Diabetes MellitusPhase 1NCT01492465
Single Ascending Dose Trial in Patients With Type 2 Diabetes
A Phase 1 study testing AMG 876 in people with Diabetes Mellitus, run by Amgen at 3 sites in United States.
Trial summary
The purpose of this study is to determine whether AMG 876 is safe and well tolerated in subjects with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- AMG 876
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2011to Oct 2012
- Phase
- Phase 1
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has provided written informed consent
- Men and women between the ages of 18 and 65, inclusive at the time of randomization
- Women must be of documented non-reproductive potential (ie, postmenopausal [see definition below]; OR history of hysterectomy; OR history of bilateral tubal ligation; OR history of bilateral oophorectomy).
- Diagnosed with type 2 diabetes
- HbA1c ≥ 6.5% and ≤ 10%
- Fasting C-peptide value ≥ 0.8 ng/mL
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- Men must agree for the duration of the study and continuing for 4 weeks after the dose of study drug, to practice a highly effective method of birth control. Highly effective methods of birth control include sexual abstinence, vasectomy or a condom with spermicide (men) in combination with either barrier methods, hormonal birth control or IUD (women).
- Men must agree to not donate sperm for the duration of the study and continuing for 4 weeks after the dose of study drug.
- Body mass index between ≥ 25.0 kg/m2 and ≤ 40.0 kg/m2 at screening
- Negative screening test for alcohol and potential drugs of abuse at screening and day -2, unless medication is prescribed by a physician and approved by the principal investigator and Amgen medical monitor
Who cannot join
- Men with partners who are pregnant at the time of screening or men with partners who plan to become pregnant during the study
- Women who are pregnant or breastfeeding History or evidence of a clinically significant disorder, condition or disease that, in the opinion of the principal investigator or Amgen medical monitor would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
- Evidence or history at screening of diabetic complications with significant end-organ damage, eg, proliferative retinopathy and/or macular edema, creatinine clearance < 60 mL/min/1.73m2 (calculated using the Modification of Diet in Renal Disease formula), or macroalbuminuria (ie, ≥ +1 proteinuria on urinalysis), diabetic neuropathy complicated by neuropathic ulcers, or severe autonomic neuropathy with gastroparesis, chronic diarrhea, or hypoglycemic unawareness
- Significant cardiac disease, including but not limited to evidence or history of coronary artery disease, unstable angina, congestive heart failure, known arrhythmias of ventricular etiology, unexplained syncope or syncope/seizures related to arrhythmia
- Positive for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (Hbs Ag), or hepatitis C virus antibodies
- An unstable medical condition, defined as having been hospitalized within 28 days before day -1, major surgery within 6 months before day -1, or otherwise unstable in the judgment of the investigator (eg, risk of complications or adverse events unrelated to study participation)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Research Site
Omaha, Nebraska, 68154
Research Site
San Antonio, Texas, 78209
Study site
San Antonio, Texas, 78209
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 876 in Subjects With Type 2 Diabetes
The purpose of this study is to determine whether AMG 876 is safe and well tolerated in subjects with type 2 diabetes.
- Conditions
- Diabetes Mellitus
- Being tested
- AMG 876
- Keywords
- Type 2 diabetes
- 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 876Drug
Ascending single doses of study drug administered SC, with one cohort administered IV
| Study group | Role | What they receive |
|---|---|---|
| AMG 876 | Active comparator | Not described Receives: Drug: AMG 876 |
| Placebo | Placebo comparator | Not described Receives: Drug: AMG 876 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject incidence of treatment-emergent adverse events
Physical examinations, vitals, clinical laboratories, and ECGs
Measured: 29 days
Safety laboratory analytes, vital signs, and ECGs
laboratory analytes, vital signs, and ECGs
Measured: 29 days
Subject incidence of anti-AMG 876 antibodies.
laboratories analytes
Measured: 29 days
Secondary outcomes (2)
AMG 876 serum PK parameters
Concentration-time profiles for AMG 876
Measured: 29 days
Pharmacodynamic parameters:
Concentration of fasting glucose, insulin and c-peptide levels; Concentration-time profiles and AUC for metabolic parameters (eg, glucose, insulin, c-peptide, glucagon and free fatty acid concentrations) following a mixed meal tolerance test; Lipid levels (ie, total cholesterol, LDL, HDL, and triglycerides); Body weight.
Measured: 29 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2011 (estimated)
- Study startNov 2011
- Primary completionJul 2012
- Study completionOct 2012
Why it stopped: Decision by Sponsor
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01492465
- Sponsor's protocol ID
- 20100015
- Status last verified
- Feb 2013
- First submitted
- 28 Sep 2011
- Last updated
- 15 Feb 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 876 in Subjects With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01492465
- Acronym / sponsor ID
- 20100015
- Conditions
- Diabetes Mellitus
- Keywords
- Type 2 diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Decision by Sponsor
- Enrolment
- 47 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 15 Dec 2011 (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 determine whether AMG 876 is safe and well tolerated in subjects with type 2 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AMG 876 | Active comparator | Drug: AMG 876 |
| Placebo | Placebo comparator | Drug: AMG 876 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subject has provided written informed consent
- Men and women between the ages of 18 and 65, inclusive at the time of randomization
- Women must be of documented non-reproductive potential (ie, postmenopausal [see definition below]; OR history of hysterectomy; OR history of bilateral tubal ligation; OR history of bilateral oophorectomy).
- Diagnosed with type 2 diabetes
- HbA1c ≥ 6.5% and ≤ 10%
Key exclusion criteria (6 listed)
- Men with partners who are pregnant at the time of screening or men with partners who plan to become pregnant during the study
- Women who are pregnant or breastfeeding History or evidence of a clinically significant disorder, condition or disease that, in the opinion of the principal investigator or Amgen medical monitor would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
- Evidence or history at screening of diabetic complications with significant end-organ damage, eg, proliferative retinopathy and/or macular edema, creatinine clearance < 60 mL/min/1.73m2 (calculated using the Modification of Diet in Renal Disease formula), or macroalbuminuria (ie, ≥ +1 proteinuria on urinalysis), diabetic neuropathy complicated by neuropathic ulcers, or severe autonomic neuropathy with gastroparesis, chronic diarrhea, or hypoglycemic unawareness
- Significant cardiac disease, including but not limited to evidence or history of coronary artery disease, unstable angina, congestive heart failure, known arrhythmias of ventricular etiology, unexplained syncope or syncope/seizures related to arrhythmia
- Positive for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (Hbs Ag), or hepatitis C virus antibodies
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 876Ascending single doses of study drug administered SC, with one cohort administered IV | Drug | AMG 876, Placebo |
Primary outcome
Subject incidence of treatment-emergent adverse events
Time frame: 29 days
Physical examinations, vitals, clinical laboratories, and ECGs
Safety laboratory analytes, vital signs, and ECGs
Time frame: 29 days
laboratory analytes, vital signs, and ECGs
Subject incidence of anti-AMG 876 antibodies.
Time frame: 29 days
laboratories analytes
2 secondary outcomes
AMG 876 serum PK parameters
Time frame: 29 days
Pharmacodynamic parameters:
Time frame: 29 days
Results and safety
The study was stopped early (reason given: Decision by Sponsor). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2013.
- 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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AMG 876 in people with Diabetes Mellitus, run by Amgen at 3 sites in United States.
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 10 inclusion and 6 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: stopped early, as of the sponsor's last update on 15 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 stopped early (reason given: Decision by Sponsor). Results are not available in the source record.
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?
Subject incidence of treatment-emergent adverse events (time frame: 29 days). The study lists 3 primary outcomes in all. 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 15 Feb 2013.