A Randomized Double Blind, Placebo Controlled Trial With AMG 108 in Patients With Type 2 Diabetes Mellitus

NCT00661921 | Withdrawn Phase 2

• 1 other identifier: 20070212
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Diabetes Mellitus

Keywords

Type 2 Diabetes Mellitus; AMG 108; HbA1C; glucose; metformin; sulfonylurea; IL-1 Inhibitor; biologic; subcutaneous injection

Outcome Measures

Primary Outcomes (1)

• Change from baseline in HbA1c at week 14 (end of treatment)

  14 weeks

Study Arms (4)

40 mg AMG 108 Q2W

ACTIVE COMPARATOR

Biological: AMG 108

150 mg AMG 108 Q2W

ACTIVE COMPARATOR

Biological: AMG 108

75 mg AMG 108 Q2W

ACTIVE COMPARATOR

Biological: AMG 108

Placebo Q2W

PLACEBO COMPARATOR

Biological: Placebo

Interventions

AMG 108 BIOLOGICAL

IL-1 inhibitor, subcutaneous injection given every 2 weeks for the duration of the trial. Doses include 150 mg, 75mg, and 40 mg.

150 mg AMG 108 Q2W; 40 mg AMG 108 Q2W; 75 mg AMG 108 Q2W

Placebo BIOLOGICAL

AMG 108 volume matching placebo

Placebo Q2W

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amgen: lead

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Interventions

AMG 108

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 17, 2008
• First Posted: April 21, 2008
• Study Start: June 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: October 1, 2009
• Last Updated: September 6, 2018

Record last verified: 2018-09