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

• Register: EUCTR
• Last refreshed on: 12 July 2021
• Main ID: EUCTR2017-003490-33-PL
• Date of registration: 09/05/2018
• Prospective Registration: Yes
• Primary sponsor: Eli Lilly and Company
• Public title: Efficacy and Safety Study of Investigational Dulaglutide Doses in Participants with Type 2 Diabetes on Metformin Therapy.
• Scientific title: A Randomized, Double-Blind, Parallel Arm Study of the Efficacy and Safety of Investigational Dulaglutide Doses When Added to Metformin in Patients with Type 2 Diabetes Mellitus - AWARD 11
• Date of first enrolment: 15/05/2018
• Target sample size: 1800
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-003490-33
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: A different dosage of the same product Number of treatment arms in the trial: 3
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Austria, Canada, Greece, Hungary, Israel, Italy, Mexico, Poland, Romania, Russian Federation, Slovakia, Spain, Taiwan, United States

Contacts

• Name: Clinical Trial Registry Office
• Affiliation: Eli Lilly

• Name: Clinical Trial Registry Office
• Affiliation: Eli Lilly

Key inclusion & exclusion criteria

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;



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Type 2 Diabetes
MedDRA version: 21.1 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]

Intervention(s)

Trade Name: Trulicity
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: Dulaglutide
Other descriptive name: DULAGLUTIDE
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 1.5-

Trade Name: Trulicity
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: Dulaglutide
Other descriptive name: DULAGLUTIDE
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 3.0-

Product Name: Dulaglutide
Product Code: LY2189265
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: Dulaglutide
Other descriptive name: DULAGLUTIDE
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 6.0-

Product Name: Dulaglutide
Product Code: LY2189265
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: Dulaglutide
Other descriptive name: DULAGLUTIDE
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 9.0-

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: Baseline and 36 weeks

Primary end point(s): The change in HbA1c from baseline

Secondary Objective: Efficacy:
To demonstrate that once weekly higher dose dulaglutide is superior to dulaglutide 1.5mg once weekly for secondary efficacy parameters
Safety:
To compare selected safety parameters

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 Outcome(s)

Timepoint(s) of evaluation of this end point: Baseline, 36 and 52 weeks

Secondary end point(s): The change in body weight from baseline;
Proportion of patients achieving HbA1c target <7.0%;
The change in fasting serum glucose from baseline;

Secondary ID(s)

H9X-MC-GBGL

2017-003490-33-SK

Source(s) of Monetary Support

Eli Lilly and Company

Ethics review

Status: Approved
Approval date: 03/04/2018
Contact:

Results

• Results available: Yes
• Date Posted: 13/06/2020
• Date Completed: 10/10/2019
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2017-003490-33/results