Diabetes Mellitus, Type 2 MedDRA version: 17.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000004861
Conditions
Interventions
Trade Name: TrulicityTM
Product Name: dulaglutide
Product Code: LY2189265
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Dulaglutide
Current Sponsor code: LY2189265
Other descriptive
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or female patients are eligible to be included in the study only if they meet all of the following criteria: [1] are men or non-pregnant women aged =18 years at screening [2] have type 2 diabetes (based on the World Health Organization’s [WHO] diagnostic criteria); [3] have been treated with basal insulin glargine once daily with or without metformin for at least 3 months prior to screening [4] doses of once daily insulin glargine and metformin (if taken) must be stable during the 3-month period prior to screening. Insulin glargine dose is considered stable when all doses during this period are within the range defined by ±10% of the most commonly used insulin glargine dose during this same period if that dose is =40 IU; if the most commonly used insulin glargine dose is =65 years) yes F.1.3.1 Number of subjects for this age range 92
Exclusion criteria
Exclusion criteria: Patients excluded from study if meet following criteria at screening, or when indicated below for specific criteria, at randomization/baseline, or any time during screening & lead-in periods: • have type 1 diabetes mellitus • treated with ANY other antihyperglycemia regimen, other than basal insulin glargine once daily with/without metformin, within 3 months prior to screening or during lead-in period • per TTT algorithm, do not require insulin glargine dose increase at randomisation based on SMPG data collected during prior week • history of =1 episode of ketoacidosis or hyperosmolar state/coma • history of hypoglycemia unawareness within 6 months prior to screening • treated with drugs promoting weight loss within 3 months prior to screening or during lead in period • receiving chronic (>14 days) systemic glucocorticoid therapy (excluding topical, intraocular, intranasal, intra-articular, or inhaled preparations) or have received such therapy within 4 weeks prior to screening or during lead in period • had any of following CV conditions within 2 months prior to screening: acute myocardial infarction , New York Heart Association Class III or IV heart failure, or cerebrovascular accident • have known clinically significant gastric emptying abnormality (eg, severe diabetic gastroparesis or gastric outlet obstruction) or have undergone gastric bypass (bariatric) surgery or restrictive bariatric surgery • have acute or chronic hepatitis, signs & symptoms of any other liver disease, or alanine aminotransferase (ALT) level >2.5 times upper limit of reference range, determined by central laboratory (patients with nonalcoholic fatty liver disease eligible) • history of chronic pancreatitis or acute idiopathic pancreatitis, or diagnosed with any type of acute pancreatitis within 3 months prior to screening • estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2, calculated by Chronic Kidney Disease-Epidemiology (CKD-EPI) equation, as determined by central laboratory; for patients on metformin, have renal disease or renal dysfunction (eg. a serum creatinine =1.5 mg/dL [male] or =1.4 mg/dL [female] or eGFR [CKD-EPI] <60 mL/min/1.73 m2) (metformin SPC, 2008; Glucophage® USPI, 2009) • have evidence of significant, uncontrolled endocrine abnormality (eg, thyrotoxicosis, adrenal crisis), in opinion of investigator • any self or family history of type 2A or type 2B multiple endocrine neoplasia (MEN 2A or 2B) in absence of known C-cell hyperplasia (exclusion includes patients with family history of MEN 2A or 2B, whose family history for the syndrome is rearranged during transfection [RET]-negative; only exception for this exclusion will be for patients whose family members with MEN 2A or 2B have known RET mutation & potential patient for study is negative for RET mutation) • any self or family history of medullary C-cell hyperplasia, focal hyperplasia, or carcinoma (including sporadic, familial, or part of MEN 2A or 2B syndrome) • serum calcitonin =20 pg/mL, determined by central laboratory • evidence of significant, active autoimmune abnormality • any other condition not listed in this section that is contraindication for use of insulin glargine, or, for patients using metformin, have a condition that is contraindication for use of metformin & would require metformin discontinuation per label • history of transplanted organ (corneal transplants [keratoplasty] are allowed) • history of active or untreated malignancy,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to show superiority of the addition of once weekly dulaglutide 1.5 mg compared to the addition of once weekly placebo to titrated basal insulin glargine, with or without metformin, on change from baseline in HbA1c after 28 weeks of treatment in patients with Type 2 Diabetes Mellitus.;Secondary Objective: Secondary Efficacy Objectives: Compare 2 groups at 28 weeks on: • % of patients at HbA1c <7.0% or =6.5% • % of patients at HbA1c <7.0% & without weight gain (<0.1 kg) at 28 weeks & without documented symptomatic hypoglycemia during maintenance period; • % of patients at HbA1c <7.0% at 28 weeks & without documented symptomatic hypoglycemia during maintenance period; • % of patients at HbA1 <7.0% & without weight gain (<0.1 kg); • Changes from baseline in: fasting serum glucose, plasma glucose from daily self-monitored plasma glucose profiles, body weight, daily mean glargine doses. Secondary Safety Objectives: Compare 2 groups at 28 weeks on incidence of: • Adjudicated deaths & nonfatal major CV events; • Self-reported hypoglycemic events & of patients discontinuing study due to severe, persistent hyperglycemia; • Pancreatitis confirmed by adjudication; • Thyroid neoplasms; • Dulaglutide anti-drug antibodies & of allergic & hypersensitivity reactions. ;Primary end point(s): Change from baseline in HbA1c;Timepoint(s) of evaluation of this end point: 28 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Compare 2 groups at 28 weeks on: • Percentage of patients at HbA1c <7.0% or =6.5% • Percentage of patients at HbA1c <7.0% & without weight gain (<0.1 kg) at 28 weeks & without documented symptomatic hypoglycemia during maintenance period; • Percentage of patients at HbA1c <7.0% at 28 weeks & without documented symptomatic hypoglycemia during maintenance period • Percentage of patients at HbA1 <7.0% & without weight gain (<0.1 kg) • Changes from baseline in: fasting serum glucose, plasma glucose from daily self-monitored plasma glucose profiles, body weight, daily mean glargine doses • Confirmed by adjudication: a. Deaths b. Non-fatal major cardiovascular events c. Confirmed pancreatitis cases d. Presence of thyroid neoplasms • Incidence of dulaglutide anti-drug antibodies & of allergic & hypersensitivity reactions. • Incidence of self-reported hypoglycemic events & of patients discontinuing study due to severe, persistent hyperglycemia. ;Timepoint(s) of evaluation of this end point: 28 weeks | — |
Countries
Czech Republic, Hungary, Italy, Spain, United Kingdom, United States, United States Minor Outlying Islands
Contacts
Public ContactClinical Trial Registry Office
Eli Lilly and Company
Outcome results
None listed