This is a phase 2a, multicenter, randomized, double-blind, placebo-controlled, parallel group, fixed dose study. AMG 151 will be evaluated in subjects with type 2 diabetes treated with metformin for at least 3 months prior to randomization.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* Age 18 to 75 years, inclusive
* Diagnosis of type 2 diabetes mellitus
* HbA1c levels 7.5% to 11.0%, inclusive, 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.
Exclusion Criteria:
* 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
* Evidence of active infections that can interfere with the study
* Presence of clinically signif…
What they're measuring
1
To evaluate the dose-effect relationship of AMG 151 compared to placebo on fasting plasma glucose in subjects with type 2 diabetes treated with metformin
Timeframe: Change in fasting plasma glucose levels from baseline to Day 28