Diabetes MellitusPhase 1NCT01755442
Investigate Effect of AMG 151 on 24-hour Ambulatory Blood Pressure & Glucose Levels in Type 2 Diabetes Mellitus Subjects
A Phase 1 study testing AMG 151 in people with Diabetes Mellitus, run by Amgen at 1 site in United States.
Trial summary
This is a phase 1, randomized, double-blind, placebo-controlled, 2-way crossover study to evaluate the effect of AMG 151 on 24-hour ambulatory blood pressure and glucose levels in subjects with type 2 diabetes mellitus who are on a stable regimen of metformin alone, metformin and a dipeptidyl peptidase-4 inhibitor… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- AMG 151
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Jan 2013
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with type 2 diabetes mellitus
- On a stable regimen of metformin alone, metformin and a DPP4, metformin and a TZD, or metformin, a DPP4, and a TZD for a minimum of 3 months prior to randomization
- Body mass indices > 25 and < 45 kg/m2
- Hemoglobin A1c levels ≥ 7.0% and ≤ 11.0% at screening
- Fasting C-peptide levels ≥ 0.2 nmol/L at screening
- Subject with a history of hypertension must be on a stable antihypertensive treatment (s) (type of medication, dose, and regimen) for at least 6 weeks prior to the first dose of investigational product
- Other criteria may apply
Who cannot join
- Subject has type 1 diabetes mellitus or history of type 1 diabetes mellitus
- Subject has had 2 or more emergency room visits or hospitalizations due to poor glucose control in the 6 months prior to screening
- Poorly controlled hypertension defined as diastolic pressure ≥ 95 mmHg or systolic ≥ 155 mmHg (confirmed by a repeat assessment) at screening
- Triglycerides ≥ 400 mg/dL (4.52 mmol/L) at screening
- Use of any known cytochrome P450 (CYP) inducers within 30 days or 5 half-lives (whichever is longer), prior to receiving the first dose of investigational product.
- Use of any known inhibitors of CYP3A4/P-glycoprotein within the 14 days or 5 half lives (whichever is longer) prior to receiving the first dose of investigational product
- Other criteria may apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Double-blind, Randomized, 2-Way Crossover, Placebo-controlled Study to Investigate the Effect of AMG 151 on 24-hour Ambulatory Blood Pressure and Glucose Levels in Subjects With Type 2 Diabetes Mellitus
This is a phase 1, randomized, double-blind, placebo-controlled, 2-way crossover study to evaluate the effect of AMG 151 on 24-hour ambulatory blood pressure and glucose levels in subjects with type 2 diabetes mellitus who are on a stable regimen of metformin alone, metformin and a dipeptidyl peptidase-4 inhibitor (DPP4), metformin and a thiazolidinedione (TZD), or metformin, a DPP4, and a TZD for a minimum of 3 months prior to randomization.
- Conditions
- Diabetes Mellitus
- Being tested
- Placebo, AMG 151
- Keywords
- Ambulatory blood pressure, 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.
PlaceboOther
Eligible subjects will be randomly assigned (1:1) to receive AMG 151 and matching placebo in 1 of 2 sequences over 2 treatment periods.
AMG 151Drug
Eligible subjects will be randomly assigned (1:1) to receive AMG 151 and matching placebo in 1 of 2 sequences over 2 treatment periods.
| Study group | Role | What they receive |
|---|---|---|
| AMG 151 | Active comparator | Not described Receives: Drug: AMG 151 |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean 24-hour systolic blood pressure
Measured: After 14 days of AMG 151 or placebo treatment
Secondary outcomes (11)
Mean 24-hour diastolic blood pressure
Measured: After 14 days of AMG 151 or placebo treatment
Mean 24-hour heart rate
Measured: After 14 days of AMG 151 or placebo treatment
24-hour concentration time profile of glucose level from continuous glucose monitoring
Measured: Day 1 and day 14 of each period
Fasting plasma glucose and fructosamine
Measured: After 13 days of AMG 151 or placebo treatment
Plasma glucose 2 hours after time 0 of mixed meal tolerance test
Measured: After 13 days of AMG 151 or placebo treatment
4-hour concentration time profile of glucose after the mixed meal tolerance test
Measured: After 13 days of AMG 151 or placebo treatment
Safety end points will include the incidence of treatment emergent adverse events.
Measured: Up to 2 Months
Serum AMG 151 concentration
Measured: Up to 2 Months
Safety end points will include laboratory safety tests.
Measured: Up to 2 Months.
Safety end points will include vital signs.
Measured: Up to 2 Months
Safety end points will include ECGs.
Measured: Up to 2 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2012 (estimated)
- Study startNov 2012
- Primary completionJan 2013
- Study completionJan 2013
Why it stopped: Amgen determined no further need for this study.
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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 5 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
- NCT01755442
- Sponsor's protocol ID
- 20120189
- Status last verified
- Apr 2013
- First submitted
- 27 Nov 2012
- Last updated
- 22 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Double-blind, Randomized, 2-Way Crossover, Placebo-controlled Study to Investigate the Effect of AMG 151 on 24-hour Ambulatory Blood Pressure and Glucose Levels in Subjects With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01755442
- Acronym / sponsor ID
- 20120189
- Conditions
- Diabetes Mellitus
- Keywords
- Ambulatory blood pressure, Type 2 diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Amgen determined no further need for this study.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 24 Dec 2012 (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.
This is a phase 1, randomized, double-blind, placebo-controlled, 2-way crossover study to evaluate the effect of AMG 151 on 24-hour ambulatory blood pressure and glucose levels in subjects with type 2 diabetes mellitus who are on a stable regimen of metformin alone, metformin and a dipeptidyl peptidase-4 inhibitor (DPP4), metformin and a thiazolidinedione (TZD), or metformin, a DPP4, and a TZD for a minimum of 3 months prior to randomization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AMG 151 | Active comparator | Drug: AMG 151 |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects with type 2 diabetes mellitus
- On a stable regimen of metformin alone, metformin and a DPP4, metformin and a TZD, or metformin, a DPP4, and a TZD for a minimum of 3 months prior to randomization
- Body mass indices > 25 and < 45 kg/m2
- Hemoglobin A1c levels ≥ 7.0% and ≤ 11.0% at screening
- Fasting C-peptide levels ≥ 0.2 nmol/L at screening
Key exclusion criteria (7 listed)
- Subject has type 1 diabetes mellitus or history of type 1 diabetes mellitus
- Subject has had 2 or more emergency room visits or hospitalizations due to poor glucose control in the 6 months prior to screening
- Poorly controlled hypertension defined as diastolic pressure ≥ 95 mmHg or systolic ≥ 155 mmHg (confirmed by a repeat assessment) at screening
- Triglycerides ≥ 400 mg/dL (4.52 mmol/L) at screening
- Use of any known cytochrome P450 (CYP) inducers within 30 days or 5 half-lives (whichever is longer), prior to receiving the first dose of investigational product.
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 |
|---|---|---|
| PlaceboEligible subjects will be randomly assigned (1:1) to receive AMG 151 and matching placebo in 1 of 2 sequences over 2 treatment periods. | Other | Placebo |
| AMG 151Eligible subjects will be randomly assigned (1:1) to receive AMG 151 and matching placebo in 1 of 2 sequences over 2 treatment periods. | Drug | AMG 151 |
Primary outcome
Mean 24-hour systolic blood pressure
Time frame: After 14 days of AMG 151 or placebo treatment
11 secondary outcomes
Mean 24-hour diastolic blood pressure
Time frame: After 14 days of AMG 151 or placebo treatment
Mean 24-hour heart rate
Time frame: After 14 days of AMG 151 or placebo treatment
24-hour concentration time profile of glucose level from continuous glucose monitoring
Time frame: Day 1 and day 14 of each period
Fasting plasma glucose and fructosamine
Time frame: After 13 days of AMG 151 or placebo treatment
Plasma glucose 2 hours after time 0 of mixed meal tolerance test
Time frame: After 13 days of AMG 151 or placebo treatment
4-hour concentration time profile of glucose after the mixed meal tolerance test
Time frame: After 13 days of AMG 151 or placebo treatment
Safety end points will include the incidence of treatment emergent adverse events.
Time frame: Up to 2 Months
Serum AMG 151 concentration
Time frame: Up to 2 Months
Safety end points will include laboratory safety tests.
Time frame: Up to 2 Months.
Safety end points will include vital signs.
Time frame: Up to 2 Months
Safety end points will include ECGs.
Time frame: Up to 2 Months
Results and safety
The study was stopped early (reason given: Amgen determined no further need for this study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 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
1 site 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 151 in people with Diabetes Mellitus, run by Amgen at 1 site 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 7 inclusion and 7 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 22 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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: Amgen determined no further need for this study.). 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?
Mean 24-hour systolic blood pressure (time frame: After 14 days of AMG 151 or placebo treatment). 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 22 Apr 2013.