Study of Dose Effect and frequency of administration in subjects with diabetes

• Conditions: Type 2 Diabetes Mellitus; MedDRA version: 14.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2012-001382-32-EE
• Lead Sponsor: Amgen Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04-27
• Last Update Posted: 4 November 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 224

Inclusion Criteria

- Age 18 to 75 years, inclusive
- Diagnosis of type 2 diabetes mellitus
- HbA1c levels = 7.5% to = 11.0% at screening
- Fasting C-peptide levels = 0.2 nmol/L at screening
- BMI = 25 to = 45 kg/m2 at screening
- Treated with metformin monotherapy for at least 3 months prior to randomization; the metformin dose must be = 850 mg daily for at least 2 months immediately prior to randomization
- If a subject is being treated for hyperlipidemia or hypertension they should be on stable medication for 30 days before randomization
- Subject has provided informed consent
- Female subjects must be of non-reproductive potential (ie. postmenopausal by history - no menses for = 1 year and by FSH [using local reference ranges]; OR history of hysterectomy; OR history of bilateral tubal ligation; OR history of bilateral oophorectomy)
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 175
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

Disease Specific
- History of type 1 diabetes
- History of significant weight gain or loss (>10%) during the 4 weeks before randomization
- Use of any weight loss medication (over the counter or prescription) within 60 days of randomization
- Use of any oral or injectable anti-hyperglycemic medication (other than metformin) within 3 months prior to randomization
- Use of chronic and/or continuous insulin administration for > 15 days in an outpatient setting to achieve and maintain glycemic control prior to randomization
- Have had 2 or more emergency room visits or hospitalizations due to poor glucose control in the past 6 months
- Have had more than 1 episode of severe hypoglycemia within 6 months prior to entry into the study, or currently diagnosed as having hypoglycemia unawareness

Other Medical Conditions
- Evidence of active infections that can interfere with the study
- Presence of clinically significant organ system disease that is not
stabilized or may interfere with the study
- Currently receiving immunosuppressive therapy
- History of positive HIV, chronic hepatitis B or C, or cirrhosis
- Have symptomatic congestive heart failure or a history of myocardial infarction, unstable angina, or decompensated congestive heart failure or stroke in the past 6 months prior to screening.
- History of gastric surgery, vagotomy, bowel resection or any surgical procedure that might interfere with gastrointestinal motility, pH or absorption
- Any finding on the screening ECG that in the opinion of the investigator requires further cardiovascular evaluation
- Poorly controlled hypertension defined as diastolic pressure = 100 mm Hg or systolic pressure = 160 mm Hg (assessed on 2 separate occasions during the screening period)
- Malignancy (other than resected cutaneous basal or cutaneous
squamous cell carcinoma, or treated in situ cervical cancer considered cured) within 5 years of screening visit (if a malignancy occurred > 5 years ago, subject is eligible with documentation of disease-free state since treatment)

Excluded Medications
- Use of known inhibitors or inducers of CYP3A4 are not permitted 30 days prior to randomization

Laboratory Abnormalities
- Triglycerides = 500 mg/dL (5.64 mmol/L) at screening
- Hepatic liver enzymes (Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), alkaline phosphatase, total bilirubin) levels > 2 times the upper limit of normal at screening
- Hemoglobin < 11 g/dL for men and < 10 g/dL for women
- Creatinine Clearance < 60 mL/min as calculated via the MDRD equation (Modification of Diet in Renal Disease study group) as required for metformin use
- Any laboratory abnormality, which, in the opinion of the investigator, will prevent the subject from completing the study or will interfere with the interpretation of the study results

General
- Male subject with a pregnant partner who is not willing to use a condom or practice abstinence during treatment and for 12 weeks after the end of treatment.
- Male subject with a partner that might become pregnant, who is not willing to use highly effective method of birth control during treatment, and for 12 weeks after the end of treatment.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified