A Study of Dulaglutide compared to Liraglutide in Patients with Type 2 Diabetes Mellitus

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 592

Inclusion Criteria

- Type 2 diabetes (based on WHO diagnostic criteria)
- Not optimally controlled on diet and exercise and a dose of metformin that is at least 1500 mg/day and has been at a stable dose for at least 3 months prior to the first study visit
- HbA1c value of =7.0% to =10.0%
- Accept continued treatment with metformin throughout the trial
- Men and nonpregnant women aged =18 years
- Stable weight (±5%) =3 months prior to screening
- 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 503
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 89

Exclusion Criteria

- Have type 1 diabetes mellitus
- Have been treated with ANY other antihyperglycemic medications (other than metformin) at the time of the first study visit or within 3 months prior to first study visit
- Have used insulin therapy (outside of pregnancy) any time in the past 2 years, except for short-term treatment of acute conditions, & up to a maximum of 4 weeks; any insulin use within 3 months prior to the first study visit
- Have been treated with drugs that promote weight loss within 3 months of first study visit
- Are receiving chronic (>14 days) systemic glucocorticoid therapy (excluding topical, intraocular, intranasal, or inhaled preparations) or have received such therapy within 4 weeks prior to first study visit
- Have had any of the following CV conditions within 2 months prior to the first study visit: acute MI, NYHA 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 (e.g. Lap-Band®)
- Have acute or chronic hepatitis, signs & symptoms of any other liver disease, or alanine transaminase (ALT) level =3 times the upper limit of the reference range
- Have history of chronic pancreatitis or acute idiopathic pancreatitis, or were diagnosed with any type of acute pancreatitis
- Have a serum creatinine =1.5 mg/dL (male) or =1.4 mg/dL (female), or a creatinine clearance <60 mL/minute
- Have 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 [see proptocol for further details]
- Have self or family history of medullary C-cell hyperplasia, focal hyperplasia, carcinoma (including sporadic, familial or part of MEN 2A or 2B syndrome)
- Have a serum calcitonin =20 pg/mL

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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