Phase 3 study to compare adding Exenatide once weekly injection to adjusted dose of basal insulin Glargine compared to placebo (no active medication) to adjusted dose of basal insulin Glargine.
- Conditions
- Diabetes MellitusMedDRA version: 17.1Level: HLTClassification code 10012602Term: Diabetes mellitus (incl subtypes)System Organ Class: 100000004860Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2014-003502-33-HU
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 440
1.Provision of informed consent prior to any study-specific procedures
2.Is able to read, understand, and sign the Informed Consent Forms (ICFs) and, if applicable, an Authorization to Use and Disclose Protected Health Information form (consistent with Health Insurance Portability and Accountability Act of 1996 [HIPAA] legislation), communicate with the Investigator, and understand and comply with protocol requirements
3.Is at least 18 years old at Visit 1 (Screening). For patients taking metformin, the upper age limit should be based on local metformin label restrictions
4.Has a diagnosis of Type 2 Diabetes Mellitus (T2DM)
5.Has HbA1c of 7.5% to 12.0%, inclusive, at Visit 1 (Screening). (Note: The acceptable HbA1c range is different for randomization; see Section 3.2 for the randomization criterion)
6.Has fasting plasma glucose (FPG) concentration <280 mg/dL (15.6 mmol/L) at Visit 1 (Screening)
7.Treated with basal insulin glargine at a dose of =20 units/day for at least 6 weeks prior to Screening, in combination with diet and exercise alone or in combination with:
?a stable dose of metformin (=1500 mg/day) for at least 8 weeks prior to Visit 1 (Screening)
?a stable dose of metformin (=1500 mg/day) for at least 8 weeks prior to Visit 1 (Screening) and a stable dose of sulfonylurea for at least 8 weeks prior to the Screening visit
8.Is male, or is female and meets all the following criteria:
?Not breastfeeding
?Negative pregnancy test result (beta-subunit [?-hCG], human chorionic gonadotropin) at Visit 1 (Screening) (not applicable to hysterectomized females.)
?If of childbearing potential (including perimenopausal women who have had a menstrual period within 1 year), must practice and be willing to continue to practice appropriate birth control (defined as a method that results in a low failure rate, ie, less than 1% per year, when used consistently and correctly, such as implants, injectables, hormonal contraceptives [pills, vaginal rings, or patches], some intrauterine contraceptive devices [levonorgestrel-releasing or copper-T], tubal ligation or occlusion, or a vasectomized partner) during the entire duration of the study. As applicable, all methods must be in effect prior to receiving the first dose of study medication
?Must practice appropriate birth control as stated above for 10 weeks after the last dose of study medication
9.Patients who are receiving the following medications must be on a stable treatment regimen for a minimum of 2 months prior to Visit 1 (Screening):
?Antihypertensive agents
?Thyroid replacement therapy
?Antidepressant agents.
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 396
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 44
1.Serum calcitonin concentration =40 pg/mL (=40 ng/L) at Visit 1 (Screening)
2.Clinically significant abnormal free T4 values or patients needing initiation or adjustment of thyroid treatment according to the Investigator. Abnormal thyroid stimulating hormone (TSH) value at Screening will be further evaluated by free T4. Patients with clinically significant abnormal free T4 values will be excluded
3.Known active proliferative retinopathy
Gastrointestinal/Hepatic Conditions
4.History of, or currently have, acute or chronic pancreatitis, or have triglyceride concentrations =500 mg/dL (=5.65 mmol/L) at Visit 1 (Screening)
5.History or presence of inflammatory bowel disease or other severe gastrointestinal diseases, particularly those which may impact gastric emptying, such as gastroparesis or pyloric stenosis
6.History of gastric bypass surgery or gastric banding surgery, or either procedure is planned during the time period of the study. Current use of gastric balloons is also excluded
7.Significant hepatic disease, including, but not limited to, acute hepatitis, chronic active hepatitis, or severe hepatic insufficiency, including patients with alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >3x upper limit of normal (ULN) and/or total bilirubin (TB) >2 mg/dL (>34.2 µmol/L). (Patients with TB >2 mg/dL [>34.2 µmol/L] and documented Gilbert’s syndrome will be allowed to participate)
8.Positive serological test for hepatitis B or hepatitis C
9.Known history of hepatotoxicity with any medication
10.Known history of severe hepatobiliary disease
Cardiovascular Conditions
11.Clinically significant cardiovascular disease or procedure within 3 months of Visit 1, including but not limited to myocardial infarction, clinically significant arrhythmia, unstable angina, coronary artery bypass surgery, or angioplasty; or are expected to require coronary artery bypass surgery or angioplasty during the course of the study
12.Presence or history of severe congestive heart failure (New York Heart Association Class IV [CCNYHA 1994])
Kidney Conditions
13.History of renal transplantation, or is currently receiving renal dialysis, or has a creatinine clearance <30 mL/min (0.50 mL/s) as calculated by the Cockcroft-Gault formula
14.If on metformin, has a serum creatinine level =1.5 mg/dL in males, =1.4 mg/dL in females, or creatinine clearance <60 mL/min (<1.0 mL/s) as calculated by the Cockcroft-Gault formula
Infection Disease/Immunologic Conditions
15.Known or suspected human immunodeficiency virus (HIV) infection
16.Presence or history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 (MEN 2) OR a family history of medullary thyroid carcinoma or MEN 2
17.Malignancy (with the exception of basal and squamous cell carcinoma of the skin) within 5 years of Visit 1 (Screening)
18.Hemoglobinopathy, hemolytic anemia, or chronic anemia (hemoglobin concentration <11.5 g/dL [115 g/L] for males, <10.5 g/dL [105 g/L] for females) or any other condition known to interfere with the HbA1c methodology
19.Any exposure to exenatide (including Byetta®, Bydureon™, or exenatide suspension) or any GLP-1 analog
20.Administration of any antihyperglycemic therapy, other than sulfonylurea (SU), insulin, or metformin, for more than 14 days (consecutive or not) during the 12 weeks prior to Visit 1 (Screening). In addition, administration of any antihyperglycemic therapy, other than sulfonylurea (SU)
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