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: March 14, 2014
Last verified: March 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
AMG 151 will be evaluated in subjects with type 2 diabetes treated with metformin for at least 3 months prior to randomization. Eligible subjects will be randomly assigned in a 1:1:1:1:1:1:1 ratio to receive AMG 151 at different doses or placebo for 28 days.
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: AMG 151
AMG 151 will be evaluated in subjects with type 2 diabetes treated with metformin for at least 3 months prior to randomization. Eligible subjects will be randomly assigned in a 1:1:1:1:1:1:1 ratio to receive AMG 151 at different doses or placebo for 28 days.
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 3
AMG 151 - Arm 3
Drug: AMG 151
AMG 151 will be evaluated in subjects with type 2 diabetes treated with metformin for at least 3 months prior to randomization. Eligible subjects will be randomly assigned in a 1:1:1:1:1:1:1 ratio to receive AMG 151 at different doses or placebo for 28 days.
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 4
AMG 151 - Arm 4
Drug: AMG 151
AMG 151 will be evaluated in subjects with type 2 diabetes treated with metformin for at least 3 months prior to randomization. Eligible subjects will be randomly assigned in a 1:1:1:1:1:1:1 ratio to receive AMG 151 at different doses or placebo for 28 days.
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 5
AMG 151 - Arm 5
Drug: AMG 151
AMG 151 will be evaluated in subjects with type 2 diabetes treated with metformin for at least 3 months prior to randomization. Eligible subjects will be randomly assigned in a 1:1:1:1:1:1:1 ratio to receive AMG 151 at different doses or placebo for 28 days.
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 6
AMG 151 - Arm 6
Drug: AMG 151
AMG 151 will be evaluated in subjects with type 2 diabetes treated with metformin for at least 3 months prior to randomization. Eligible subjects will be randomly assigned in a 1:1:1:1:1:1:1 ratio to receive AMG 151 at different doses or placebo for 28 days.
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.
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
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: March 14, 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
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014