Type 2 Diabetes MedDRA version: 19.1 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Trade Name: Trulicity
Product Name: Trulicity
Product Code: LY2189265
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Dulaglutide
Other descriptive name: DULAGLU
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Have had T2D for =6 months according to the World Health Organization (WHO) classification; Have HbA1c of 7.0% to 10.0%, inclusive; Have been treated with stable doses of metformin for at least 3 months (dose of =1500 mg/day) and the maximum-approved dose per country-specific label; lower doses will be allowed only with documented GI intolerability in the required dose range; Have had stable body weight for at least 3 months; body weight will be considered stable if it has not changed more than 5% in the past 3 months; Agree not to initiate a diet and/or exercise program during the study with the intent of reducing body weight other than the lifestyle and dietary measures for diabetes treatment; Have a body mass index (BMI) =25 kg/m2; In the investigator’s opinion, are well motivated, capable, and willing to: [a] self-inject treatment; [b] perform fingerstick plasma glucose (PG) monitoring at least once daily and up to 6 times per day once weekly throughout the trial; [c] maintain a study diary as required for this protocol. 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 242 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: [13] have type 1 diabetes (T1D); [14] have been treated with any excluded medication within 3 months prior to screening and/or between study entry and randomization; excluded glucocorticoids must not have been used for =14 days within 1 month prior to Visit; [15] have used any glucose-lowering medication other than metformin 3 months prior to study entry or during screening/lead-in period or have used any GLP-1 RAs at any time in the past. Short-term use of insulin for acute conditions is allowed ( >14 days); [16] have a condition that is a contraindication for use of the GLP-1 RA class or metformin; [17] have a history of =1 episode of ketoacidosis or hyperosmolar state/coma; [18] have had =1 episode of severe hypoglycemia and/or =1 episode of hypoglycemia unawareness within the 6 months; [19] have had any of the following CV conditions: acute myocardial infarction (MI), New York Heart Association (NYHA) Class III or Class IV heart failure, or cerebrovascular accident (stroke); [20] 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®); [21] have acute or chronic hepatitis, signs and symptoms of any other liver disease other than nonalcoholic fatty liver disease (NAFLD), or alanine aminotransferase (ALT) level >2.5 times the upper limit of the reference range, as determined by the central laboratory at study entry; patients with NAFLD are eligible for participation in this trial; [22] have had chronic or acute pancreatitis any time prior to study entry; [23] have an estimated glomerular filtration rate (eGFR) <45 mL/min/1.73m2, calculated by the Chronic Kidney Disease-Epidemiology (CKD-EPI) equation, as determined by the central laboratory [24] have a personal or family history of medullary thyroid carcinoma (MTC) or personal history of Multiple Endocrine Neoplasia syndrome type 2 (MEN 2); [25] have serum calcitonin =20 pg/mL, as determined by the central laboratory at study entry; [26] have evidence of significant, active autoimmune abnormality (eg, lupus, rheumatoid arthritis); [27] have a history of active or untreated malignancy, or are in remission from a clinically significant malignancy (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) during the past 5 years; [28] any serious disease or other condition (e.g, known drug or alcohol abuse) which, in the opinion of the investigator, would pose a significant risk to the patient or interfere with the interpretation of safety, efficacy, or PD data; [29] have any hematologic condition that may interfere with HbA1c measurement (eg, hemolytic anemias, sickle-cell disease); [30] 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); [31] are currently enrolled in any other clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study; [32] are Lilly employees; [33] have participated, within the last 30 days in a clinical trial involving an investigational product. If the previous investigational product has a long half-life, 3 months or 5 half-lives (whichever is longer) should ha
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To show superiority of the 3 dulaglutide doses, including the two higher doses (4.5 mg and 3.0 mg) and the approved 1.5 mg dose to placebo in change in HbA1c.;Secondary Objective: To determine if the two higher doses of Trulicity are effective and safe. Efficacy: To compare each dulaglutide arm (4.5 mg, 3.0 mg, 1.5 mg) to the placebo arm at 18 weeks for secondary efficacy parameters. Safety: To compare each dulaglutide arm (4.5 mg, 3.0 mg, 1.5 mg) to the placebo arm for selected safety parameters at 18 weeks. PK/PD: To characterize the pharmacokinetics (PK) of dulaglutide and establish the relationships between dose/exposure and key safety and efficacy measures.;Primary end point(s): Change in HbA1c from baseline ;Timepoint(s) of evaluation of this end point: Baseline and 18 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Proportion of patients achieving HbA1c target of <7.0% • The change in fasting serum glucose (FSG; central laboratory) from baseline • The change in body weight from baseline • Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) • Discontinuation of study drug due to adverse events (AEs) • Incidence and rate of hypoglycemia (severe, total, documented symptomatic, and nocturnal) • PK parameters (eg, Cmax, AUC) • Pharmacodynamic evaluations will include HbA1c, FSG, body weight, QTcF interval, and heart rate ;Timepoint(s) of evaluation of this end point: • 18 weeks • Baseline and 18 weeks • Baseline and 18 weeks • Baseline through 18 weeks • 18 weeks • 18 weeks • Week 0 through week 22 • Week 0 through week 22 • | — |
Countries
Czech Republic, Mexico, Poland, Romania, United States
Contacts
Public ContactClinical Trial Registry Office
Eli Lilly
Outcome results
None listed