| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
|
| E.1.1.1 | Medical condition in easily understood language |
|
| E.1.1.2 | Therapeutic area | Diseases [C] - Nutritional and Metabolic Diseases [C18] |
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 20.0 |
| E.1.2 | Level | PT |
| E.1.2 | Classification code | 10067585 |
| E.1.2 | Term | Type 2 diabetes mellitus |
| E.1.2 | System Organ Class | 10027433 - Metabolism and nutrition disorders |
|
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
| 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. |
|
| E.2.2 | Secondary objectives of the trial |
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 |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal 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. |
|
| E.4 | Principal 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;
|
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
| The change in HbA1c from baseline |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
| E.5.2 | 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;
|
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
| Baseline, 36 and 52 weeks |
|
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | No |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | Yes |
| E.6.7 | Pharmacodynamic | Yes |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | Yes |
| E.6.10 | Pharmacogenetic | Yes |
| E.6.11 | Pharmacogenomic | Yes |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | No |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | No |
| E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | No |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | Yes |
| E.8.1.5 | Parallel group | Yes |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | No |
| E.8.2.2 | Placebo | No |
| E.8.2.3 | Other | Yes |
| E.8.2.3.1 | Comparator description |
| A different dosage of the same product |
|
| E.8.2.4 | Number of treatment arms in the trial | 3 |
| E.8.3 |
The trial involves single site in the Member State concerned
| No |
| E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
| E.8.4.1 | Number of sites anticipated in Member State concerned | 9 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 96 |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
| E.8.6.2 | Trial being conducted completely outside of the EEA | No |
| E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
| Argentina |
| Austria |
| Canada |
| Greece |
| Hungary |
| Israel |
| Italy |
| Mexico |
| Poland |
| Romania |
| Russian Federation |
| Slovakia |
| Spain |
| Taiwan |
| United States |
|
| E.8.7 | Trial has a data monitoring committee | Yes |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
| The date of the last visit or last scheduled study procedure for the last patient. |
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| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 1 |
| E.8.9.1 | In the Member State concerned months | 6 |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial years | 1 |
| E.8.9.2 | In all countries concerned by the trial months | 6 |
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