Diabetes Mellitus, Type 2 MedDRA version: 16.0 Level: PT Classification code 10012601 Term: Diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Product Name: LY2189265
Product Code: LY2189265
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Dulaglutide
Current Sponsor code: LY2189265
Other descriptive name: Dulaglutide
Concent
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Type 2 diabetes (based on the World Health Organization’s [WHO] diagnostic criteria) a. Not optimally controlled on diet and exercise and a stable dose of sulfonylurea that is at least 50% of the maximum approved dose per the local label for at least 3 months prior to the first study visit b. HbA1c value of =7.5% and =9.5% 2. Accept continued treatment with sulfonylurea therapy, throughout the trial, as required per protocol 3. Men and nonpregnant women aged =18 years - only in Austria: Men or nonpregnant women aged =18 years of age and = 80 years of age 4. Stable weight (±5%) =3 months prior to screening 5. BMI =45 kg/m2 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 240 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 45
Exclusion criteria
Exclusion criteria: 1. Type 1 diabetes mellitus 2. Have been treated with ANY other antihyperglycemic medications (other than sulfonylurea) at the time of the first study visit or within 3 months of the first study visit 3. Have used insulin therapy (outside of pregnancy) any time in the past 2 years, except for short-term treatment of acute conditions, and up to a maximum of 4 weeks. Any insulin within 3 months prior to the first study visit is exclusionary. 4. Have been treated with drugs that promote weight loss within 3 months of the first study visit 5. Are receiving chronic (>14 days) systemic glucocorticoid therapy or have received such therapy within the 4 weeks immediately prior to the first study visit 6. Have had any of the following CV conditions within 2 months prior to the first study visit: acute myocardial infarction, New York Heart Association (NYHA) Class III or Class IV heart failure, or cerebrovascular accident (stroke) 7. Have a 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 (eg, Lap-Band®) 8. Have acute or chronic hepatitis, signs and symptoms of any other liver disease, or alanine transaminase (ALT) level =2.5 times the upper limit of the reference range 9. Have a history of chronic pancreatitis or acute idiopathic pancreatitis, or were diagnosed with any type of acute pancreatitis 10. Have an estimated glomerular filtration rate [eGFR] <30 mL/min/1.73 m2 11. Have any self or family history of type 2A or type 2B multiple endocrine neoplasia (MEN 2A or 2B) in the absence of known C-cell hyperplasia (this exclusion includes those patients with a family history of MEN 2A or 2B, whose family history for the syndrome is RET negative; the only exception for this exclusion will be for patients whose family members with MEN 2A or 2B have a known RET mutation and the potential patient for the study is negative for that RET mutation) 12. Have any self or family history of medullary C-cell hyperplasia, focal hyperplasia, carcinoma (including sporadic, familial or part of MEN 2A or 2B syndrome)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to demonstrate that once-weekly dulaglutide 1.5 mg is superior to placebo as measured by glycosylated hemoglobin A1c (HbA1c) at 24 weeks (change from baseline) in patients with type 2 diabetes mellitus on concomitant sulfonylurea therapy;Primary end point(s): The primary endpoint in this study is change in HbA1c from baseline to 24 weeks;Timepoint(s) of evaluation of this end point: 24;Secondary Objective: The secondary objectives of this study are as follows: • To compare the effect of dulaglutide and placebo treatments at 24 wks: o Change in body weight and body mass index from baseline o Fasting blood glucose (central lab) and blood glucose values from the 7-point self-monitored plasma glucose o Percentage of patients attaining HbA1c <7.0% and =6.5% o Percentage of patients requiring an additional antihyperglycemic therapy • To compare the safety of dulaglutide and placebo treatment groups at 24 weeks o Cardiovascular (CV) system-related safety o Pancreas-related safety o Thyroid gland-related safety o Glycemia-related safety: self-reported hypoglycemic events Dulaglutide anti-drug antibody titer and immune system-related adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): o Change in body weight and body mass index (BMI) from baseline o Fasting blood glucose (central lab) and blood glucose values from the 7-point self-monitored plasma glucose (SMPG) profiles (actual values and change from baseline) o Percentage of patients attaining HbA1c <7.0% and =6.5% o Percentage of patients requiring an additional antihyperglycemic therapy due to severe, persistent hyperglycemia, and time to initiation of the intervention o reported and adjudicated CV events o events of adjudicated acute pancreatitis, pancreatic enzymes o Thyroid gland-related safety: serum calcitonin o self-reported hypoglycemic events o Dulaglutide anti-drug antibody titer and immune system-related adverse events;Timepoint(s) of evaluation of this end point: 24 | — |
Countries
Argentina, Austria, Brazil, Croatia, Mexico, Slovenia, South Africa, United States
Contacts
Public ContactClinical Trial Information
Eli Lilly
Outcome results
None listed