid profile ochanges in plasminogen activator inhibitor (PAI1) ochanges in high sensitivity C reactive protein (hsCRP) concentrations ochanges in adiponectin levels •incidence and rate of hypoglycaemic events •resource utilisation •safety and tolerability •health outcomes. ;Timepoint(s) of evaluation of this end point: 26 Weeks | — |
Countries
Ireland, United Kingdom
Contacts
Public ContactClinical Trial Information
Eli Lilly
Outcome results
None listed