A Randomized Double Blind, Placebo Controlled Trial With AMG 108 in Patients With Type 2 Diabetes Mellitus
Primary Purpose
Diabetes Mellitus
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
AMG 108
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Diabetes Mellitus focused on measuring Type 2 Diabetes Mellitus, AMG 108, HbA1C, glucose, metformin, sulfonylurea, IL-1 Inhibitor, biologic, subcutaneous injection
Eligibility Criteria
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
- Active or latent Mycobacterium tuberculosis infection as defined by known positive PPD or chest x-ray findings and failure to complete treatment with appropriate chemoprophylaxis, or exposure to a person with active tuberculosis within 6 months prior to randomization
- Existence of non-healing wounds or ulcers
- Known to be positive for hepatitis B surface antigen (HbsAg), hepatitis C virus (HCV) or human immunodeficiency virus (HIV)
- Estimated GFR (eGFR) at screening < 30 mL/min as calculated via the MDRD equation (Modification of Diet in Renal Disease study group)
- Clinical evidence of current malignancy, with the following exceptions: basal or squamous cell carcinoma of the skin, cervical intraepithelial neoplasia, prostate cancer (if stable localized disease, with life expectancy of > 3 years); or receiving or has received chemotherapy and/or radiation therapy for treatment of a malignancy within 6 months prior to randomization
- Clinically significant cardiovascular disease (eg, heart failure of New York Heart Association [NYHA] class 3 or 4), hematological abnormality, asthma, or chronic obstructive pulmonary disease (eg, requiring oral or IV steroids), in the opinion of the investigator
- Receipt of any biologic or immunosuppressive therapy (experimental or commercial), including anakinra (Kineret®) or any tumor necrosis factor (TNF) blocking agents (eg, etanercept and infliximab), or live vaccines, within 3 months of randomization
- Previously received AMG 108
- Subject is evidently pregnant (eg, positive human chorionic gonadotropin [HCG] test), is breast feeding, or is of child-bearing potential and not using adequate contraceptive precautions, as determined by the investigator
- Subject currently is enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study(s), or subject is receiving other investigational agent(s)
- Subject has any kind of condition (eg, psychiatric illness) or situation that, in the investigator's opinion, compromises the ability of the subject to give written informed consent, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
40 mg AMG 108 Q2W
150 mg AMG 108 Q2W
75 mg AMG 108 Q2W
Placebo Q2W
Arm Description
Outcomes
Primary Outcome Measures
Change from baseline in HbA1c at week 14 (end of treatment)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00661921
Brief Title
A Randomized Double Blind, Placebo Controlled Trial With AMG 108 in Patients With Type 2 Diabetes Mellitus
Official Title
A Mutiple Dose, Randomized, Double-blind, Placebo-controlled Study of Subcutaneous AMG 108 in Patients With Type 2 Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Program Development discontinued
Study Start Date
June 2008 (undefined)
Primary Completion Date
June 2009 (Anticipated)
Study Completion Date
October 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Amgen
4. Oversight
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus
Keywords
Type 2 Diabetes Mellitus, AMG 108, HbA1C, glucose, metformin, sulfonylurea, IL-1 Inhibitor, biologic, subcutaneous injection
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
40 mg AMG 108 Q2W
Arm Type
Active Comparator
Arm Title
150 mg AMG 108 Q2W
Arm Type
Active Comparator
Arm Title
75 mg AMG 108 Q2W
Arm Type
Active Comparator
Arm Title
Placebo Q2W
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
AMG 108
Intervention Description
IL-1 inhibitor, subcutaneous injection given every 2 weeks for the duration of the trial. Doses include 150 mg, 75mg, and 40 mg.
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
AMG 108 volume matching placebo
Primary Outcome Measure Information:
Title
Change from baseline in HbA1c at week 14 (end of treatment)
Time Frame
14 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Active or latent Mycobacterium tuberculosis infection as defined by known positive PPD or chest x-ray findings and failure to complete treatment with appropriate chemoprophylaxis, or exposure to a person with active tuberculosis within 6 months prior to randomization
Existence of non-healing wounds or ulcers
Known to be positive for hepatitis B surface antigen (HbsAg), hepatitis C virus (HCV) or human immunodeficiency virus (HIV)
Estimated GFR (eGFR) at screening < 30 mL/min as calculated via the MDRD equation (Modification of Diet in Renal Disease study group)
Clinical evidence of current malignancy, with the following exceptions: basal or squamous cell carcinoma of the skin, cervical intraepithelial neoplasia, prostate cancer (if stable localized disease, with life expectancy of > 3 years); or receiving or has received chemotherapy and/or radiation therapy for treatment of a malignancy within 6 months prior to randomization
Clinically significant cardiovascular disease (eg, heart failure of New York Heart Association [NYHA] class 3 or 4), hematological abnormality, asthma, or chronic obstructive pulmonary disease (eg, requiring oral or IV steroids), in the opinion of the investigator
Receipt of any biologic or immunosuppressive therapy (experimental or commercial), including anakinra (Kineret®) or any tumor necrosis factor (TNF) blocking agents (eg, etanercept and infliximab), or live vaccines, within 3 months of randomization
Previously received AMG 108
Subject is evidently pregnant (eg, positive human chorionic gonadotropin [HCG] test), is breast feeding, or is of child-bearing potential and not using adequate contraceptive precautions, as determined by the investigator
Subject currently is enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study(s), or subject is receiving other investigational agent(s)
Subject has any kind of condition (eg, psychiatric illness) or situation that, in the investigator's opinion, compromises the ability of the subject to give written informed consent, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
12. IPD Sharing Statement
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website
Learn more about this trial
A Randomized Double Blind, Placebo Controlled Trial With AMG 108 in Patients With Type 2 Diabetes Mellitus
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