Diabetes MellitusPhase 2NCT01464437

AMG 151 Amgen Protocol Number 20100761

A Phase 2 study testing AMG 151 and Metformin in people with Diabetes Mellitus, run by Amgen at 77 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This is a phase 2a, multicenter, randomized, double-blind, placebo-controlled, parallel group, fixed dose study. AMG 151 will be evaluated in subjects with type 2 diabetes treated with metformin for at least 3 months prior to randomization. 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 and Metformin
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 236 participants
Where: 77 sitesin 5 countries
Study dates: Sep 2011to Dec 2012
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 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age 18 to 75 years, inclusive
Diagnosis of type 2 diabetes mellitus
HbA1c levels 7.5% to 11.0%, inclusive, at screening
Fasting C-peptide levels ≥ 0.2 nmol/L at screening
BMI ≥ 25 to < 45 kg/m2 at screening
Treated with metformin monotherapy for at least 3 months prior to randomization; the metformin dose must be ≥ 850 mg daily for at least 2 months immediately prior to randomization
If a subject is being treated for hyperlipidemia or hypertension they should be on stable medication for 30 days before randomization
Subject has provided informed consent.

Who cannot join

History of type 1 diabetes
History of significant weight gain or loss (> 10%) during the 4 weeks before randomization
Use of any weight loss medication (over the counter or prescription) within 60 days of randomization
Use of any oral or injectable anti-hyperglycemic medication (other than metformin) within 3 months prior to randomization
Use of chronic and/or continuous insulin administration for > 15 days in an outpatient setting to achieve and maintain glycemic control prior to randomization
Have had 2 or more emergency room visits or hospitalizations due to poor glucose control in the past 6 months

Show all 17Show fewer

Have had more than 1 episode of severe hypoglycemia within 6 months prior to entry into the study, or currently diagnosed as having hypoglycemia unawareness
Evidence of active infections that can interfere with the study
Presence of clinically significant organ system disease that is not stabilized or may interfere with the study
Currently receiving immunosuppressive therapy
History of positive HIV, chronic hepatitis B or C, or cirrhosis
Have symptomatic congestive heart failure or a history of myocardial infarction, unstable angina, or decompensated congestive heart failure or stroke in the past 6 months prior to screening.
History of gastric surgery, vagotomy, bowel resection or any surgical procedure that might interfere with gastrointestinal motility, pH or absorption
Any finding on the screening ECG that in the opinion of the investigator requires further cardiovascular evaluation
Poorly controlled hypertension defined as diastolic pressure > 100 mm Hg or systolic pressure > 160 mm Hg (assessed on two separate occasions during the screening period)
Malignancy (other than resected cutaneous basal or cutaneous squamous cell carcinoma, or treated in situ cervical cancer considered cured) within 5 years of screening visit (if a malignancy occurred > 5 years ago, subject is eligible with documentation of disease-free state since treatment)
Use of known inhibitors or inducers of CYP3A4 are not permitted 30 days prior to randomization

Trial locations and contacts

77 sites in 5 countries.

Country

City, postcode or hospital

77 sites in 5 countries

United States65 sites

Research Site
Anaheim, California, 92801
Research Site
Atlanta, Georgia, 30338
Research Site
Bethesda, Maryland, 20817
Research Site
Birmingham, Alabama, 35216
Research Site
Bismarck, North Dakota, 58503
Research Site
Bozeman, Montana, 59718
Research Site
Bradenton, Florida, 34208
Research Site
Brooksville, Florida, 34601
Research Site
Chigago, Illinois, 60607
Research Site
Chula Vista, California, 91911
Research Site
Cincinnati, Ohio, 45227
Research Site
Clearwater, Florida, 33756
Research Site
Cleveland, Ohio, 44122
Research Site
Columbus, Georgia, 31904
Research Site
Dallas, Texas, 75235
Research Site
Dallas, Texas, 75247
Research Site
Dayton, Ohio, 45439
Research Site
Draper, Utah, 84020
Research Site
Dunwoody, Georgia, 30338
Research Site
Fargo, North Dakota, 58103
Research Site
Fort Myers, Florida, 33912
Research Site
Fresno, California, 93720
Research Site
Greenbrae, California, 94904
Research Site
Houston, Texas, 77029
Research Site
Houston, Texas, 77074
Research Site
Indianapolis, Indiana, 46202
Research Site
Inglewood, California, 90301
Research Site
Kettering, Ohio, 45429
Research Site
Kissimmee, Florida, 34741
Research Site
Las Vegas, Nevada, 89106
Research Site
Las Vegas, Nevada, 89117
Research Site
Little Rock, Arkansas, 72205
Research Site
Lomita, California, 90717
Research Site
Los Angeles, California, 90017
Research Site
Los Angeles, California, 90057
Research Site
Maitland, Florida, 32751
Research Site
Meridian, Idaho, 83642
Research Site
Metairie, Louisiana, 70006
Research Site
Midlothian, Virginia, 23114
Research Site
Mineola, New York, 11501
Research Site
Norfolk, Virginia, 23510
Research Site
Norman, Oklahoma, 73069
Research Site
Oklahoma City, Oklahoma, 73112
Research Site
Palm Desert, California, 92260
Research Site
Palm Harbor, Florida, 34684
Research Site
Phoenix, Arizona, 85021
Research Site
Raleigh, North Carolina, 27612
Research Site
Rapid City, South Dakota, 57702
Research Site
Richmond, Virginia, 23219
Research Site
Roseville, California, 95661
Research Site
Roswell, Georgia, 30076
Research Site
Salem, Virginia, 24153
Research Site
Salt Lake City, Utah, 84124
Research Site
San Antonio, Texas, 78229
Research Site
San Diego, California, 92161
Research Site
San Jose, California, 95123
Research Site
Shelby, North Carolina, 28150
Research Site
St Louis, Missouri, 63128
Research Site
St. Petersburg, Florida, 33709
Research Site
St. Petersburg, Florida, 33716
Research Site
Tampa, Florida, 33606
Research Site
Tucson, Arizona, 85704
Research Site
Walnut Creek, California, 94598
Research Site
Watsonville, California, 95076
Research Site
Winter Park, Florida, 32789

Other trials in United States

Puerto Rico6 sites

Research Site
Carolina, 00983
Research Site
Cidra, 00739
Research Site
San Juan, 00909
Research Site
San Juan, 00917
Research Site
San Juan, 00920
Research Site
San Juan, 00926-2832

Other trials in Puerto Rico

Czechia3 sites

Research Site
Brno, 602 00
Research Site
Pardubice, 530 02
Research Site
Prague, 130 00

Other trials in Czechia

Poland2 sites

Research Site
Lodz, 90-368
Research Site
Warsaw, 04-730

Other trials in Poland

Estonia1 site

Research Site
Tallinn, 10128

Other trials in Estonia

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Explore Dose Effect and Frequency of Administration of AMG 151 in Subjects With Type 2 Diabetes Mellitus

Conditions: Diabetes Mellitus
Being tested: AMG 151, Placebo, Metformin
Keywords: diabetes, mellitus, metformin
Medical subject headings: Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AMG 151Drug
Drug: AMG 151 50 mg BID
PlaceboDrug
Placebo
MetforminDrug
Subjects will remain on their metformin regimen throughout the study. The metformin dose must be ≥ 850 mg/day for at least 2 months immediately prior to randomization.
AMG 151Drug
Drug: AMG 151 100 mg BID
AMG 151Drug
Drug: AMG 151 200 mg BID
AMG 151Drug
Drug: AMG 151 100 mg QD
AMG 151Drug
Drug: AMG 151 200 mg QD
AMG 151Drug
Drug: AMG 151 400 mg QD

Study groups in NCT01464437
Study group	Role	What they receive
AMG 151 - Arm 1	Active comparator	AMG 151 - Arm 1 Receives: Drug: AMG 151; Drug: Metformin
AMG 151 - Arm 2	Active comparator	AMG 151 - Arm 2 Receives: Drug: Metformin; Drug: AMG 151
AMG 151 - Arm 3	Active comparator	AMG 151 - Arm 3 Receives: Drug: Metformin; Drug: AMG 151
AMG 151 - Arm 4	Active comparator	AMG 151 - Arm 4 Receives: Drug: Metformin; Drug: AMG 151
AMG 151 - Arm 5	Active comparator	AMG 151 - Arm 5 Receives: Drug: Metformin; Drug: AMG 151
AMG 151 - Arm 6	Active comparator	AMG 151 - Arm 6 Receives: Drug: Metformin; Drug: AMG 151
Placebo Arm	Placebo comparator	AMG 151 Placebo Arm Receives: Drug: Placebo; Drug: Metformin

What is being measured

The primary outcome is the main question the study is designed to answer.

To evaluate the dose-effect relationship of AMG 151 compared to placebo on fasting plasma glucose in subjects with type 2 diabetes treated with metformin
Measured: Change in fasting plasma glucose levels from baseline to Day 28

Secondary outcomes (2)

To assess the effect of AMG 151 on postprandial glucose levels in response to a meal tolerance test
Measured: Change in area under the curve from 0-4 hours (AUC0-4hr) glucose after a meal tolerancetest from baseline to Day 28, Change in incremental AUC0-4hr glucose after a meal tolerance test from baseline to Day 28
Adverse events
Measured: Incidence of serious adverse events from signing of ICF to Day 42. Incidence of non-serious adverse events from randomization to Day 42.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2011Dec 2012

First posted3 Nov 2011 (estimated)
Study startSep 2011
Primary completionOct 2012
Study completionDec 2012

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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 236 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01464437
Sponsor's protocol ID: 20100761
Status last verified: Apr 2014
First submitted: 14 Oct 2011
Last updated: 13 May 2014
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Diabetes and Heart Disease Risk in Blacks
Cardiovascular Diseases, Diabetes
RecruitingObservational study
Genetic Studies of Insulin and Diabetes
Diabetes Mellitus, Severe Insulin Resistance
RecruitingObservational study
Urinary Vitamin C Loss in Diabetic Subjects
Diabetes
Active, not recruitingObservational study
Healthy Aging in Neighborhoods of Diversity Across the Life Span (HANDLS)
Diabetes, Cerebrovascular Disease
Active, not recruiting
Dietary Behavior Intervention in African Americans at Risk for Cardiovascular Disease
Diet, Cooking

All Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 13 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Explore Dose Effect and Frequency of Administration of AMG 151 in Subjects With Type 2 Diabetes Mellitus
ClinicalTrials.gov ID: NCT01464437
Acronym / sponsor ID: 20100761
Conditions: Diabetes Mellitus
Keywords: diabetes, mellitus, metformin
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 236 participants (actual)
Lead sponsor: AmgenIndustry (pharma, biotech, devices)
Study start: Sep 2011
Primary completion: Oct 2012 (actual)
Study completion: Dec 2012 (actual)
First posted: 3 Nov 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 7

Arm	Type	Receives
AMG 151 - Arm 1	Active comparator	Drug: AMG 151, Drug: MetforminAMG 151 - Arm 1
AMG 151 - Arm 2	Active comparator	Drug: Metformin, Drug: AMG 151AMG 151 - Arm 2
AMG 151 - Arm 3	Active comparator	Drug: Metformin, Drug: AMG 151AMG 151 - Arm 3
AMG 151 - Arm 4	Active comparator	Drug: Metformin, Drug: AMG 151AMG 151 - Arm 4
AMG 151 - Arm 5	Active comparator	Drug: Metformin, Drug: AMG 151AMG 151 - Arm 5
AMG 151 - Arm 6	Active comparator	Drug: Metformin, Drug: AMG 151AMG 151 - Arm 6
Placebo Arm	Placebo comparator	Drug: Placebo, Drug: MetforminAMG 151 Placebo Arm

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Age 18 to 75 years, inclusive
Diagnosis of type 2 diabetes mellitus
HbA1c levels 7.5% to 11.0%, inclusive, at screening
Fasting C-peptide levels ≥ 0.2 nmol/L at screening
BMI ≥ 25 to < 45 kg/m2 at screening

Key exclusion criteria (17 listed)

History of type 1 diabetes
History of significant weight gain or loss (> 10%) during the 4 weeks before randomization
Use of any weight loss medication (over the counter or prescription) within 60 days of randomization
Use of any oral or injectable anti-hyperglycemic medication (other than metformin) within 3 months prior to randomization
Use of chronic and/or continuous insulin administration for > 15 days in an outpatient setting to achieve and maintain glycemic control prior to randomization

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 151Drug: AMG 151 50 mg BID	Drug	AMG 151 - Arm 1
PlaceboPlacebo	Drug	Placebo Arm
MetforminSubjects will remain on their metformin regimen throughout the study. The metformin dose must be ≥ 850 mg/day for at least 2 months immediately prior to randomization.	Drug	AMG 151 - Arm 1, AMG 151 - Arm 2, AMG 151 - Arm 3, AMG 151 - Arm 4, AMG 151 - Arm 5, AMG 151 - Arm 6, Placebo Arm
AMG 151Drug: AMG 151 100 mg BID	Drug	AMG 151 - Arm 2
AMG 151Drug: AMG 151 200 mg BID	Drug	AMG 151 - Arm 3
AMG 151Drug: AMG 151 100 mg QD	Drug	AMG 151 - Arm 4
AMG 151Drug: AMG 151 200 mg QD	Drug	AMG 151 - Arm 5
AMG 151Drug: AMG 151 400 mg QD	Drug	AMG 151 - Arm 6

Primary outcome

To evaluate the dose-effect relationship of AMG 151 compared to placebo on fasting plasma glucose in subjects with type 2 diabetes treated with metformin
Time frame: Change in fasting plasma glucose levels from baseline to Day 28

2 secondary outcomes

To assess the effect of AMG 151 on postprandial glucose levels in response to a meal tolerance test
Time frame: Change in area under the curve from 0-4 hours (AUC0-4hr) glucose after a meal tolerancetest from baseline to Day 28, Change in incremental AUC0-4hr glucose after a meal tolerance test from baseline to Day 28
Adverse events
Time frame: Incidence of serious adverse events from signing of ICF to Day 42. Incidence of non-serious adverse events from randomization to Day 42.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2014.
AmgenTrials clinical trials websiteLink provided by the sponsor.

Related trials for Diabetes Mellitus

RecruitingObservational study
Diabetes and Heart Disease Risk in Blacks
Cardiovascular Diseases, Diabetes
RecruitingObservational study
Genetic Studies of Insulin and Diabetes
Diabetes Mellitus, Severe Insulin Resistance
RecruitingObservational study
Urinary Vitamin C Loss in Diabetic Subjects
Diabetes
Active, not recruitingObservational study
Healthy Aging in Neighborhoods of Diversity Across the Life Span (HANDLS)
Diabetes, Cerebrovascular Disease
Active, not recruiting
Dietary Behavior Intervention in African Americans at Risk for Cardiovascular Disease
Diet, Cooking

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

77 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AMG 151 and Metformin in people with Diabetes Mellitus, run by Amgen at 77 sites in 5 countries.

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 8 inclusion and 17 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: finished, as of the sponsor's last update on 13 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 77 sites in United States, Puerto Rico, Czechia, Poland, Estonia. 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 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

To evaluate the dose-effect relationship of AMG 151 compared to placebo on fasting plasma glucose in subjects with type 2 diabetes treated with metformin (time frame: Change in fasting plasma glucose levels from baseline to Day 28). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01464437.

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 13 May 2014; AzTrials last refreshed its copy on 30 Oct 2026.