A study of dulaglutide compared to placebo in patients receiving sulfonylurea therapy with type 2 diabetes

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 285

Inclusion Criteria

1. Type 2 diabetes (based on the World Health Organization’s [WHO] diagnostic criteria)
a. Not optimally controlled on diet and exercise and a stable dose of sulfonylurea that is at least 50% of the maximum approved dose per the local label for at least 3 months prior to the first study visit
b. HbA1c value of =7.5% and =9.5%
2. Accept continued treatment with sulfonylurea therapy, throughout the trial, as required per protocol
3. Men and nonpregnant women aged =18 years
4. Stable weight (±5%) =3 months prior to screening
5. BMI =45 kg/m2
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 240
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 45

Exclusion Criteria

1. Type 1 diabetes mellitus
2. Have been treated with ANY other antihyperglycemic medications (other than sulfonylurea) at the time of the first study visit or within 3 months of the first study visit
3. Have used insulin therapy (outside of pregnancy) any time in the past 2 years, except for short-term treatment of acute conditions, and up to a maximum of 4 weeks. Any insulin within 3 months prior to the first study visit is exclusionary.
4. Have been treated with drugs that promote weight loss within 3 months of the first study visit
5. Are receiving chronic (>14 days) systemic glucocorticoid therapy or have received such therapy within the 4 weeks immediately prior to the first study visit
6. Have had any of the following CV conditions within 2 months prior to the first study visit: acute myocardial infarction, New York Heart Association (NYHA) Class III or Class IV heart failure, or cerebrovascular accident (stroke)
7. 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®)
8. Have acute or chronic hepatitis, signs and symptoms of any other liver disease, or alanine transaminase (ALT) level =2.5 times the upper limit of the reference range
9. Have a history of chronic pancreatitis or acute idiopathic pancreatitis, or were diagnosed with any type of acute pancreatitis
10. Have an estimated glomerular filtration rate [eGFR] <30 mL/min/1.73 m2
11. Have any self or family history of type 2A or type 2B multiple endocrine neoplasia (MEN 2A or 2B) in the absence of known C-cell hyperplasia (this exclusion includes those patients with a family history of MEN 2A or 2B, whose family history for the syndrome is RET negative; the only exception for this exclusion will be for patients whose family members with MEN 2A or 2B have a known RET mutation and the potential patient for the study is negative for that RET mutation)
12. Have any self or family history of medullary C-cell hyperplasia, focal hyperplasia, carcinoma (including sporadic, familial or part of MEN 2A or 2B syndrome)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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