AMG 151 Amgen Protocol Number 20100761

Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01464437
• Other study ID #: 20100761
• Status: Completed
• Phase: Phase 2
• First received: October 14, 2011
• Last updated: April 24, 2014
• Start date: September 2011
• Est. completion date: December 2012

Study information

• Verified date: April 2014
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationEstonia: The State Agency of MedicineCzech Republic: State Institute for Drug ControlPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsDenmark: Danish Health and Medicines Authority
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 236
• Est. completion date: December 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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)

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Drug:
• AMG 151
Drug: AMG 151 50 mg BID
• Placebo
Placebo
• Metformin
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
Drug: AMG 151 100 mg BID
• AMG 151
Drug: AMG 151 200 mg BID
• AMG 151
Drug: AMG 151 100 mg QD
• AMG 151
Drug: AMG 151 200 mg QD
• AMG 151
Drug: AMG 151 400 mg QD

Locations

Country	Name	City	State
Czech Republic	Research Site	Brno
Czech Republic	Research Site	Pardubice
Czech Republic	Research Site	Praha 3
Estonia	Research Site	Tallinn
Poland	Research Site	Lodz
Poland	Research Site	Warszawa
Puerto Rico	Research Site	Carolina
Puerto Rico	Research Site	Cidra
Puerto Rico	Research Site	San Juan
Puerto Rico	Research Site	San Juan
Puerto Rico	Research Site	San Juan
Puerto Rico	Research Site	San Juan
United States	Research Site	Anaheim	California
United States	Research Site	Atlanta	Georgia
United States	Research Site	Bethesda	Maryland
United States	Research Site	Birmingham	Alabama
United States	Research Site	Bismarck	North Dakota
United States	Research Site	Bozeman	Montana
United States	Research Site	Bradenton	Florida
United States	Research Site	Brooksville	Florida
United States	Research Site	Chigago	Illinois
United States	Research Site	Chula Vista	California
United States	Research Site	Cincinnati	Ohio
United States	Research Site	Clearwater	Florida
United States	Research Site	Cleveland	Ohio
United States	Research Site	Columbus	Georgia
United States	Research Site	Dallas	Texas
United States	Research Site	Dallas	Texas
United States	Research Site	Dayton	Ohio
United States	Research Site	Draper	Utah
United States	Research Site	Dunwoody	Georgia
United States	Research Site	Fargo	North Dakota
United States	Research Site	Fort Myers	Florida
United States	Research Site	Fresno	California
United States	Research Site	Greenbrae	California
United States	Research Site	Houston	Texas
United States	Research Site	Houston	Texas
United States	Research Site	Indianapolis	Indiana
United States	Research Site	Inglewood	California
United States	Research Site	Kettering	Ohio
United States	Research Site	Kissimmee	Florida
United States	Research Site	Las Vegas	Nevada
United States	Research Site	Las Vegas	Nevada
United States	Research Site	Little Rock	Arkansas
United States	Research Site	Lomita	California
United States	Research Site	Los Angeles	California
United States	Research Site	Los Angeles	California
United States	Research Site	Maitland	Florida
United States	Research Site	Meridian	Idaho
United States	Research Site	Metairie	Louisiana
United States	Research Site	Midlothian	Virginia
United States	Research Site	Mineola	New York
United States	Research Site	Norfolk	Virginia
United States	Research Site	Norman	Oklahoma
United States	Research Site	Oklahoma City	Oklahoma
United States	Research Site	Palm Desert	California
United States	Research Site	Palm Harbor	Florida
United States	Research Site	Phoenix	Arizona
United States	Research Site	Raleigh	North Carolina
United States	Research Site	Rapid City	South Dakota
United States	Research Site	Richmond	Virginia
United States	Research Site	Roseville	California
United States	Research Site	Roswell	Georgia
United States	Research Site	Saint Petersburg	Florida
United States	Research Site	Salem	Virginia
United States	Research Site	Salt Lake City	Utah
United States	Research Site	San Antonio	Texas
United States	Research Site	San Diego	California
United States	Research Site	San Jose	California
United States	Research Site	Shelby	North Carolina
United States	Research Site	St. Louis	Missouri
United States	Research Site	St. Petersburg	Florida
United States	Research Site	Tampa	Florida
United States	Research Site	Tucson	Arizona
United States	Research Site	Walnut Creek	California
United States	Research Site	Watsonville	California
United States	Research Site	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Czech Republic,  Estonia,  Poland,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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.	Yes

External Links

•   AmgenTrials clinical trials website