AMG 151 Amgen Protocol Number 20100761

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01464437
First received: October 14, 2011
Last updated: April 24, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus
Drug: AMG 151
Drug: Placebo
Drug: Metformin
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: Yes ]

Enrollment: 236
Study Start Date: September 2011
Study Completion Date: December 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: AMG 151 - Arm 1
AMG 151 - Arm 1
Drug: AMG 151
Drug: AMG 151 50 mg BID
Drug: 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.
Active Comparator: AMG 151 - Arm 2
AMG 151 - Arm 2
Drug: 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.
Drug: AMG 151
Drug: AMG 151 100 mg BID
Active Comparator: AMG 151 - Arm 3
AMG 151 - Arm 3
Drug: 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.
Drug: AMG 151
Drug: AMG 151 200 mg BID
Active Comparator: AMG 151 - Arm 4
AMG 151 - Arm 4
Drug: 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.
Drug: AMG 151
Drug: AMG 151 100 mg QD
Active Comparator: AMG 151 - Arm 5
AMG 151 - Arm 5
Drug: 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.
Drug: AMG 151
Drug: AMG 151 200 mg QD
Active Comparator: AMG 151 - Arm 6
AMG 151 - Arm 6
Drug: 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.
Drug: AMG 151
Drug: AMG 151 400 mg QD
Placebo Comparator: Placebo Arm
AMG 151 Placebo Arm
Drug: Placebo
Placebo
Drug: 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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01464437

  Show 77 Study Locations
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01464437     History of Changes
Other Study ID Numbers: 20100761
Study First Received: October 14, 2011
Last Updated: April 24, 2014
Health Authority: United States: Food and Drug Administration
Estonia: The State Agency of Medicine
Czech Republic: State Institute for Drug Control
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Denmark: Danish Health and Medicines Authority

Keywords provided by Amgen:
diabetes
mellitus
metformin

Additional relevant MeSH terms:
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Metformin
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014