NCT00661921
Withdrawn
Phase 2
A Mutiple Dose, Randomized, Double-blind, Placebo-controlled Study of Subcutaneous AMG 108 in Patients With Type 2 Diabetes Mellitus
ConditionsDiabetes Mellitus
Overview
- Phase
- Phase 2
- Status
- Withdrawn
- Sponsor
- Amgen
- Primary Endpoint
- Change from baseline in HbA1c at week 14 (end of treatment)
Overview
Brief Summary
The purpose of this study is to investigate the effects of blocking IL-1 signaling with AMG 108 in type 2 diabetes mellitus patients on glycemic control, as measured by change in HbA1c from baseline to end of treatment (EOT).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of T2DM ≥ 3 months at time of randomization
- •HbA1c of 7.0 - 9.5% (inclusive) at screening
- •≥ 18 years of age at the time of randomization
- •BMI ≥ 25 kg/m2 and ≤ 45 kg/m2 at screening, and, per patient self-report, following their regular weight maintenance or reduction diet for the management of diabetes for at least 4 weeks prior to randomization
- •Fasting plasma glucose ≤ 240 mg/dL (13.3 mmol/L) at each of 2 determinations during screening (samples taken at least 1 day apart)
- •No new therapy for the treatment of elevated blood pressure or dyslipidemia, use of any weight loss medication (over the counter or prescription), or initiation of a prescribed weight management or exercise program within 4 weeks before randomization
- •Subject is able and willing to comply with the study's visit requirement
Exclusion Criteria
- •History of type 1 insulin-dependent diabetes
- •Significant signs and symptoms of uncontrolled hyperglycemia (ie, polyuria, polydypsia, polyphagia), in the opinion of the investigator
- •History of significant weight gain or loss (+/- 5%) during the 4 weeks before randomization
- •Triglycerides ≥ 400 mg/dL (4.5 mmol/L) and/or total cholesterol ≥340 mg/dL (8.7 mmol/L) at screening
- •Currently receiving or received within 60 days prior to screening any anti-diabetic pharmaceutical therapy (eg, insulin) other than metformin and/or sulfonylurea. If receiving metformin or sulfonylurea, doses must be stable for ≥ 60 days.
- •Uncontrolled hypertension defined as diastolic pressure \> 95 mmHg and/or systolic \> 170 mmHg during screening
- •Hepatic function test (alanine aminotranferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, total bilirubin) results at screening \> 2 times the upper limit of normal for the central laboratory
- •White blood cell count \< 3000 / μL, absolute neutrophil count (ANC) of \< 2500 / μL, or platelet count of \< 125,000 / μL at screening
- •Any significant inflammatory, rheumatologic, or systemic autoimmune disease in the opinion of the investigator
- •Evidence of active infection, recent infection, or chronic infection, requiring treatment with anti-infectives, hospitalization or IV antibiotics within 4 weeks prior to randomization
Outcomes
Primary Outcomes
Change from baseline in HbA1c at week 14 (end of treatment)
Time Frame: 14 weeks
Secondary Outcomes
No secondary outcomes reported
Investigators
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