AMG 151 Amgen Protocol Number 20100761

NCT01464437 | Completed Phase 2 DMC

• 1 other identifier: 20100761
• Study Type: interventional
• Target: 236
• Locations: 5 countries
• Sites: 77

Brief 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.

Conditions

Diabetes Mellitus

Keywords

diabetes; mellitus; metformin

Outcome Measures

Primary Outcomes (1)

• 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

  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

  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

  Incidence of serious adverse events from signing of ICF to Day 42. Incidence of non-serious adverse events from randomization to Day 42.

Study Arms (7)

AMG 151 - Arm 1

ACTIVE COMPARATOR

AMG 151 - Arm 1

Drug: AMG 151; Drug: Metformin

AMG 151 - Arm 2

ACTIVE COMPARATOR

AMG 151 - Arm 2

Drug: Metformin; Drug: AMG 151

AMG 151 - Arm 3

ACTIVE COMPARATOR

AMG 151 - Arm 3

Drug: Metformin; Drug: AMG 151

AMG 151 - Arm 4

ACTIVE COMPARATOR

AMG 151 - Arm 4

Drug: Metformin; Drug: AMG 151

AMG 151 - Arm 5

ACTIVE COMPARATOR

AMG 151 - Arm 5

Drug: Metformin; Drug: AMG 151

AMG 151 - Arm 6

ACTIVE COMPARATOR

AMG 151 - Arm 6

Drug: Metformin; Drug: AMG 151

Placebo Arm

PLACEBO COMPARATOR

AMG 151 Placebo Arm

Drug: Placebo; Drug: Metformin

Interventions

AMG 151 DRUG

Drug: AMG 151 50 mg BID

AMG 151 - Arm 1

Placebo DRUG

Placebo

Placebo Arm

Metformin DRUG

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 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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Amgen: lead

Study Sites (77)

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Birmingham, Alabama, 35216, United States

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Phoenix, Arizona, 85021, United States

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Tucson, Arizona, 85704, United States

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Little Rock, Arkansas, 72205, United States

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Anaheim, California, 92801, United States

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Chula Vista, California, 91911, United States

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Fresno, California, 93720, United States

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Greenbrae, California, 94904, United States

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Inglewood, California, 90301, United States

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Lomita, California, 90717, United States

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Los Angeles, California, 90017, United States

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Los Angeles, California, 90057, United States

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Palm Desert, California, 92260, United States

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Roseville, California, 95661, United States

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San Diego, California, 92161, United States

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San Jose, California, 95123, United States

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Walnut Creek, California, 94598, United States

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Watsonville, California, 95076, United States

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Bradenton, Florida, 34208, United States

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Brooksville, Florida, 34601, United States

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Clearwater, Florida, 33756, United States

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Fort Myers, Florida, 33912, United States

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Kissimmee, Florida, 34741, United States

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Maitland, Florida, 32751, United States

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Palm Harbor, Florida, 34684, United States

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St. Petersburg, Florida, 33709, United States

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St. Petersburg, Florida, 33716, United States

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Tampa, Florida, 33606, United States

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Winter Park, Florida, 32789, United States

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Atlanta, Georgia, 30338, United States

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Columbus, Georgia, 31904, United States

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Dunwoody, Georgia, 30338, United States

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Roswell, Georgia, 30076, United States

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Meridian, Idaho, 83642, United States

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Chigago, Illinois, 60607, United States

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Indianapolis, Indiana, 46202, United States

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Metairie, Louisiana, 70006, United States

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Bethesda, Maryland, 20817, United States

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St Louis, Missouri, 63128, United States

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Bozeman, Montana, 59718, United States

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Las Vegas, Nevada, 89106, United States

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Las Vegas, Nevada, 89117, United States

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Mineola, New York, 11501, United States

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Raleigh, North Carolina, 27612, United States

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Shelby, North Carolina, 28150, United States

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Bismarck, North Dakota, 58503, United States

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Fargo, North Dakota, 58103, United States

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Cincinnati, Ohio, 45227, United States

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Cleveland, Ohio, 44122, United States

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Dayton, Ohio, 45439, United States

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Kettering, Ohio, 45429, United States

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Norman, Oklahoma, 73069, United States

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Oklahoma City, Oklahoma, 73112, United States

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Rapid City, South Dakota, 57702, United States

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Dallas, Texas, 75235, United States

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Dallas, Texas, 75247, United States

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Houston, Texas, 77029, United States

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Houston, Texas, 77074, United States

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San Antonio, Texas, 78229, United States

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Draper, Utah, 84020, United States

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Salt Lake City, Utah, 84124, United States

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Midlothian, Virginia, 23114, United States

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Norfolk, Virginia, 23510, United States

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Richmond, Virginia, 23219, United States

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Salem, Virginia, 24153, United States

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Brno, 602 00, Czechia

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Pardubice, 530 02, Czechia

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Prague, 130 00, Czechia

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Tallinn, 10128, Estonia

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Lodz, 90-368, Poland

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Warsaw, 04-730, Poland

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Carolina, 00983, Puerto Rico

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Cidra, 00739, Puerto Rico

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San Juan, 00909, Puerto Rico

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San Juan, 00917, Puerto Rico

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San Juan, 00920, Puerto Rico

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San Juan, 00926-2832, Puerto Rico

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Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Metformin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2011
• First Posted: November 3, 2011
• Study Start: September 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: December 1, 2012
• Last Updated: May 13, 2014

Record last verified: 2014-04

Locations

PR (6); CZ (3); US (65); PL (2); ES (1)