Diabetes MellitusPhase 2NCT00661921
A Randomized Double Blind, Placebo Controlled Trial With AMG 108 in Patients With Type 2 Diabetes Mellitus
A Phase 2 study testing AMG 108 in people with Diabetes Mellitus, run by Amgen.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- AMG 108
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2008to Oct 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
About this study
Official title: A Mutiple Dose, Randomized, Double-blind, Placebo-controlled Study of Subcutaneous AMG 108 in Patients With Type 2 Diabetes Mellitus
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
- Being tested
- AMG 108, Placebo
- Keywords
- Type 2 Diabetes Mellitus, AMG 108, HbA1C, glucose, metformin, sulfonylurea, IL-1 Inhibitor, biologic, subcutaneous injection
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMG 108Biological
IL-1 inhibitor, subcutaneous injection given every 2 weeks for the duration of the trial. Doses include 150 mg, 75mg, and 40 mg.
PlaceboBiological
AMG 108 volume matching placebo
| Study group | Role | What they receive |
|---|---|---|
| 40 mg AMG 108 Q2W | Active comparator | Not described Receives: Biological: AMG 108 |
| 150 mg AMG 108 Q2W | Active comparator | Not described Receives: Biological: AMG 108 |
| 75 mg AMG 108 Q2W | Active comparator | Not described Receives: Biological: AMG 108 |
| Placebo Q2W | Placebo comparator | Not described Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in HbA1c at week 14 (end of treatment)
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2008 (estimated)
- Study startJun 2008
- Primary completionJun 2009 (estimated)
- Study completionOct 2009 (estimated)
Why it stopped: Program Development discontinued
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00661921
- Sponsor's protocol ID
- 20070212
- Status last verified
- Sep 2018
- First submitted
- 17 Apr 2008
- Last updated
- 6 Sep 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mutiple Dose, Randomized, Double-blind, Placebo-controlled Study of Subcutaneous AMG 108 in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00661921
- Acronym / sponsor ID
- 20070212
- Conditions
- Diabetes Mellitus
- Keywords
- Type 2 Diabetes Mellitus, AMG 108, HbA1C, glucose, metformin, sulfonylurea, IL-1 Inhibitor, biologic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Program Development discontinued
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Jun 2009 (estimated)
- Study completion
- Oct 2009 (estimated)
- First posted
- 21 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AMG 108IL-1 inhibitor, subcutaneous injection given every 2 weeks for the duration of the trial. Doses include 150 mg, 75mg, and 40 mg. | Biological | 150 mg AMG 108 Q2W, 40 mg AMG 108 Q2W, 75 mg AMG 108 Q2W |
| PlaceboAMG 108 volume matching placebo | Biological | Placebo Q2W |
Primary outcome
Change from baseline in HbA1c at week 14 (end of treatment)
Time frame: 14 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2018.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AMG 108 in people with Diabetes Mellitus, run by Amgen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in HbA1c at week 14 (end of treatment) (time frame: 14 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2018.