Efficacy and Safety Study of Investigational Dulaglutide Doses in Participants with Type 2 Diabetes on Metformin Therapy.
- Conditions
- Type 2 DiabetesMedDRA version: 20.0Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2017-003490-33-HU
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1800
Have had T2D for =6 months according to the World Health Organization (WHO) classification treated with stable doses of metformin for at least 3 months.
Men or nonpregnant women aged =18 years;
Have HbA1c =7.5% and =11.0% inclusive;
Treated with stable doses of metformin for at least 3 months prior to screening, and between screening and randomisation;
Have stable body weight for at least 3 months prior to screening;
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 as required (visually impaired persons who are not able to perform the injections must have the assistance of a sighted individual trained to inject)the study drug; persons with physical limitations who are not able to perform the injections must have the assistance of an individual trained to inject the study drug);
[b] perform finger stick PG monitoring at least once daily every day and up to 6 times one day per week at designated times throughout the trial;
[c] maintain a study diary
women of childbearing potential participating must agree to remain abstinent, or use 1 highly effective method of contraception, or a combination of 2 effective methods of contraception starting at screening and continuing until 4 weeks after the last dose of the randomized therapy;
Women of childbearing potential participating must test negative for pregnancy at screening followed by a negative urine pregnancy test within 24 hours prior to exposure;
Women must not be breastfeeding;
Women not of childbearing potential may participate;
Have given written consent to participate in this study.
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 1380
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 420
Have type 1 diabetes;
Have had any of the following CV conditions within 2 months prior to screening: acute myocardial infarction, New York Heart Association 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 (eg, Lap-Band®) or chronically take drugs that directly reduce gastrointestinal motility;
Have acute or chronic hepatitis, signs and symptoms of any other liver disease other than nonalcoholic fatty liver disease, or alanine aminotransferase level >2.5 times the upper limit of the reference range;
Have had chronic or acute pancreatitis any time prior to study entry;
Have an eGFR <30 mL/min/1.73 m2 (or lower than the country-specific threshold for discontinuing metformin therapy per local label);
Have a personal or family history of medullary thyroid carcinoma or personal history of multiple endocrine neoplasia syndrome type 2;
Have serum calcitonin =20 ng/L,
Have evidence of significant, active autoimmune abnormality (eg, lupus, rheumatoid arthritis);
Have active or untreated malignancy, or have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer) for less than 5 years;
Known proliferative retinopathy or maculopathy requiring acute treatment according to the opinion of the investigator;
Have used any GLP-1 RAs (including investigational agents with GLP-1 RA activity) or insulin at any time in the past, except for short-term (=14 consecutive days) use of insulin for acute conditions;
Have used any other glucose-lowering medications other than metformin (including insulin) 3 months prior to study entry or during the Screening/Lead-In Periods;
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To demonstrate that once weekly higher dose dulaglutide is superior to dulaglutide 1.5mg once weekly as measured by change from baseline in HbA1c in patients with inadequately controlled T2D on concomitant metformin therapy.;Secondary Objective: Efficacy:<br>To demonstrate that once weekly higher dose dulaglutide is superior to dulaglutide 1.5mg once weekly for secondary efficacy parameters <br>Safety:<br>To compare selected safety parameters ;Primary end point(s): The change in HbA1c from baseline;Timepoint(s) of evaluation of this end point: Baseline and 36 weeks
- Secondary Outcome Measures
Name Time Method Secondary end point(s): The change in body weight from baseline;<br>Proportion of patients achieving HbA1c target <7.0%; <br>The change in fasting serum glucose from baseline;<br>;Timepoint(s) of evaluation of this end point: Baseline, 36 and 52 weeks