Diabetes Mellitus, Type 2 MedDRA version: 14.1 Level: PT Classification code 10012601 Term: Diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Product Name: dulaglutide
Product Code: LY2189265
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Dulaglutide
Current Sponsor code: LY2189265
Concentration unit:
Sponsors
Eli Lilly & Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Type 2 diabetes (based on WHO diagnostic criteria) - Not optimally controlled on diet and exercise and a dose of metformin that is at least 1500 mg/day and has been at a stable dose for at least 3 months prior to the first study visit - HbA1c value of =7.0% to =10.0% - Accept continued treatment with metformin throughout the trial - Men and nonpregnant women aged =18 years - Stable weight (±5%) =3 months prior to screening - 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 503 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 89
Exclusion criteria
Exclusion criteria: - Have type 1 diabetes mellitus - Have been treated with ANY other antihyperglycemic medications (other than metformin) at the time of the first study visit or within 3 months prior to first study visit - Have used insulin therapy (outside of pregnancy) any time in the past 2 years, except for short-term treatment of acute conditions, & up to a maximum of 4 weeks; any insulin use within 3 months prior to the first study visit - Have been treated with drugs that promote weight loss within 3 months of first study visit - Are receiving chronic (>14 days) systemic glucocorticoid therapy (excluding topical, intraocular, intranasal, or inhaled preparations) or have received such therapy within 4 weeks prior to first study visit - Have had any of the following CV conditions within 2 months prior to the first study visit: acute MI, NYHA Class III or Class IV heart failure, or cerebrovascular accident (stroke) - 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 (e.g. Lap-Band®) - Have acute or chronic hepatitis, signs & symptoms of any other liver disease, or alanine transaminase (ALT) level =3 times the upper limit of the reference range - Have history of chronic pancreatitis or acute idiopathic pancreatitis, or were diagnosed with any type of acute pancreatitis - Have a serum creatinine =1.5 mg/dL (male) or =1.4 mg/dL (female), or a creatinine clearance <60 mL/minute - Have 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 [see proptocol for further details] - Have self or family history of medullary C-cell hyperplasia, focal hyperplasia, carcinoma (including sporadic, familial or part of MEN 2A or 2B syndrome) - Have a serum calcitonin =20 pg/mL
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that once-weekly dulaglutide (1.5 mg dose) is noninferior to once-daily liraglutide (1.8 mg dose) as measured by HbA1c at 26 weeks (change from baseline) in patients with type 2 diabetes mellitus who are taking a stable dose of metformin;Secondary Objective: - If noninferiority is passed, to assess if dulaglutide is superior to liraglutide at 26 weeks (measured by change in HbA1c from baseline). To compare dulaglutide and liraglutide for: - Change in body weight & BMI - FPG & fasting plasma glucose 7-point self-monitored plasma glucose profiles - % patients attaining HbA1c <7.0% and =6.5% -Homeostasis Model Assessment 2 steady-state ß-cell function - Incidence of gastrointestinal AEs, injection site reactions & allergic or hypersensitivity reactions - Reported & adjudicated CV events, ECG parameters, heart rate & blood pressure - Serum calcitonin - Events of adjudicated acute pancreatitis and pancreatic enzymes - Hypoglycemic events - % patients requiring an additional intervention due to severe persistent hyperglycemia; & time to initiation of the additional intervention - Lipid panel - To evaluate anti-drug antibodies and adverse effect in those patients randomised to dulaglutide ;Primary end point(s): The primary endpoint in this study is change in HbA1c from baseline to 26 weeks;Timepoint(s) of evaluation of this end point: 26 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Change in HbA1c from baseline to 26 weeks - Change in body weight & BMI - FPG & 7-point self-monitored plasma glucose profiles - % patients attaining HbA1c <7.0% and =6.5% - Homeostasis Model Assessment 2 steady state ß-cell function (HOMA2-%B) - Incidence of gastrointestinal AEs, injection site reactions, & allergic or hypersensitivity reactions - Reported and adjudicated CV events, ECG parameters, heart rate, & blood pressure - Serum calcitonin - Events of adjudicated acute pancreatitis and pancreatic enzymes - Hypoglycemic events - % patients requiring an additional intervention due to severe persistent hyperglycemia; and time to initiation of the additional intervention - Lipid panel - Anti-drug antibody titer and adverse effect in those patients randomized to dulaglutide ;Timepoint(s) of evaluation of this end point: 26 weeks | — |
Countries
Czech Republic, Germany, Hungary, Mexico, Poland, Romania, Russian Federation, Slovakia, Spain, United States
Contacts
Public ContactClinical Trial Information
Eli Lilly
Outcome results
None listed