Efficacy and Safety Study of Investigational Dulaglutide Doses in Participants with Type 2 Diabetes on Metformin Therapy.

Phase 1

• Conditions: Type 2 Diabetes; MedDRA version: 20.0 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2017-003490-33-GR
• Lead Sponsor: Eli Lilly and Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-04-26
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 1800

Inclusion Criteria

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

Exclusion Criteria

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